CA3113414A1 - Psychedelics protocol computer systems and methods - Google Patents

Abstract

A method of structuring a client's participation in a psychedelics integration or cleansing protocol includes storing an integration protocol record for the client in a psychedelics protocols database embodied in a physical computer-readable storage medium, the record defining an integration protocol for the client. At each of a plurality of times specified by the integration protocol, a processor automatically selects one of a plurality of components of the protocol and sends the client a notification including a suggestion to perform the one component. The processor receives and stores in the database, biometric data and psychometric data for the client. If the biometric or psychometric data satisfy a predefined condition, the processor automatically reduces a frequency at which the particular component is selected and included in the suggestion.

Description

PSYCHEDELICS PROTOCOL COMPUTER SYSTEMS AND METHODS
FIELD OF THE INVENTION
The present invention relates to computer-implemented methods and systems for psychedelics protocols.
BACKGROUND OF THE INVENTION
Scientific research into the potential mental health benefits of psychedelics, such as psilocybin, DMT, LSD, mescaline and MDMA for example, has intensified in recent years as a result of promising new studies and discoveries. In 2019 for example, the U.S. Food and Drug Administration (FDA) granted a "Breakthrough Therapy" designation to psilocybin treatment, for treatment-resistant major depression disorder, and for major depressive disorder generally.
The recent renewal of scientific interest in psychedelics follows a period of decades of comparative inattention, during which research was stymied by issues of legality and politics. In many ways, therefore, the scientific and medical study of psychedelics is still in its infancy.
Recent PCT publication no. WO 2020/237394 brings database technology to bear on bioactive products such as cannabis or psychedelics. A knowledge graph database is organized according to specified product formulation, methods of delivery, and surveyed consumer outcomes, and customers are organized by cohorts according to consumer profiles, allowing a consumer to be provided with a recommended formulation of a bioactive product.
Date Recue/Date Received 2021-03-29

-2-SUMMARY
In one aspect of the present description, the present inventors have defined integration protocols and cleansing protocols to be used in conjunction with psychedelics medicine protocols.
Integration and cleansing protocols are typically non-medical protocols, i.e., protocols that consist of a combination of components that do not amount to methods of medical treatment. For example, a cleansing protocol may precede a psychedelics medicine protocol, and may consist of a combination of requirements for food, water, fasting, or abstinence for pre-defined periods of time preceding the administration of a psychedelic compound during components of a psychedelics medicine protocol. As a further example, an integration protocol may consist of a combination of activities which, although not amounting to methods of medical treatment, may nevertheless provide ancillary wellness benefits in conjunction with those provided by the psychedelics medicine protocol itself. Such integration activities may be performed by the client on an ongoing basis, for periods preceding, during or following a psychedelics medicine protocol, and may include activities such as breathwork, meditation, journaling, music, yoga, muscle relaxation, guided curiosity, etc.
In addition to activities, cleansing protocols and integration protocols may also include repeated assessments to establish baseline and ongoing psychometric data. An integration or cleansing protocol may include one of a number of predefined or default protocols, or may be custom-created for a particular client by a medical practitioner and the client deciding upon a specific combination of activities and assessments that best suits the particular client's needs.
In another aspect of the present description, the present inventors have integrated both biometric and psychometric data into a psychedelics protocols database, to allow for intelligent automatic computer-implemented adjustment of Date Recue/Date Received 2021-03-29

-3-integration or cleansing protocols in response to the biometric and psychometric data for the client.
In one illustrative embodiment of the invention, a computer-implemented method structures a client's participation in a psychedelics integration protocol.
The method includes storing an integration protocol record for the client in a psychedelics protocols database embodied in a physical computer-readable storage medium. The integration protocol record defines an integration protocol for the client, the integration protocol including a plurality of components.
A
processor automatically selects, at each of a plurality of times specified by the integration protocol, one component of the plurality of components and sends the client a notification including a suggestion to perform the one component. In response to the processor detecting repeated non-completion of a particular component of the plurality of components, the processor automatically reduces a frequency at which the particular component is selected and included in the suggestion to perform the one component.
In another illustrative embodiment of the invention, a computer-implemented method structures a client's participation in a psychedelics integration or cleansing protocol. The method includes storing an integration or cleansing protocol record for the client in a psychedelics protocols database embodied in a physical computer-readable storage medium. The integration or cleansing protocol record defines an integration or cleansing protocol for the client, the integration or cleansing protocol including a plurality of components. At each of a plurality of times specified by the integration or cleansing protocol, a processor automatically selects one component of the plurality of components and sends the client a notification including a suggestion to perform the one component.
In association with each of the plurality of components, the processor receives and stores in the psychedelics protocols database, at least one of: biometric data representing at least one biometric of the client; and psychometric data Date Recue/Date Received 2021-03-29

-4-indicative of at least one psychometric of the client. In response to the processor determining that the biometric data or the psychometric data associated with a particular component of the plurality of components of the protocol satisfies a predefined condition, the processor automatically reduces a frequency at which the particular component is selected and included in the suggestion to perform the one component.
In another illustrative embodiment, a computer-implemented method of monitoring a client's participation in a psychedelics medicine protocol, includes a processor receiving and storing, in a psychedelics protocols database embodied in a physical computer-readable storage medium, biometric data representing at least one biometric of the client while the client is participating in each of a plurality of components of the psychedelics medicine protocol. In response to the processor determining that the biometric data during a particular component of the plurality of components deviates from a desired range for the particular component by more than a predefined threshold, the method further includes the processor automatically alerting a clinician overseeing the particular component.
In another illustrative embodiment, a computer system includes a psychedelics protocols database embodied in a physical computer-readable storage medium, the database storing a plurality of psychedelics protocol records defining respective psychedelics protocols for a plurality of clients, each of the protocols comprising a plurality of components. The computer system further includes a processor in communication with the database, and a computer-readable medium in communication with the processor. The medium stores instructions which, when executed by the processor, cause any one or more of the methods described herein to be carried out.
Date Recue/Date Received 2021-03-29

-5-Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
In drawings which illustrate embodiments of the invention, Figure 1 is a schematic illustration of a computer system according to a first embodiment of the invention, in communication with a plurality of clients, a plurality of associated medical health professionals and a plurality of associated clinicians;
Figure 2 is a tabular representation of a psychedelics protocol record stored in a psychedelics protocols database of the computer system of Fig. 1;
and Figure 3 is a flow chart of an illustrative psychedelics protocol structuring method performed by a processor of the computer system of Fig. 1.
DETAILED DESCRIPTION
System Overview Referring to Figures 1 and 2, a computer system according to a first embodiment of the invention is shown generally at 100 in Figure 1. In this embodiment, the computer system 100 includes a psychedelics protocols database 102 embodied in a physical computer-readable storage medium. The psychedelics protocols database 102 stores a plurality of psychedelics protocol records such as that shown at 200 in Figure 2. The protocol records define respective psychedelics protocols for a plurality of clients, and each of the protocols includes a plurality of components, as described in greater detail below.
Date Recue/Date Received 2021-03-29

-6-In this embodiment, the computer system 100 includes a processor 110 in communication with the psychedelics protocols database 102, and a computer-readable medium 104 in communication with the processor 110. The computer-readable medium 104 stores instructions which, when executed by the processor 110, cause the various methods described herein to be carried out.
In this embodiment, the computer system 100 further includes a medical database 106 and a memory 108 in communication with the processor 110.
In the present embodiment, the computer system 100 is in communication with a network 120, which in this embodiment includes the Internet. The computer system 100 is in further communication, via the network 120, with a plurality of clients 130, a plurality of healthcare professionals 140 and a plurality of clinicians 150.
In this embodiment, each of the clients 130 is undergoing or scheduled to undergo a psychedelics protocol, which may include a psychedelics medicine protocol prescribed by one of the health care professionals 140, involving the administration of a psychedelic substance in a clinical setting under the supervision of one of the clinicians 150. In conjunction with the medicine protocol, the psychedelics protocol for each client further includes a cleansing protocol to precede the medicine protocol, and an integration protocol to be followed concurrently with or after completion of the medicine protocol.
In this embodiment, each of the clients 130 has a smartphone 132 and a biometric monitoring device 134, both in communication with the computer system 100 via the network 120. If desired, each of the clients 130 may additionally or alternatively communicate with the computer system 100 via a desktop computer, tablet or any other device in communication with the network 120.
Date Recue/Date Received 2021-03-29

-7-Similarly, in this embodiment each of the health care professionals 140 uses a smartphone or tablet 142 and a desktop computer 144 to communicate with the computer system 100 via the network 120. Likewise, in this embodiment each of the clinicians 150 uses a smartphone or tablet 152 and a desktop computer 154 to communicate with the computer system 100 via the network 120.
Psychedelics Protocol Records Referring to Figures 1 and 2, an illustrative psychedelics protocol record is shown generally at 200 in Figure 2. Generally, in this embodiment the psychedelics protocols database 102 embodied in a physical computer-readable storage medium, and stores one or more protocol records 200 for each client 130, each protocol record defining a respective protocol for the client. More particularly, for each of the clients 130, in this embodiment the psychedelics protocols database 102 stores records for at least one medicine protocol, and for a cleansing protocol and an integration protocol that correspond to the medicine protocol.
In this embodiment, the psychedelics protocols database 102 stores a plurality of psychedelics protocol records defining a plurality of respective "default"
protocols that can be readily selected by a healthcare professional 140 for use by a client 130. For example, in this embodiment the database 102 stores records defining a plurality of default psychedelic medicine protocols, including at least one medicine protocol for the administration of each respective one of a plurality of psychedelic or psychoactive compounds, which in this embodiment include psilocybin, DMT, LSD, mescaline and MDMA. Alternatively, medicine protocols may be defined for other psychedelic or psychoactive compounds, or combinations of such compounds.
In this embodiment, for each default psychedelics medicine protocol, the psychedelics protocols database 102 stores at least one corresponding default cleansing protocol and at least one corresponding default integration protocol.
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-8-Alternatively, larger numbers of default protocols may be stored in the database 102 if desired. Or, as a further alternative, rather than selecting from among a plurality of "default" protocols, a set of psychedelics protocols may be customized for a particular client 130 by the client's healthcare professional 140 and by the client 130, through their respective interactions with the computer system 100 to effectively add, drop or modify certain components in their protocols.
Generally, unlike the medicine protocols which may include the administration of a drug to a client 130 under the supervision of a clinician 150, in this embodiment the cleansing protocols and integration protocols consist of components or activities that do not amount to methods of medical treatment, as described in greater detail below.
Figure 2 shows an illustrative example of a psychedelics protocol record 200.
In this embodiment, the record 200 generally includes a plurality of fields for storing different types of data, including protocol definition fields 210, client fields 220, diet fields 230, activities fields 240, psychometrics fields 250, biometrics fields 260, and history fields 270.
In this embodiment, the protocol definition fields 210 include a protocol type field 212 and a protocol ID field 214. The protocol type field 212 stores an identification of a type of psychedelics protocol, which in this embodiment is one of three predefined types: cleansing protocols, medicine protocols and integration protocols. The protocol ID field 214 stores a unique ID for each unique protocol (although each protocol can be assigned to more than one client, resulting in more than one psychedelics record 200 for the unique protocol, i.e. one record for each client). The protocol ID fields 214 may also store identifications of related protocol records: for example, the protocol ID fields 214 of the record 200 for each one of the cleansing, medicine and integration protocols for a particular client 130 also store identifications of the protocol records defining the other two of these protocols for that client.
Date Recue/Date Received 2021-03-29

-9-In this embodiment, the client fields 220 include a client ID field 222 and a client calendar field 224. The client ID field 222 stores an identification of the client 130 to whom the record 200 relates. In this embodiment, the client ID field 222 stores either a unique number identifying the client or an encryption of information identifying the client, rather than storing information that legibly identifies the client.
Alternatively, the client's name can be stored with appropriate permissions and security. In this embodiment, the client calendar field 224 stores a plurality of times that the client 130 is available for cleansing or integration activities or assessments if the record 200 pertains to a cleansing or integration protocol.
Alternatively, the client calendar field 224 may store a schedule for a psychedelics medicine protocol.
In this embodiment, the diet fields 230 include a plurality of diet-related protocol components, including food fields 232, water fields 234, and abstinence fields 236.
For example, if the record 200 defines a cleansing protocol preceding a psilocybin medicine protocol (with the corresponding medicine protocol being identified as a related protocol in the protocol ID fields 214 of the cleansing protocol record 200), the food and water fields 232 and 234 may contain instructions to eat a meal and drink water three hours before a scheduled component of the corresponding psilocybin medicine protocol. Alternatively, other medicine protocols may require abstinence from alcohol, nicotine or other drugs or combinations of drugs for a predetermined period of time preceding a component of the medicine protocol, in which case the abstinence fields 236 of the corresponding cleansing protocol record 200 may specify such abstinence requirements.
In the present embodiment, the activities fields 240 define a plurality of activities that can form part of a particular protocol. In this embodiment, the activities fields 240 include at least the following: breathwork fields 241, meditation fields 242, journaling fields 243, music fields 244, yoga fields 245, muscle relaxation fields 246 and guided curiosity fields 247. Generally, the activities fields 240 allow the healthcare professional 140 and client 130 to select or de-select each of the Date Recue/Date Received 2021-03-29

-10-activities 241 to 247, and to set a relative weight of each activity. In this embodiment, the relative weight can range from zero (for an activity that is omitted from the protocol) to as high as one (for an activity that is the sole activity of the protocol). For example, if a particular integration protocol contains five components intended to be performed with equal frequency, then each activity would have a relative weight of 0.2. Although the above examples of activities relate primarily to integration protocols and cleansing protocols, such activities may also be provided in medicine protocols if desired.
In this embodiment, the psychometrics fields 250 define psychometric assessment components of the protocol defined by the record 200. More particularly, in this embodiment the psychometrics fields 250 include sleep review fields 251, cognitive dissonance (CD) fields 252, mood report fields 253 and values clarification fields 254. More particularly still, in this embodiment the sleep review fields 251 store information defining questions or sets of questions for the processor 110 to pose to a client 130 regarding the client's sleep or sleep patterns. Similarly, in this embodiment the CD fields 252 store information defining cognitive dissonance questions or sets of questions for the processor 110 to pose to the client 130, and the mood report fields 253 store information defining mood-related questions for the processor 110 to pose to the client 130. In this embodiment, the values clarification fields 254 store information defining questions for the processor 110 to pose to the client 130 to clarify the client's values on a range of topics, which in this embodiment include the following illustrative list of topics: family, career, spirituality, love, fun, nature, wealth, loyalty, friendship, fairness, and peace.
Generally, the psychometrics fields 250 allow the healthcare professional 140 and the client 130 to select or omit each of these types of assessment from the protocol, and to select a frequency with which each type of assessment should be repeated. For example, in this embodiment the values clarification fields 254 are included in each "default"
cleansing protocol to obtain an initial or baseline assessment of the values of the client 130 before commencing a medicine protocol, and likewise, in this Date Recue/Date Received 2021-03-29

-11-embodiment the values clarification fields 254 are included in each "default"
integration protocol to mandate one or more subsequent reassessments of the client's values.
In this embodiment, the biometrics fields 260 specify one or more types of commonly available biometric inputs to be included in or omitted from the protocol.
More particularly, in this embodiment the biometrics fields 260 include resting heart rate fields 261, heart rate variability fields 262, skin temperature variability fields 263, breathing rate fields 264, oxygen saturation (Sp02) fields 265, and sleep pattern fields 266. In this embodiment the fields 261 to 265 correspond to biometric data that can be obtained from commonly available biometric monitoring devices 134 such as a FitBitTM for example, and the field 266 relates to data that can be obtained from a typical smartphone 132 such as an iPhoneTM. Alternatively, other types of biometrics may be added or substituted. The biometrics fields 260 allow the healthcare professional 140 and the client 130 to select or omit each of these types of biometric data from the protocol for the client 130, and to indicate times and any conditions for obtaining these biometric data.
In this embodiment, the history fields 270 may be used effectively track the history of a particular protocol, such as a "default" integration protocol. The history fields 270 may include past instances fields 272 identifying the locations of other records in the database 102 of past instances of the same protocol (having the same protocol ID 214). The history fields 270 may further include outcome scores fields 274, including an outcome score for the current protocol record 200 for the current client 130, and an average of outcome scores for the past instances of the same protocol.
Prior to execution of the protocol structuring routine 300 by the processor 110, the client 130 and the healthcare professional 140 will have created one or more protocol records 200 defining one or more respective psychedelics protocols for the Date Recue/Date Received 2021-03-29

-12-client 130. Typically three protocol records 200 will be created for each client 130, including respective records for a cleansing protocol, a medicine protocol and an integration protocol.
Although a specific structure of a protocol record 200 has been described for illustrative purposes, alternatively other structures may be substituted.
Protocol Structuring Routine Referring to Figures 1-3, the protocol structuring routine is shown generally at 300 in Figure 3. It will be appreciated that the protocol structuring routine 300 described below merely provides one illustrative example of a routine in accordance with an embodiment of the invention. In other embodiments, different functions and routines may be added or substituted.
In this embodiment, the protocol structuring routine 300 begins with blocks 302 and 304 of codes, which generally direct the processor 110 to automatically select, at each of a plurality of times specified by an integration or cleansing protocol, one component of the protocol, and to send the client a notification including a suggestion to perform the one component.
To achieve this, block 302 first directs the processor 110 to determine whether it is time to suggest an activity of an integration or cleansing protocol to a client 130. It will be recalled that the client calendar fields 224 of each psychedelics protocol record 200 may store indications of available times for the particular client 130 to perform some of the components of an integration or cleansing protocol. For example, the calendar fields 224 for an integration protocol for a particular client 130 may indicate that the client 130 is available weekday evenings at 7 pm, or weekend afternoons. Block 302 directs the processor 110 to search through the database 102 to locate any psychedelics protocol records 200 that are identified in Date Recue/Date Received 2021-03-29

-13-their protocol type fields 212 as being either cleansing or integration protocols, and having client calendar fields 224 indicating that the client 130 has become currently available to participate in an activity of the protocol. For each such identified integration or cleansing protocol record 200 for which a client 130 is currently available, the processor is directed to blocks 304 to 334 below.
Following location of such a record 200 at block 302, in this embodiment block directs the processor 110 to automatically select one component of the protocol to which the record 200 pertains, and to send to the relevant client 130 a notification including a suggestion to perform the one selected component of the protocol.
To achieve this, in this embodiment block 304 directs the processor 110 to randomly select one of the activities components of the protocol, according to the selection weights stored in the relevant activities fields 240 for the respective activities. For example, an illustrative integration protocol for a particular client 130 might involve only four of the possible activities, e.g. yoga, breathwork, music and journaling, but might specify a preference for the particular client to do yoga twice as often as each of the other three activities. In this example, the breathwork fields 241, journaling fields 243, music fields 244, yoga fields 245 would store selection weights of 0.2, 0.2, 0.2 and 0.4 respectively, and block 304 would direct the processor 110 to make a weighted random selection with a 40% chance of selecting yoga, a 20% chance of selecting breathwork, a 20% chance of selecting journaling and a 20% chance of selecting music.
Upon making a weighted random selection of an activity component of the protocol record 200, block 304 further directs the processor to send to the client 130 a notification including a suggestion to perform the selected component. In this embodiment, block 304 achieves this by directing the processor 110 to transmit a push notification to an application running on the smartphone 132 of the client 130 to whom the located record 200 pertains. The application running on the smartphone 132 responds to the push notification by displaying to the client 130 a Date Recue/Date Received 2021-03-29

-14-suggestion to perform the selected component of the protocol. For example, if the selected component was "yoga," block 304 may direct the processor 110 to prompt the smartphone application to display a message, "How about some yoga now'?"
in conjunction with displayed option buttons such as "yes" or "no".
In response to client actuation of a displayed "Yes" or "No" button, the smartphone application transmits an appropriate "acceptance" or "rejection" signal to the processor 110 via the network 120. In this embodiment, the smartphone application also opens an activity dashboard in the form of a visual graphical interface displayed on the smartphone 132, allowing the client 130 to select and perform activity and assessment components of psychedelics cleansing and integration protocols for the client.
If at block 304 a "Yes" (acceptance) response is received from the smartphone by the processor 110, block 306 directs the processor 110 to increment an acceptance counter in the relevant one of the activities fields 240 for the currently selected and suggested component of the protocol record 200, and to proceed to block 314 below.
If at block 306 a "No" response is received from the smartphone 132 by the processor 110, or if no response is received within a predefined interval, block 310 directs the processor 110 to determine whether the client 130 has selected an alternative component of the protocol record. For example, in response to a client selection of "No" or a failure to respond, the smartphone application may use the activity dashboard to ask the client 130 if they would like to perform a different component specified in the protocol record 200. In response to input from the client 130 selecting a different component of the protocol record 200, the smartphone application transmits a message to the processor 110 via the network 120, including an identification of the different component selected by the client 130. If at block 310 the processor 110 receives such a message, block 312 directs the Date Recue/Date Received 2021-03-29

-15-processor 110 to increment an acceptance counter in the relevant one of the activities fields 240 for the different component of the protocol selected by the client 130, and to proceed to block 314 below.
In this embodiment, block 314 directs the processor 110 to obtain and store baseline biometrics and psychometrics data for the client 130, as the client begins the selected component of the psychedelics cleansing or integration protocol. In this embodiment, the actual biometric and psychometric input data received from the client 130 is stored in a separate corresponding record in a medical database 106, and the client identification number stored in the client ID
field 222 acts as a cross-reference between the protocol record 200 and the corresponding record in the medical database 106. Alternatively, if desired, the biometric and psychometric data may be stored in the psychedelics protocols database 102, provided appropriate privacy and confidentiality safeguards are adopted.
Block 314 first directs the processor 110 to begin receiving and storing each of the biometrics specified in the biometrics fields 260 of the currently addressed protocol record 200. For example, in a "default" integration protocol record 200, the contents of the resting heart rate fields 261, heart rate variability fields 262, skin temperature variability fields 263, breathing rate fields 264, and oxygen saturation (Sp02) fields 265 are all set "active" so that all five of these types of biometric data are included in the integration protocol. In this embodiment, block 314 directs the processor 110 to receive each of these five biometric data types from the biometric monitoring device 134 of the client 130, and also directs the processor 110 to receive the most recent sleep pattern data from the smartphone 132 of the client 130, as specified by "active" contents of the sleep pattern data fields 266 of the current protocol record 200. Block 314 directs the processor 110 to store each of these six biometric data types in a record in the medical database 106 corresponding to the currently addressed protocol record 200.
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-16-Block 314 then directs the processor 110 to obtain baseline psychometric data at the commencement of the component of the protocol. For example, the activities fields 240 for the current component of the protocol record 200 may specify one or more questions to be posed to the client 130 at the commencement of the component, such as, "Do you feel happy?" or "Do you feel sad?" Alternatively, block 314 may direct the processor 110 to pose predefined questions to the client 130 specified in one or more of the various psychometrics fields 250 for the currently addressed protocol record 200.
In this embodiment, block 316 then directs the processor 110 to monitor the biometric data received from the biometric monitoring device 134 and to compare the received data to predefined thresholds associated with dangerous conditions.
For example, the client identification fields 220 may store a maximum heart rate for the particular client 130 (e.g. 220 minus the client's age), in which case block 316 may direct the processor to monitor the heart rate data received from the biometric monitoring device 134 to determine whether the current heart rate of the client 130 exceeds the maximum heart rate stored for the client. As a further example of a dangerous condition, block 316 may also direct the processor 110 to monitor skin temperature data received from the biometric monitoring device 134 and compare the received skin temperature to a predefined threshold associated with hyperthermia (e.g. 39 or 40 degrees Celsius).
If at block 316 a dangerous condition is detected from the biometric data, then block 318 directs the processor 110 to generate and send appropriate alerts to the client 130 and to the client's healthcare professional 140, to alert the client 130 to cease the current activity / component and to alert both the client and the healthcare professional 140 to the occurrence of the dangerous condition.
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-17-Block 318 directs the processor 110 to determine whether the current activity /
component of the protocol has been completed, by checking each of a plurality of predefined conditions. As examples of the predefined conditions, block 318 may direct the processor 110 to determine whether it has received a message from the smartphone application running on the smartphone 132, indicating that the client 130 has used the activity dashboard in the smartphone application to mark the current component of the protocol as completed. Alternatively, it may be assumed that each type of activity has been completed when a predetermined characteristic time interval has elapsed since their commencement.
If the current component of the protocol has not yet completed, block 322 directs the processor 110 to continue monitoring and storing biometric data received from the biometrics monitoring device 134, and the processor is directed back to blocks 316 to 320 to continue monitoring the biometric data for dangerous conditions until the current component of the protocol is completed.
If at block 320 it is determined that the current component of the protocol has completed, block 324 directs the processor 110 to obtain further psychometric data.
For example, in this embodiment the activities fields 240 for each activity component of the protocol specify specific questions to be posed to the client upon completion of an instance of the component of the protocol, such as, "Do you feel better now?" Alternatively, block 324 may direct the processor 110 to pose further questions to the client selected from those stored in the psychometrics fields 250 of the current protocol record 200.
In this embodiment, block 326 then directs the processor 110 to automatically reduce a frequency at which the particular component is selected and suggested to the client as discussed at block 304 above, in response to the processor determining that the biometric data or the psychometric data associated with the currently completed component of the protocol satisfies a predefined adjustment Date Recue/Date Received 2021-03-29

-18-condition. In this regard, the activities fields 240 for each of the components of the protocol may specify specific expected ranges for biometric data, as well as expected conditions for psychometric data to satisfy, for the particular component.
For example, for a "journaling" component of the protocol, it may be expected that the client's resting heart rate should remain below a threshold rate and not increase by more than a threshold amount associated with an onset of anxiety, so a departure from this expectation is an example of a biometric adjustment condition.
Similarly, it may be expected that the client's mood or disposition will not suddenly worsen after completion of the component of the protocol, so a departure from this expectation (by comparing the psychometric data obtained at blocks 324 and 314 above) is an example of a psychometric adjustment condition. If at block 326 a biometric or psychometric adjustment condition is detected, then block 326 further directs the processor 110 to readjust the selection weights of the components as stored in their respective activities fields 240 of the currently addressed protocol record 200. For example, if the journaling fields 243 of the current protocol record 200 initially specified a selection weight of 0.2 representing a 20% chance of journaling being randomly selected and suggest at block 304, block 326 may direct the processor 110 to update the selection weights of the activities fields 240 for the various components of the protocol, by reducing the selection weight of the journaling component by (e.g.) 25% to 0.16, and by redistributing the difference of 0.04 among the suggestion weights of the other activity components of the protocol.
Following execution of block 326, the processor is directed back to block 302.
If at block 310 above the client 130 declined to choose any component of the protocol, then block 328 directs the processor 110 to generate missed activity notifications. In this embodiment, block 328 directs the processor 110 to send such a missed activity notification only to the healthcare professional 140 and not directly to the client 130, in an attempt to avoid nagging or shaming the client 130, either of which might deter the client's compliance with the protocol. In this embodiment, the processor 110 sends a missed-event notification message to the healthcare Date Recue/Date Received 2021-03-29

-19-professional 140 via a graphical interface generated on the healthcare professional's computer 144 or smartphone 142. The graphical interface presents the healthcare professional 140 with options, such as whether to telephone the client, or manually adjust the selection weights of the components of the protocol.
Block 330 then directs the processor 110 to increment a rejection counter stored in the relevant activities fields 240 for the component that was suggested to the client above at block 304.
In this embodiment, blocks 332 and 334 then direct the processor 110 to automatically reduce a frequency at which a particular component is selected and included in the suggestion at block 304, in response to the processor 110 detecting repeated non-completion of the particular component. More particularly, block directs the processor 110 to determine whether a rejection threshold has been exceeded for the component that was suggested to the client at block 304. To achieve this, block 332 directs the processor 110 to compare an acceptance counter and a rejection counter stored in the activities fields 240 of the component that was suggested to the client at block 304. In this embodiment, if the total rejection percentage exceeds a first threshold, or if the rejection percentage in the most recent time period exceeds a second threshold, block 332 directs the processor 110 to decrease the selection weight of the component that was suggested at block 304. This reduction may be achieved in the same way as described above in connection with block 326 for example. Following a reduction of the selection weight of the rejected component at block 334, the processor 110 is directed back to block 302.
If at block 302 there are no more current activity suggestions to be made to clients 130, block 336 then directs the processor 110 to determine whether it is time for one or more psychometric assessments. In this regard, for a particular protocol record 200, the psychometrics fields 250 for one or more of the available types of Date Recue/Date Received 2021-03-29

-20-psychoactive assessments may be set active so that they are included in the protocol, and the client's calendar 224 may include an indication of times at which the client 130 should be prompted to provide specific psychometric input for each one of the selected assessment types. Block 336 directs the processor 110 to search the database 102 for any records 200 for which it is time to solicit psychometric inputs from the client, and upon locating any such records at block 336, block 338 directs the processor 110 to prompt the client 130 to provide the specified psychometric inputs, such as answers to specific questions.
In this embodiment, if at block 336 no further records 200 are identified for which it is time to request psychometric input, block 340 directs the processor 110 to determine whether any psychedelics medicine protocol components are commencing or are in progress. For example, a psilocybin medicine protocol may involve the client 130 visiting one of the clinicians 150, to undergo administration of the psilocybin by the clinician and within the supervised confines of the clinic.
Upon detecting such a medicine protocol component commencing or in progress at block 340, block 342 directs the processor 110 to begin receiving and storing, in the psychedelics protocols database 102, biometric data representing at least one biometric of the client 130 while the client is participating in the psychedelics medicine protocol component. In this embodiment the processor 110 receives the biometric data from the biometric monitoring device 134 and from the smartphone 132 of the client 130.
Block 344 then directs the processor 110 to detect any one of a plurality of predefined conditions from the received biometric data. For example, detecting a predefined condition may include determining that the current biometric data deviates from a desired range for the current component of the medicine protocol by more than a predefined threshold. Thus, for example, detecting predefined conditions may include detecting any of the dangerous conditions described above Date Recue/Date Received 2021-03-29

-21-in connection with block 316, such as critically high heart rate or skin temperature, for example. Additionally, the predefined conditions may include conditions which, though not dangerous, may nevertheless warrant intervention by the clinician.
For example, a heart rate elevated well above rest levels but also well below the client's maximum heart rate may suggest client anxiety, suggesting that a calming intervention may be desirable.
Upon detecting any such predefined condition at block 344, block 346 directs the processor 110 to automatically alerting a clinician 150 overseeing the current component of the medicine protocol, in response to the processor xxx, send an alert message to the clinician 150 via the network 120 and the clinician's computer 154 or smartphone 152. In this embodiment, the alert includes an identification of the cause of the alert (e.g., elevated heart rate), and a predefined suggested intervention corresponding to the identified cause (e.g., reassure the client verbally, or change to more soothing background music, etc.).
Block 348 directs the processor 110 to determine whether the medicine protocol component has concluded, and if not, the processor 110 may be directed back to block 342 to continue monitoring biometric data and checking for intervention conditions as described at blocks 344 and 346.
If at block 348 it is determined that the medicine protocol component has completed, block 350 directs the processor 110 to determine whether all protocols in the database 102 have been fully completed, and if not, the processor is directed back to blocks 302, 336 and 340 to continue structuring cleansing and integration protocol activities and assessments, and to continue monitoring medicine protocols, as described above.
Alternatives Date Recue/Date Received 2021-03-29

-22-The above description is merely illustrative. Other ways of structing cleansing and integration protocols, and other ways of monitoring medicine protocols, may be substituted.
Although blocks 342 to 346 described generating alert notifications during a psychedelics medicine protocol component in response to biometric information, alternatively such notifications may be generated in response to psychometric information, or a combination of biometric and psychometric information, in a manner similar to that described above in connection with block 326.
Although the above-described embodiments involved psychometric information being extracted from clients 130 primarily through questioning, alternatively, other ways of obtaining psychometric data may be substituted. For example, journal entries or recorded audio speech or video recordings of the client may be analyzed by a Machine Learning (ML) algorithm to automatically detect a sentiment or mood of the client 130.
Although the above description has focused on protocols such as integration and cleansing protocols that are ancillary to a psychedelics medicine protocol, alternatively the methods described herein may be applied to integration and cleansing protocols that are ancillary to other medical treatment protocols.
In addition to the embodiments described above, it is contemplated that any one or more features of any particular embodiment may be combined with any one or more features of any other embodiment, except where such features have been explicitly described as mutually exclusive alternatives.
While specific embodiments of the invention have been described and illustrated, such embodiments should be considered illustrative of the invention only and not as limiting the invention as construed in accordance with the accompanying claims.
Date Recue/Date Received 2021-03-29

Claims (4)

THE SUBJECT-MATTER OF THE INVENTION FOR WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED IS DEFINED AS FOLLOWS:

1. A computer-implemented method of structuring a client's participation in a psychedelics integration protocol, the method comprising:
storing an integration protocol record for the client in a psychedelics protocols database embodied in a physical computer-readable storage medium, the integration protocol record defining an integration protocol for the client, the integration protocol comprising a plurality of [non-medical treatment]
components;
a processor automatically selecting, at each of a plurality of times specified by the integration protocol, one component of the plurality of components and sending the client a notification including a suggestion to perform the one component; and in response to the processor detecting repeated non-completion of a particular component of the plurality of components, the processor automatically reducing a frequency at which the particular component is selected and included in the suggestion to perform the one component.

2. A computer-implemented method of structuring a client's participation in a psychedelics integration or cleansing protocol, the method comprising:
storing an integration or cleansing protocol record for the client in a psychedelics protocols database embodied in a physical computer-readable storage medium, the integration or cleansing protocol record defining an integration or cleansing protocol for the client, the protocol comprising a plurality of [non-medical treatment] components;
at each of a plurality of times specified by the integration or cleansing protocol, a processor automatically selecting one component of the plurality of components and sending the client a notification including a suggestion to perform the one component;

in association with each of the plurality of components, the processor receiving and storing in the psychedelics protocols database, at least one of:

biometric data representing at least one biometric of the client; and psychometric data indicative of at least one psychometric of the client; and in response to the processor determining that the biometric data or the psychometric data associated with a particular component of the plurality of components of the protocol satisfies a predefined condition, the processor automatically reducing a frequency at which the particular component is selected and included in the suggestion to perform the one component.

3. A computer-implemented method of monitoring a client's participation in a psychedelics medicine protocol, the method comprising:
a processor receiving and storing, in a psychedelics protocols database embodied in a physical computer-readable storage medium, biometric data representing at least one biometric of the client while the client is participating in each of a plurality of components of the psychedelics medicine protocol; and in response to the processor determining that the biometric data during a particular component of the plurality of components deviates from a desired range for the particular component by more than a predefined threshold, automatically alerting a clinician overseeing the particular component.

4. A computer system comprising:
a psychedelics protocols database embodied in a physical computer-readable storage medium, the database storing a plurality of psychedelics protocol records defining respective psychedelics protocols for a plurality of clients, each of the protocols comprising a plurality of components;
a processor in communication with the database; and a computer-readable medium in communication with the processor, the medium storing instructions which, when executed by the processor, cause the method of any one of claims 1-3 to be carried out.