WO2024011105A1 - Méthodes et systèmes de traitement d'acouphènes à l'aide d'agents thérapeutiques numériques - Google Patents

Méthodes et systèmes de traitement d'acouphènes à l'aide d'agents thérapeutiques numériques Download PDF

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Publication number
WO2024011105A1
WO2024011105A1 PCT/US2023/069613 US2023069613W WO2024011105A1 WO 2024011105 A1 WO2024011105 A1 WO 2024011105A1 US 2023069613 W US2023069613 W US 2023069613W WO 2024011105 A1 WO2024011105 A1 WO 2024011105A1
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patient
tinnitus
data
digital
therapeutic
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PCT/US2023/069613
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English (en)
Inventor
Steven BASTA
Simon Levy
Julie Miller
Kayla KRAICH
Amy SCHREINER
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Mahana Therapeutics, Inc.
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Publication of WO2024011105A1 publication Critical patent/WO2024011105A1/fr

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/70—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Definitions

  • a patient when a patient is diagnosed with one or more medical conditions, the patient may be referred to additional health professionals for further care and treatment.
  • a patient may be referred to a psychologist, psychiatrist, counselor, or other mental health professional.
  • a patient may also be directed to one or more support groups to assist with any psychological distress that the patient may be experiencing. While these traditional face-to-face options may be greatly beneficial to a patient, often times they do not provide enough psychological support.
  • a patient is alone, at home, or not otherwise engaged directly with their mental health professional or support group, they may experience a significant degree of one or more negative emotional states, such as fear, anxiety, panic, and depression.
  • Tinnitus health conditions may include subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnitus, medication-induced tinnitus, vaccination-induced tinnitus, acute tinnitus, chronic tinnitus, and combinations thereof
  • Medication-induced tinnitus may be associated with one or more of anti-anxiety drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), chloroquine, hydroxy choloroquine, blood pressure drugs, isotretinoin, chemotherapy drugs, diuretics, proton pump inhibitors, anticonvulsants, antibiotics, angiotensin drugs, anti-inflammatory drugs, and combinations thereof.
  • anti-anxiety drugs tri
  • behavioral therapy is also a valuable tool for addressing a variety of mental health issues, including anxiety and depression, and improving an individual’s ability to manage and respond effectively to external stimuli, such as stress.
  • behavioral therapy is administered via a mental health professional, such as a therapist, for example through regular sessions between an individual and their therapist.
  • a mental health professional such as a therapist
  • Such interactions can be time consuming, inconvenient, and costly, thereby limiting accessibility of behavioral therapy treatment.
  • Embodiments of the present disclosure provide a technical solution to the technical problem of effectively, efficiently, and remotely treating tinnitus conditions using digital therapeutics in combination with other therapies, in order to ensure that patients receive adequate care, support, and treatment.
  • the invention described herein is an innovative way to deliver interactive psychotherapies concurrent with other tinnitus therapies via a digital therapeutic platform broadly available to all tinnitus patients and optimized to improve the effectiveness of these combination therapies, including tailoring to address individual differences, addressing co-occurring disorders and associated symptoms and medication side effects, and incorporating other optimization strategies.
  • Further embodiments of the present disclosure relate to methods of diagnosing or prognosing a tinnitus condition in a patient.
  • the invention(s) disclosed herein can employ non- traditional systems and methods for providing services such as interventions to patients exhibiting symptoms associated with one or more tinnitus conditions.
  • the invention(s) can deliver psychological-based interventions to patients, such as, but not limited to, cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MB SR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, hypnosis, and combinations thereof, as well as other types of interventions, which are described in more detail below, by way of a platform having components implemented in a mobile device environment and/or other computer or internet-based architecture.
  • the invention(s) use components of the platform to
  • digital therapeutics (DTX) technologies may be used to administer behavioral therapy treatments in combination with a variety of non-behavioral therapy treatments in a controlled fashion, as treatment for one or more conditions described herein.
  • provided technologies address physiological conditions (e.g., conditions with one or more physical symptoms, features, or manifestations) that may be affected by a subject’s mental health state, for example, presence of a mental health condition such as, but not limited to anxiety, depression, and/or stress.
  • the DTX technologies disclosed herein can be used to administer guided behavioral therapies in combination with a variety of non-behavioral therapies to treat individuals suffering from certain particular physiological conditions.
  • the DTX technologies can be used in combination with treatments utilizing one or more pharmaceutical compositions.
  • the DTX system disclosed herein may be used to improve efficacy of other types of therapies and/or ameliorate side effects of other types of therapies.
  • guided behavioral therapy tools provided by the DTX system disclosed herein may facilitate adherence to various treatment regimens (e.g., of pharmaceutical compositions or use of medical devices), and/or management of dosing (e.g., providing insight and/or guidance relevant to dosage adjustments).
  • the DTX technologies described herein may be used to treat, prevent, ameliorate, or reduce the likelihood of developing one or more side effects or comorbidities associated with one or more non-behavioral therapies for a tinnitus condition in a patient who is undergoing said one or more non-behavioral therapies.
  • the DTX systems and methods may be used to treat, prevent, ameliorate, or reduce likelihood of developing one or more side effects or comorbidities associated with one or more medications used to treat a variety of tinnitus conditions.
  • the DTX systems and methods disclosed herein may be used to enhance the performance of a non-digital therapeutic intervention administered to a patient for the treatment, prevention, amelioration, or reduction in the likelihood of developing a tinnitus condition, and/or for the treatment, prevention, amelioration, or reduction in the likelihood of developing one or more symptoms associated with the tinnitus condition.
  • the DTX systems and methods described herein may be used to enhance performance of the therapeutic intervention for the treatment, prevention, amelioration, or reduction in the likelihood of developing one or more side effects associated with the therapeutic intervention.
  • a pre-assessment of a patient exhibiting one or more tinnitus symptoms is performed by the DTX system to generate patient profile and pre-assessment data.
  • the patient profile and pre-assessment data is processed by the DTX system to generate patient condition data, wherein the patient condition data includes an identification of the patient’s condition, condition sub-type, and/or condition severity.
  • the patient profile and pre-assessment data and the patient condition data are processed by the DTX system to generate a personalized intervention regimen for the patient, wherein the personalized intervention regimen defines both behavioral therapy components and non- behavioral therapy components to be administered to the patient.
  • the one or more behavioral therapy components are administered, through the user interface of the DTX system, to the patient according to the personalized intervention regimen generated for the patient.
  • the one or more non-behavioral therapy components are administered to the patient in combination with the one or more behavioral therapy components according to the personalized intervention regimen generated for the patient.
  • the patient’s interactions with the one or more behavioral therapy components and the one or more non-behavioral therapy components are monitored remotely in near real-time to generate patient interaction data.
  • the patient interaction data is processed by the DTX system to generate intervention modification data representing recommended modifications to the patient’s personalized intervention regimen.
  • aspects of the behavioral therapy and/or the non-behavioral therapy components defined by the patient’s personalized intervention regimen are dynamically modified.
  • the invention(s) can also provide interventions that are tailored to individual users/patients suffering from a variety of symptoms, such as, but not limited to, perception of one or more sounds by the patient, wherein the one or more sounds are not present in an external environment of the patient.
  • the one or more sounds perceived by the patient may be ringing sounds, buzzing sounds, hissing sounds, whistling sounds, swooshing sounds, clicking sounds, musical sounds, somatic sounds, body circulatory system based sounds, or combinations thereof.
  • the invention(s) can also be used for acquisition of user/patient data from multiple data sources, including, but not limited to, health data, user demographic data, user mood data, user behavior data, patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, and patient biometric data.
  • health data user demographic data, user mood data, user behavior data, patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine
  • the invention(s) can also be used for generation of training datasets, whereby the training datasets can be used for training machine learning models (e.g., neural networks, etc.) that take input data pertaining to users/patients and produce outputs that can be used to guide customization of interventions.
  • Surveying tools derived from one or more patient reported outcome instruments may be used, including tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, and a PHQ-9 depression questionnaire.
  • Non-survey data obtained from electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, and cochlear implants may be used.
  • the present disclosure provides methods for remotely administering behavioral therapy to a user/patient via a controlled progression of interactive therapy modules, through a graphical user interface (GUI) of a digital therapeutics (DTX) system.
  • GUI graphical user interface
  • technologies described herein allow an individual user/patient to access and take part in a series of guided lessons that provide training in various behavioral skills.
  • these guided lessons may be presented as a sequence of interactive lesson modules that provide training and practice via a graphical user interface (GUI) of a DTX system.
  • GUI graphical user interface
  • approaches described herein provide structured behavioral therapy that is targeted at managing triggers and/or symptoms associated with specific physical conditions. Accordingly, in some embodiments, a behavioral therapy toolkit as provided by the systems and methods described herein can be tailored for a particular physical condition.
  • the present disclosure provides methods for providing for interactive creation of a user personal model via a graphical user interface (GUI) of a DTX system, allowing a user to identify cycles of behaviors, thoughts, emotions, and stressors that influence the frequency and/or severity of symptoms associated with a particular physical condition from which the user is suffering,
  • GUI graphical user interface
  • technologies described herein can increase access to and/or facilitate effective administration of behavioral therapy, and moreover can achieve effective impact on physiological conditions through guided behavioral therapy in combination with other types of therapies.
  • the present disclosure provides improvements to technologies and methods for administering cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MB SR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, and hypnosis.
  • the present disclosure provides improvements to technologies for administering a wide variety of therapy modalities, individually, or in combination with other modalities.
  • embodiments of the present disclosure provide a technical solution to the technical problem of effectively, efficiently, and remotely treating tinnitus conditions using digital therapeutics in combination with other therapies, in order to ensure that patients receive adequate care, support, and treatment.
  • FIG. 2A depicts a flowchart of a method for treating tinnitus conditions using digital therapeutics in combination with other therapies, according to one or more embodiments.
  • FIG. 2B depicts a flowchart of a method for providing adaptive interventions for tinnitus conditions, according to one or more embodiments.
  • FIG. 2C depicts a flowchart of a method for providing adaptive interventions for tinnitus conditions, according to one or more embodiments.
  • FIG. 3 A depicts a schematic of architecture implemented for delivery of intervention regimen components and/or modules, according to one or more embodiments.
  • FIG. 3B depicts examples of individual sections that may make up an introduction and education module of an intervention regimen, according to one or more embodiments.
  • FIG. 3C depicts an exemplary set of tinnitus-specific therapy modules, according to one or more embodiments.
  • FIG. 4 depicts an example of formation of a personal disease model, according to one or more embodiments.
  • FIG. 5 A depicts a flowchart of a process for determining severity of a tinnitus condition, according to one or more embodiments.
  • FIG. 5B depicts examples of a process for determining severity of a tinnitus condition, according to one or more embodiments.
  • FIG. 6 depicts a flowchart of a pre-assessment and onboarding process of a method for providing adaptive interventions, according to one or more embodiments.
  • FIG. 7 depicts examples of system aspects of a program for personalized health condition monitoring and improvement, according to one or more embodiments.
  • FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, and FIG. 8E depict example schematics of conditional branching architecture implemented for delivery of intervention regimen components, according to one or more embodiments.
  • FIG. 9A, FIG. 9B, FIG. 9C, and FIG. 9D are screenshots of several portions of an exemplary GUI for a system for treating tinnitus conditions using digital therapeutics, according to one or more embodiments.
  • FIG. 10A, FIG. 10B, FIG. IOC, and FIG. 10D are screenshots of example user interactions with an initial lesson module for content tailored for a patient with tinnitus according to one or more embodiments.
  • FIG. 11A and FIG. 11B are screenshots showing gate features of an exemplary GUI for a system for treating tinnitus conditions using digital therapeutics, in accordance with one or more embodiments.
  • FIG. 12A, FIG. 12B, FIG. 12C, and FIG. 12D are screenshots of an exemplary GUI for a symptom diary lesson module, according to one or more embodiments.
  • FIG. 13 A and FIG. 13B are screenshots of example user interactions with a symptom diary practice module, in accordance with one or more embodiments.
  • behavioral therapy may include therapies such as, but not limited to, cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MB SR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, hypnosis, and combinations thereof.
  • CBT cognitive behavioral therapy
  • MB SR mindfulness-based stress reduction
  • ACT acceptance and commitment therapy
  • BA behavioral activation
  • BA systematic desensitization
  • TAT tinnitus activities treatment
  • TRT tinnitus retraining therapy
  • PTM progressive tinnitus management
  • TCT task concentration training
  • HRT habit reversal therapy
  • habituation training relaxation therapy
  • acoustic (sound) therapy bimodal therapy
  • such guided behavioral therapy technologies are based at least in part on cognitive behavioral therapy (CBT), and provide structured modules and/or lessons via a graphical user interface (GUI) of a digital therapeutics (DTX) system, for example to allow patients to develop a skillset for treating a physiological disease, disorder and/or condition, and for managing stress and/or other psychological symptoms associated with such disease, disorder and/or condition.
  • CBT cognitive behavioral therapy
  • GUI graphical user interface
  • DTX digital therapeutics
  • a relevant disease, disorder or condition may be or comprise a tinnitus condition, such as, but not limited to subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnitus, medication- induced tinnitus, vaccination-induced tinnitus, acute tinnitus, chronic tinnitus, and combinations thereof.
  • a tinnitus condition such as, but not limited to subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnit
  • the medication-induced tinnitus may be associated with one or more of anti-anxiety drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), chloroquine, hydroxy choloroquine, blood pressure drugs, isotretinoin, chemotherapy drugs, diuretics, proton pump inhibitors, anticonvulsants, antibiotics, angiotensin drugs, anti-inflammatory drugs, and combinations thereof.
  • anti-anxiety drugs tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), chloroquine, hydroxy choloroquine, blood pressure drugs, isotretinoin, chemotherapy drugs, diuretics, proton pump inhibitors, anticonvulsants, antibiotics, angiotensin drugs, anti-inflammatory drugs, and combinations thereof.
  • SSRIs selective serotonin reuptake inhibitors
  • tinnitus may be addressed in this manner, too, including head injury, whiplash, multiple sclerosis, vestibular schwannoma, cerebellopontine-angle tumors, age-related hearing loss, ear injury, damaged cochlea, damage to auditory nerve, Eustachian tube dysfunction, ear bone changes, circulatory system conditions, Meniere’s disease, misophonia, phonophobia, sinus pressure, ear infection, sinus infection, hyperlipidemia, diabetes, thyroid disease, anemia, autoimmune disorders, fibromyalgia, hormonal changes in women, temporomandibular joint disorder, acoustic neuroma, head or neck tumors, one or more vestibular conditions, and combinations thereof.
  • approaches described herein provide patients with structured behavioral therapy that is targeted at managing triggers and/or symptoms associated with specific physical and/or physiological conditions.
  • many physiological conditions such as tinnitus conditions
  • symptoms and effects of these physiological conditions may trigger and/or worsen related mental health conditions and can be a source of significant stress for many patients.
  • This feedback loop can create a vicious cycle, in which symptoms of a particular physiological condition trigger and/or worsen mental health states, causing issues such as anxiety and/or depression, which, in turn, trigger and/or worsen physical/physiological symptoms.
  • Feedback loops of this kind are particularly relevant to tinnitus conditions.
  • symptoms associated with a tinnitus condition may be triggered by stress, and mental health conditions such as depression and/or anxiety can worsen such symptoms.
  • a behavioral therapy toolkit as provided by technologies (e.g., systems and methods) disclosed herein can be tailored for a particular physical/physiological condition.
  • particular behavioral therapy lesson modules can be designed to facilitate tracking of specific symptoms, tracking and elucidating specific stressors, and/or providing targeted exercises (e.g., breathing, progressive relaxation, etc.), which are well suited for managing specific triggers and symptoms of the particular physiological condition.
  • the technologies, methods, and systems disclosed herein provide a valuable complement to physician visits and recommendations (e.g., with regard to lifestyle changes) and standard of care therapies (e.g., administration of medication(s)). Furthermore, technologies disclosed herein can increase access to and/or facilitate effective administration of behavioral therapy to achieve effective impact on physiological conditions such as, but not limited to, tinnitus conditions, through guided behavioral therapy.
  • the term “patient,” and/or “subject,” may include an individual who is suffering from a relevant disease, disorder or condition.
  • a patient/ subject is an individual who is susceptible to a disease, disorder, or condition.
  • a patient/ subject displays one or more symptoms or characteristics of a disease, disorder or condition.
  • a patient/ subject does not display any symptom or characteristic of a disease, disorder, or condition.
  • a patient/subj ect is someone with one or more features characteristic of susceptibility to or risk of a disease, disorder, or condition.
  • a patient/subj ect is an individual to whom diagnosis and/or therapy is and/or has been administered.
  • a patient/subj ect is an individual who has been diagnosed with one or more diseases, disorders, and/or conditions and is the recipient of one or more therapies in a clinical or non- clinical setting. In some embodiments, a patient/subj ect is an individual who has not been diagnosed with a health condition, but is a recipient of one or more therapies in a clinical or non-clinical setting.
  • the term “digital therapeutics system,” “digital therapeutics (DTX)” and/or “digital therapeutics (DTX) system,” may include a system utilized for remotely administering a therapy to a patient, wherein the digital therapeutics system is required to be approved by a government agency before it can be marketed for administration to humans.
  • a digital therapeutics system requires FDA approval and rigorous clinical evidence to substantiate intended use and impact on disease state.
  • a digital therapeutics system is typically a system for which either a clinical diagnosis or self-identification using medical standards of the underlying condition (in this case, tinnitus), or a medical prescription is required for administration to patients.
  • the term “user” may include a patient/subj ect who utilizes a digital therapeutics system or a digital therapeutics (DTX) system.
  • DTX digital therapeutics
  • an individual who is “suffering from” a disease, disorder, and/or condition displays one or more symptoms of a disease, disorder, and/or condition and/or has been diagnosed with the disease, disorder, or condition.
  • the term “therapy,” “behavioral therapy,” and/or “guided behavioral therapy” may include psychological techniques, methodologies, and/or modalities intended or demonstrated to achieve impact on and/or alteration of one or more behaviors of a patient/subj ect.
  • therapies may include, but are not limited to, psychotherapy, cognitive behavioral therapy (CBT), acceptance commitment therapy (ACT), dialectical behavioral therapy (DBT), exposure therapy, habituation therapy, mindfulness-based cognitive therapy (MCBT), relaxation therapy, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), biofeedback therapy, somatic anchoring therapy, hypnotherapy, experiential therapy, and psychodynamic therapy.
  • the term “mind-body intervention,” may include one or more therapeutic practices that employ a variety of techniques designed to facilitate the mind’s capacity to affect bodily function and systems.
  • Examples of mind-body interventions may include, but are not limited to, relaxation, imagery, biofeedback, meditation, hypnosis, tai, chi, and yoga.
  • the phrase “administration” may include providing, delivering, and/or applying a therapy to a patient.
  • a therapy may be administered to a patient directly by a health practitioner.
  • a therapy may be administered to a patient remotely, for example, over the internet or through a computer system, without the direct involvement of a health practitioner.
  • the therapy may be self-administered by the patient.
  • a therapy may also be administered to a patient remotely with partial involvement of a health practitioner.
  • the therapy to be administered may be selected by a health practitioner, but the therapy may then be self-administered by the patient, utilizing a computer system, or the therapy may be administered to the patient by a computer system, but a health practitioner may monitor the patient’s response data.
  • the term “treat,” “treatment,” or “treating” may include administration of therapy that has been established to partially or completely alleviate, ameliorate, relieve, inhibit, prevent, delay onset of, reduce severity of, and/or reduce incidence of one or more symptoms or features of a disease, disorder, and/or condition (e.g., when administered to a relevant population).
  • treatment may be administered to a patient who is not exhibiting (and/or has not exhibited) one or more signs of a relevant disease, disorder, and/or condition.
  • treatment may be administered to a patient who exhibits only early signs of the disease, disorder, and/or condition, for example for the purpose of decreasing risk of developing one or more features of pathology associated with the disease, disorder, and/or condition.
  • a treatment is termed “therapeutic” when administered to a patient who is displaying or has displayed one or more features, symptoms, or other characteristics of a relevant disease, disorder and/or condition.
  • a treatment is termed “prophylactic” when administered to a patient who has not displayed features, symptoms, or other characteristics of a relevant disease, disorder and/or condition.
  • the term “protocol” or “therapeutic protocol” may include procedures and/or systems of rules for administration of a therapy.
  • a therapeutic protocol defines the rules, syntax, semantics, and synchronization of communications with a patient.
  • a therapy may include a series of modules, lessons, questionnaires, and exercises, and a related protocol may dictate the order, speed, and/or frequency in which various modules, lessons, exercises and questionnaires are presented to a patient.
  • a protocol may also dictate the specific layout, content and general presentation of the various lessons, exercises and questionnaires.
  • a protocol can be as specific as to dictate each word or sequence of words selected for use in the therapy.
  • a therapy may be administered to a patient according to any number of protocols or any number of combinations of protocols.
  • a therapeutic regimen or “intervention regimen” may include a therapy for administration to a patient as part of a therapeutic treatment, wherein the therapy is administered to the patient according to a specific set of therapeutic protocols.
  • a therapeutic/intervention regimen for a behavioral therapy may include a specific set of modules, lessons, questionnaires, exercises, and other content, which may be administered to a patient in a particular order, at a particular frequency, utilizing a particular layout, etc.
  • a therapeutic/intervention regimen for a non-behavioral therapy may include administration of a non-behavioral therapy, such as a pharmaceutical or nutraceutical composition, in a particular amount, according to a particular dosing schedule, or the use of a medical device, according to particular instructions for use.
  • a therapeutic/intervention regimen may be correlated with a desired or beneficial therapeutic outcome.
  • a therapeutic/intervention regimen may be personalized or tailored to meet the needs of a specific patient.
  • the term “combination therapy” may include situations in which a subject is simultaneously exposed to two or more therapeutic regimens (e.g., two or more therapeutic modalities and/or agents).
  • the two or more regimens may be administered simultaneously; in some embodiments, such regimens may be administered sequentially (e.g., all “doses” of a first regimen are administered prior to administration of any doses of a second regimen); in some embodiments, such modalities and/or agents are administered in overlapping dosing regimens.
  • “administration” of combination therapy may involve administration of one or more agent(s) or modality(ies) to a subject receiving the other agent(s) or modality(ies) in the combination.
  • combination therapy does not require that individual agents be administered together in a single composition (or even necessarily at the same time), although in some embodiments, two or more agents, or active moieties thereof, may be administered together in a combination composition, or even in a combination compound (e.g., as part of a single chemical complex or covalent entity).
  • the term “therapeutic agent” may include any agent that elicits a desired effect when administered to an organism, e.g., in a pharmaceutical composition, via a digital therapeutics (DTX) system, and/or according to a therapeutic regimen as described herein.
  • an agent is considered to be a therapeutic agent if it demonstrates a statistically significant effect across an appropriate population.
  • the appropriate population may be a population of model organisms.
  • an appropriate population may be defined by various criteria, such as a certain age group, gender, genetic background, preexisting conditions, etc.
  • a therapeutic agent can be used to alleviate, ameliorate, relieve, inhibit, prevent, delay onset of, reduce severity of, and/or reduce incidence of one or more symptoms or features of a disease, disorder, and/or condition.
  • the term “dosing regimen” and/or “dosing schedule” may include a set of unit doses (typically more than one) that are administered individually to a subject, typically separated by periods of time.
  • a given therapeutic agent or modality has a recommended dosing regimen, which may involve one or more doses.
  • a dosing regimen comprises a plurality of doses each of which is separated in time from other doses.
  • individual doses are separated from one another by a time period of the same length; in some embodiments, a dosing regimen comprises a plurality of doses and at least two different time periods separating individual doses.
  • all doses within a dosing regimen are of the same unit dose amount. In some embodiments, different doses within a dosing regimen are of different amounts. In some embodiments, a dosing regimen comprises a first dose in a first dose amount, followed by one or more additional doses in a second dose amount different from the first dose amount. In some embodiments, a dosing regimen comprises a first dose in a first dose amount, followed by one or more additional doses in a second dose amount same as the first dose amount In some embodiments, a dosing regimen is correlated with a desired or beneficial outcome when administered across a relevant population (i.e., is a therapeutic dosing regimen).
  • the term “pharmaceutical composition” may include a composition in which an active agent is formulated together with one or more pharmaceutically acceptable carriers.
  • the active agent is present in unit dose amount appropriate for administration in a therapeutic regimen that has been established a statistically significant probability of achieving a predetermined therapeutic effect when administered to a relevant population.
  • a pharmaceutical composition may be specially formulated for administration in a particular form (e.g., in a solid form or a liquid form), and/or may be specifically adapted for, for example: oral administration (for example, as a drenche [aqueous or non-aqueous solutions or suspensions], tablet, capsule, bolus, powder, granule, paste, etc., which may be formulated specifically for example for buccal, sublingual, or systemic absorption); parenteral administration (for example, by subcutaneous, intramuscular, intravenous or epidural injection as, for example, a sterile solution or suspension, or sustained-release formulation, etc.); topical application (for example, as a cream, ointment, patch or spray applied for example to skin, lungs, or oral cavity); intravaginal or intrarectal administration (for example, as a pessary, suppository, cream, or foam); ocular administration; nasal or pulmonary administration, etc.
  • oral administration for example, as a drenche
  • nutraceutical composition may include a composition comprising one or more food(s) and/or food component(s), and/or one or more microbiome components, that provide medical or health benefits.
  • a nutraceutical is or comprises a component selected from the group consisting of microorganisms, proteins, vitamins, herbs, and combinations thereof, such as bacteria.
  • nutraceutical compositions are dietary supplements.
  • nutraceutical compositions are medical foods.
  • the term “amelioration” may include prevention (e.g., delay), reduction (e.g., in frequency and/or intensity), improvement, and/or palliation of a state, or one or more features thereof, experienced by a patient. Amelioration may include, but does not require, complete recovery or complete prevention of a disease, disorder or condition (e.g., radiation injury).
  • an appropriate reference measurement may be or may comprise a measurement in a particular system (e.g., in a single individual) under otherwise comparable conditions absent (e.g., prior to and/or after addition of) a particular agent or treatment, or in presence of an appropriate comparable reference agent.
  • an appropriate reference measurement may be or may comprise a measurement in a comparable system known or expected to respond in a particular way, for example in presence of the relevant agent or treatment.
  • prevention when used in connection with the occurrence of a disease, disorder, and/or condition, may include reducing a risk of developing the disease, disorder and/or condition and/or to delaying onset of one or more characteristics or symptoms of the disease, disorder or condition. Prevention may be considered complete when onset of a disease, disorder or condition has been delayed for a predefined period of time.
  • patient illness narrative may include a narrative expressed by a patient regarding the patient’s personal experiences with a disease, disorder, and/or condition.
  • An illness narrative is typically a narrative solicited from a patient, which enables a healthcare practitioner to build a more complete picture of the patient’ s past and present health state in the context of the patient’ s life, while providing the patient with an opportunity for self-reflection and validation.
  • the term “personal model” and/or “personal disease model” may include a construction built based on patient input, which enables the patient to identify stressors, counterproductive behaviors, unhelpful thoughts, and negative emotions as associated with the patient’s disease, disorder, and/or condition.
  • a personal model is constructed as a graphical representation, which comprises text corresponding to patient-selected counter-productive behavior(s), unhelpful thought(s), and negative emotion(s), superimposed on a flow diagram illustrating links between the patient’s behaviors, thoughts, and emotions.
  • a personal model graphical representation comprises text corresponding to causes and/or stressors of symptoms.
  • a personal model may be utilized to help a patient identify links between their behaviors, thoughts, and emotions, and to help a patient consider possible changes in their behavior that could be implemented to address their symptoms.
  • the term “ecological momentary assessment” may include repeatedly sampling a subject’s current behaviors and experiences in real time, in the subject’s natural environment, with the aim of minimizing recall bias and allowing study of microprocesses that influence behavior in real-world contexts.
  • machine learning module may include a computer implemented process that implements one or more particular machine learning algorithms, such as supervised, unsupervised, and semi-supervised systems, an artificial neural network (ANN), random forest, decision trees, support vector machines, and the like, in order to determine, for a given input, one or more output values.
  • machine learning algorithms such as supervised, unsupervised, and semi-supervised systems, an artificial neural network (ANN), random forest, decision trees, support vector machines, and the like, in order to determine, for a given input, one or more output values.
  • FIG. 1A depicts a schematic of a system 100A for treating tinnitus conditions using digital therapeutics in combination with other therapies, according to one or more embodiments.
  • system 100A includes: an online system 110 for digital content associated with the adaptive interventions, one or more client devices including client device 120 for delivering the behavioral therapy and skills training to one or more users, one or more external systems including external system 130, and a network 140 for data transmission between the online system 110, the client device(s) 120, and the external system(s) 130.
  • the system 100A includes functionality for educating patients (e.g., patients, users of the platform, etc.) regarding treatment and therapy options in the context of improving symptoms associated with tinnitus conditions; detecting, in real or near-real time, states of tinnitus condition symptom severity in non-invasive manners; and delivering therapeutic interventions in a customized, and adaptive manner to one or more users/patients exhibiting tinnitus condition symptoms.
  • patients e.g., patients, users of the platform, etc.
  • therapeutic interventions in a customized, and adaptive manner to one or more users/patients exhibiting tinnitus condition symptoms.
  • the system 100A can provide tailored cognitive behavioral therapies (CBTs) and/or other therapeutic modalities, such as cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, hypnosis, and combinations thereof, for patients in an adaptive and customizable manner.
  • CBTs cognitive behavioral therapy
  • MSR mindfulness-based stress reduction
  • ACT acceptance and commitment therapy
  • BA behavioral activation
  • BA systematic desensitization
  • TAT tinnitus activities treatment
  • TRT tinnitus retraining therapy
  • PTM progressive tinnitus management
  • TCT task concentration training
  • HRT habit reversal therapy
  • the online system 110 functions to generate, store, and transmit digital content associated with the behavioral therapy and related adaptive interventions, according to algorithms that allow the online system 110 to administer (or guide administration) of interventions to patients in a timely and customized manner.
  • the online system 110 thus procures digital content associated with one or more therapeutic interventions and allows users/patients of the system 100A to access the digital content in an active or passive manner, in order to improve the patient(s)’ ability to manage tinnitus condition symptoms.
  • the online system 110 can include content generation components 112, content storage components 114, content transmission components 116, communication elements 118, and/or analytic platform 119 elements, implemented in computer architecture.
  • the online system 110 can additionally or alternatively include any other suitable subsystems or components associated with administration of guided therapy, adaptive interventions, and/or monitoring of patient health condition states.
  • the online system 110 can include computing architecture configured for generation of interactive digital objects in computer-readable formats, where such interactive digital objects can be included in modules of therapeutic interventions provided to patients exhibiting one or more tinnitus condition symptoms.
  • the content generation components 112 can include architecture for generation of content in one or more of: visual formats (e.g., with image objects, video objects, etc.), audible formats, haptic formats, and any other suitable formats.
  • Such content can be delivered through output devices of other components of the system 100A, such as display components (e.g., of a device, of an augmented reality device, of a virtual reality device, etc.), speaker components, haptic output device components, and/or any other suitable components.
  • display components e.g., of a device, of an augmented reality device, of a virtual reality device, etc.
  • speaker components e.g., of a headset, etc.
  • haptic output device components e.g., haptic output device components, and/or any other suitable components.
  • the online system 110 can include architecture for storage and retrieval of computer-readable media associated with digital content and/or other objects.
  • Data storage systems can be associated with any suitable format, and include components configured for cloud and/or non-based cloud computing.
  • the information stored in the content storage components 114 can be organized according to specific data structures (e.g., with relational, columnar, correlation, or other suitable architecture).
  • Stored content can be associated with various digital objects (e.g., graphical/textual/audio/visual/haptic objects associated with content, and/or rearrangement of objects within particular environments, as associated with therapeutics and/or communications between entities, as described in more detail below).
  • the online system 110 can be configured to transmit content over wired and/or wireless interfaces, through network 140 (described in more detail below).
  • the content transmission components 116 of the online system 110 can include interfaces to the network 140, for content transmission to client devices 120 and/or external systems 130.
  • the online system 110 can include elements that enable communications between patients and other entities (e g., care providers, coaches associated with health interventions, other patients, etc.) in text format, in audio format, and/or in any other suitable formats.
  • the online system 110 can support messaging, calling, and/or any other suitable communication types using web or other computer-based communication subsystems.
  • the online system 110 can include architecture for an analytics platform 119 for performing analytics in relation to generation of interventions (e.g., digital therapeutics as monotherapies, digital therapeutics as combinatorial therapies), evaluation of performance of interventions (e.g., in relation to performance, in relation to effectiveness, etc.), modification of interventions (e g., in relation to content aspects, in relation to frequency aspects, etc.), provision of interventions (e.g., delivery method, etc.), generating and processing training data for refinement of models for intervention generation and provision, and other architecture for performing analytics.
  • interventions e.g., digital therapeutics as monotherapies, digital therapeutics as combinatorial therapies
  • evaluation of performance of interventions e.g., in relation to performance, in relation to effectiveness, etc.
  • modification of interventions e.g., in relation to content aspects, in relation to frequency aspects, etc.
  • provision of interventions e.g., delivery method, etc.
  • generating and processing training data for refinement of models for intervention generation and provision e.g., delivery method, etc.
  • one or more portions of the online system 110 can include processing subsystem components comprising non-transitory media storing instructions for executing one or more method operations described below.
  • the processing subsystem components can be distributed across the online system 110, client devices 120, and external systems 130, or organized in any other suitable manner.
  • the online system 110 can be implemented in a network- addressable computing system that can host one or more components for generating, storing, receiving, and sending data (e.g., content-related data, user-related data, data related to entities associated with various therapeutics, etc.).
  • the online system 110 can thus be accessed by the other components of the system 100A either directly or via network 140 described below.
  • the online system 110 can include one or more servers (e.g., unitary servers, distributed servers spanning multiple computers or multiple datacenters, etc.).
  • the servers can include one or more server types (e.g., web server, messaging servers, advertising servers, file servers, application servers, exchange servers, database servers, proxy servers, etc.) for performing functions or processes described.
  • each server can thus include one or more of: hardware, software, and embedded logic components for carrying out the appropriate functionalities associated with the method(s) described below.
  • the client device(s) 120 function to deliver the behavioral therapy and/or adaptive interventions generated and/or stored by the online system 110 to patients exhibiting tinnitus condition symptoms in a timely manner.
  • the client device(s) 120 can include computing components, input devices, and/or output devices providing interfaces for receiving patient inputs and transmitting digital content data and/or sensor-derived data over the network 140 (described in more detail below).
  • the client device(s) 120 can include one or more of: mobile computing devices (e.g., a smartphone a personal digital assistant); a conventional computing system (e.g., desktop computer, laptop computer); a tablet computing device; a wearable computing device (e.g., a wrist-borne wearable computing device, a head-mounted wearable computing device, an apparel-coupled wearable computing device); a toilet-interfacing computing device; and any other suitable computing device.
  • mobile computing devices e.g., a smartphone a personal digital assistant
  • a conventional computing system e.g., desktop computer, laptop computer
  • a tablet computing device e.g., a wearable computing device (e.g., a wrist-borne wearable computing device, a head-mounted wearable computing device, an apparel-coupled wearable computing device); a toilet-interfacing computing device; and any other suitable computing device.
  • a wearable computing device e.g., a wrist-borne wearable computing device, a head-mounted wearable computing device
  • the client device(s) 120 can be configured to store and/or execute an application (e.g., mobile application, web application) that allows a user of the client device 120 to interact with the online system 110 by way of the network 140, in order to receive digital content associated with one or more therapeutic interventions and/or provide data associated with survey responses, sensor-derived data associated with interactions with such interventions, and/or any other suitable data.
  • an application e.g., mobile application, web application
  • the client device(s) 120 can include operation modes for administering treatments to the user (e.g., in relation to providing digital therapeutics upon diagnosis of the tinnitus condition of the user, in relation to providing medications, etc.).
  • the external system(s) 130 function to transmit data (e.g., 3 rd party data) and/or receive data (e.g., 3 rd party data) associated with therapeutic interventions and/or user data (e.g., patient data).
  • the external system(s) 130 can include systems associated with electronic health records (EHRs) of the patient(s), systems associated with collection and/or storage of patient data (e.g., biometric data, behavioral data, social network data, communication data, etc.), systems associated with care providers (e.g., health insurance providers, health care practitioners, etc.), and/or any other suitable systems.
  • EHRs electronic health records
  • care providers e.g., health insurance providers, health care practitioners, etc.
  • the external system(s) can provide applications for communicating data in a manner that is protective of personal health information (PHI) and/or other sensitive patient data. Additionally or alternatively, the external system(s) can be associated with 3 rd party content generators and generate digital content in visual formats, audible formats, haptic formats, and/or any other suitable formats.
  • PHI personal health information
  • the external system(s) can be associated with 3 rd party content generators and generate digital content in visual formats, audible formats, haptic formats, and/or any other suitable formats.
  • the external system(s) 130 and/or client device(s) 120 can be configured to interact with the online system 110 by way of an application programming interface (API) executing on a native operating system of the external system(s) 130 and/or client device(s), in order to access API-associated data associated with the therapeutic interventions, patient health records, and/or other data (e.g., biometric data, patient behavior data through social networks, communication data through communication subsystems, etc.).
  • API application programming interface
  • the external system(s) 130 and/or client devices 120 can further include sensing components configured to generate data from which patient biometrics and/or behaviors can be extracted.
  • the external system(s) 130 and/or client devices 120 can include sensing components associated with one or more of: activity of a patient (e g., through accelerometers, gyroscopes, motion coprocessing devices, etc ); facial expressions of the patient (e.g., through eye tracking, through image/video processing) for determination of cognitive states (e.g., associated with depression, anxiety, emotions, etc.) and/or performance of activities and/or interacting with content provided through the intervention regimen; auditory information; physiological and/or psychological stress of a patient (e.g., in relation to respiration parameters, in relation to cardiovascular parameters, in relation to galvanic skin response, in relation to neurological activity, in relation to other stress biometrics, etc.); sleep behavior of a patient (e.g., with a sleep
  • the external system(s) 130 and/or client devices 120 can include components for extracting behavioral data associated with communications and social behavior, which can be indicative of changes in patient health associated with different symptoms.
  • Such components can include location sensors (e.g., direct location sensors, location sensing modules based on connections to local networks, triangulation systems, etc.) for tracking user motility and/or other behavior patterns, components associated with API access to social networking data, components associated with messaging communication behavior (e.g., components for accessing SMS or other messaging application data of a patient, with respect to messaging entities, messaging content, etc ), components associated with calling communication behavior (e g., in relation to inbound/outbound calls, in relation to call duration, in relation to call content, etc.), data from digital assistants (e.g., voice-activated digital assistants) and any other suitable components from which behavioral data can be extracted.
  • location sensors e.g., direct location sensors, location sensing modules based on connections to local networks, triangulation systems, etc.
  • components associated with API access to social networking data
  • the network 140 functions to enable data transmission between the online system 110, the client device(s) 120, and the external system(s) 130, in relation to detection of patient states of wellbeing (e.g. with respect to tinnitus condition symptoms).
  • the network 140 can include a combination of one or more of local area networks and wide area networks, and/or can include wired and/or wireless connections to the network 140.
  • the network 140 can implement communication linking technologies including one or more of: Ethernet, worldwide interoperability for microwave access (WiMAX), 802.11 architecture (e.g., Wi-Fi, etc.), 3G architecture, 4G architecture, 5G architecture, long term evolution (LTE) architecture, code division multiple access (CDMA) systems, digital subscriber line (DSL) architecture, and any other suitable technologies for data transmission.
  • WiMAX worldwide interoperability for microwave access
  • 802.11 architecture e.g., Wi-Fi, etc.
  • 3G architecture 4G architecture
  • 4G architecture 5G architecture
  • long term evolution (LTE) architecture long term evolution
  • CDMA code division multiple access
  • DSL digital subscriber line
  • the network 140 can be configured for implementation of networking protocols and/or formats including one or more of: hypertext transport protocol (HTTP), multiprotocol label switching (MPLS), transmission control protocol/Intemet protocol (TCP/IP), file transfer protocol (FTP), simple mail transfer protocol (SMTP), hypertext markup language (HTML), extensive markup language (XML), and any other suitable protocol/format.
  • HTTP hypertext transport protocol
  • MPLS multiprotocol label switching
  • TCP/IP transmission control protocol/Intemet protocol
  • FTP file transfer protocol
  • SMTP simple mail transfer protocol
  • HTML hypertext markup language
  • XML extensive markup language
  • the network 140 can also be configured for and/or provide, through communication links, encryption protocols for improving security of patient data transmitted over the network 140.
  • the system 100A can include or be configured to interface with other system components associated with generation and/or delivery of behavioral therapy and related adaptive interventions.
  • the system 100A can include or be associated with environmental control devices configured to affect patient states of wellbeing passively or actively, in relation to the intervention types described in more detail below.
  • such devices can include environmental control devices, including one or more of: lighting control devices, audio output devices, temperature control devices, and any other suitable environmental control devices.
  • the system 100A can coordinate operation of such devices with delivery of adaptive interventions to patients, such that aspects of the patient’s environment can be modulated in coordination with other therapeutic measures to improve patient wellbeing in relation to tinnitus condition symptoms.
  • the system 100A can include an output device (e.g., component of client device 120, component of external system 130, etc.) that functions as an environmental control device in an environment of the patient, where the processing subsystem further includes instructions for adjusting the operation mode in coordination with monitoring a change in symptoms (e.g., pain symptoms) of the patient. Modulation of output device operation modes can thereby produce an adjustment in symptoms (e.g., pain volume) associated with the condition of the patient.
  • the environmental control device can modulate one or more of: an audio output, a thermal parameter adjustment, a visually-observed output, a haptic output, and a light output in the environment.
  • the system 100A can include an output device (e.g., component of client device 120, component of external system 130, etc.) that functions as a communication device for transmitting communications between the patient and an entity associated with the patient, where the processing subsystem further includes instructions for generating a scripted communication for transmission to an entity associated with the patient, in coordination with monitoring a change in a physiological symptoms of the patient.
  • an output device e.g., component of client device 120, component of external system 130, etc.
  • the processing subsystem further includes instructions for generating a scripted communication for transmission to an entity associated with the patient, in coordination with monitoring a change in a physiological symptoms of the patient.
  • the system 100A can be configured to interface or include any other suitable system components.
  • Embodiments, variations, and examples of one or more components of the system 100A described above can implement one or more embodiments, variations, and examples of the methods 200A, 200B, and/or 200C, as described below.
  • the system 100A can additionally or alternatively be configured to implement other methods.
  • FIG. IB depicts a block diagram of a production environment 100B for treating tinnitus conditions using digital therapeutics in combination with other therapies, according to one or more embodiments.
  • production environment 100B includes DTX computing environment 141, patient 142, and patient computing systems 144.
  • production environment 100B optionally includes patient monitoring devices 146, health practitioner 148, and/or health practitioner computing systems 149.
  • production environment 100B includes communications channels 143, which facilitate communication between DTX computing environment 141 and one or more of patient computing systems 144, patient monitoring devices 146, and health practitioner computing systems 149.
  • DTX computing environment 141 includes DTX user interface 150, patient monitoring system 152, patient condition determination system 166, personalized regimen generation system 168, content selection system 170, and module gating system 172.
  • DTX computing environment 141 further includes therapeutic module database 174.
  • therapeutic module database 174 includes therapeutic module data 176, which further includes first therapeutic module 178, and second therapeutic module 184 through Nth therapeutic module 190.
  • first therapeutic module 178 includes module 1 content data 180 and module 1 protocol data 182
  • second therapeutic module 184 includes module 2 content data 186 and module 2 protocol data 188
  • Nth therapeutic module 190 includes module N content data 192 and module N protocol data 194.
  • DTX computing environment 141 further includes processor 196 and physical memory 198, which together coordinate the operation and interaction of the data and data processing systems associated with DTX computing environment 141.
  • processor 196 and physical memory 198 which together coordinate the operation and interaction of the data and data processing systems associated with DTX computing environment 141.
  • therapeutic module database 174 contains a repository of data related to each of the available therapy modules, including module content data and module protocol data.
  • a therapeutic protocol defines the rules, syntax, semantics, and synchronization of communications with a patient.
  • the therapeutic module database may be populated and/or updated periodically by health practitioner 148, for example, through health practitioner computing systems 150.
  • module gating system 172 is responsible for determining which parts of the intervention regimen patient 142 has already completed, if any, as well as determining which modules and/or module content should be gated, locked, and/or unlocked. The operation of module gating system 172 will be discussed in additional detail below.
  • content selection system 170 may select module 1 content data 180 from first therapeutic module 178 of therapeutic module database 174. Content selection system 170 may then administer module 1 content data 180 to patient 142 through DTX user interface 150. In one embodiment, module 1 content data 180 is administered to patient 142 according to one or more therapeutic protocols defined by module 1 protocol data 182.
  • first therapeutic module 178 may be an introduction and education module, which introduces the patient to the system features, and provides education to the patient relating to the methods utilized by the system and/or relating to the patient’s particular disease, disorder, and/or condition.
  • first therapeutic module 178 also generates patient profile and pre-assessment data 158 by virtue of interaction between patient 142 and the content provided through DTX user interface 150 of the DTX system.
  • patient profile and pre-assessment data is generated independently of first therapeutic module 178. Additional details regarding first therapeutic module 178 (the introduction and education module) will be provided below.
  • second therapeutic module 184 may be a physical illness narrative module, which, in some embodiments, solicits narratives from the patient regarding the impact that the patient’s disease, disorder, and/or condition has had on their lifestyle, mental state, and overall well-being.
  • second therapeutic module 184 generates patient illness narrative data (not shown) by virtue of interaction between patient 142 and the content provided through DTX user interface 150 of the DTX system.
  • second therapeutic module 184 also introduces the patient to the concept of a personal disease model, and guides the user through the process of creating a personal model.
  • second therapeutic module 184 solicits additional data from the patient for use in creation of the personal model, such as data related to the patient’s counter-productive behaviors, unhelpful thoughts, and negative emotions. Additional details regarding second therapeutic module 184 (the physical illness narrative module) will be provided below.
  • patient profile and pre-assessment data 158 is processed by patient condition determination system 166 of the DTX system to generate patient condition data 162, as will be discussed in additional detail below.
  • personalized regimen generation system 168 utilizes patient profile and pre-assessment data 158 and patient condition data 162 to generate a personalized intervention regimen for the patient, which is represented in FIG. IB by patient personalized regimen data 164.
  • patient personalized regimen data 164 includes data representing regimen details such as, but not limited to, which of the available remaining therapy modules to administer to the patient, in what order to administer the therapy modules, a time schedule for when/how often to administer the therapy modules, what content to include in each of the therapy modules, and how to present the therapy module content to the patient.
  • personalized regimen generation system 168 may further process patient profile and pre-assessment data 158 and patient condition data 162 to identify one or more current or potential complementary therapies to be administered to patient 142 in combination with the behavioral therapy components represented by therapeutic module data 176.
  • complementary therapies may include one or more non-behavioral therapies, such as pharmaceutical and/or nutraceutical compositions or use of medical devices, and personalized regimen generation system 168 may incorporate data related to administration of such therapies (e.g. therapy type, dosage amount, and dosage schedules) into patient personalized regimen data 164. Additional details regarding generation of a personalized intervention regimen for the patient will be discussed below.
  • patient personalized regimen data 164 is provided to module gating system 172 to determine which components of the intervention should be gated, locked, or unlocked, and content selection system 170 may then administer content data related to the appropriate therapeutic module to patient 142 through DTX user interface 150.
  • content selection system 170 may provide one or more options, notifications, alerts, and/or recommendations to patient 142 through DTX user interface 150, wherein the one or more options, notifications, alerts, and/or recommendations relate to current or potential complementary (non-behavioral) therapies to be administered in combination with the behavioral therapy modules/components.
  • the patient’s interactions with the behavioral therapy components and/or the patient’s interactions with and/or reactions to the non- behavioral therapy components of the personalized intervention regimen may be monitored remotely, either at fixed intervals, or in near real-time.
  • the patient’s interactions with the regimen components such as through a patient monitoring system 152 of the DTX system, or through external patient monitoring devices 146, such as sensors, etc., which may then transmit patient data and/or patient interaction data 154 over one or more communications networks 143.
  • the patient’s personalized intervention regimen may be modified and/or updated. For example, user input in one module might change the recommendation for how to present subsequent modules, and a patient’s reactions to one more non-behavioral therapy components may change the recommendations for the dosing of that particular component. In the case where the patient is being remotely monitored in near real-time, this allows for the personalized intervention regimen to be dynamically adaptive, thus resulting in administration of the guided therapy in combination with other types of tinnitus therapies in a manner that is most efficient and effective for the patient. Additional details regarding dynamically modifying the patient’s personalized intervention regimen will be discussed in further detail below.
  • FIG. 2A depicts a flowchart of a method 200A for treating tinnitus conditions using digital therapeutics in combination with other therapies, according to one or more embodiments.
  • the method 200A can include operations for: providing a patient with a user interface to a digital therapeutics (DTX) system wherein the DTX system remotely administers guided behavioral therapy to the patient 204; performing, by the DTX system, a pre-assessment of a patient exhibiting one or more tinnitus condition symptoms to generate patient profile and pre-assessment data 206; processing, by the DTX system, the patient profile and pre-assessment data to generate patient condition data, wherein the patient condition data includes an identification of the patient’s condition, condition sub-type and/or condition severity 208; processing, by the DTX system, the patient profile and pre-assessment data and the patient condition data to identify one or more complementary non-behavioral therapy components to be administered to the patient in combination with behavioral therapy components 210; processing, by the DTX system, the patient profile and pre-assessment data and the patient condition data to generate a personalized intervention regimen for
  • method 200A functions to educate users regarding treatment and therapy options in the context of improving symptoms associated with a variety of health conditions; detect, in real or near-real time, states of health condition symptom severity in non- invasive manners; and administer therapeutic interventions in a customized, and adaptive manner to one or more patients exhibiting health condition symptoms.
  • the method 200A can be used to provide tailored behavioral therapy to patients in an adaptive and customizable manner.
  • the method 200A can be used to provide behavioral therapy to patients in combination with other types of complementary, non-behavioral therapies. Method 200A will be discussed in additional detail below.
  • FIG. 2B depicts a flowchart of a method 200B for providing adaptive interventions for tinnitus conditions, according to one or more embodiments.
  • a method 200B can include operations for: performing a pre-assessment of a patient exhibiting one or more tinnitus condition symptoms 226; generating an intervention regimen for the patient upon processing data from the pre-assessment with an intervention-determining model 228; delivering the intervention regimen to the patient 230; monitoring a set of interactions between the patient and modules of the intervention regimen and a health status progression of the patient contemporaneously with delivery of the intervention regimen 232; and in response to at least one of the set of interactions and the health status progression, performing an action configured to improve wellbeing of the patient with respect to the tinnitus condition 234.
  • Method 200B will be discussed in additional detail below.
  • FIG. 2C depicts a flowchart of a method 200C for providing adaptive interventions for tinnitus conditions, according to one or more embodiments.
  • a method 200C can include operations for: establishing an interface between a device and a user 240; from the interface, receiving a set of signals associated with a health condition of the user, wherein the set of signals encodes physiological data, behavioral data, environmental stress data, emotional data, and cognitive data of the user 242; determining a characterization of the tinnitus condition upon processing the set of signals with a model 244; based upon the characterization, modulating content of a treatment comprising a set of components, the set of components comprising a subset of cognitive behavioral therapy (CBT) components for improving a state of the user 246; and administering the treatment to the user 248.
  • CBT cognitive behavioral therapy
  • Methods 200B and 200C function to educate patients regarding treatment and therapy options in the context of improving symptoms associated with tinnitus conditions; detect, in real or near-real time, states of tinnitus condition symptom severity in non-invasive manners; and deliver interventions in a customized, and adaptive manner to one or more users exhibiting tinnitus condition symptoms.
  • methods 200B and 200C can be used to provide tailored cognitive behavioral therapy (CBT) and/or other therapeutic modalities to patients in an adaptive and customizable manner. While tinnitus condition symptoms are described, variations of the methods 200B and 200C can be adapted for generation and provision of interventions for systems associated with other health conditions.
  • CBT cognitive behavioral therapy
  • aspects of methods 200A, 200B, and 200C can be performed at desired frequencies (e.g., weekly, more often than weekly, less often than weekly).
  • desired frequencies e.g., weekly, more often than weekly, less often than weekly.
  • the method can promote interactions more often than weekly (e.g., daily, 2 times a week, 3 times a week, four times a week, five times a week, six times a week, etc.) or less often than weekly, in relation to reinforcement of skills acquired by the patients.
  • received data can be processed in real time, or non-real time.
  • the methods 200A, 200B, and 200C can have delivery and processing aspects associated with other suitable frequencies.
  • the methods 200A, 200B, and 200C can be performed by an embodiment, variation, or example of the system 100A described in above (e.g., in relation to processing subsystem components with instructions stored in non-transitory media and other input/output devices); however, the methods 200A, 200B, and 200C can additionally or alternatively be performed using any other suitable system components.
  • FIG. 2A depicts a flowchart of a method 200A for treating tinnitus conditions using digital therapeutics in combination with other therapies, according to one or more embodiments.
  • method 200A begins at BEGIN 202, and method flow proceeds to operation 204.
  • a patient is provided with a user interface to a digital therapeutics (DTX) system wherein the DTX system remotely administers guided behavioral therapy to the patient.
  • DTX digital therapeutics
  • a patient may consult with one or more healthcare practitioners regarding symptoms that the patient is experiencing, and the healthcare practitioner may determine that the patient is suffering from one or more health-related conditions.
  • CBT cognitive behavioral therapy
  • MB SR mindfulness-based stress reduction
  • ACT acceptance and commitment therapy
  • BA behavioral activation
  • BA systematic desensitization
  • TAT tinnitus activities treatment
  • TRT tinnitus retraining therapy
  • PTM progressive tinnitus management
  • TCT task concentration training
  • habit reversal therapy HRT
  • habituation training relaxation therapy
  • acoustic (sound) therapy bimodal therapy
  • hypnosis and combinations thereof.
  • components of the above listed modalities may be combined to form a hybrid type of therapy.
  • a hybrid therapy may utilize particular components taken from CBT, ACT, and DBT, wherein the components are selected based on the specific needs of the patient.
  • behavioral therapies can also be combined with other types of non-behavioral therapies, as will be discussed in detail below.
  • CBT cognitive behavioral therapy
  • OCD obsessive-compulsive disorder
  • PTSD post-traumatic stress disorder
  • behavioral therapy has traditionally involved counseling by a mental health provider such as a psychiatrist, psychologist, or other provider; typically, behavioral therapy provides a structured format and a limited (i.e., finite) number of sessions.
  • the present disclosure provides new behavioral therapy technologies which may, in some embodiments, be provided to an individual via non-human interactions, such as via a computer-based system.
  • computer-based systems are designed to mimic portions of interactions, such as useful exercises, assessments, and techniques that may traditionally be carried out in the context of counseling sessions with a mental health provider and/or via exercises recommended thereby (e.g., ‘homework,’ such as values inventories, journaling exercises, self-assessments, and the like).
  • provided behavioral therapies e.g., cognitive behavioral therapies
  • the doctor may prescribe a therapeutics system to the patient.
  • the therapeutics system is a digital therapeutics (DTX) system.
  • DTX digital therapeutics
  • a DTX system differs from traditional computer-based wellness systems, in that the DTX system is required to be approved by a government agency before it can be marketed for administration to humans.
  • a DTX system requires FDA approval and rigorous clinical evidence to substantiate intended use and impact on disease state.
  • a DTX system is typically a system for which a medical prescription is required for administration to patients.
  • DTX digital therapeutics
  • an embodiment of the online system in coordination with the network and a client device, can perform the pre-assessment of operation 206 contemporaneously with executing an onboarding process with the patient with the online system.
  • Operation 206 functions to retrieve data describing characteristics of the patient, preferences of the patient, goals of the patient and/or any other suitable patient features that can be used to provide adaptive interventions through an intervention regimen associated with administration of guided behavioral therapy to the patient in a customized and personalized manner.
  • operation 206 can include preassessing and onboarding patients to generate patient profile and pre-assessment data, wherein the patient profile and pre-assessment data includes one or more of: demographics (e.g., genders, ages, familial statuses, residential location, ethnicities, nationalities, socioeconomic statuses, sexual orientations, etc ), household situations (e g., living alone, living with family, living with a caregiver, etc.), dietary characteristics (e.g., omnivorous, vegetarian, pescatarian, vegan, reduced carbohydrate consumption, reduced acid consumption, gluten-free, simple carbohydrate, or other dietary restrictions, etc.), levels of activity, levels of alcohol consumption, levels of drug use, psychological symptom severity, levels of mobility (e.g., in relation to distance traveled in a period of time), biomarker statuses (e.g., fecal calprotectin, cholesterol levels, lipid states, blood biomarker statuses, etc.), weight
  • demographics e.g., genders,
  • patient profile and pre-assessment data generated at operation 206 includes data related to non-behavioral therapies that the patient is receiving and/or has received.
  • patient profile and pre-assessment data may include data such as, but not limited to, data indicating the type of non-behavioral therapy (e.g., pharmaceutical, nutraceutical, medical device, etc.), data indicating the class of non-behavioral therapy, data relating to the amount/dosage of the non-behavioral therapy, data relating to timing of one or more doses of the non-behavioral therapy, data indicating a duration of use of a product and/or device associated with the non- behavioral therapy, data indicating any side effects of the non-behavioral therapy that have been experienced by the patient, and/or data indicating whether dosage timing is relative to another event.
  • another event may include events such as, but not limited to, eating, exercise, exposure to light and/or temperature, exposure to one or
  • the non-behavioral therapy comprises one or more pharmaceutical compositions each comprising at least one compound independently selected from the group consisting of anesthetics, heart rhythm medications, anti-anxiety medications, anti-seizure drugs, antidepressants, calcium channel blockers, muscle relaxers, and combinations thereof.
  • the non-behavioral therapy comprises one or more nutraceutical compositions each comprising at least one nutraceutical component independently selected from the group consisting of lipoflavanoids, minerals, proteins, vitamins, herbs, ear drops, melatonin, ginkgo biloba, zinc supplements, magnesium supplements, and combinations thereof.
  • the non-behavioral therapy comprises one or more medical devices each independently selected from the group consisting of bimodal stimulation devices, bimodal neuromodulation devices, brain stimulation therapies, tinnitus masking devices, tinnitus retraining devices, hearing aids, and combinations thereof.
  • patient profile and pre-assessment data includes data, such as, but not limited to, physiological data (including auditory data), behavioral data, environmental stress data, emotional data, and cognitive data of the patient.
  • the pre-assessment and/or onboarding process performed in operation 206 can identify mental health statuses of the patient, in relation to comorbid or non-comorbid conditions (e.g., associated with anxiety, associated with depression, associated with social behavior, etc.), where the intervention regimen described in more detail below can be configured to improve mental health states of the patient in a timely and adaptive manner.
  • comorbid or non-comorbid conditions e.g., associated with anxiety, associated with depression, associated with social behavior, etc.
  • related data can include psychological and/or disease symptom/clinical profile data that informs selection of high priority therapy components, where examples include data such as, but not limited to: illness-related ruminations being predominant; symptoms triggered by anticipatory anxiety; aspects adapted for types of reinforcement based on level of anhedonia, as assessed from system-provided tools associated with depression assessment (e.g., upon identification of anhedonia characteristics of the patient, promoting behavioral activation content by the system and response chaining, where response chaining involves linking of effortful avoided tasks to those that are neutral or slightly rewarding); sources of motivation; reward sensitivity (e.g., sensitivity associated with drive and reward responsiveness (e.g., using a BIS/BAS assessment tool); and threat sensitivity.
  • data such as, but not limited to: illness-related ruminations being predominant; symptoms triggered by anticipatory anxiety; aspects adapted for types of reinforcement based on level of anhedonia, as assessed from system-provided tools associated with depression assessment (e.g., upon identification of anhedonia
  • the method 200A can include receiving a reward sensitivity dataset characterizing motivation and reinforcement behavior of the patient, and modulating aspects of the treatment upon processing the reward sensitivity dataset with one or more models described herein.
  • Mental health, reward tendencies and sensitivity, and motivational aspect identification can, however, be assessed outside of the pre-assessment of operation 206.
  • the pre-assessment and/or onboarding process performed in operation 206 can identify user preferences associated with scheduling of content delivery (e.g., in relation to frequencies of content delivery described above) associated with one or more aspects of the intervention regimen, preferred formats (e.g., visual formats, audio formats, haptic formats, etc.) of content delivery, frequency of content delivery, location of user when content is delivered, specific device(s) to which content is delivered, and/or any other suitable user preferences.
  • preferred formats e.g., visual formats, audio formats, haptic formats, etc.
  • the preassessment and/or onboarding process performed in operation 206 can identify user goals for improving health, in relation to the intervention regimen.
  • Such goals can include one or more goals, such as, but not limited to: reduction of anxiety, reduction of negative emotions, reduction of depression symptoms, improvement of sleep behavior, improvement in socialization, improvement of tinnitus condition symptoms, improvement of medication adherence, improvement in tinnitus- related quality of life, improvement of other health condition symptoms, and/or any other suitable goals.
  • Goals can be organized at a high level of abstraction (e.g., improve sleep behavior), and/or at lower levels of abstraction (e.g., improve quality of sleep, reduce number of symptom-induced disturbances to sleep, etc.).
  • the patient profile and pre-assessment data can be obtained through various mechanisms, including, but not limited to, from a pre-assessment module of the DTX system, from patient health records accessible by the DTX system, from API access of health monitoring systems through the DTX system, and/or from biometric sensor data obtained by the DTX system from various devices utilized by the patient.
  • patient profile and pre-assessment data can be collected repeatedly throughout performance of the methods described herein, as will be discussed in additional detail below.
  • the online system and/or other system components can implement surveying tools (e.g., to obtain self-report data from the patient) and/or non-survey-based tools for acquisition of data.
  • Survey tools can be delivered through an application associated with the DTX system executing on the client device of the patient and/or through another suitable method, where the survey tools can implement architecture for assessing the patient in relation to mental health, pain, tinnitus symptom severity or disease activity, types of tinnitus condition symptoms, and/or other statuses.
  • the surveying tools can be derived from one or more patient reported outcome instruments, such as, but not limited to: a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, and combinations thereof, and any other tool or instrument.
  • patient reported outcome instruments such as, but not limited to: a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, and combinations thereof, and any other tool or instrument.
  • survey components can be implemented during preassessment of a patient and/or within modules of the intervention regimen, as described in more detail below.
  • the online system and/or other system components can implement data from devices (e.g., non-survey data).
  • embodiments of the system can perform pre-assessment with implementation of data from devices including one or more devices, such as, but not limited to: electronic health record-associated devices; wearable devices (e.g., wrist-borne wearable devices, head-mounted wearable devices, etc.) for monitoring behavior and activities (e g., related to physiological/cognitive stress, related to respiration activity, related to sedentary and active states, etc.) of the user; devices to assess auditory characteristics, abilities and limitations; non-invasive torso-coupled devices; ingestible smart-pill devices; smart toilet devices and/or other devices for analyzing stool and/or urine samples from the patient; and other devices.
  • devices including one or more devices, such as, but not limited to: electronic health record-associated devices; wearable devices (e.g., wrist-borne wearable devices, head-mounted wearable devices, etc.) for monitoring behavior and activities (e g., related to physiological/cognitive stress, related to respiration activity, related to sedentary and active states, etc.
  • Non-survey-derived data can additionally or alternatively include data derived from API access of social networking platforms, other communication platforms (e.g., for extracting social behavior characteristics associated with text, voice, and other communications of the users), location-determining platforms, and/or other platforms, in order to assess social behaviors of the user.
  • multiple surveying tools may be combined in a single assessment module, or may be provided as distinct, separate, assessment modules.
  • Assessment modules may be based on, and used to solicit input for, a variety of diagnostic questionnaires, depending on a particular tinnitus condition that a patient is to be evaluated for. Additionally or alternatively, assessment modules may be designed to evaluate any other physiological and/or psychological conditions of the patient.
  • data pertaining to patient symptoms, quality of life, and other medical information may be obtained via access to electronic health records (EHRs) and/or electronic medical records (EMRs).
  • EHRs electronic health records
  • EMRs electronic medical records
  • applications in accordance with technologies as described herein may provide for communication with a secure database in order to receive and/or access EHR and/or EMR data for the user.
  • Such data may be used to populate a patient profile, and as a basis for tailoring content, e.g., as described herein.
  • method flow proceeds to operation 208.
  • the DTX system processes the patient pre-assessment data to generate patient condition data, wherein the patient condition data includes an identification of the patient’s condition, condition sub-type, and/or condition severity.
  • processing of the patient pre-assessment data in operation 208 can result in identification of the patient as having tinnitus condition symptoms associated with tinnitus, such as, but not limited to, perception of one or more sounds by the patient, wherein the one or more sounds are not present in an external environment of the patient and/or any other suitable symptoms. Further, processing of the patient assessment data at 208 can result in identification of a subtype of a tinnitus disorder.
  • processing of the patient pre-assessment data in operation 208 can result in identification of the patient as having one or more comorbidities associated with tinnitus.
  • operation 208 can further identify one or more sub-types of a tinnitus condition, and/or one or more sub-types of comorbidities associated with the tinnitus condition.
  • the DTX system can be configured to receive, automatically detect, or automatically extract information regarding the particular subtype(s) of the tinnitus condition that a patient has, based on a combination of patient health record data, data collected from health monitoring systems, data collected from biometric sensors, and data collected from patient- reported outcome instruments, in order to prioritize relevant content provided to the patient, in the interests of customizing the program.
  • subtype identification may be determined outside of the processing of operation 208.
  • operation 208 of method 200A includes a method of determining severity of the tinnitus condition.
  • operation 208 can calculate levels of a tinnitus condition-associated marker (e.g., from interactions with the system, etc.) to identify the patient as having a certain state of severity (e.g., expression, phenotype, etc.) of the tinnitus condition.
  • a tinnitus condition-associated marker e.g., from interactions with the system, etc.
  • operation 208 can be implemented through the DTX system executing on a mobile device or other device associated with the patient, where a user interface of the DTX system prompts inputs from the patient pertaining to various symptoms, and generates a report indicating severity of the tinnitus condition.
  • the DTX system disclosed herein can include architecture for receiving data derived from the patient (e g , through sensor components, through survey components, associated with tinnitus characteristics, cognitive function characteristics, and other characteristics), processing the data with one or more models, and returning scores (e.g., measures of symptom severity, etc.). Scores can also be used for tagging user data with symptom severity, in relation to model aspects and model training/refinement described below.
  • method flow proceeds to operation 210.
  • the patient profile and preassessment data and the patient condition data are processed to identify one or more complementary non-behavioral therapy components to be administered to the patient in combination with behavioral therapy components.
  • the digital therapeutics (DTX) system disclosed herein may utilize behavioral therapy components in combination with non-behavioral therapy components to provide treatment for various physiological conditions (e.g., conditions with one or more physical symptoms, features, or manifestations), such as those described herein.
  • the DTX system disclosed herein may administer behavioral therapies and associated components in combination with one or more non-behavioral therapies and associated components, such as those described herein.
  • behavioral therapy is administered to subject(s) who are receiving or have received non-behavioral therapy for a relevant disease, disorder, or condition.
  • behavioral therapies and non-behavioral therapies may be approved, and/or administered as a combination product.
  • digital therapeutics (DTX) systems and methods described herein are utilized to administer guided behavioral therapy to a patient undergoing treatment for one or more tinnitus conditions via administration of one or more non-behavioral therapies.
  • tinnitus conditions those skilled in the art will be familiar with various approved and/or otherwise accepted non-behavioral therapies for tinnitus conditions, including, for example, pharmaceutical compositions such as, but not limited to: anesthetics, heart rhythm medications, anti-anxiety medications, anti-seizure drugs, antidepressants, calcium channel blockers, muscle relaxers, and combinations thereof; nutraceutical compositions such as, but not limited to: lipoflavanoids, minerals, proteins, vitamins, herbs, ear drops, melatonin, ginkgo biloba, zinc supplements, magnesium supplements, and combinations thereof; and medical devices such as, but not limited to: bimodal stimulation devices, bimodal neuromodulation devices, brain stimulation therapies, tinnitus masking devices, tinnitus retraining devices, hearing aids, wearable devices, ingestible devices, implanted devices, biofeedback devices, transcutaneous electrical nerve stimulation (TENS) and microcurrent nerve stimulation (MEN
  • DTX may be used in combination with one or more pharmaceutical compositions, nutraceutical compositions and/or medical devices for the treatment, prevention, amelioration, or reduction in the likelihood of developing a tinnitus condition in a patient.
  • One or more non-behavioral therapies may further include nutritional therapies (e.g., enteral nutrition), acupuncture, mind-body interventions (e.g., relaxation, meditation, yoga), whole system medicine (e.g., Eastern Medicine, Ayurveda), and physical exercises.
  • nutritional therapies e.g., enteral nutrition
  • mind-body interventions e.g., relaxation, meditation, yoga
  • whole system medicine e.g., Eastern Medicine, Ayurveda
  • physical exercises e.g., a patient suffering from a tinnitus condition may be treated using any combination of the above listed non-behavioral therapies.
  • the digital therapeutics (DTX) systems and methods disclosed herein collect patient medication information, for example in the pre-assessment operation discussed above, via interactive lesson modules such as a pre-assessment module, via modules specifically related to medication, etc., and/or via user entry into a user profile.
  • the digital therapeutics (DTX) systems and methods described herein may collect and offer recommendations regarding an amount and/or timing of dosage of particular medications. Such recommendations regarding amount and/or timing may be absolute and/or relative to other events and/or activities. For example, recommendations may comprise a particular schedule of dosage, e.g., a particular rate, timing (e.g., in a morning, afternoon, or evening), etc.
  • Timings and/or amounts relative to other activities may include timings and/or amounts relative to other activities, such as meal consumption, physical exercises, seasons, social gatherings, travel, work, etc.
  • recommendations may be based on data provided by the patient, for example in daily symptom diary entries, via assessment modules, personal model creation modules, etc., such as those described in more detail below.
  • such recommendations are generated via use of one or more machine learning modules that receive, as input, data corresponding to patient symptom and/or habits, as tracked by various modules such as those described herein. In some embodiments, this information is used as feedback, to refine and dynamically update parameters of machine learning modules. In some embodiments, dosage recommendations provided via the approaches described herein are restricted to fall within a pre-defined range, for example as specified by a physician.
  • dosage recommendations provided by technologies (e g., systems and methods) described herein comprise an identification of one or more specific symptoms, so as to provide recommendation to discuss particular symptoms with a medical professional, such as a physician and/or therapist (e.g., to discuss particular changes to medication regimens and/or types of medication, so as to best manage particular symptoms).
  • a medical professional such as a physician and/or therapist (e.g., to discuss particular changes to medication regimens and/or types of medication, so as to best manage particular symptoms).
  • the non-behavioral therapy components are related to therapies that have previously been administered to the patient. In one embodiment, the non-behavioral therapy components are related to therapies that are currently being administered to the patient. In one embodiment, the non-behavioral therapy components are related to therapies that will be and/or are recommended to be administered to the patient.
  • method flow proceeds to operation 212.
  • the patient profile and pre-assessment data and the patient condition data are processed to generate a personalized intervention regimen for the patient, wherein the personalized intervention regimen defines both behavioral therapy components and non-behavioral therapy components to be administered to the patient.
  • the personalized intervention regimen provides, through client devices, an array of empirically-supported intervention options or actions delivered via a modular and flexible approach, whereby modules of the regimen (a set of overarching principles and evidence-based interventions) can be adaptively provided based on patient states assessed in real-time or near real-time. This allows for individualized treatment planning.
  • guided behavioral therapy technologies as provided herein provide a user with a sequence of interactive lesson modules that the user accesses and interacts with via a graphical user interface (GUI) of a DTX system, which may include a web-based application accessible via a web-browser of a user personal computer (e.g., desktop, laptop, etc.), and/or a mobile application, running, at least in part, on and/or accessible via a user mobile computing device.
  • GUI graphical user interface
  • Each interactive lesson module may represent a guided lesson in a particular behavioral therapy skill and includes specific graphical content and/or graphical widgets designed to introduce a user to a particular behavioral therapy skill, such as keeping a symptom diary, managing symptoms, setting goals, identifying and understanding thoughts (e.g. , unhelpful and/or irrational thoughts), and the like.
  • a user completes various interactive lesson modules, they are introduced to, and learn to practice, a specific behavioral therapy skill
  • interactive lesson modules are arranged in a particular sequence.
  • a DTX system in accordance with approaches described herein may include controls that encourage and/or require a user to progress through a particular sequence of lesson modules in a prescribed order.
  • the DTX system may restrict access by the user to certain lesson modules, occurring later in the sequence, until others have been completed first.
  • the order of modules of the intervention regimen provided can vary from patient to patient and/or vary based on other factors (e.g., due to refinement and training of models, as described in further detail below); however, in some embodiments, all patients will have access to and be offered all of the skill modules through DTX systems executing on their respective client devices.
  • the skills- based interventions rely on skill acquisition (initial phase of learning the new skill), then skill practice before proceeding to learn the subsequent new skill (e.g., in one’s natural home/social environment). Monitoring of task performance and practicing skills is described in further detail below.
  • the modules can allow users to develop and train core skills (e g., 8 core skills, another suitable number of core skills, etc.) associated with understanding their disease, disorder, and/or condition, therapies available; relaxation skills; behavioral change, avoidance, and activation; problem solving and coping; tinnitus management; cognitive flexibility; social problem solving and communication; and relapse prevention and skills maintenance.
  • core skills e g. 8 core skills, another suitable number of core skills, etc.
  • sizes of lesson modules - for example, a number of screens a user cycles through, a number of graphical widgets they interact with, an estimated approximate time they are expected to spend with various lesson module(s), etc. - may be tailored to remain relatively small, so as to provide a user ‘bite-sized’ lessons that can and/or are designed to facilitate retention.
  • lesson modules may be designed such that they may be completed with no more than about twenty minutes of continuous user interaction.
  • lesson modules may be designed such that they may be completed with no more than about fifteen minutes of continuous user interaction.
  • lesson modules may be designed such that they may be completed with no more than about ten minutes of continuous user interaction.
  • Disease, condition, and/or syndrome-specific components include content addressing one or more of: an illness narrative, symptom management for pain and other symptoms, diseasespecific psychoeducation, social skills training, and emphasis on tinnitus condition cognitions, beliefs, and behaviors.
  • Intervention modules can further include general cognitive behavioral components shared across psychological conditions/disorders such as behavioral activation, attentional processes, relaxation, problem solving, cognitive reframing, and other areas.
  • generating a personalized intervention regimen can include defining a type, amount, and/or dosing schedule of a non-behavioral therapy to be administered to the patient in combination with the behavioral therapy components.
  • a dosing schedule for administration of a non- behavioral therapy may be defined relative to a schedule for administration of the behavioral therapy.
  • generating a personalized intervention regimen can include adjusting (e.g., decreasing, increasing, maintaining) an amount of the non-behavioral therapy treatment administered to the patient, for example, based upon the state of the patient’s health condition symptom severity, and/or correspondingly adjusting (e.g., decreasing, increasing, maintaining) an amount of a behavioral therapy treatment provided to the patient, thereby titrating relative treatment types provided to the patient based upon returned outputs of models associated with the methods described.
  • a treatment cocktail can include digital therapeutic aspects (e.g. behavioral therapy components) as well as non-digital therapeutic aspects (e.g. non-behavioral therapy components).
  • FIG. 3A depicts a schematic of architecture 300 implemented for delivery of behavioral therapy intervention regimen components and/or modules, according to one or more embodiments.
  • architecture 300 includes introduction and education module 301, which in some embodiments, also includes symptom assessment module 302.
  • introduction and education module 301 is utilized to generate patient profile and pre-assessment data.
  • the patient profile and pre-assessment data is generated and/or obtained outside of the functioning of the introduction and education module 301.
  • architecture 300 further includes physical illness narrative module 304, which is utilized to generate patient illness narrative data, which in turn, may be utilized for personalization of an intervention regimen, as well as for constructing personal model 303.
  • the patient profile and pre-assessment data generated by introduction and education module 301, and the patient illness narrative data generated by physical illness narrative module 304 are processed through the DTX system to generate a personalized and adaptive intervention regimen for the patient, as will be discussed in additional detail below.
  • the personalized intervention regimen includes one or more additional interactive therapy modules, such as, but not limited to, relaxation module 306, behavioral change and avoidance module 308, problem solving and coping module 310, tinnitus management module 312, cognitive restructuring and flexibility module 314, social problem-solving and communication module 316, relapse prevention and skills maintenance module 318, and adherence module 320.
  • additional interactive therapy modules such as, but not limited to, relaxation module 306, behavioral change and avoidance module 308, problem solving and coping module 310, tinnitus management module 312, cognitive restructuring and flexibility module 314, social problem-solving and communication module 316, relapse prevention and skills maintenance module 318, and adherence module 320.
  • a symptom diary and trigger tracking module 321, and a medication adherence module 323 are also provided.
  • method flow proceeds to operation 214.
  • the one or more behavioral therapy components are administered to the patient through the user interface of the digital therapeutics (DTX) system according to the personalized intervention regimen generated for the patient.
  • DTX digital therapeutics
  • the behavioral and cognitive change interventions described below interrupt the problematic behaviors that are maintaining/perpetuating the targeted symptoms, provide new adaptive coping strategies, and improve perceived control of symptom management in a positive manner.
  • the ability to tailor ‘at the right time’ requires relevant information about the user that is used to decide under what conditions to provide an intervention and the appropriateness of the intervention.
  • the following interactive therapy modules will be discussed with reference to FIG. 3A. As noted above, inclusion of these therapy modules and/or the order of inclusion of these additional therapy modules, in various embodiments, is dependent on the personalized intervention regimen generated for a particular patient.
  • modules are described in a particular order, it should be noted that the modules can be performed in any other suitable sequence, omit operations, and/or include additional operations (e.g., based on refinement and training of models described below, and/or based on other factors). Furthermore, aspects of the modules can overlap with each other in any suitable manner.
  • introduction and education module 301 focuses on education about the patient’s disease and symptoms (e.g., more common symptoms, less common symptoms, etc.).
  • the introduction and education module is designed to create awareness about what matters to the patient (their reason for trying the program), introduce therapy concepts (e.g., related to CBT, related to other therapies), introduces skills that the user will build by interacting with the system, and assesses user’s level of commitment for change.
  • an overview of this program links to the patient’s specific psychological/disease management challenges.
  • the following points are emphasized: (1) the treatment is modular/flexible in nature and tailored for patient’s needs (2) the patient will learn skills, that if practiced, will help them manage their symptoms (e.g., with highlighting of red flag symptoms), improve their quality of life, and lessen the toll that the patient’s health conditions take on the patient.
  • Introduction and education module 301 thus can guide the patient to explore the influence that moods, attitudes, beliefs and behavior exert on health and the impact of illness.
  • Introduction and education module 301 can further function to provide tools for education, persuasion (e.g., regarding effectiveness of program completion), personalization, motivation enhancement, setting expectations, eliciting commitment by users, and establishing a relationship between users and the system (e.g., in lieu of a human coach, with supplementation of therapy by a human coach, etc.).
  • Delivery methods for introduction and education module 301 can include one or more of: graphics/animations, metaphorical digital content, interactive exercises provided in a DTX system environment, and a clinical vignette simulating patient-provider interactions.
  • introduction and education module 301 may include a variety of individual sections designed to lay a foundation for progression through later modules. While the sections described below are described in a particular order for illustrative purposes, variations of introduction and education module 301 can additionally or alternatively be arranged in another suitable order, omit sections as desired, and/or include additional sections as desired.
  • FIG. 3B depicts examples of individual sections that may make up therapeutic and education modules 301 of an intervention regimen, according to one or more embodiments.
  • FIG. 3C depicts an alternative with tinnitus digital therapeutics modules for an exemplary 30-day treatment regimen.
  • introduction and education module 301 includes a First Section 322 configured to welcome the patient and introduce the patient to goals of the intervention regimen delivered through the online system and client device.
  • the First Section 322 is delivered by the system in an interactive format (e.g., with video and text content) that creates a feedback loop with users and processes user responses to tailor subsequent module delivery and content, in order to increase engagement.
  • goals can be set in coordination with user desires, with establishment of collaborative empirence. Goals can be specific, in terms of detailed planning of what users will do, including frequency, intensity, duration, and context (e.g., where, when, how, with whom, etc.) of the goal(s).
  • introduction and education module 301 can determine topics having greater relevance to the user’s current issues (e.g., in relation to comorbid conditions, such as anxiety and depression, in relation to health condition subtypes).
  • the First Section 322 can include a description of how the program will involve regular practice (e.g., daily, every two days, every 3 days, etc.) of skills (e.g., core skills described above and below), with a guideline for program length (e.g., 8 weeks, less than 8 weeks, more than 8 weeks), and methods of identifying personal progress (e.g., feeling better with mastery of a subset of skills).
  • introduction and education module 301 includes a Second Section 324 configured to allow the patient to submit information, through a user interface of the DTX system, regarding personal aspects of his/her health condition as an initial physical illness narrative, along with video content to which the patient can compare his/her experiences.
  • Second Section 324 has goals of facilitating emotional awareness, establishing a physical illness narrative that can be revisited as the user gains mastery of skills, and helping the user to articulate and track his/her experiences.
  • introduction and education module 301 includes a Third Section 326 configured for personalization of subsequent portions of the intervention regimen to the patient, by allowing the patient to indicate, through a user interface of the DTX system, which symptoms are most bothersome.
  • Third Section 326 can also include architecture for mapping the user’s symptoms and health condition-induced factors to various impacts associated with the user’s values.
  • one or more of the mappings can be created, such as, but not limited to: symptoms associated with tinnitus with mappings to aspects of life (e.g., relationships, work, school, hobbies, daily activities, etc.) that have been affected by such symptoms and the reason such aspects have been affected; medication side effects with mappings to aspects of life (e.g., relationships, work, school, hobbies, daily activities, etc.) that have been affected by such symptoms and the reason such aspects have been affected; social/relationship issues (e.g., stress on loved ones, impacts on friendships, etc.) with mappings to behaviors (e.g., relationships, work, school, hobbies, daily activities, etc.) that have been affected by such symptoms and the reason such aspects have been affected; and behavioral, mental, and emotional factors (e.g., exhaustion, lack of control, inability to perform activities, additional help needed for tasks, limitations in diet, limitations in travel, embarrassment, worry, disease progression, lack of confidence, dwelling thoughts, etc.) with mappings to
  • introduction and education module 301 includes a Fourth Section 328 configured for personalization and values identification, with tools for allowing the user to provide data related to positive and negative changes in his/her life that are attributed to having the health condition, in relation to changes in relationships, levels of embarrassment, curiosity, being understood, stress to self and loved ones, confidence, energy levels, senses of lack of control, worry (e.g., about health issues experienced outside of a comfortable environment, about disease progression, and symptoms, about medication effects, about ability to conduct daily activities, about dietary constraints, about travel, etc.), and other aspects.
  • Fourth Section 328 configured for personalization and values identification, with tools for allowing the user to provide data related to positive and negative changes in his/her life that are attributed to having the health condition, in relation to changes in relationships, levels of embarrassment, curiosity, being understood, stress to self and loved ones, confidence, energy levels, senses of lack of control, worry (e.g., about health issues experienced outside of a comfortable environment, about disease progression, and symptoms, about medication effects
  • Fourth Section 328 can also revisit aspects of the user’s initial physical illness narrative, with ranking of: symptoms; social/interpersonal factors (e.g., changes to relationships, embarrassment, stress to loved ones, dealing with constant questions about illness, not being understood, etc ); emotional factors (e g., lack of confidence, mental exhaustion, lack of control, etc.); cognitive factors (e.g., worry about health issues outside of places of comfort, worry about disease progression, catastrophizing, depression, anxiety, other comorbid conditions, etc.); and behavioral factors (e.g., not being able to conduct daily activities, travel restrictions, etc.).
  • social/interpersonal factors e.g., changes to relationships, embarrassment, stress to loved ones, dealing with constant questions about illness, not being understood, etc .
  • emotional factors e.g., lack of confidence, mental exhaustion, lack of control, etc.
  • cognitive factors e.g., worry about health issues outside of places of comfort, worry about disease progression, catastrophizing, depression
  • introduction and education module 301 includes a Fifth Section 330 configured for allowing further customization, by providing the patient with interactive elements that allow the patient to prioritize the order in which content associated with interventions is received.
  • introduction and education module 301 also includes a Sixth Section 332 configured for introducing subsequent portions/modules of the intervention according to user preferences indicated from outputs of the Fifth Section 330, where the goals of Sixth Section 332 include promotion of treatment credibility (e.g., through presentation of video content by patients having experiences similar to those of the user(s)).
  • introduction and education module 301 includes a Seventh Section 334 configured for delivery of content for educating the patient about their condition, where the content includes an animated element and audio format content configured to actively interact with the user.
  • the interactive elements function to gauge how well the patient understands the content provided, and to provide additional content to engage and inform the patient depending upon responses of the patient.
  • the Seventh Section 334 has goals of shaping knowledge of symptoms and treatment components of the intervention regimen and enhancing motivation.
  • Seventh Section 334 can teach users of the system regarding tinnitus. As such, the user can be primed to gain skills by changing behaviors, attentional biases, and automatic thought patterns. Seventh Section 334 can further gage internalization and understanding of the user, with provision of further content in this section and/or the eighth section to promote further understanding.
  • introduction and education module 301 includes an Eighth Section 336 configured for delivery of content for educating the patient in a manner personalized to the patient, where the content includes video and audio format content configured to actively interact with the user, in order to aid the user in understanding influences on the perception of symptoms, based on symptom severity (e.g., related to a threshold level of severity of symptoms, related to fight-or-flight responses, etc ).
  • Eighth Section 336 also provides interactive exercises for learning about physiological-cognitive pathways for perceiving and responding to experienced symptoms and implements architecture for assessing stress and other disease aspects, with implementation of therapeutic techniques for changing reactivity of the brain, thereby decreasing symptom severity.
  • introduction and education module 301 includes a Ninth Section 338 configured for eliciting commitment from the patient, in relation to different set goals of the patient.
  • the digital content of Ninth Section 338 includes interactive elements for creating a reminder system (according to personalized user preferences and formats for receiving reminders), and interactive elements for setting goals to improve one or more aspects of dealing with the patient’s health condition (e.g., with a menu of choices as well as a field for custom user inputs and a field for prompting the user to confirm chosen goals, where example choices can include repeating of tasks, reviewing content, reflecting, identifying entities for social accountability, relocation of application icons on a home screen of a device in a manner that promotes regular use, identifying factors that may obstruct progress, etc.), where the interactive elements allow the patient to confirm when (e.g., specific times), how often, and where the patient will perform activities to meet such goals.
  • the term “physical illness narrative,” “personal illness narrative,” and/or “patient illness narrative” may include a narrative expressed by a patient regarding the patient’s personal experiences with a disease, disorder, and/or condition.
  • An illness narrative is typically a narrative solicited from a patient, which enables a healthcare practitioner to build a more complete picture of the patient’s past and present health state in the context of the patient’s life, while providing the patient with an opportunity for self-reflection and validation.
  • physical illness narrative module 304 provides a form of validation (being heard), highlights cognitive distortions/attentional biases and other clinically relevant processes to address, as well as begins the work of emotional exposure. It also provides a point of reference for reflection throughout and at the end of the program. Physical illness narrative module 304 promotes formation of a “personal disease model,” or “personal model” for users, such that they can identify patterns and/or cycles in their disease expression and/or progression, in relation to biology, behaviors, environment, stressors, emotions, and thoughts.
  • the term “personal model,” and/or “personal disease model” may include a construction built based on patient input, which enables the patient to identify stressors, counter-productive behaviors, unhelpful thoughts, and negative emotions as associated with the patient’s disease, disorder, and/or condition.
  • a personal model may be utilized to help a patient identify such links, and to consider possible changes in their behavior that could be implemented to address their symptoms.
  • second patient response data representing the patient’s responses to content provided to the patient through the second interactive therapy module is obtained, for example, through the user interface of the DTX system, or from a variety of patient devices, such as, but not limited to, sensors and/or biometric devices.
  • the DTX system then processes the second patient response data to generate physical illness narrative data, which can then be used for a variety of purposes.
  • the patient illness narrative data can be utilized to personalize an intervention regimen for the patient, as will be discussed in additional detail below.
  • the patient illness narrative data generated by physical illness narrative module 304 can also be utilized as the basis for formation of a personal model, such as personal model 303 of FIG. 3A, which can then be graphically represented to the user to aid in progression through the intervention regimen.
  • key functions of physical illness narrative module 304 can include creation of a patient’s personal model 303, validation of a patient’s experience, enhancement of self-understanding and illness comprehension, setting the stage for application of behavioral therapy skills to accept uncontrollable elements of physical illness and/or or increase proactivity to address controllable elements of physical illness, and generation of interest for patient engagement.
  • physical illness narrative module 304 prior to soliciting user input for creating a patient’s own personal model 303, introduces a patient to a process for creating a personal model 303, for example so as to orient them and provide content designed to offer helpful motivation.
  • graphical content representing educational material is displayed to a patient, for example to introduce them to concept of vicious cycles, and explain how symptoms, stress, and pain can create a feedback loop.
  • graphical content corresponding to shared patient experiences and/or testimonials is displayed.
  • viewing shared experiences from other patients may help prime a patient to be receptive to therapy, provide motivation, and foster a particular sense of therapy.
  • such content can serve to reinforce skills that lesson modules present to a patient, by allowing the patient to hear benefits of various lessons and/or skill practice from real patients.
  • testimonial content can comprise stories from patients describing their experiences living with a particular health condition and which behavioral therapy skills and/or lesson they found particularly helpful.
  • patients providing videos may be loosely coached, e.g., to structure, direct, etc. their stories in a particular way, while still allowing them to provide authentic, ‘from the heart’ descriptions of their experiences.
  • viewing relatable experiences from real patients can provide a patient with a helpful sense of not being alone in their experiences.
  • a patient may be prompted to read about another patient’s experiences with their condition and guided behavioral therapy approaches such as those described herein.
  • a patient may view exemplary personal models created by and shared by others.
  • screens comprising graphical content providing helpful encouragement are displayed within a GUI of the DTX system.
  • Other lesson modules for example any lesson modules described herein and/or additional lesson modules, providing for development of other behavioral therapy skills provided via the technologies described herein may also include content comprising patient experiences and/or testimonials.
  • FIG. 4 depicts an example of formation of a personal disease model, according to one or more embodiments.
  • physical illness narrative module 304 can receive patient report data (or other data) regarding the patient’s illness history (e.g., painful experiences in a clinical setting, such as with a clinician or hospital environment), thoughts (e.g., thoughts of guilt or responsibility for condition and behaviors, etc.), emotions (e.g., in relation to helplessness, feeling worthless, in relation to embarrassment, etc.), in order to address cognitive distortions for emotional exposure throughout subsequent interactions with the system.
  • patient report data or other data regarding the patient’s illness history (e.g., painful experiences in a clinical setting, such as with a clinician or hospital environment), thoughts (e.g., thoughts of guilt or responsibility for condition and behaviors, etc.), emotions (e.g., in relation to helplessness, feeling worthless, in relation to embarrassment, etc.), in order to address cognitive distortions for emotional exposure throughout subsequent interactions with the system.
  • physical illness narrative module 304 is used to implement, via a GUI of the DTX system, a structured process for conveniently soliciting patient input of specific counter-productive behaviors, unhelpful thoughts, and negative emotions that they identify, e.g., in their life and/or as associated with their particular condition for use in creating a patient’s own personal model 303.
  • physical illness narrative module 304 can include architecture for prompting the patient to provide data and/or automatically receiving data (e.g., through API access of health monitoring systems, through receiving of sensor signals of devices of the patient, etc.) pertaining to one or more aspects such as, but not limited to: pain symptoms, stress symptoms, behaviors and behavioral changes, and other aspects.
  • physical illness narrative module 304 may automatically return an analysis summarizing the personal model 303 of the patient (e.g., in a visual format, etc.). Such personalization thus promotes interruption of vicious cycles for patients.
  • the method 200A can include returning a mapping with a network of flows between a set of behaviors specific to the patient, a set of thought patterns specific to the patient, a set of physiological symptoms specific to the patient, a set of emotions specific to the patient, and environmental triggers specific to the patient, where returned outputs of models described can be configured to disrupt flows of the network contributing to deterioration of symptoms of the patient.
  • a personal model is constructed as a graphical representation, which comprises text corresponding to patient-selected counter-productive behavior(s), unhelpful thought(s), and negative emotion(s), superimposed on a flow diagram illustrating links between each other.
  • a personal model graphical representation comprises text corresponding to causes and/or stressors of symptoms. Examples of personal model graphical representations will be provided below in the discussion of the DTX user interface.
  • generation of a visual or graphical representation of a personal model 303 may include, retrieving, by the illness narrative module 304, stored information previously input by a patient.
  • a patient may have previously provided input identifying causes and/or stressors that impact their particular condition.
  • a patient provides input corresponding to causes and/or stressors associated with their particular condition via the physical illness narrative module 304.
  • a graphical representation of a partially completed personal model 303 is rendered, showing the patient identified causes and stressors superimposed on a flow diagram, with portions allocated for graphical representations of additional information such as counter-productive behaviors, unhelpful thoughts, and negative emotions, to be displayed.
  • the physical illness narrative module 304 includes graphical content prompting a patient to review their personal model 303.
  • a series of questions e.g., from a predefined list of questions, e.g., based on a therapeutic protocol
  • graphical content including passages of rendered text, mimicking conversation with a therapist can be displayed.
  • encouraging graphical content is displayed, and the patient is returned to a home screen.
  • delivery methods for the physical illness narrative module 304 can include audio format content and/or textual content for guiding exercises.
  • physical illness narrative module 304 may be a subcomponent of multiple modules, such that its content can be revisited. For instance, upon development of core skills associated with the modules, the system can trigger revisitation of aspects of physical illness narrative module 304 within the DTX system, such that patients can solidify new skills, reflect on their initial versions of their physical illness narrative and what has changed, generalize skills, maintain skills, and implement cognitive flexibility.
  • a relaxation module 306 provides a patient with understanding of what physiological stress feels like (e.g., with education on fight or flight responses) and recognition of the importance of actively optimizing their stress response, particularly because of the connection between stress reactivity, stress hormones and autonomic arousal, and flares in symptoms.
  • Relaxation module 306 informs the patient that (1) stress is a natural reaction and it causes its own physical symptoms (2) the brain does not differentiate between an event that is actually happening to us and an event that we only think is happening, and (3) the connection between stress and symptoms.
  • relaxation module 306 provides the patient with a rationale for each type of relaxation and how it is tailored for their specific stress symptoms, and provides guided relaxation exercises (e.g., through an application associated with the DTX system executing at the client device).
  • Relaxation module 306 promotes mastery of at least one relaxation technique.
  • Key functions of relaxation module 306 can include decreasing physiological reactivity associated with stress, worry, anxiety, and pain, activation (for depression symptoms), and stress management.
  • Delivery methods for relaxation module 306 can include audio format and/or visual content for guiding exercises associated with targeted muscle groups for progressive muscle relaxation, video-guided demonstration of diaphragmatic breathing, and haptic feedback for exercise guidance.
  • relaxation module 306 can include video format content that introduces the general concept of relaxation; educates the patient on the applicability of stressreduction exercises to specific health conditions, with active text boxes that promote user engagement and personalization of the module to the patient’ s specific symptoms and contexts; addresses common doubts or concerns about relaxation; promotes a guided breathing exercise with a diaphragmatic breathing demonstration and corresponding animated graphic; promotes guided exercises for muscle relaxation using progressive muscle relaxation (PMR) techniques using graphical animations (e.g., of targeted muscle groups); provides information on how relaxation practices can be used (e.g., for abdominal pain, for anxiety, for other stressors, etc ), and encourages practice of exercises by including active interactive elements that the patient can use for scheduling and/or accountability in practicing exercises.
  • PMR progressive muscle relaxation
  • behavior change and avoidance module 308 provides content covering the importance of activation and approaching avoided situations/experiences in breaking the cycle of persistent tinnitus symptoms and depressive and/or anxious mood.
  • Specific action plans are developed for decreasing avoidance behavior.
  • Key functions of this module can include linking behaviors and mood, mood monitoring (e.g. self-monitoring), activity scheduling, identifying and counteracting avoidance behavior, action planning, activity scheduling, creating anxiety hierarchies, self-monitoring, behavioral experiments, exposure (e.g., imaginal exposure, actual exposure to counteract anxiety) and systematic desensitization for anxiety, coping performance, confidence building, and routine building.
  • Delivery methods for behavior change and avoidance module 308 can include use of automated tailoring for choosing topics that have greater relevance to a patient's current problems (e.g., if a patient reports anxiety, information about physiological responses of anxiety and their relationship with thoughts and behaviors would be more appropriate than information about the physiological symptoms of depression or generic stress).
  • problem solving and coping module 310 provides content covering howto differentiate controllable vs. uncontrollable stressors, problem- focused coping (e.g., with problem identification, solution brainstorming, evaluation of solution options, etc.) vs. emotion-focused coping (e.g., with grounding exercises), as well as types of adaptive and maladaptive coping. Mood/anxiety/stress may be managed/ameliorated by using externally- focused coping to distressing and modifiable conditions and internally-focused coping to adjust one’s expectations and interpretations for unmodifiable conditions.
  • problem solving and coping module 310 can include architecture and instructions for promoting practicing of problem solving and coping methods by the patient, such that the patient is better able to handle stronger symptoms (and milder symptoms).
  • Delivery methods for problem solving and coping module 310 can include digital content with explanations and testimonials of other patients and their uses of problem solving skills, peer support groups facilitated by the DTX system, and other delivery methods.
  • tinnitus management module 312 focuses on awareness of the pain experience, discusses how pain influences mood and vice versa, promotes recognition of certain behaviors (e.g., overactivity, avoidance) and automatic thoughts that may influence pain as well as how to feel more in control of pain by also improving physical and role functioning though increasing adaptive behaviors/coping (attention) and decreasing avoidance/maladaptive behaviors.
  • Key functions of tinnitus management module 312 can include behavioral experimentation, behavior substitution, acceptance of pain, and self-monitoring, with one or more disease-or-syndrome-specific targets.
  • tinnitus management module 312 can include architecture and content for educating patients regarding re-directing attention away from tinnitus symptoms by focusing on parts of the body that are not in pain, and other methods.
  • the system can include a processor with instructions stored in non-transitory media that when executed, perform operations for identifying when a patient is experiencing symptoms of tinnitus, and triggering a response (e.g., verbal cues and instructions to modify attention and/or engage in various tinnitus observation exercises, a change in the environment of the patient, by playing music, by activating a display and providing video or image content, by providing haptic stimulation to the patient, etc.).
  • a response e.g., verbal cues and instructions to modify attention and/or engage in various tinnitus observation exercises, a change in the environment of the patient, by playing music, by activating a display and providing video or image content, by providing haptic stimulation to the patient, etc.
  • delivery methods for tinnitus management module 312 can include audio format content and/or textual content for managing tinnitus (e.g., with music, exercise, etc.) and/or for promoting attention restructuring.
  • cognitive restructuring and flexibility module 314 targets one’s interpretations of events/experiences (e.g., how core thoughts influence our feelings and behavior).
  • Cognitive restructuring and flexibility module 314 emphasizes connections between thoughts and physical sensations due to a variety of symptoms.
  • the aim of cognitive restructuring and flexibility module 314 is to teach patients how to identify unhelpful automatic thinking patterns and develop a new pattern of realistic, balanced, and flexible thinking.
  • a health behavior change is targeted in the area of sleep and worry by providing education about worry and how it might interfere with sleep.
  • Strategies to manage worry before bedtime e.g., use a relaxation practice are provided as well as basic sleep hygiene.
  • Cognitive restructuring and flexibility module 314 can include resetting of cognitive distortions (e.g., about self, others, and the world), identification of unhelpful thoughts, challenging of automatic thoughts, creating more balanced thoughts, re-attribution, appraisals of moods, and improving cognitive flexibility.
  • Delivery methods for cognitive restructuring and flexibility module 314 can include a tool providing digital content for reassembling a traditional thought record in which patients enter an unhelpful automatic thought and select from a list of negative thoughts that best matched. After selecting from a list of most common automatic thoughts, the tool can generate a list of possible challenge/alternative thoughts. The patient can then input their own personalized challenge/alternative thought.
  • social problem solving and communication module 316 provides content promoting effective social behaviors in the context of a variety of health conditions.
  • Social problem solving and communication module 316 can provide tools for one or more of: action planning, social skills training, social support, exposure, and activation, with identification of oneself as a role model, and presentation of information regarding vicarious consequences.
  • social problem solving and communication module 316 is intended to assist interactions between patients and their social environment in the context of their health condition(s), and how to communicate effectively about the medical condition/disease.
  • Some examples include requesting support in college (disability services office) or at work; informing a patient that his/her behavior may be an example to others; and problem solving about tinnitus related challenges and worries.
  • Key functions of social problem solving and communication module 316 can include activation and action planning, problem solving by analysis of factors influencing the behavior and generating strategies to overcome barriers, demonstrating one’s ability to cope, decreasing avoidance behaviors, ensuring practice of new coping skills, when symptoms are more severe (e.g., with behavioral rehearsal, etc.).
  • Delivery methods for social problem solving and communication module 316 can include digital content with testimonials of other patients and their uses of problem solving, peer support groups facilitated by the DTX system, and other delivery methods.
  • social problem solving and communication module 316 can include architecture for triggering actions based on detected changes in symptoms. For instance, in one example, social problem solving and communication module 316 can process data generated by interactions between the user and the system (e.g., with sensor-based monitoring of symptom progression, with user input-based monitoring of symptom progression, etc ), and based upon the data, generate control instructions for recommended actions that would improve social problem solving ability.
  • Examples of recommended actions can include one or more of: guidance for conducting a conversation regarding symptoms (e.g., example language for communicating pain or other-related symptoms to an entity, so that the user can experience relief, etc.); triggering automatic communications between the patient and an entity (e.g., automatically sending a private message to a teacher so that the teacher can excuse the patient to manage tinnitus-related and/or other symptoms); and performing other suitable actions.
  • symptoms e.g., example language for communicating pain or other-related symptoms to an entity, so that the user can experience relief, etc.
  • triggering automatic communications between the patient and an entity e.g., automatically sending a private message to a teacher so that the teacher can excuse the patient to manage tinnitus-related and/or other symptoms
  • performing other suitable actions e.g., guidance for conducting a conversation regarding symptoms (e.g., example language for communicating pain or other-related symptoms to an entity, so that the user can experience relief, etc.); triggering automatic communications between the patient and an entity (e.
  • relapse prevention and skills maintenance module 318 encourages maintenance/continuation of treatment gains, and reinforces positive changes in thoughts and behavior that were accomplished during the active treatment time.
  • Key functions of relapse prevention and skills maintenance module 318 can include skills generalization, skills maintenance, and adaptive monitoring to refresh skills learned. Additionally, relapse prevention and skills maintenance module 318 can perform one or more of: informing patients of signs of relapse into old patterns, development of specific proactive coping tools for future challenges, encouragement of proactive coping for mood regulation, explaining perseverance, education regarding sequential coping strategies, and identification of skills/techniques that were most effective for the user, based on analysis of user outcomes. Delivery methods for relapse prevention and skills maintenance module 318 can include digital content and/or notifications related to monitored states of the patient (e.g., related to relapse) as described in further detail below. Symptom Diary and Trigger Tracking Module 321
  • an intervention regimen may include a symptom diary module that introduces and familiarizes a patient with techniques for tracking their tinnitus condition symptoms and identifying tinnitus triggers.
  • technologies described herein provide a convenient interface that facilitates patient tracking and/or monitoring of their tinnitus condition symptoms on a regular basis.
  • a patient may use utilize the DTX system disclosed herein to rate tinnitus and stress on a scale and provide information characterizing their daily routines.
  • symptom diary and trigger tracking module 321 may include features providing options for setting goals, for example, goals pertaining to a regular timing and/or type of non-triggering alternative ( .g., regular consumption of meals, e.g., of a particular and/or consistent size and/or at a particular and/or consistent time) and/or activity (e.g., physical exercise, meditation, breathing and/or relaxation exercises, reflection exercise, e.g., including skills introduced via lesson modules and/or practicable via interaction with one or more other practice modules, such as keeping a regular symptom diary, e/c.).
  • a regular timing and/or type of non-triggering alternative .g., regular consumption of meals, e.g., of a particular and/or consistent size and/or at a particular and/or consistent time
  • activity e.g., physical exercise, meditation, breathing and/or relaxation exercises, reflection exercise, e.g., including skills introduced via lesson modules and/or practicable via interaction with one or more other practice modules, such as keeping a regular
  • daily activities with associated tinnitus symptoms may be characterized via use of a streamlined tracking interface.
  • conventional tracking tools typically allow users to input a wide array of information, including detailed information characterizing types of activities that may trigger tinnitus episodes.
  • approaches described herein provide a streamlined tracking interface that expressly limits a range of user input and avoids allowing a user to input detailed information regarding daily activities and known/potential tinnitus associations.
  • tinnitus condition symptom tracking may not necessarily be of utmost importance for tinnitus condition symptom tracking.
  • less finely grained information such as a broad categorization of activity (e.g., meals, sleep, exercise, interactions, stressors), and a particular time at which the activity occurred mapped against tinnitus histories can provide sufficient information for tracking tinnitus triggers and/or evaluating tinnitus condition symptoms, in the context of daily activities and/or identifying patterns.
  • this approach may facilitate user input of activities information, and can improve adherence to treatment protocols. Moreover, beyond facilitating treatment protocol adherence, without wishing to be bound to any particular theory, this approach encompasses recognition that patients suffering from certain tinnitus conditions and associated mental health conditions, such anxiety and/or depression, can suffer from unhelpful thoughts and compulsive behavior, which conventional, overly complex activity trackers may exacerbate. Accordingly, among other things, by providing, in some embodiments, a streamlined activity tracking approach, technologies described herein can address unique challenges associated with a particular patient population.
  • the digital therapeutics (DTX) system described herein can include mechanisms to facilitate a patient’s adherence to one or more particular non-behavioral therapies, such as dosing regimens of pharmaceutical compositions, nutraceutical compositions, and/or therapies involving use of medical devices.
  • various lesson modules and/or practice modules, as described herein may include features that allow a patient to track their adherence to medication.
  • medication adherence module 323 may include features that provide for patient input (e.g., via one or more graphical widgets) of when and what medication the patient took. Tracking features such as these may serve as a helpful reminder to the patient to actually take their medication.
  • tracking features may allow identification of patterns related to a patient’s medication regimens, such as benefits with respect to symptom improvement conferred by adherence to a regimen and/or symptoms and/or activities that are associated with degree to which the patient adheres to a medication regimen.
  • medication adherence module 323 may provide features for setting goals pertaining to adherence to medication.
  • goals pertaining to medication adherence may include goals relating to a timing and/or particular type of medication, such as adherence to a regular schedule and/or timing of a particular medication.
  • medication adherence goals may include timing of a particular medication in relation to symptoms (e.g, of a user physiological condition) and/or other events, such as relative to meal consumption, physical exercises, seasons, social gatherings, travel, work, etc.
  • guided behavioral therapy technologies described herein may provide alerts, such as in-app pop up messages, push notifications, digital calendar integration, email/text message reminders, and the like, that facilitate medication adherence. Such notifications may include, for example, reminders to take particular medications.
  • the DTX systems and methods as described herein may provide for communication between a patient and one or more external medication tracking devices, as will be discussed in additional detail below.
  • guided behavioral therapy technologies described herein may also provide content (e.g, graphical content, e.g., presented within a GUI, such as those described herein) that explains and/or educates a user about one or more particular medications that they are taking.
  • medication adherence module 323 may be a standalone module, or may be included in the DTX system as part of another module, such a daily symptom diary and trigger tracking module 321 discussed above.
  • exercises associated with the intervention regimen can include one or more of: a card sorting task to identify a patient’s reinforcers/motivators (e.g., in relation to social reinforcers, reminders, accountability, gaming/competition, responsiveness to quantitative summary feedback, monetary incentives, altruism, learning, elimination of symptoms, etc.); computerized performance tasks (e.g., delayed discounting) to measure/identify salient reinforcers and/or learning style; and performance tasks (e.g., validated distress tolerance computer tasks, tasks associated with mimicked social interactions, etc.) to measure emotional awareness and ability to tolerate various types of distress (psychological, physical, etc.).
  • a card sorting task to identify a patient’s reinforcers/motivators (e.g., in relation to social reinforcers, reminders, accountability, gaming/competition, responsiveness to quantitative summary feedback, monetary incentives, altruism, learning, elimination of symptoms, etc.); computerized performance tasks (e.g., delayed discounting) to measure/identify salient reinforcer
  • modules are described in a particular order, it should be noted that the modules can be performed in any other suitable sequence, omit operations, and/or include additional operations (e.g., based on refinement and training of models described below, and/or based on other factors). Furthermore, aspects of the modules can overlap with each other in any suitable manner.
  • method flow proceeds to operation 215.
  • the one or more non-behavioral therapy components are administered to the patient in combination with the one or more behavioral therapy components according to the personalized intervention regimen generated for the patient.
  • administering therapies according to an intervention regimen can further include administration of other types of interventions, such as those including non-behavioral therapy components, in combination with interventions that include behavioral therapy components, by way of the online system in coordination with other devices, where monitoring of performance of activities with such interventions is described below.
  • non-behavioral therapy components can include one or more of: treatments utilizing one or more pharmaceutical compositions, nutraceutical compositions, medical devices, diagnostic devices, physical activities, mind-body interventions, whole system medicine, acupuncture, magnets, surgeries, and combinations thereof.
  • some therapies can be administered via a variety of routes, such as, but not limited to, ocular, oral, parenteral, topical, bronchial (e.g., by bronchial instillation), buccal, dermal (which may be or comprise, for example, one or more of topical to the dermis, intradermal, interdermal, transdermal, etc.), enteral, intra-arterial, intradermal, intragastric, intramedullary, intramuscular, intranasal, intraperitoneal, intrathecal, intravenous, intraventricular, within a specific organ (e.g., intrahepatic), mucosal, nasal, oral, rectal, subcutaneous, sublingual, topical, tracheal (e.g., by intratracheal instillation), vaginal, and vitreal.
  • routes such as, but not limited to, ocular, oral, parenteral, topical, bronchial (e.g., by bronchial instillation), buccal,
  • administration may be performed via a medical device such as, for example, bimodal stimulation devices, bimodal neuromodulation devices, brain stimulation therapies, tinnitus masking devices, tinnitus retraining devices, hearing aids, and combinations thereof.
  • therapies can be self-administered by patients, for example, in the case of therapies involving physical exercise or mind-body interventions.
  • method flow proceeds to operation 216.
  • the patient’ s interactions with the one or more behavioral therapy components and the one or more non-behavioral therapy components are monitored remotely in near real-time to generate patient interaction data.
  • an embodiment of the online system in coordination with the network and a client device, can monitor the patient’s interactions with the behavioral and non-behavioral therapy components contemporaneously with administration of the intervention regimen.
  • Monitoring patient interactions functions to provide intimate understanding of progress of the patient in achieving health goals, and to provide further personalization of and administration of intervention content at appropriate times, in order to maintain or improve progress of the patient.
  • Monitoring is preferably performed in near-real time or real time, such that actions can be taken to adjust interventions to patient states according to just-in-time adaptive intervention (J1TAI) protocols.
  • J1TAI just-in-time adaptive intervention
  • monitoring can be performed with any suitable delay (e.g., in relation to achieving better accuracy of assessed states of the patient).
  • monitoring can be performed using survey components, such as the patient reported outcome instruments described above, which may be delivered with interactive interventions of the intervention regimen, where the patient is prompted and provided with interactive elements that allow the patient to provide self-report data indicating progress statuses.
  • Monitoring can additionally or alternatively be performed with processing of other non-survey data streams, where the non-survey data streams are associated with system or device usage metrics, social networking behavior extracted from usage of social networking platforms and communication platforms, sensor-derived data, and/or other data. Monitoring can thus occur with any frequency and/or level of intrusiveness.
  • operation 216 can process monitoring data (e.g., real time data, non-real time data, dynamic data, static data) with a predictive model that outputs indications of one or more of symptom severity predictions, predictions of patient states, indications of predicted success of the patient in achieving goals, and/or other predictions, where training of the predictive model with training sets of data is described in additional detail below.
  • monitoring data e.g., real time data, non-real time data, dynamic data, static data
  • a predictive model that outputs indications of one or more of symptom severity predictions, predictions of patient states, indications of predicted success of the patient in achieving goals, and/or other predictions, where training of the predictive model with training sets of data is described in additional detail below.
  • ecological momentary assessments of the patient can be used for monitoring.
  • client device usage parameters can be used for monitoring.
  • client device usage parameters can include frequency of application switching, duration of time spent in association with each application login, screen time parameters, data usage associated with different applications and/or types of applications (e.g., social networking, creative, utility, travel, activity-related, etc.) executing on the client device of the patient, time of day of application usage, location of device usage, and other client device usage parameters.
  • applications e.g., social networking, creative, utility, travel, activity-related, etc.
  • the system can process voice data and/or text communication data of the patient for monitoring and modifying interventions and program aspects.
  • voice data can include voice sampling data from which emotional states can be extracted using voice processing models.
  • natural language processing of textual data e.g., from communication platforms, from social networking platforms
  • the client device can be used to provide context for behaviors of the patient and/or assess emotional or cognitive states of the patient.
  • electronic health record data can be used for monitoring.
  • the online system can be configured to receive a notification providing information regarding the type of care the patient has received, and to use this data for monitoring statuses of the patient.
  • the system can include architecture for processing data from other sensors of the client device, devices in the environment of the patient, and/or wearable computing devices can be used for monitoring.
  • device data can include activity data, location data, motion data, biometric data, and/or other data configured to provide context to behaviors associated with the health condition of the patient.
  • motion data from motion of sensors of the client device can indicate that the user is sedentary, and may be experiencing symptoms that can be addressed with components of the intervention regimen.
  • device usage data can indicate that the patient has been using a particular device (e.g., a tablet device in proximity to the patient, where use does not require extensive motion of the patient), in a fixed location (e.g., from GPS data), and in a prone position (e.g., from motion chip data), and may be experiencing health condition symptoms that can be addressed with components of the intervention regimen.
  • a particular device e.g., a tablet device in proximity to the patient, where use does not require extensive motion of the patient
  • a fixed location e.g., from GPS data
  • a prone position e.g., from motion chip data
  • the DTX systems and methods as described herein may provide for communication between a patient and one or more external medication tracking devices, such as a smart pill packet, smart pill bottle, etc.
  • external medication tracking devices such as a smart pill packet or smart pill bottle may communication with and provide data to a cloud-based system to indicate, for example, if/when/how often a patient takes their medication.
  • technologies described herein may receive updates from the cloud-based system to track the patient’s taking of their medication.
  • An application may, for example, use received updates to check that a patient is adhering to their medication schedule, goals, etc., and present reminders accordingly.
  • technologies described herein may provide for other approaches of communication, e.g., directly, with external medication devices, for example wirelessly, e.g.. over a wireless network, via Bluetooth®, and the like.
  • monitoring the patient’s interactions with the behavioral and non-behavioral therapy components includes obtaining one or more of patient physiological health data; patient psychological health data; patient condition data; patient symptoms data; patient medications data; patient medication adherence data; patient progress report data; patient system usage data; patient device usage data; patient social networking behavior data; patient voice data; patient textual data; patient activity data; patient location data; patient motion data; and patient biometric data.
  • active monitoring of patient states can be used to adjust administration of intervention regimen modules in order to appropriately meet the needs of the patient.
  • Other data and combinations of data can, however, be used for monitoring.
  • method flow proceeds to operation 218.
  • the patient interaction data is processed by the DTX system to generate intervention modification data representing recommended modifications to the patient’s personalized intervention regimen.
  • the recommended modifications to the patient’s personalized intervention regimen include recommended modifications to aspects of the behavioral therapy components of the regimen, based on processing of patient interaction data representing patient interactions with the behavioral therapy components of the regimen, wherein the patient interaction data is generated by the monitoring operation 216, as discussed above.
  • operation 218 functions to generate recommendations for further customization of the behavioral therapy components of the intervention regimen, in order to improve personalization of delivered content to meet the needs of the patient, in an adaptive manner.
  • Operation 218 can also function to generate recommendations for increasing engagement between the patient and the intervention regimen, in order to improve effectiveness of provided treatments and increase the chances of success of the patient in achieving their goals.
  • the invention is implemented as a stand-alone therapeutic program to treat tinnitus in an adaptive manner that adjusts to focus on modules and education responsive to the current needs and difficulties currently identified by the digital therapeutics system based on user activities and responses.
  • This can be accomplished by the program interacting with the user, or, in other embodiments, the program may send and/or receive share data with various third party sources, such as electronic health records, and/or may integrate healthcare personnel input.
  • behavioral therapy components of the intervention regimen may include a plurality of interactive therapy modules.
  • recommendations for modifying aspects of the behavioral therapy components of the patient’s personalized intervention regimen can include one or more recommendations, such as, but not limited to: adjusting the order of administration of the behavioral therapy components; adjusting the frequency of administration of the behavioral therapy components; adjusting the mode of administration of the behavioral therapy components; adjusting the content of the behavioral therapy components; adjusting the content size of the behavioral therapy components; adjusting the presentation of the behavioral therapy components; adjusting the layout of the behavioral therapy components; updating the patient’s electronic health records (EHRs); updating the patient’s personal health records (PHRs); updating the patient’s open medical records, for instance by writing to or modifying records whenever new information is generated regarding the user/patient.
  • EHRs electronic health records
  • PHRs personal health records
  • recommendations for modifying aspects of the behavioral therapy components of the patient’s personalized intervention regimen can include recommendations for providing features for increasing engagement and optimal learning.
  • specific descriptions self-reported by the patient can be used in subsequent portions of the intervention regimen to increase personalization of the intervention to drive engagement.
  • features for increasing engagement and optimal learning can include features that mimic therapist/healthcare provider, or social group interactions (e.g., patient testimonials, clinician video content, etc.).
  • features for increasing engagement and optimal learning can include features that link the patient’s specific current problems and/or challenges faced by the patient as a trigger to notify the patient to interact with content of the intervention regimen and recommend appropriate skill for improving health states.
  • the recommended modifications to the patient’s personalized intervention regimen include recommended modifications to aspects of the non-behavioral therapy components of the regimen, based on processing of patient interaction data representing patient interactions with the non-behavioral therapy components of the regimen, wherein the patient interaction data is generated by the monitoring operation 216, as discussed above.
  • recommendations for modifying aspects of the non-behavioral therapy components of the patient’s personalized intervention regimen can include one or more recommendations, such as, but not limited to: adjusting the order of administration of the non- behavioral therapy components; adjusting the frequency of administration of the non-behavioral therapy components; adjusting the mode of administration of the non-behavioral therapy components; adjusting the content of the non-behavioral therapy components; adjusting the dosage amount of the non-behavioral therapy components; and adjusting the dosage schedule of the non-behavioral therapy components.
  • a dosage amount of the non-behavioral therapy treatment may be based upon the state of the patient’s health condition symptom severity.
  • a dosing schedule for administration of a non-behavioral therapy may be relative to a schedule for administration of the behavioral therapy.
  • Such recommendations regarding amount and/or dosing may be absolute and/or relative to other events and/or activities.
  • recommendations may comprise a particular schedule of dosage, e.g., a particular rate, timing (e.g., in a morning, afternoon, or evening), etc.
  • Recommendations regarding timing may include timings and/or amounts relative to other activities, such as meal consumption, physical exercises, seasons, social gatherings, travel, work, etc.
  • adjusting an amount of the non-behavioral therapy can include correspondingly adjusting an amount of a behavioral therapy treatment provided to the patient, thereby titrating relative treatment types provided to the patient based upon returned outputs of models associated with the methods described.
  • dosage recommendations provided via the approaches described herein are restricted to fall within a pre-defined range, for example as specified by a physician.
  • dosage recommendations provided by technologies (e.g., systems and methods) described herein comprise an identification of one or more specific symptoms, so as to provide recommendation to discuss particular symptoms with a medical professional, such as a physician and/or therapist (e.g., to discuss particular changes to medication regimens and/or types of medication, so as to best manage particular symptoms).
  • recommendations may be generated via use of one or more machine learning modules that receive, as input, data corresponding to patient symptom and/or habits, as tracked by various modules such as those described herein. In some embodiments, this information is used as feedback, to refine and dynamically update parameters of machine learning modules.
  • one or more notifications are issued to a computing device accessible to one or more health practitioners associated with the patient (e.g., nurses, physicians, dieticians, therapists, etc., who may be registered to view patient updates with a secure hub).
  • one or more notifications are issued to a patient computing device, for example, through the DTX system disclosed herein, and/or via an out-of-app notification, such as text message, push notification, email, calendar reminder, etc.
  • the one or more notifications include options and/or recommendations for modifications to the patient’s personalized intervention regimen, for the patient to discuss with their healthcare practitioner
  • the one or more notifications include identification of activities, behaviors, and/or symptoms of the patient.
  • the one or more notifications include options and/or recommendations for new therapies and/or potential adjustments to current therapies being administered to the patient.
  • the options and/or recommendations are based on potential compatibility of new and/or modified therapies with the identified activities, behaviors, and/or symptoms of the patient.
  • options and/or recommendations may include adjusting aspects of the patient’s intervention regimen, such that it is compatible with the patient’s physical exercise, travel, work, etc.
  • the one or more notifications include options and/or recommendations for one or more tests for the patient to complete (e.g., blood test, ultrasound.)
  • the one or more notifications include alerts and/or reminders to the patient to self-administer at least a portion of a therapy.
  • a notification may be a reminder to take a particular pharmaceutical composition and/or a particular nutraceutical composition and/or a notification may be a reminder to use a medical device for a prescribed period of time according to a particular therapeutic regimen.
  • method flow proceeds to operation 220.
  • aspects of the behavioral therapy and/or the non-behavioral therapy components defined by the patient’s personalized intervention regimen may be modified based on the intervention modification data.
  • an embodiment of the online system in coordination with the network and a client device can, based on the intervention modification data, perform one or more actions to dynamically modify aspects of the behavioral therapy and/or the non-behavioral therapy components defined by patient’s personalized intervention regimen.
  • dynamically modifying aspects of the behavioral and non- behavioral therapy components of the patient’s personalized intervention regimen includes one or more of: adjusting the order of administration of the behavioral therapy components; adjusting the order of administration of the non-behavioral therapy components; adjusting the frequency of administration of the behavioral therapy components; adjusting the frequency of administration of the non-behavioral therapy components; adjusting the mode of administration of the behavioral therapy components; adjusting the mode of administration of the non-behavioral therapy components; adjusting the content of the behavioral therapy components; adjusting the content of the non- behavioral therapy components; adjusting the content size of the behavioral therapy components; adjusting the dosage amount of the non-behavioral therapy components; adjusting the dosage schedule of the non-behavioral therapy components; adjusting the presentation of the behavioral therapy components; adjusting the layout of the behavioral therapy components; updating the patient’s electronic health records; updating the patient’s personal health records; updating the patient’s open medical records; and increasing personalization of the intervention regimen.
  • dynamically modifying aspects of the patient’s personalized intervention regimen to promote patient engagement can be done using one or more of: artificial reality tools (e.g., augmented reality platforms, virtual reality platforms) for reducing depression, anxiety, pain, and/or other symptoms; artificial intelligence-based coaching elements for driving interactions with the patient; smart assistants (e g., AlexaTM, SiriTM, GoogleTM Assistant, etc.) for assisting the patient in relation to task management, gamification elements within intervention regimen-associated applications executing on the client device; gamification elements of other devices (e g., smart toilet devices having interactive elements, such as buttons that control flushing and other subsystems, for promoting triggering of stool sample tracking in relation to various symptoms); smart pill devices and/or medication-dispensing devices that provide insights in an engaging manner in coordination with intervention regimen modules; adjustment of reinforcement schedules (e.g., in relation to reward sensitivity, positive reinforcement, negative reinforcement, etc.) for providing intervention regimen content to the patient; and other elements for increasing engagement.
  • artificial reality tools e.g., augmented
  • features for modifying, updating, and/or personalizing the intervention regimen, as well as for promoting engagement with the intervention regimen can be delivered within modules of the intervention regimen before, during and/or after monitoring of the patient at operation 216.
  • the patient’ s personalized intervention regimen is modified dynamically, in near-real time, based on the intervention modification data generated at operation 218.
  • method flow may return to operation 214 to continue administering the intervention according to the modified personalized intervention regimen.
  • method flow proceeds to END operation 222, and the method 200A for treating tinnitus conditions using digital therapeutics in combination with other therapies is exited to await new instructions.
  • FIG. 2B depicts a flowchart of a method 200B for providing adaptive interventions for tinnitus conditions, according to one or more embodiments.
  • method 200B begins at BEGIN 224, and method flow proceeds to operation 226.
  • operation 226 a pre-assessment of a patient exhibiting one or more tinnitus condition symptoms is performed.
  • an embodiment of the online system in coordination with the network and a client device, can perform operation 226, performing a pre-assessment of a patient exhibiting one or more tinnitus symptoms, contemporaneously with executing an onboarding process with the patient with the online system.
  • Operation 226 functions to retrieve data describing characteristics of the patient, preferences of the patient, goals of the patient and/or any other suitable patient features that can be used to provide adaptive interventions in a customized and personalized manner, in order to promote user engagement with the intervention regimen(s) described in subsequent operations of the method 200B.
  • operation 226 can include preassessing and onboarding patients and assessing characteristics including one or more of: demographics (e.g., genders, ages, familial statuses, residential location, ethnicities, nationalities, socioeconomic statuses, sexual orientations, etc.), household situations (e.g., living alone, living with family, living with a caregiver, etc.), dietary characteristics (e.g., omnivorous, vegetarian, pescatarian, vegan, reduced carbohydrate consumption, reduced acid consumption, gluten-free, simple carbohydrate, or other dietary restrictions, etc.), levels of activity, levels of alcohol consumption, levels of drug use, psychological symptom severity, levels of mobility (e.g., in relation to distance traveled in a period of time), biomarker statuses (e.g., fecal calprotectin, cholesterol levels, lipid states, blood biomarker statuses, etc.), weight, height, body mass index, genotypic factors, durations of mindfulness (e g., mindful minutes), e., mindful minutes, etc.
  • the pre-assessment and/or onboarding process performed in operation 226 can identify the patient as having tinnitus symptoms such as, but not limited to, perception of one or more sounds by the patient, wherein the one or more sounds are not present in an external environment of the patient, and/or any other suitable symptoms.
  • a set of signals can encode physiological data, behavioral data, environmental stress data, emotional data, and cognitive data of the user, from the pre-assessment, health record access, API access of health monitoring systems, and/or biometric sensors. Furthermore, such signals can be collected repeatedly throughout performance of the methods described, as will be discussed in additional detail below.
  • the pre-assessment can be configured to receive information regarding (or automatically detect, or automatically extract, based upon symptoms, etc.) the subtype(s) of a tinnitus disorder a patient has, in order to prioritize relevant content provided to the patient, in the interests of customizing the program.
  • Subtype identification can, however, be assessed outside of the pre-assessment of operation 226.
  • digital therapeutics (DTX) provided by the method 200B and system 100AA can be provided as monotherapies, or as complementary therapies.
  • complementary therapies for tinnitus can include one or more therapies, such as, but not limited to: treatments utilizing one or more pharmaceutical compositions; treatments utilizing one or more nutraceutical compositions; treatments utilizing one or more medical devices; treatments utilizing one or more diagnostic devices; treatments utilizing one or more physical activities; treatments utilizing one or more mind-body interventions; treatments utilizing whole system medicine; treatments utilizing acupuncture; treatments utilizing magnets; and treatments utilizing one or more surgeries.
  • therapies such as, but not limited to: treatments utilizing one or more pharmaceutical compositions; treatments utilizing one or more nutraceutical compositions; treatments utilizing one or more medical devices; treatments utilizing one or more diagnostic devices; treatments utilizing one or more physical activities; treatments utilizing one or more mind-body interventions; treatments utilizing whole system medicine; treatments utilizing acupuncture; treatments utilizing magnets; and treatments utilizing one or more surgeries.
  • operation 226 of method 200B includes a method of determining severity of an associated condition.
  • FIG. 5 A depicts a flowchart of a process for determining severity of an associated condition, according to one or more embodiments.
  • FIG. 5B depicts examples of a process for determining severity of a tinnitus condition, according to one or more embodiments.
  • the process 500 can include operation 501 for calculating levels of a tinnitus condition-associated marker to identify the user (e.g. the patient), as having a certain state of severity (e.g., expression, phenotype, etc.) of the tinnitus condition.
  • operation 501 of FIG. 5 can include operation 501 for calculating levels of a tinnitus condition-associated marker to identify the user (e.g. the patient), as having a certain state of severity (e.g., expression, phenotype, etc.) of the tinnitus condition.
  • 5A can be implemented through a DTX system executing on a mobile device or other device associated with the user, where a user interface of the DTX system prompts inputs from the user pertaining to various symptoms (e.g., tinnitus severity, energy levels, cognitive symptoms, behavioral effects, etc.) and generates a report indicating severity of the tinnitus condition as shown in FIG. 5B.
  • various symptoms e.g., tinnitus severity, energy levels, cognitive symptoms, behavioral effects, etc.
  • the process 500 shown in FIG. 5 A can then include operation 502, administering a treatment (e.g., monotherapy, complementary therapy) to the user having the state of severity, where the treatment comprises one or more of the therapies described.
  • a treatment e.g., monotherapy, complementary therapy
  • the process 200B can include adjusting (e.g., decreasing, increasing, maintaining) an amount of a non-behavioral therapy treatment provided to the user based upon the state of severity, and/or correspondingly adjusting (e.g., decreasing, increasing, maintaining) an amount of a behavioral therapy treatment provided to the user, thereby titrating relative treatment types provided to the user based upon returned outputs of models associated with the methods described.
  • a treatment cocktail can include digital therapeutic aspects and non-digital therapeutic aspects.
  • the pre-assessment and/or onboarding process performed in operation 226 can identify mental health statuses of the patient, in relation to comorbid or non-comorbid conditions (e.g., associated with anxiety, associated with depression, associated with social behavior, etc.), where the intervention regimen described in more detail above can be configured to improve mental health states of the patient in a timely and adaptive manner.
  • the DTX systems and methods described herein may be used to treat, ameliorate, prevent, or reduce the likelihood of developing one or more comorbidities associated with tinnitus in a patient.
  • the one or more comorbidities associated with tinnitus and treated using the DTX systems and methods described herein include, but not limited to a generalized anxiety disorder, a social anxiety disorder, a depressive disorder, an attention deficit hyperactivity disorder, an obsessive compulsive disorder, a post- traumatic stress disorder, an eating disorder, a substance use disorder, an anhedonia disorder, a cardiovascular disease, a sleep disorder, chronic fatigue, hypertension, asthma, gastroesophageal reflux disease, functional dyspepsia, and/or any other suitable comorbidities.
  • a generalized anxiety disorder a social anxiety disorder, a depressive disorder, an attention deficit hyperactivity disorder, an obsessive compulsive disorder, a post- traumatic stress disorder, an eating disorder, a substance use disorder, an anhedonia disorder, a cardiovascular disease, a sleep disorder, chronic fatigue, hypertension, asthma, gastroesophageal reflux disease, functional dyspepsia, and/or any other suitable
  • related data can include psychological and/or disease symptom/clinical profile data that informs selection of high priority therapy components, where examples include data such as, but not limited to: illness-related ruminations being predominant; symptoms triggered by anticipatory tinnitus; sources of motivation; reward sensitivity (e.g., sensitivity associated with drive and reward responsiveness (e.g., using a BIS/BAS assessment tool); and threat sensitivity.
  • reward sensitivity e.g., sensitivity associated with drive and reward responsiveness (e.g., using a BIS/BAS assessment tool)
  • threat sensitivity e.g., sensitivity associated with drive and reward responsiveness (e.g., using a BIS/BAS assessment tool)
  • threat sensitivity e.g., threat sensitivity.
  • the method 200B can include receiving a reward sensitivity dataset characterizing motivation and reinforcement behavior of the user, and modulating aspects of the treatment upon processing the reward sensitivity dataset with one or more models described.
  • the pre-assessment and/or onboarding process performed in operation 226 can identify user preferences associated with scheduling of content delivery (e.g., in relation to frequencies of content delivery described above) associated with one or more aspects of the intervention regimen, preferred formats (e.g., visual formats, audio formats, haptic formats, etc.) of content delivery, frequency of content delivery, location of user when content is delivered, specific device(s) to which content is delivered, and/or any other suitable user preferences.
  • preferred formats e.g., visual formats, audio formats, haptic formats, etc.
  • the preassessment and/or onboarding process performed in operation 226 can identify user goals for improving health, in relation to the intervention regimen.
  • Such goals can include one or more goals, such as, but not limited to: reduction of anxiety, reduction of negative emotions, reduction of depression symptoms, improvement of sleep behavior, improvement in socialization, improvement of tinnitus condition symptoms, improvement of medication adherence, improvement in tinnitus- related quality of life, improvement of other health condition symptoms, and/or any other suitable goals.
  • Goals can be organized at a high level of abstraction (e.g., improve sleep behavior), and/or at lower levels of abstraction (e.g., improve quality of sleep, reduce number of symptom-induced disturbances to sleep, etc.).
  • the online system and/or other system components can implement surveying tools (e.g., for self-report of data from the patient) and/or non-survey-based tools for acquisition of data.
  • Survey tools can be delivered through an application associated with the DTX system executing on the client device of the patient and/or through another suitable method, where the survey tools can implement architecture for assessing the patient in relation to mental health, tinnitus, tinnitus symptom severity or disease activity, types of tinnitus condition symptoms, and/or other statuses.
  • the surveying tools can be derived from one or more tools such as, but not limited to a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, a profile of mood states, a pain assessment questionnaire, and any other tool or instrument.
  • Survey components can be implemented during pre-assessment of a patient and/or within modules of the intervention regimen, as described in more detail above.
  • the system can include architecture for receiving data derived from the patient (e.g., through sensor components, through survey components, associated with pain characteristics, digestive characteristics, cognitive characteristics, and other characteristics), processing the data with one or more models, and returning scores (e.g., measures of symptom severity, etc.). Scores can also be used for tagging user data with symptom severity, in relation to model aspects and model training/refinement described below.
  • the online system and/or other system components can implement data from devices (e.g., non-survey data).
  • devices e.g., non-survey data
  • embodiments of the system can perform preassessment with implementation of data from devices including one or more devices, such as, but not limited to: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and/or other platforms, in order to assess social behaviors of the user.
  • devices including one or more devices, such as, but not limited to: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices
  • FIG. 6 depicts a flowchart of a pre-assessment and onboarding process of a method for providing adaptive interventions, according to one or more embodiments.
  • the pre-assessment and onboarding process 600 can include operation 611, which facilitates downloading of an application associated with the system and/or using of a non-downloadable version of the system (e.g., via web application, etc.) for delivering the intervention regimen by a client device of the patient; operation 612, which renders a welcome/introduction screen within the application associated with the system; operation 613, which delivers content within the application for educating the patient regarding the purpose of the system and provides an overview of the intervention regimen; operation 614, which creates a patient profile within the online system, resulting in a first tier of personalization by implementing survey and non-survey based tools (e.g., to assess gender, age, preferences for scheduling of content delivery, specific tinnitus symptoms of the patient, etc.); and operation 615, which, within the application associated with the system, assesses goals of the patient, resulting in a second tier of personalization.
  • operation 611 which facilitates downloading of an application associated with the system and/or using of
  • the second tier of personalization can operate by assessing goals related to anxiety reduction, depression reduction, reduction of tinnitus symptoms, improvement of sleep, improvement of socialization, and other goals.
  • FIG. 6 further depicts operation 616, which, in one embodiment, processes the data from operations 614 and 61 with an intervention-determining model to output a personalized intervention regimen with adaptive behavioral therapy tools and exercises for improving health and wellbeing of the patient, in relation to his/her specific goals.
  • FIG. 6 also depicts operation 617 where a first module of the intervention regimen is delivered to the patient within the application associated with the system, and operation 618, which provides further adaptation of modules of the intervention regimen as the patient progresses through the intervention regimen and interacts with content.
  • FIG. 7 depicts examples of system aspects of a program for personalized health condition monitoring and improvement, according to one or more embodiments.
  • components delivered through a DTX system may include content such as, but not limited to: onboarding material, daily (or other time scale) review, progress summaries, tinnitus management content, personal model analyses, symptom management material, educational material, symptom tracking analyses, personalized treatment analyses, quick references, and multiple engagement tactics material.
  • content such as, but not limited to: onboarding material, daily (or other time scale) review, progress summaries, tinnitus management content, personal model analyses, symptom management material, educational material, symptom tracking analyses, personalized treatment analyses, quick references, and multiple engagement tactics material.
  • process flow proceeds to operation 228.
  • an intervention regimen for the patient is generated upon processing data from the preassessment with an intervention-determining model.
  • one embodiment of the online system in coordination with the network and a client device, can process data from the pre-assessment with an intervention-determining model.
  • Operation 228 functions to generate an intervention regimen for the patient upon processing pre-assessment data, in order to design a customized intervention regimen to address specific symptoms and needs of the patient. While operation 228 is described in relation to pre-assessment data, model architecture and associated algorithms can additionally or alternatively be applied to assessment of patient data as the patient interacts with content of the intervention regimen, in order to adaptively modify delivery of intervention regimen components to the patient, with processing of incoming data.
  • the intervention-determining model contemporaneously processes data associated with patient goals, user tinnitus symptoms, patient mental health states, other characteristics, and interactions with content of the DTX system, providing the intervention regimen as inputs, in order to output a customized and modulatable intervention regimen to improve the health and/or wellbeing of the patient.
  • the intervention-determining model can include architecture for one or more of: conditional decision making (e.g., with conditional branching structure that processes input data in stages and determines an output at each node of the branching structure); ranking (e.g., with ranking algorithms configured to rank candidate intervention regimen components according to appropriateness, based on the input data); matching (e.g., with performance of best match operations between input data and different groups representing modules of the intervention regimen, with centroid-based approaches, etc.); correlation (e.g., correlation functions that process input data to generate outputs associated with different intervention regimen components); and/or any other suitable architecture. Training of models is further described below.
  • conditional decision making e.g., with conditional branching structure that processes input data in stages and determines an output at each node of the branching structure
  • ranking e.g., with ranking algorithms configured to rank candidate intervention regimen components according to appropriateness, based on the input data
  • matching e.g., with performance of best match operations between input data and different groups representing modules of the intervention regimen, with cent
  • method flow proceeds to operation 230.
  • the online system in coordination with other system components (e.g., the client device, external systems, network, etc.) delivers the intervention regimen to the patient, for instance, through an application associated with the DTX system executing at the client device of the patient.
  • content associated with the intervention regimen can be of visual (e.g., image format, video format), textual, audio, haptic, and/or other formats, through connected devices (e.g., mobile computing devices, wearable devices, audio output devices, displays, temperature control devices, lighting control devices, etc.) and generated in a manner that promotes user engagement.
  • connected devices e.g., mobile computing devices, wearable devices, audio output devices, displays, temperature control devices, lighting control devices, etc.
  • the system in providing the interventions (e.g., such as interventions described in more detail below), can coordinate with and/or provide instructions for control of other devices, for intervention delivery.
  • the system can coordinate with environmental control devices (e.g., connected audio output devices, connected temperature control devices, connected lighting control devices, connected pill dispensing devices, connected smart pill devices, etc.) to change aspects of the patient’s environment in association with provision of the intervention regimen.
  • environmental control devices e.g., connected audio output devices, connected temperature control devices, connected lighting control devices, connected pill dispensing devices, connected smart pill devices, etc.
  • the intervention regimen can provide a grounding exercise to reduce anxiety regarding tinnitus symptoms, where the user is prompted to observe aspects of the environment with multiple senses, and the system can coordinate with environmental control devices to adjust one or more of lighting (e.g., colors, intensity, etc.), sounds (e.g., through audio output devices), and/or temperature in the patient’s environment.
  • the intervention regimen can provide a relaxation exercise to reduce pain associated with tinnitus symptoms, and coordinate with an audio output device to play music pleasing to the patient.
  • the intervention regimen can provide an exercise activity involving movements or dancing, to reduce bloating and depression associated with tinnitus symptoms, and coordinate with an audio output device to play dance music to the user, while reducing environmental temperature with a smart thermostat device.
  • the system can provide coordinated interventions, however, in any other suitable manner, where details of interventions are provided in more detail above. DTX far use in the improvement of non-digital therapeutic interventions far tinnitus conditions.
  • a method of enhancing the performance of a therapeutic intervention administered to a patient for the treatment, prevention, amelioration, or reduction in the likelihood of developing a tinnitus condition and/or one or more side effects associated with the therapeutic intervention comprising: remotely administering a digital therapeutic to said patient, wherein administering said digital therapeutic includes: providing said patient with a digital therapeutic user interface; administering one or more digital therapeutic treatment components to said patient through the digital therapeutic user interface; remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components; dynamically modifying one or more of the digital therapeutic treatment components based at least partly on said patient’s interactions with the digital therapeutic treatment components; and administering one or more of the modified digital therapeutic treatment components to said patient through the user interface of the digital therapeutic.
  • the therapeutic intervention for the tinnitus condition includes treatments utilizing one or more pharmaceutical compositions.
  • the one or more side effects associated with the one or more pharmaceutical compositions are each independently selected from the group consisting of constipation, nausea, vomiting, fatigue, stomach ache, diarrhea, headaches, drowsiness, dizziness, confusion, tiredness, insomnia, nervousness, dizziness, abdominal pain, muscle pain, itching, rapid heartbeat, hypertension, mood swings, upset stomach, paresthesia, vision disturbances, indigestion, tinnitus, restlessness, anxiety, difficulty sleeping, feeling sick, dry cough, increased heartbeat, rash, insomnia, loss of libido, erectile dysfunction, GI dysfunction, confusion, depression, ringing or buzzing in ears, itching, tiredness, reduced libido, stomach pain, heartbum, vaginal itching, fatigue, loss of libido, low libido, ringing or buzzing in ears, itching, increased heart rate, sexual dysfunction, cardiac arrhythmia, fatigue,
  • the one or more pharmaceutical compositions are each independently selected from the group consisting of anesthetics, heart rhythm medications, anti-anxiety medications, anti-seizure drugs, antidepressants, calcium channel blockers, muscle relaxers, and combinations thereof.
  • enhancing performance of the therapeutic intervention comprises adjusting dosage of the one or more pharmaceutical compositions.
  • adjusting the dosage of the one or more pharmaceutical composition comprises increasing the dosage to increase effectiveness of the therapeutic intervention without increasing the associated side effects.
  • adjusting dosage of the one or more pharmaceutical composition comprises increasing the dosage of the one or more pharmaceutical compositions without increasing the associated side effects to a higher amount that is therapeutically effective in a patient who is not responsive to lower amounts of the one or more pharmaceutical compositions.
  • adjusting dosage of the one or more pharmaceutical composition comprises reducing the dosage of the one or more pharmaceutical compounds responsive to treatment or amelioration of one or more symptoms of the tinnitus condition using the digital therapeutics; and wherein the reduced dosage is therapeutically effective.
  • enhancing performance of the therapeutic intervention comprises reducing, ameliorating, or preventing the one or more side effects associated with the therapeutic intervention.
  • enhancing performance of the therapeutic intervention comprises increasing bioavailability of the one or more pharmaceutical compositions by reducing, ameliorating, or preventing one or more of side effects associated with the therapeutic intervention and/or by reducing, ameliorating, or preventing one or more symptoms associated with the tinnitus condition.
  • a method of treating, preventing, ameliorating, or reducing the likelihood of developing a tinnitus condition in a patient comprising: remotely administering a digital therapeutic to said patient, wherein administering said digital therapeutic includes: providing said patient with a digital therapeutic user interface; administering one or more digital therapeutic treatment components to said patient through the digital therapeutic user interface; remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components; dynamically modifying one or more of the digital therapeutic treatment components based at least partly on said patient’s interactions with the digital therapeutic treatment components; and administering one or more of the modified digital therapeutic treatment components to said patient through the user interface of the digital therapeutic.
  • the patient is undergoing or has undergone a therapeutic intervention for said condition.
  • the therapeutic intervention comprises one or more non-digital treatments selected from the group consisting of: treatments utilizing one or more pharmaceutical compositions; treatments utilizing one or more nutraceutical compositions; treatments utilizing one or more medical devices; treatments utilizing one or more physical activities; treatments utilizing one or more mind-body interventions; treatments utilizing whole system medicine; treatments utilizing one or more surgeries; and combinations thereof.
  • the therapeutic intervention comprising one or more non-digital treatments is provided prior to, contemporaneously with, and/or after administering the digital therapeutic to the patient.
  • the one or more pharmaceutical compositions are each independently selected from the group consisting of anesthetics, heart rhythm medications, anti-anxiety medications, anti-seizure drugs, antidepressants, calcium channel blockers, muscle relaxers, and combinations thereof.
  • the one or more nutraceutical compositions each comprise at least one nutraceutical component independently selected from the group consisting of lipoflavanoids, minerals, proteins, vitamins, herbs, ear drops, melatonin, ginkgo biloba, zinc supplements, magnesium supplements, and combinations thereof.
  • the one or more medical devices are each independently selected from the group consisting of bimodal stimulation devices, bimodal neuromodulation devices, brain stimulation therapies, tinnitus masking devices, tinnitus retraining devices, hearing aids, and combinations thereof.
  • the tinnitus condition is selected from the group consisting of subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnitus, medication-induced tinnitus, vaccination- induced tinnitus, acute tinnitus, chronic tinnitus, and combinations thereof.
  • the digital therapeutic treatment components include components of therapies selected from the group of therapies consisting of: cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MB SR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, hypnosis, and combinations thereof.
  • CBT cognitive behavioral therapy
  • MB SR mindfulness-based stress reduction
  • ACT acceptance and commitment therapy
  • BA behavioral activation
  • BA systematic desensitization
  • TAT tinnitus activities treatment
  • TRT tinnitus retraining therapy
  • PTM progressive tinnitus management
  • TCT task concentration training
  • HRT habit reversal therapy
  • habituation training relaxation therapy
  • remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components includes obtaining patient data including one or more of: patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, patient biometric data, and combinations thereof.
  • patient data including one or more of: patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, patient biometric data, and combinations thereof.
  • remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components includes utilizing surveying tools derived from one or more patient reported outcome instruments selected from the group consisting of a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, and combinations thereof.
  • remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components includes utilizing non-survey data obtained from one or more devices selected from the group consisting of electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and combinations thereof
  • dynamically modifying one or more of the digital therapeutic treatment components includes one or more of: adjusting the order of administration of the digital therapeutic components; adjusting the order of administration of the non-digital treatment; adjusting the frequency of administration of the digital therapeutic components; adjusting the frequency of administration of the non-digital treatments; adjusting the mode of administration of the digital therapeutic components; adjusting the mode of administration of the non-digital treatments; adjusting the content of the digital therapeutic components; adjusting the content of the non-digital treatments; adjusting the content size of the digital therapeutic components; adjusting the dosage amount of the non-digital treatments; adjusting the dosage schedule of the non-digital treatments; adjusting the presentation of the digital therapeutic components; adjusting the layout of the digital therapeutic components; and increasing personalization of the digital therapeutic components.
  • DTX for use in the treatment of symptoms associated with tinnitus conditions.
  • a method of treating, preventing, ameliorating, or reducing the likelihood of developing one or more symptoms associated with a tinnitus condition in a patient comprising: remotely administering a digital therapeutic to said patient, wherein administering said digital therapeutic comprises: providing said patient with a digital therapeutic user interface; administering one or more digital therapeutic treatment components to said patient through the digital therapeutic user interface; remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components; dynamically modifying one or more of the digital therapeutic treatment components based at least partly on said patient’s interactions with the digital therapeutic treatment components; and administering one or more of the modified digital therapeutic treatment components to said patient through the user interface of the digital therapeutic.
  • the one or more symptoms include perception of one or more sounds by the patient, wherein the one or more sounds are not present in an external environment of the patient.
  • the one or more sounds perceived by the patient may include one or more of ringing sounds, buzzing sounds, hissing sounds, whistling sounds, swooshing sounds, clicking sounds, musical sounds, somatic sounds, body circulatory system based sounds, or combinations thereof.
  • the patient is undergoing or has undergone one or more non-digital therapeutic interventions for said condition.
  • the one or more non-digital therapeutic interventions is provided prior to, contemporaneously with, and/or after administering the digital therapeutic to the patient.
  • the one or more non-digital therapeutic interventions are each independently selected from the group consisting of: treatments utilizing one or more pharmaceutical compositions; treatments utilizing one or more nutraceutical compositions; treatments utilizing one or more medical devices; treatments utilizing one or more diagnostic devices; treatments utilizing one or more physical activities; treatments utilizing one or more mind-body interventions; treatments utilizing whole system medicine; treatments utilizing acupuncture; treatments utilizing magnets; treatments utilizing one or more surgeries; and combinations thereof.
  • the tinnitus condition is selected from the group consisting of subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnitus, medication-induced tinnitus, vaccination- induced tinnitus, acute tinnitus, chronic tinnitus, and combinations thereof.
  • DTX for use in improvement of adherence to non-digital therapeutic interventions for tinnitus conditions
  • a method of improving patient adherence to a treatment regimen of a therapeutic intervention administered to said patient for the treatment, prevention, amelioration, or reduction in the likelihood of developing a tinnitus condition and/or one or more side effects or comorbidities associated with said therapeutic intervention comprising: remotely administering a digital therapeutic to said patient, wherein administering said digital therapeutic includes: providing said patient with a digital therapeutic user interface; administering one or more digital therapeutic treatment components to said patient through the digital therapeutic user interface; remotely monitoring said patient’s interactions with one or more of the digital therapeutic treatment components; dynamically modifying one or more of the digital therapeutic treatment components based at least partly on said patient’s interactions with the digital therapeutic treatment components; and administering one or more of the modified digital therapeutic treatment components to said patient through the user interface of the digital therapeutic.
  • the therapeutic intervention for the tinnitus condition includes treatments utilizing one or more pharmaceutical compositions.
  • the tinnitus condition is selected from the group consisting of subjective tinnitus, objective tinnitus, idiopathic tinnitus, neurological tinnitus, somatic tinnitus, sensorineural tinnitus, pulsatile tinnitus, tonal tinnitus, musical tinnitus, medication-induced tinnitus, vaccination-induced tinnitus, acute tinnitus, chronic tinnitus, and combinations thereof.
  • improving patient adherence to the therapeutic intervention comprises: receiving, via one or more of the digital therapeutic treatment components, patient adherence data; identifying patterns related to said patient’s treatment regimen based on symptom changes associated adherence to the treatment regimen and/or symptoms and/or activities that are associated with degree to which said patient adheres to the treatment regimen; dynamically modifying one or more of the digital therapeutic treatment components based at least partly on the patient adherence data and the identified patterns; and administering one or more of the modified digital therapeutic treatment components to said patient through the user interface of the digital therapeutic.
  • FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, and FIG. 8E depict example schematics of conditional branching architecture implemented for delivery of intervention regimen components, according to one or more embodiments.
  • the interventiondetermining model includes architecture for processing input data (e.g., from the pre-assessment and in real-time as the patient interacts with content of the intervention regimen), with a conditional branching model (e.g., with if-then branches coupled to nodes associated with outputs) that processes input data to tailor individual psychological interventions to the patient in an individualized manner.
  • the conditional branching model thus includes decision rules linking characteristics of the patient (e.g., clinical and symptom presentation, demographics, etc.) to different components of the intervention regimen, as an adaptive intervention.
  • FIG. 8A depicts architecture of the conditional branching model for a generalized pathway where, based on severity of physical illness symptoms exhibited by a patient, the model guides (e.g., through an application associated with the DTX system executing at the client device) the patient through foundational behavioral skills appropriate to the state and goals of the patient.
  • the order of modules can vary from patient to patient. Decisions (within app) about which modules to prioritize first are based on patient’s presentation and needs (e.g., symptom patterns, etc.). For example, if tinnitus is what is most bothersome to the patient, the digital therapeutic will recommend the tinnitus management module after completing one of the modules (e.g. the relaxation module).
  • the conditional branching model shown in FIG. 8A selects a Behavior Change and Avoidance module for delivery, where the module informs the patient of links between behaviors and moods/feelings, and actively coaches the patient with respect to addressing avoidance behaviors in relation to tinnitus condition symptoms, in order to replace avoidance behaviors with alternative healthier behaviors.
  • the behavioral therapy techniques implemented in the selected intervention can address problem-focused coping tools and/or emotion-focused coping tools, with additional tailoring for different mental health issues associated with the tinnitus or comorbid condition symptoms of the patient.
  • conditional branching model outputs behavioral activation exercises, cognitive reframing techniques, talent practicing and reinforcement exercises, and/or other exercises to mitigate depression symptoms.
  • conditional branching model outputs exposure-based exercises associated with anxiety sources, anxiety tolerance skill-building exercises, grounding exercises, and/or other exercises to mitigate anxiety symptoms.
  • the conditional branching model outputs problem-solving exercises with respect to controllable vs. uncontrollable stressors, and other exercises to mitigate problem-solving issues.
  • the conditional branching model further receives inputs (e.g., rankings of symptom severity) related to symptoms that the patient wishes to improve (e.g., related to pain management, related to sleep, related to adherence, related to communication, related to social problem solving, related to relapse prevention, etc.), and then based upon the inputs, guides the user through additional cognitive skills tailored to improve symptoms in the manner that the patient desires.
  • inputs e.g., rankings of symptom severity
  • related to symptoms that the patient wishes to improve e.g., related to pain management, related to sleep, related to adherence, related to communication, related to social problem solving, related to relapse prevention, etc.
  • FIG. 8B depicts architecture of the conditional branching model for an anxiety-specific pathway where, based on severity of physical illness symptoms exhibited by a patient, the model guides (e.g., through an application associated with the DTX system executing at the client device) the patient through foundational behavioral skills appropriate to the state and goals of the patient.
  • the conditional branching model selects a Behavior Change and Avoidance module for delivery, where the module informs the patient of links between behaviors and moods/feelings, and actively coaches the patient with respect to addressing avoidance behaviors in relation to tinnitus condition symptoms, in order to replace avoidance behaviors with alternative healthier behaviors.
  • the conditional branching model of FIG. 8B outputs exposure-based desensitization exercises associated with anxiety sources, anxiety tolerance skill-building exercises, grounding exercises, and/or other exercises to mitigate anxiety symptoms.
  • the conditional branching model of FIG. 8B further receives inputs (e.g., rankings of symptom severity) related to sleep and/or other symptoms (e.g., fatigue, sleep hygiene, worry, etc.) that the patient wishes to improve, and then based upon the inputs, guides the user through additional cognitive skills, problem-solving exercises, and behavior change exercises, tailored to improve sleep symptoms related to his/her tinnitus condition.
  • FIG. 8C depicts architecture of the conditional branching model for a depression-specific pathway where, based on severity of physical illness symptoms exhibited by a patient, the model guides (e.g., through an application associated with the DTX system executing at the client device) the patient through foundational behavioral skills appropriate to the state and goals of the patient.
  • the conditional branching model selects a Behavior Change and Avoidance module for delivery, where the module informs the patient of links between behaviors and moods/feelings, and actively coaches the patient with respect to addressing avoidance behaviors in relation to tinnitus condition symptoms, in order to replace avoidance behaviors with alternative healthier behaviors.
  • the conditional branching model of FIG. 8C outputs behavioral activation exercises, cognitive reframing techniques, and reinforcement exercises, and/or other exercises to mitigate depression symptoms.
  • the conditional branching model of FIG. 8C further receives inputs (e.g., rankings of symptom severity) related to sleep and/or other symptoms (e.g., fatigue, sleep hygiene, worry, etc.) that the patient wishes to improve, and then based upon the inputs, guides the user through additional cognitive skills, problem-solving exercises, and behavior change exercises, tailored to improve sleep symptoms related to his/her tinnitus condition.
  • FIG. 8D depicts architecture of the conditional branching model for a pathway targeted to anxiety and depression (e.g., with a GAD-7 score greater than or equal to 11) where, the model guides (e.g., through an application associated with the DTX system executing at the client device) the patient through foundational behavioral skills appropriate to the state and goals of the patient.
  • the conditional branching model selects a Behavior Change and Avoidance module for delivery, where the module informs the patient of links between behaviors and moods/feelings, and actively coaches the patient with respect to addressing avoidance behaviors in relation to tinnitus condition symptoms, in order to replace avoidance behaviors with alternative healthier behaviors.
  • the conditional branching model of FIG. 8D outputs exposure-based desensitization exercises associated with anxiety sources, anxiety tolerance skill-building exercises, grounding exercises, and/or other exercises to mitigate anxiety symptoms.
  • the model also determines if the patient is suffering from tinnitus symptoms, and provides the patient with tinnitus management exercises.
  • the model also then sequentially determines if the user is exhibiting symptoms of depression (e.g., if PHQ-9 score is greater than or less than 10), and addresses depression symptoms sequentially relative to other symptoms (e.g., sleep, communication, medication adherence) based upon symptom severity.
  • FIG. 8E depicts architecture of the conditional branching model for a pathway that is not specific to anxiety or depression where, based on severity of physical illness symptoms exhibited by a patient, the model guides (e.g., through an application associated with the DTX system executing at the client device) the patient through foundational behavioral skills appropriate to the state and goals of the patient.
  • the conditional branching model selects a. Behavior Change and Avoidance module for delivery, where the module informs the patient of links between behaviors and moods/feelings, and actively coaches the patient with respect to addressing avoidance behaviors in relation to tinnitus condition symptoms, in order to replace avoidance behaviors with alternative healthier behaviors.
  • the conditional branching model of FIG. 8E outputs problem-solving exercises with respect to controllable vs. uncontrollable stressors, and other exercises to mitigate problem-solving issues.
  • the conditional branching model of FIG. 8E further receives inputs (e.g., rankings of symptom severity) related to sleep and/or other symptoms (e.g., fatigue, sleep hygiene, worry, etc.) that the patient wishes to improve, and then based upon the inputs, guides the user through additional cognitive skills, problemsolving exercises, and behavior change exercises, tailored to improve sleep symptoms related to his/her tinnitus condition.
  • method flow proceeds to operation 232.
  • operation 232 a set of interactions between the patient and modules of the intervention regimen and a health status progression of the patient are monitored contemporaneously with delivery of the intervention regimen.
  • an embodiment of the online system in coordination with the network and a client device, can monitor a set of interactions between the patient and modules of the intervention regimen and a health status progression of the patient contemporaneously with delivery of the intervention regimen.
  • Monitoring interactions functions to provide intimate understanding of progress of the patient in achieving health goals, and to provide further personalization of and delivery of intervention content at appropriate times, in order to maintain or improve progress of the patient.
  • Monitoring is preferably performed in near-real time or real time, such that actions can be taken to adjust interventions to user states according to just-in time adaptive intervention (JITAI) protocols.
  • JITAI just-in time adaptive intervention
  • monitoring can be performed with any suitable delay (e.g., in relation to achieving better accuracy of assessed states of the patient).
  • Monitoring can be performed using survey components delivered with interactive interventions of the intervention regimen, where the user is prompted and provided with interactive elements that allow the patient to provide self-report data indicating progress statuses Monitoring can additionally or alternatively be performed with processing of other data streams, where the data streams are associated with system or device usage metrics, social networking behavior extracted from usage of social networking platforms and communication platforms, sensor-derived data, and/or other data. Monitoring can thus occur with any frequency and/or level of intrusiveness.
  • operation 232 can process monitoring data (e.g., real time data, non-real time data, dynamic data, static data) with a predictive model that outputs indications of one or more of symptom severity predictions, predictions of patient states, indications of predicted success of the patient in achieving goals, and/or other predictions, where training of the predictive model with training sets of data is described in additional detail below.
  • monitoring data e.g., real time data, non-real time data, dynamic data, static data
  • a predictive model that outputs indications of one or more of symptom severity predictions, predictions of patient states, indications of predicted success of the patient in achieving goals, and/or other predictions, where training of the predictive model with training sets of data is described in additional detail below.
  • ecological momentary assessments of the patient can be used for monitoring.
  • client device usage parameters can be used for monitoring. Examples of client device usage parameters can include frequency of application switching, duration of time spent in association with each application login, screen time parameters, data usage associated with different applications and/or types of applications (e.g., social networking, creative, utility, travel, activity-related, etc.) executing on the client device of the patient, time of day of application usage, location of device usage, and other client device usage parameters.
  • applications e.g., social networking, creative, utility, travel, activity-related, etc.
  • the system can process voice data and/or text communication data of the patient for monitoring and modifying interventions and program aspects.
  • voice data can include voice sampling data from which emotional states can be extracted using voice processing models.
  • natural language processing of textual data e.g., from communication platforms, from social networking platforms
  • the client device can be used to provide context for behaviors of the patient and/or assess emotional or cognitive states of the patient.
  • electronic health record data can be used for monitoring.
  • the online system can be configured to receive a notification providing information regarding the type of care the patient has received, and to use this data for monitoring statuses of the patient.
  • the system can include architecture for processing data from other sensors of the client device, devices in the environment of the patient, and/or wearable computing devices can be used for monitoring.
  • device data can include activity data, location data, motion data, biometric data, and/or other data configured to provide context to behaviors associated with the health condition of the patient.
  • motion data from motion of sensors of the client device can indicate that the user is sedentary, and may be experiencing symptoms that can be addressed with components of the intervention regimen.
  • device usage data can indicate that the patient has been using a particular device (e.g., a tablet device in proximity to the patient, where use does not require extensive motion of the patient), in a fixed location (e.g., from GPS data), and in a prone position (e.g., from motion chip data), and may be experiencing GI health condition symptoms that can be addressed with components of the intervention regimen.
  • a particular device e.g., a tablet device in proximity to the patient, where use does not require extensive motion of the patient
  • a fixed location e.g., from GPS data
  • a prone position e.g., from motion chip data
  • active monitoring of patient states can be used to adjust delivery of intervention regimen modules in order appropriately meet the needs of the patient.
  • Other data and combinations of data can, however, be used for monitoring.
  • process flow proceeds to operation 234.
  • operation 234 in response to at least one of the set of interactions and the health status progression, an action configured to improve wellbeing of the patient with respect to the tinnitus condition is performed.
  • an embodiment of the online system in coordination with the network and a client device can, in response to at least one of the set of interactions and the health status progression, perform an action configured to improve health and wellbeing of the patient with respect to the tinnitus condition.
  • Operation 234 functions to provide further customization of the intervention regimen, in order to improve personalization of delivered content to needs of the patient, in an adaptive manner.
  • Operation 234 can also function to increase engagement between the patient and the intervention regimen, in order to improve effectiveness of provided treatments and increase success of the patient in achieving his/her goals.
  • the action performed according to operation 234 can include one or more of: adjusting order of and/or content of intervention modules provided, where intervention types and content are described above; updating electronic health records (EHRs), personal health records (PHRs), and/or open medical records, for instance by writing to or modifying records whenever new information is generated regarding the user/patient/patient; providing and/or facilitating provision of supplemental interventions (e.g., hypnotherapy, physical exercises, medications, supplements, etc.) beyond standard content of the intervention regimen, for instance, under physician-guidance or treatment recommendations; generating and/or providing notifications to the patient regarding changes in behavior or health statuses; generating and/or providing notifications to entities (e.g., relatives, acquaintances having permission of the patient, health care providers, etc.) associated with the patient regarding changes in behavior or health statuses; and/or any other suitable action.
  • EHRs electronic health records
  • PHRs personal health records
  • open medical records for instance by writing to or modifying records whenever new information is generated regarding the user/patient/patient
  • operation 234 can additionally or alternatively include functionality for increasing engagement of the patient with respect to interactions with content of the intervention regimen.
  • features for increasing engagement and optimal learning can include text-based functionality for self-monitoring and symptom tracking, where the system can process real time text interactions with provision of interactive tasks, which increases likelihood of patient responses.
  • specific descriptions self-reported by the patient can be used in subsequent portions of the intervention regimen to increase personalization of the intervention to drive engagement.
  • features for increasing engagement and optimal learning can include features that mimic therapist/healthcare provider, or social group interactions (e.g., patient testimonials, clinician video content, etc.).
  • features for increasing engagement and optimal learning can include features that link the patient’s specific current problems (e.g., from operation 232) and/or challenges faced by the patient as a trigger to notify the patient to interact with content of the intervention regimen and recommend appropriate skill for improving health states.
  • engagement can be promoted using one or more of: artificial reality tools (e.g., augmented reality platforms, virtual reality platforms) for reducing depression, anxiety, pain, and/or other symptoms; artificial intelligence-based coaching elements for driving interactions with the patient; smart assistants (e.g., AlexaTM, SiriTM, GoogleTM Assistant, etc.) for assisting the patient in relation to task management, gamification elements within intervention regimen-associated applications executing on the client device; gamification elements of other devices; smart pill devices and/or medication-dispensing devices that provide insights in an engaging manner in coordination with intervention regimen modules; adjustment of reinforcement schedules (e.g., in relation to reward sensitivity, positive reinforcement, negative reinforcement, etc.) for providing intervention regimen content to the patient; and other elements for increasing engagement.
  • artificial reality tools e.g., augmented reality platforms, virtual reality platforms
  • artificial intelligence-based coaching elements for driving interactions with the patient
  • smart assistants e.g., AlexaTM, SiriTM, GoogleTM Assistant, etc.
  • intervention regimen-associated applications e.g.
  • FIG. 2C is a flowchart depicting a method 200C for providing adaptive interventions for tinnitus conditions, in accordance with one embodiment.
  • method 200C begins at BEGIN 238, and method flow proceeds to operation 240.
  • operation 240 an interface between a device and a user is established.
  • method flow proceeds to operation 242.
  • a set of signals associated with a tinnitus or comorbid condition of the user is received from the interface, wherein the set of signals encodes physiological data, behavioral data, environmental stress data, emotional data, and cognitive data of the user.
  • a characterization of the tinnitus condition is determined upon processing the set of signals with a model.
  • method flow proceeds to operation 246.
  • content of a treatment comprising a set of components is modulated, wherein the set of components comprises a subset of cognitive behavioral therapy (CBT) components for improving a state of the user.
  • CBT cognitive behavioral therapy
  • method flow proceeds to operation 248.
  • the treatment is administered to the user.
  • method flow proceeds to END operation 250, and the method 200C for providing adaptive interventions for tinnitus conditions is exited to await new instructions
  • the methods 200A, 200B, and/or 200C can further include operations for detecting performance of activities associated with the intervention regimen, by the patient; reinforcing user performance or engagement with the intervention regimen; determining undesired levels of performance or engagement with the intervention regimen; and driving improved engagement with the intervention.
  • the methods 200A, 200B, and/or 200C can include functionality for detecting performance or non-performance of activities (e.g., based on system engagement, based upon sensor-detected measures of activity, etc.).
  • the methods 200A, 200B, and/or 200C can include functionality for reinforcing performance through provision of various rewards (e.g., rests, rewards of monetary value, etc ). If the patient does not perform activities appropriately, the methods 200A, 200B, and/or 200C can include functionality for determining causes of non-performance (e.g., nonengaging content, external factors associated with the patient’s life, etc.) and adjust content delivery, provide modified interventions, and/or adjust reinforcement schedules accordingly.
  • causes of non-performance e.g., nonengaging content, external factors associated with the patient’s life, etc.
  • the methods 200A, 200B, and/or 200C can include functionality for developing and training predictive models for predicting states of the patient during the course of the intervention regimen, in order to improve chances of success in outcomes.
  • the methods 200A, 200B, and/or 200C can thus include functionality for aggregation of training datasets from various data sources described above, and processing training datasets with one or more types of model architecture in order to improve predictions and/or selection of appropriate modules of the intervention regimen for delivery to the patient.
  • Models associated with the methods 200A, 200B, and/or 200C can be defined within architecture of computing systems described above, and include elements for statistical analysis of data and/or machine learning.
  • input to a machine learning module comprises one or more textual words, phrases, or lengthier strings.
  • the input comprises various data elements, such as numerical values corresponding to user responses to a series of questions in a questionnaire (e.g., ranking various symptom severities on a scale).
  • one or more output values of a machine learning module comprise values representing a classification of a particular condition of a user.
  • machine learning modules implementing machine learning techniques are trained, for example using curated and/or manually annotated datasets. Such training may be used to determine various parameters of machine learning algorithms implemented by a machine learning module, such as weights associated with layers in neural networks.
  • machine learning module may receive feedback, e.g., based on user review of accuracy, and such feedback may be used as additional training data, for example to dynamically update the machine learning module.
  • a trained machine learning module is a classification algorithm with adjustable and/or fixed (e.g., locked) parameters, e.g., a random forest classifier.
  • two or more machine learning modules may be combined and implemented as a single module and/or a single software application.
  • two or more machine learning modules may also be implemented separately, e.g., as separate modules or applications.
  • a machine learning module may be software and/or hardware.
  • a machine learning module may be implemented entirely as software, or certain functions of a ANN module may be carried out via specialized hardware (e.g., via an application specific integrated circuit (ASIC)).
  • ASIC application specific integrated circuit
  • the method can include: generating a combined dataset upon applying a first set of transformations to an aggregate dataset including physiological data, behavioral data, environmental stress data, emotional data, and cognitive data from a set of users exhibiting a form of the tinnitus condition; collecting a treatment dataset comprising treatment outcome labels (e.g., quantitative or qualitative labels describing efficacy of individual treatment components) associated with the subset of behavioral therapy components applied to the set of users; creating a first training dataset comprising the combined dataset and the treatment dataset; and training the model with the first training dataset.
  • treatment outcome labels e.g., quantitative or qualitative labels describing efficacy of individual treatment components
  • the model can be structured and ultimately refined for receiving data objects associated with at least one of: physiological data, behavioral data, environmental stress data, emotional data, and cognitive data of the user, and returning a set of outputs comprising a selection of treatment subcomponents tagged with efficacy indicators.
  • Statistical analyses and/or machine learning algorithm(s) can be characterized by a learning style including any one or more of: supervised learning (e.g., using back propagation neural networks), unsupervised learning (e g., K-means clustering), semi-supervised learning, reinforcement learning (e.g., using a Q-learning algorithm, using temporal difference learning, etc ), and any other suitable learning style.
  • supervised learning e.g., using back propagation neural networks
  • unsupervised learning e.g., K-means clustering
  • semi-supervised learning e.g., reinforcement learning (e.g., using a Q-learning algorithm, using temporal difference learning, etc ), and any other suitable learning style.
  • any algorithm(s) can implement any one or more of: a regression algorithm, an instance-based method (e.g., k-nearest neighbor, learning vector quantization, selforganizing map, etc.), a regularization method, a decision tree learning method (e.g., classification and regression tree, chi-squared approach, random forest approach, multivariate adaptive approach, gradient boosting machine approach, etc.), a Bayesian method (e.g., naive Bayes, Bayesian belief network, etc.), a kernel method (e.g., a support vector machine, a linear discriminate analysis, etc.), a clustering method (e.g., k-means clustering), an associated rule learning algorithm (e.g., an Apriori algorithm), an artificial neural network model (e g., a back-propagation method, a Hopfield network method, a learning vector quantization method, etc.), a deep learning algorithm (e.g., a Boltzmann machine, a
  • FIG. 9A, FIG. 9B, FIG. 9C, and FIG. 9D are screenshots of several portions of an exemplary GUI for a system for treating tinnitus conditions using digital therapeutics, according to one or more embodiments. Screenshots in FIG. 9A, FIG. 9B, FIG. 9C, and FIG. 9D show a GUI in an initial state, corresponding to a starting point for a user that has just begun to use the system.
  • FIG. 9A shows a home screen that provides user access to an initial, first, lesson module.
  • a selectable icon 902 representing the initial lesson module may be displayed, which a user may select to begin.
  • FIG. 9B shows another screen of a GUI, through which a user may track their progress through a sequence of interactive lesson modules.
  • lesson modules are grouped into sub-sequences referred to as sessions, with each session comprising lessons that are related, e.g., thematically.
  • FIG. 9B shows a first icon 904a representing a first session directed to symptoms and stress, a second icon 904b representing a second session comprising lessons that introduce a user to tools for managing symptoms, and a third icon 904c representing a third session comprising lessons related to managing eating patterns.
  • a GUI restricts user access to subsequent sessions (i.e., sessions two and above in the example of FIG.
  • a GUI may include visual cues indicating which sessions are accessible and which are locked including, for example, graphical indicators (e.g., a picture of a lock), shading, colorization, etc., as shown in FIG. 9B.
  • graphical indicators e.g., a picture of a lock
  • certain lesson modules are associated with practice modules that allow a user to use and practice particular skills on a regular and/or as needed basis, outside of a sequence of lesson modules.
  • access to a particular practice module is restricted until the user has completed a lesson module with which it is associated.
  • practice modules indicated via icons 906a, 906b, 906c, 906d, 906e, and 906f are initially locked, but may be unlocked via completion of various associated lessons.
  • lesson modules may also be associated with resources, such as, but not limited to, video guides to particular breathing techniques and/or relevant articles.
  • access to resources may also be restricted such that a particular resource is locked (e g., inaccessible) until a lesson module with which it is associated has been completed.
  • a GUI may also comprise a stored profile of the user.
  • a user profile may be populated via various lesson modules that solicit input from the user, for example regarding personal characteristics, thoughts and feelings, symptom logging, identification of stressors, stress level tracking, and completion of diagnostic assessments aimed at characterizing their condition.
  • various patient reported outcome instruments which, for example, measure condition symptom severity, quality of life, etc., can be used.
  • FIG. 10A, FIG. 10B, FIG. 10C, and FIG. 10D are screenshots of example user interactions with an initial lesson module for content tailored for a patient with tinnitus, according to one or more embodiments.
  • FIG. 10A a user may select icon 1002 representing the initial lesson module from their home-screen to begin the initial lesson module.
  • a user may step through content of a lesson module by tapping a selectable graphical button 1004, until they have viewed all screens comprising all graphical content and widgets of the lesson module.
  • FIG. 10D in some embodiments, a user may be presented with a final screen that provides an indication that they have completed a particular lesson module. The user may select a graphical button 1006 to confirm completion of the particular lesson module. Following completion of an initial lesson module, the user may progress onto a subsequent one.
  • FIG. 11A and FIG. 11B are screenshots showing gate features of an exemplary GUI for a system for treating tinnitus conditions using digital therapeutics, in accordance with one or more embodiments.
  • progression onto a next lesson module is not necessarily instantaneous and/or direct. Instead, as described above, gate features may be used to introduce friction and/or to control a rate of progression from one lesson module to a next.
  • FIG. 11 A shows an example soft-gate, wherein a user is not fully prevented from beginning a second lesson module, but is encouraged to delay moving on, and required to provide additional input to do so.
  • Inter-lesson gate screen 1102 represents a soft-gate, and includes graphical content prompting the user to delay progressing onto the second lesson until the next day.
  • Example screen 1104 also includes delay button 1104a and continue button 1104b graphical widgets, wherein selection of the delay button 1104a graphical widget returns the user to the home-screen.
  • delay button 1104a and continue button 1104b graphical widgets are rendered graphically so as to visually emphasize delay button 1104a, and de-emphasize continue button 1104b, thereby encouraging the user to delay moving on to the second lesson module.
  • a soft-gate is based on time-relationship criteria with respect to a user’s time of completion of the first lesson module.
  • a soft- gate is used to encourage a user to wait until a next day to begin the second lesson module.
  • inter-lesson gate screen 1106 represents a hard-gate and does not allow for continued user progression onto the second lesson module. Instead, inter-lesson gate screen 1106 includes graphical content that encourages the user to take a break and practice particular behavioral skills via a practice module identified by graphical icon 506a.
  • graphical icon 1108a is a graphical widget - e.g., a selectable graphical button.
  • a graphical icon 1108a provides a link to a particular practice module, such that user selection of the graphical icon 1108a causes initiation (e.g., display) of a particular practice module to which it links (e.g., a symptom diary practice module, as shown in the example screen of FIG.1 IB, or other practice modules).
  • an inter-lesson gate screen may comprise a graphical widget that returns a user to a home screen.
  • inter-lesson gate screen 1106 comprises graphical widget 1108b, displaying text “Okay,” whereupon a user selection of graphical widget 1108b, they are returned to a home screen shown.
  • FIG. 12A, FIG. 12B, FIG. 12C, and FIG. 12D are screenshots of an exemplary GUI for a symptom diary lesson module, according to one or more embodiments.
  • a sequence of interactive lesson modules may include a symptom diary lesson module that introduces and familiarizes a user with techniques for tracking their tinnitus or comorbid condition symptoms and/or medication side effects.
  • technologies described herein provide a convenient GUI that can (e g., be demonstrated and/or designed to) facilitate user tracking and/or monitoring of their tinnitus or comorbid condition symptoms and/or medication side effects on a regular basis.
  • a tracking GUI may be included within a same system that provides, and controls user progression through interactive lesson modules, for example as a symptom diary practice module associated with a symptom diary lesson module.
  • access to a symptom diary practice module may be unlocked following completion of a symptom diary lesson module by the user, for example, as shown in FIG. 12C.
  • a selectable icon 1202 representing, and providing access to, the symptom diary practice module may be displayed on a user home-screen.
  • embodiments of the present disclosure provide a technical solution to the technical problem of effectively, efficiently, and remotely treating tinnitus conditions using digital therapeutics in combination with other therapies in order to ensure that patients receive adequate care, support, and treatment for their tinnitus condition.
  • the inventions covered by the system and method disclosed herein can confer several benefits over conventional systems and methods, and such inventions are further implemented into many practical applications related to improvement of user health.
  • a computing system implemented method for treating tinnitus conditions using digital therapeutics in combination with other therapies comprises: providing a patient with a user interface to a therapeutics system; performing, by the therapeutics system, a pre- assessment of a patient exhibiting one or more tinnitus condition symptoms; generating, by the therapeutics system, patient profile and pre-assessment data based on the results of the patient preassessment; processing, by the therapeutics system, the patient profile and pre-assessment data to generate patient condition data; and processing, by the therapeutics system, the patient profile and pre-assessment data and the patient condition data to generate a personalized intervention regimen for the patient wherein the personalized intervention regimen defines a combination of first therapeutic treatment components and second therapeutic treatment components.
  • the computing system implemented method further comprises administering one or more of the first therapeutic treatment components to the patient through the user interface of the therapeutics system according to the personalized intervention regimen generated for the patient; administering one or more of the second therapeutic treatment components to the patient in combination with the one or more first therapeutic treatment components according to the personalized intervention regimen generated for the patient; monitoring the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components to generate patient interaction data representing the patient’s interactions with the first and second therapeutic treatment components; processing, by the therapeutics system, the patient interaction data to generate intervention modification data representing recommended modifications to the patient’s personalized intervention regimen; at least partly based on the intervention modification data, dynamically modifying aspects of the patient’s personalized intervention regimen to generate a modified personalized intervention regimen for the patient; and administering one or more of the first therapeutic treatment components in combination with one or more of the second therapeutic treatment components according to the modified personalized intervention regimen for the patient.
  • the therapeutics system is a digital therapeutics (DTX) system.
  • the patient health condition symptoms are associated with one or more of: a tinnitus condition and a comorbid condition.
  • performing a pre-assessment of a patient includes utilizing surveying tools derived from one or more patient reported outcome instruments selected from the group of patient reported outcome instruments selected from the group consisting of a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, and combinations thereof.
  • a tinnitus handicap inventory selected from the group of patient reported outcome instruments selected from the group consisting of a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a
  • performing a pre-assessment of a patient includes utilizing nonsurvey data obtained from one or more devices selected from the group of devices consisting of: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and combinations thereof.
  • devices selected from the group of devices consisting of: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and combinations thereof.
  • generating the patient profile and pre-assessment data includes obtaining one or more of: patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, patient biometric data, and combinations thereof.
  • generating the patient condition data includes of one or more of: identifying the patient’s condition as a tinnitus condition; identifying a comorbid condition; identifying symptoms of the patient’s tinnitus and/or comorbid condition; identifying a severity of the patient’s symptoms of the tinnitus and/or comorbid condition(s); identifying the patient’s medication for the tinnitus and/or comorbid condition(s); identifying the patient’s side effects from medication; identifying the patient’s dosage information for medications; and identifying a severity of the patient’s medication side effects.
  • generating a personalized intervention regimen includes one or more of: processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to determine a first therapeutic treatment to be administered to the patient; defining a first plurality of therapeutic components associated with the first therapeutic treatment; processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to select one or more of the first plurality of therapeutic components to be administered to the patient; generating first therapeutic treatment component data representing the selected one or more of the first plurality of therapeutic components; defining a first plurality of therapeutic protocols to be utilized in administration of the components represented by the first therapeutic treatment component data; processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to select one or more of the first plurality of therapeutic protocols to utilize in administration of the components represented by the first therapeutic treatment component data; and generating first therapeutic treatment protocol data representing the selected one or more of the first plurality of therapeutic protocols to utilize in administration of the components represented by the first
  • generating a personalized intervention regimen further includes one or more of: processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to determine a second therapeutic treatment to be administered to the patient in combination with the first therapeutic treatment; defining a second plurality of therapeutic components associated with the second therapeutic treatment; processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to select one or more of the second plurality of therapeutic components to be administered to the patient; generating second therapeutic treatment component data representing the selected one or more of the second plurality of therapeutic components; defining a second plurality of therapeutic protocols to be utilized in administration of the components represented by the second therapeutic treatment component data; processing, through the therapeutics system, the patient profile and pre-assessment data and the patient condition data to select one or more of the second plurality of therapeutic protocols to utilize in administration of the components represented by the second therapeutic treatment component data; and generating second therapeutic treatment protocol data representing the selected one or more of the second plurality of therapeutic protocols to utilize
  • generating a personalized intervention regimen further includes one or more of: generating, by the therapeutics system, a personalized intervention regimen for the patient, wherein the personalized intervention regimen for the patient defines the first therapeutic treatment component data to be administered to the patient according to the first therapeutic treatment protocol data in combination with the second therapeutic treatment component data to be administered to the patient according to the second therapeutic treatment protocol data.
  • the first therapeutic treatment is a guided behavioral therapeutic treatment, further wherein the guided behavioral therapeutic treatment is administered remotely through a user interface of the therapeutics system.
  • the guided behavioral therapeutic treatment includes components of therapies selected from the group of therapies consisting of: cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MB SR), acceptance and commitment therapy (ACT), behavioral activation (BA), systematic desensitization, tinnitus activities treatment (TAT), tinnitus retraining therapy (TRT), progressive tinnitus management (PTM), task concentration training (TCT), habit reversal therapy (HRT), habituation training, relaxation therapy, acoustic (sound) therapy, bimodal therapy, hypnosis, and combinations thereof.
  • CBT cognitive behavioral therapy
  • MB SR mindfulness-based stress reduction
  • ACT acceptance and commitment therapy
  • BA behavioral activation
  • BA systematic desensitization
  • TAT tinnitus activities treatment
  • TRT tinnitus retraining therapy
  • PTM progressive tinn
  • the second type of therapeutic treatment is a non-behavioral therapeutic treatment including components of non-behavioral therapeutic treatments selected from the group of non-behavioral therapeutic treatments consisting of: treatments utilizing one or more pharmaceutical compositions; treatments utilizing one or more nutraceutical compositions; treatments utilizing one or more medical devices; treatments utilizing one or more diagnostic devices; treatments utilizing one or more physical activities; treatments utilizing one or more mind-body interventions; treatments utilizing whole system medicine; treatments utilizing acupuncture; treatments utilizing magnets; treatments utilizing one or more surgeries; and combinations thereof.
  • monitoring the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components includes utilizing surveying tools derived from one or more patient reported outcome instruments selected from the group consisting of a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression questionnaire, and combinations thereof.
  • a tinnitus handicap inventory selected from the group consisting of a tinnitus handicap inventory, a tinnitus reaction questionnaire, a tinnitus functional index, a tinnitus severity index, a tinnitus primary functions questionnaire, a tinnitus handicap questionnaire, a visual analog scale, a patient health questionnaire, a GAD-7 anxiety disorder questionnaire, a PHQ-9 depression
  • monitoring the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components includes utilizing non-survey data obtained from one or more devices selected from the group of devices consisting of: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and combinations thereof.
  • devices selected from the group of devices consisting of: electronic health record-associated devices, torso-coupled devices, wearable devices, implanted devices, cardiovascular monitoring devices, sleep monitoring devices, location monitoring devices, social networking tracking devices, audio generation devices, audio-recognition devices, audiometry devices, accelerometers, neuroimaging devices, electronystagmography devices, electrocardiographs, magnetic resonance imaging (MRI) devices, cochlear implants, and combinations thereof.
  • monitoring the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components includes obtaining patient data including one or more of: patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, patient biometric data, and combinations thereof.
  • patient data including one or more of: patient sound masking data, patient physiological health data, patient psychological health data, patient audiology data, patient condition data, patient symptoms data, patient medications data, patient medication adherence data, patient progress report data, patient system usage data, patient device usage data, patient social networking behavior data, patient voice data, patient textual data, patient activity data, patient location data, patient hearing protection usage data, patient alcohol, caffeine and/or nicotine usage data, patient motion data, patient biometric data, and combinations thereof.
  • the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components are monitored remotely, in near-real time, contemporaneously with administration of one or more of: the first therapeutic treatment; and the second therapeutic treatment.
  • a request for approval of the intervention modification data is communicated remotely to one or more of: a health care practitioner associated with the patient; the patient; a relative of the patient; a caregiver of the patient; and a third party associated with the patient.
  • dynamically modifying aspects the patient’s personalized intervention regimen includes one or more of: adjusting the order of administration of the behavioral therapy components; adjusting the order of administration of the non-behavioral therapy components; adjusting the frequency of administration of the behavioral therapy components; adjusting the frequency of administration of the non-behavioral therapy components; adjusting the mode of administration of the behavioral therapy components; adjusting the mode of administration of the non-behavioral therapy components; adjusting the content of the behavioral therapy components; adjusting the content of the non-behavioral therapy components; adjusting the content size of the behavioral therapy components; adjusting the dosage of the non-behavioral therapy components; adjusting the presentation of the behavioral therapy components; adjusting the layout of the behavioral therapy components; updating the patient’s electronic health records; updating the patient’s personal health records; updating the patient’s open medical records; and increasing personalization of the intervention regimen.
  • the patient’s personalized intervention regimen is modified remotely, in near-real time, contemporaneously with administration of one or more of: the first therapeutic treatment; and the second therapeutic treatment.
  • a method for providing a digital therapeutics (DTX) system for remotely administering guided behavioral therapy in combination with other types of tinnitus conditions comprises: providing a patient with a therapeutics system; performing a pre-assessment of a patient exhibiting one or more health condition symptoms; generating patient profile and pre- assessment data based on the results of the patient pre-assessment; processing the patient profile and pre-assessment data to generate patient condition data; processing the patient profile and preassessment data and the patient condition data to generate a personalized intervention regimen for the patient wherein the personalized intervention regimen defines a combination of first therapeutic treatment components and second therapeutic treatment components; administering one or more of the first therapeutic treatment components to the patient according to the personalized intervention regimen generated for the patient; administering one or more of the second therapeutic treatment components to the patient in combination with the one or more first therapeutic treatment components according to the personalized intervention regimen generated for the patient; monitoring the patient’s interactions with the first therapeutic treatment components and the second therapeutic treatment components to generate patient interaction data representing the patient
  • a system comprises one or more processors and one or more physical memories, the one or more physical memories having stored therein data; a patient computing system; a user interface provided to the patient computing system, the user interface providing access to a therapeutics system; a therapeutics system which provides remotely located patients and caretakers access to the therapeutics system, the therapeutics system using the one or more processors and one or more physical memories to perform the above described methods/processes.
  • the systems and methods disclosed herein allow behavioral therapy to be administered to patients suffering from tinnitus conditions in a convenient and flexible, yet structured fashion, via a digital therapeutics (DTX) system in combination with one or more non- behavioral therapies.
  • the invention(s) can employ non-traditional systems and methods for providing interventions to patients exhibiting symptoms associated with one or more health conditions.
  • the invention(s) can deliver psychological-based interventions, such as behavioral therapy -based interventions and other interventions (described in more detail above) to users/patients, by way of a platform having components implemented in a mobile device environment and/or other computer or internet-based architecture.
  • digital therapeutics (DTX) technologies may be used to administer behavioral therapies in combination with a variety of non-behavioral therapies in a controlled fashion, as treatment for one or more conditions described herein.
  • the invention(s) use components of the platform to process large amounts of user data, create individual user baselines (e.g., health, pain, mood, symptoms, medication side effects, etc. over time), remotely deliver personalized interventions, and remotely monitor user interactions with such interventions in near real-time, i.e. dynamically, in a manner that cannot be practically implemented by the human mind.
  • the disclosed method and system for effectively, efficiently, and remotely administering guided behavioral therapy in combination with other types of tinnitus therapies requires specific processes that utilize components of the platform disclosed herein to process user data, deliver interventions, and monitor user interactions with such interventions, and as such, does not encompass, embody, or preclude other forms of innovation in the area of healthcare technologies. Further, the disclosed embodiments of systems and methods for dynamically, efficiently, and remotely treating tinnitus conditions using digital therapeutics are not abstract ideas for at least several reasons.
  • the present invention also relates to an apparatus or system for performing the operations described herein.
  • This apparatus or system may be specifically constructed for the required purposes, or the apparatus or system can comprise a system selectively activated or configured/reconfigured by a computer program stored on a non-transitory computer readable medium for carrying out instructions using a processor to execute a process, as discussed or illustrated herein that can be accessed by a computing system or other device.
  • the present invention is well suited to a wide variety of computer network systems operating over numerous topologies.
  • the configuration and management of large networks comprise storage devices and computers that are communicatively coupled to similar or dissimilar computers and storage devices over a private network, a LAN, a WAN, a private network, or a public network, such as the Internet.

Abstract

L'invention concerne des systèmes et des méthodes permettant de traiter, d'atténuer ou de prévenir un acouphène, un ou de plusieurs symptômes et comorbidités associés à l'acouphène et/ou un ou plusieurs effets secondaires associés à des interventions thérapeutiques pour traiter l'acouphène, ou de réduire la probabilité d'aggravation de l'acouphène, à l'aide d'agents thérapeutiques numériques. L'invention concerne en outre des systèmes et des méthodes permettant d'améliorer le respect des interventions thérapeutiques, d'améliorer les performances des interventions thérapeutiques et de diagnostiquer ou de pronostiquer des acouphènes à l'aide d'agents thérapeutiques numériques.
PCT/US2023/069613 2022-07-05 2023-07-05 Méthodes et systèmes de traitement d'acouphènes à l'aide d'agents thérapeutiques numériques WO2024011105A1 (fr)

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