Dynamically targeting substance use disorder and condition via personalized digital therapeutics

A digital therapeutic combining training activities for inhibitory control and working memory addresses cognitive deficits in SUDs, improving executive control and reducing relapse through personalized, dynamically adjusted interventions.

JP2025116846APending Publication Date: 2025-08-08CLICK THERAPEUTICS INC
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Patent Information

Application Number
JP2025011258
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-11-18
Filing Date
2025-01-27
Publication Date
2025-08-08

AI Technical Summary

Technical Problem

Existing treatments for substance use disorders (SUDs) are ineffective in addressing cognitive deficits and psychological factors, leading to high relapse rates due to a lack of personalized interventions that target neural components contributing to maladaptive behaviors.

Method used

A digital therapeutic application that combines three training activities to enhance executive control, targeting overlapping neural network substrates, including inhibitory control and working memory, with real-world relevance, and dynamically adjusts interventions based on user performance.

Benefits of technology

This approach improves inhibitory control and working memory, reducing substance use by shifting habit-based drug-taking responses to goal-oriented behaviors, enhancing clinical effectiveness and personalizing treatment for SUDs.

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Abstract

To provide a system and method for presenting intervention to address a substance use disorder (SUD) in a user.SOLUTION: A method of providing an instruction for an activity to address a maladaptive behavior associated with substance use in a user, includes the steps of: identifying, by one or more processors, for the user with a substance use disorder, a profile including a plurality of substance use words; presenting, by the one or more processors, a plurality of memory words not related to the substance use, and an instruction to memorize the plurality of memory words; providing, by the one or more processors, an instruction to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; and updating, by the one or more processors, the profile of the user by using the execution of the activity by the user.SELECTED DRAWING: Figure 6
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Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 626,465, filed January 29, 2029, entitled "MANAGING SESSION TO PROVIDE PSYCHOTHERAPEUTIC COMPONENTS TO ADDRESS USER CONDITIONS," the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Substance use disorders (SUDs) result from the repetitive and compulsive use of alcohol, drugs, or other substances, leading to cognitive impairment, health risks, and impairment. Common SUDs include alcohol use disorder (AUD), opioid use disorder (OUD), and drug use disorder. These conditions arise from a variety of biological and environmental factors. For example, specific factors that may lead to SUDs include genetics, brain chemistry (e.g., altered levels of neurotransmitters such as dopamine), mental health disorders (e.g., anxiety, depression, attention deficit hyperactivity disorder (ADHD)), personality traits (e.g., impulsive behavior), coping mechanisms (e.g., lack of effective coping strategies), or early exposure (e.g., during adolescence, when the brain is still developing). Other factors that may lead to SUDs include external influences such as family (e.g., substance use within the family), peer pressure (e.g., initiation of substance use by peers), availability (e.g., ease of substance use), socioeconomic status (e.g., poverty, unemployment), cultural norms (e.g., a culture that values alcohol), or media (e.g., media portrayals of drug use).

[0003] SUDs affect the physical health, mental health, social well-being, and overall quality of life of those affected. Individuals with SUDs are more susceptible to a variety of physical complications. In addition, individuals with SUDs are at increased risk for psychological disorders, such as cognitive impairment and emotional distress, as well as a higher risk of drug overdose. Overall quality of life is often significantly impaired for individuals with SUDs.

[0004] At the nervous system level, SUDs alter synaptic strength and connectivity, particularly in the brain's reward circuitry, contributing to the persistence of addictive behaviors. Specifically, SUDs not only alter brain structure and function but also cause neurotransmitter imbalances that are essential for cognition and overall brain function. Furthermore, individuals with SUDs are at increased risk for developing neurological disorders (e.g., stroke, Parkinson's disease) and mental health disorders (e.g., depression, anxiety). For example, opioids bind to opioid receptors in the brain, reducing pain perception and inducing euphoria. Specifically, SUDs, like OUD, cause impairments in cognitive function (e.g., executive function, memory) and alter brain structure, particularly in areas related to stress, decision-making, and behavioral regulation.

[0005] Treatment for SUDs can be administered to halt or reduce the side effects of substance use. These treatments include, for example, in-person behavioral therapy, pharmacotherapy, outpatient and inpatient treatment programs, detoxification, and support groups. However, reducing relapse in SUDs is challenging due to the potential for ineffective treatments. In particular, failure to address an individual's motivation to adhere to treatment and the underlying cognitive deficits that lead to substance use reduces the effectiveness of SUD treatments. For example, individuals participating in inpatient rehabilitation may relapse upon returning to their daily lives. Failure to consider both cognitive deficits and psychological factors (e.g., motivation) can result in ineffective SUD treatments, ultimately resulting in little or no improvement in substance use disorder and relapse. These treatments do not take into account the challenges associated with maintaining an individual's commitment to abstaining from substance use or the cognitive impact of SUDs on individuals. Furthermore, these treatments do not directly target the reorganization or regulation of neural components that contribute to the persistence of maladaptive behaviors associated with SUDs. Summary of the Invention

[0006] Presented herein are systems and methods for delivering digital therapeutics that target a user's executive control system. The digital therapeutic application described herein offers a unique combination of complex neuromodulatory interventions aimed at targeting cognitive deficits associated with substance use disorders (SUDs). Specifically, this novel integrated approach first combines two training activities in a single immersive task, targeting overlapping neural network substrates. This functions to simultaneously train two subdomains of executive control (e.g., inhibitory control and working memory), potentially simulating a critical period-like state that enhances plasticity through flexibility mechanisms. This combined training paradigm can add a third training activity as a synergistic psychotherapeutic component, leveraging the plasticity induced by the two preceding activities. This is achieved by applying the third training activity to real-world-relevant activities, thereby helping to guide the user's targeted real-life behaviors related to substance use disorders, potentially enhancing the clinical effectiveness of these exercises.

[0007] Particularly in a multidisciplinary training program, these three training activities are most effective when conducted together in a continuous, repeated cycle. Over time, a user's habit-based drug-taking responses can be shifted to responses focused on achieving future goals. Thus, the first two training activities build the user's "mental muscles" of impulse control and planning, while the third training activity applies the skills developed during the first two training activities in real-world situations. The combination of these three training modules has a synergistic effect in strengthening a user's impulse control and curbing substance use disorders.

[0008] This integration represents a significant improvement over other intervention techniques that focus solely on cognitive or psychological components, without overcoming limitations in integrating the two or transferring their effects to real-world situations. When an imbalance exists between an overactive impulsive system and an underactive executive control system, the training activities disclosed herein can improve the capacity and efficiency of the executive control system, thereby improving its functionality. The combination of the three training activities described herein targets overlapping neural network substrates within the prefrontal cortex involved in both decision-making and working memory function, potentially optimizing the brain's learning mechanisms.

[0009] Furthermore, this digital therapeutic application addresses the lack of personalized solutions that effectively target both the brain's decision-making and working memory functions. The application blends activities that simultaneously target inhibitory control and working memory, integrating goal-relevant context to translate improvements in inhibitory control and working memory into real-world improvements. Based on the user's performance, the application increases the difficulty of these activities to further improve an individual's inhibitory control and working memory. The digital therapeutic application can use information about the user to specifically tailor interventions for SUD. Activity result scores, indicating the user's performance and progress, are presented to the user, allowing them to track their progress and encourage adherence to the intervention regimen. The digital therapeutic application is continuously updated during the intervention, encouraging the user to make further efforts, ensuring the intervention remains effective and aligned with the evolving state of the user's executive control system.

[0010] This digital therapeutic application therefore addresses the lack of integrated cognitive and psychological treatments by providing digital interventions that are dynamically adjusted based on an individual's response to various activities. The application further provides a specifically tailored approach to addressing SUDs that is aligned with each user's specific needs and physiological profile. This integration of digital, cognitive, and psychological solutions significantly improves the effectiveness of treatment for SUDs and related disorders, leading to better outcomes and overall patient care.

[0011] SUDs result in several problems that affect the physical health, social well-being, and mental health of those affected. Individuals with SUDs are more susceptible to a variety of physical health complications, including liver disease, pulmonary disease, cardiovascular disease, neurological disorders, human immunodeficiency virus (HIV), hepatitis B and C, sexually transmitted diseases (STDs), nutritional deficiencies, sleep disorders, and an increased risk of overdose.

[0012] The digital therapeutic application described herein generates and maintains for each user a set of substance use words associated with the user's SUB and a set of non-substance use related memory words (e.g., different from the set of substance use words).

[0013] In the first part, the user is instructed not to select substance use words (substance use words) or memory words (memory words) that can be presented to the user, but instead to select only neutral words. This activity improves the user's executive control system, including breaking associations (e.g., triggers) that the user associates with substance use. Over time, substance use words and memory words (i.e., words to which the user should refrain from responding) appear less frequently than neutral words (i.e., words to which the user should respond), allowing the latter to become dominant (e.g., automatic). This also teaches the user to pay less attention to the substance use words. Furthermore, the brief appearance of words to which the user should (or should not) respond trains inhibitory control and encourages a rapid response speed to break the connection between the user and the substance use words.

[0014] In the second part, the user is instructed to perform an activity based on visualizing a future event. This future event may be related to the user's health, relationships, values, finances, fun, charitable giving, abstinence, lifestyle, overcoming maladaptive behaviors associated with the user's substance use, or other categories. Alternatively, the user may be instructed to create or identify a goal to achieve. The user is then instructed to create a cue word or image to remind the user of the future event in a later session.

[0015] In the third part, users are instructed to perform the same activities as in the first part. Specifically, they are instructed not to select the substance use or memory words displayed on the screen, but instead to select neutral words. In the fourth part, users are presented with a prompt containing previously generated cue words and images to re-envision the future event. The prompts can be descriptions or visual depictions of the future event, or a vision board simulating sticky notes or handwritten notes on a corkboard, displaying information from multiple sessions (different future events) collected in a single design or on a single screen. Users can modify, delete, or create new cue words and images over time (e.g., as goals change over time or as the time of the future event elapses).

[0016] This cycle can be repeated multiple times over time: (1) asking the user to select no substance use and / or memory words displayed on the screen, and then (2) asking the user to visualize future events based on previously generated cue words or images, including creating new future events and new cue words or images. In this way, this application can reduce substance use and mitigate relapse by improving executive control using a variety of activities delivered at different times. These regular activities are tailored to target the user's progress by improving inhibitory control and working memory, while simultaneously leveraging the plasticity induced by improved executive control through visualization of future events. This application can integrate various techniques to target brain function impaired by substance use, simultaneously providing a sustainable intervention that promotes user adherence while avoiding the unnecessary time and expense of traditional, ineffective SUD treatments.

[0017] As the user becomes more skilled and experienced with an activity, the application adaptively adjusts the difficulty of the activity to keep the user stimulated and challenged, further enhancing the user's executive control. For example, over time, new memory words can be added to the list for the user to memorize and withhold responses. This can be gradually increased in difficulty, such as by increasing the number of words added each day. The application can also quiz the user to test whether they have memorized all of the memory words, and the results of the quiz can be used to determine whether to increase the number of memory words or maintain the same number. As another example, a user score can be created based on the number or percentage of correct interactions with substance use words, memory words, or both, the user's selection speed, or both. Once the score meets a threshold, the application can increase the difficulty by, for example, increasing the number of words in subsequent activities.

[0018] The digital therapeutic application described herein can reopen the period of plasticity in adults typically limited to childhood. This digital therapeutic can mimic key principles of learning (e.g., plasticity) observed during the period when experience shapes traits and behaviors develop. For example, the first training activity, with its prepotent response, short response times, and indication-specific words, can create a challenging and salient learning environment for users to focus their attention and rapidly adapt under given conditions. Furthermore, the progressive difficulty element of the second training activity mimics the way and manner in which skills are naturally acquired during sensitive periods of development (e.g., the childhood plasticity period). The third training activity can exploit the neural plasticity that supports episodic memory formation throughout the user's lifespan. Combining the third training activity with the first and second training activities can support neural plasticity across relevant brain regions, enhancing the clinical effectiveness of this digital therapeutic application. [Brief explanation of the drawings]

[0019] The above and other objects, aspects, features, and advantages of the present disclosure will become more apparent and will be better understood by referring to the following description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 illustrates a block diagram of a system for presenting an interactive session to address a user's substance use, according to an illustrative embodiment. [Figure 2] 2A and 2B show a block diagram of a process for providing a user with a session for conducting substance use language activities according to an illustrative embodiment. [Figure 3] 3A and 3B show block diagrams of a process for providing a user with a session for performing a visualization activity, according to an example embodiment. [Figure 4] 4A and 4B show a block diagram of a process for providing a user with a session for performing a memory quiz activity, according to one example embodiment. [Figure 5] FIG. 5 illustrates a flowchart of a visualization activity, according to an exemplary embodiment. [Figure 6] FIG. 6 shows a flowchart of a method for a user to select an activity to address substance use, according to an exemplary embodiment. [Figure 7] Figure 7 shows a representative study timeline for the CT-102 mobile app engagement study. [Figure 8] FIG. 8 shows a flowchart of a method for remitting a user's substance use through the application of a digital therapeutic, according to an exemplary embodiment. [Figure 9] FIG. 9 is a block diagram of a server system and a client computer system according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0020] In reading the following description of the various embodiments, it will be helpful to refer to the descriptions and respective contents listed following each section of the specification.

[0021] Section A describes systems and methods for providing instructions regarding interventions for a user's substance use disorder (SUD).

[0022] Section B describes systems and methods for remitting a user's substance use through the application of digital therapeutics.

[0023] Section C is a description of network and computing environments that may be useful in implementing the embodiments described herein.

[0024] A. Systems and Methods for Providing Instructions Regarding Intervention for a User's SUD Aspects of the present disclosure relate to a treatment selection system and method for providing instructions for an activity to address a user's maladaptive behaviors associated with substance use. One or more processors can identify a profile for a user with a substance use disorder, the profile including a plurality of substance use words. The one or more processors can present a plurality of memory words unrelated to substance use and instructions for memorizing the plurality of memory words. The one or more processors can provide instructions for performing an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. The one or more processors can update the user's profile using the user's performance of the activity. The activity of refraining from selecting one or more of the plurality of memory words can be performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

[0025] In some implementations, the one or more processors may provide instructions for performing an activity that provides information about a future event. The future event may be related to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use. Before providing the instructions for performing the activity, the one or more processors may provide instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use. The one or more processors may also provide instructions for the user to select a category of the future event before providing the instructions for performing the activity. The category of the future event may be selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0026] In various implementations, the one or more processors can provide instructions for selecting a time frame for the future event. The future event can occur less than one month in the future. The future event can occur more than one month in the future. The one or more processors can provide instructions for the user to generate one or more visual cues based on the information about the future event provided by the user. The visual cues can be images or text, including free text, provided by the user. The one or more processors can provide subsequent instructions for performing an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. The instructions can also include instructions for performing an activity to select one or more neutral words unrelated to substance use and different from the memory words. The one or more processors can also provide a prompt including the visual cues associated with the information about the future event and instructions for performing an activity associated with the visual cues. The prompt can be a timeline identifying multiple visual cues. The timeline can automatically update based on times tagged to the visual cues. The activity may include an audio recording or a text description.

[0027] In some embodiments, the activity includes providing information related to overcoming maladaptive behaviors associated with substance use, or providing information related to the user's health, relationships, values, finances, enjoyment, charitable contributions, abstinence, or lifestyle. In some embodiments, instructions for the user to select an activity selected from providing information related to overcoming maladaptive behaviors associated with substance use, or providing information related to the user's health, relationships, values, finances, enjoyment, charitable contributions, abstinence, or lifestyle are provided prior to the instructions to perform the activity. In some embodiments, instructions for the user to select a category of the future event are provided prior to the instructions to perform the activity.

[0028] In various embodiments, the one or more processors can provide subsequent instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. The one or more processors can provide the prompt related to the information regarding the future event following the performance of the activity to refrain from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words. The one or more processors can also provide instructions to perform an activity to refrain from selecting one or more of the plurality of substance use words prior to the instructions to perform the activity to refrain from selecting one or more of the plurality of memory words and one or more of the plurality of substance use words. Similarly, the instructions can include instructions to perform an activity to select one or more neutral words that are not related to substance use and are not one or more of the memory words.

[0029] In various embodiments, the one or more processors can provide instructions for performing an activity of selecting all of the memory words from a plurality of words. The one or more processors can provide instructions for performing an activity of selecting one or more of the memory words from a plurality of words. The one or more processors can calculate a score indicating a percentage of correct interaction with the memory words, and the one or more processors can then select the plurality of memory words based on the score. In various embodiments, a correct interaction refers to the user selecting (e.g., selecting, engaging, choosing, contacting, touching) the word or refraining from selecting the word (e.g., allowing the word to be displayed on a display device without selecting, contacting, or touching).

[0030] In some implementations, the one or more processors may calculate a score indicative of correct interaction, speed of the user selection, or both, during the activity of selecting all mnemonic words from a plurality of words. In response to the score meeting a threshold, the one or more processors may determine a subsequent activity of refraining from selecting one or more of the plurality of mnemonic words, an activity of refraining from selecting one or more of the plurality of mnemonic words, or an increase in the number of words for the activity of selecting all mnemonic words from a plurality of words. The one or more processors may display the score indicative of at least one of a percentage of correct interaction, speed of user selection, or both, during one or more activities.

[0031] The one or more processors may calculate a score indicative of correct interaction, speed of user selection, or both, during performance of one or more activities, and then select, by the one or more processors, a plurality of subsequent substance use words, a plurality of subsequent memory words, or both, based on the score. The score may be calculated by the number of correct interactions, speed of user selection, or both, during performance of the activity of selecting all of the memory words from a plurality of words. The one or more processors may calculate a score indicative of correct interaction, speed of user selection, or both, during performance of the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words. In response to the score meeting a threshold, the one or more processors may determine an increase in the number of words for the subsequent activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words.

[0032] The one or more processors may generate one or more cue words or images based on the information about the future event provided by the user, and the prompt associated with the information about the future event includes the one or more cue words or images.

[0033] In various embodiments, the one or more processors can provide instructions for performing the activity of refraining from selecting one or more of the plurality of substance use words and / or one or more of the plurality of memory words, which can include providing instructions by the one or more processors for performing an activity in which the user selects one or more neutral words unrelated to substance use and different from the memory words. The one or more processors can provide instructions for performing the activity of refraining from selecting one or more of the plurality of substance use words or one or more of the plurality of memory words, which can include presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or 10 seconds or more. The instructions for performing an activity can be provided to the user at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week. The one or more activities can be performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. The prompt may be provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

[0034] The one or more processors may receive a request from the user indicating an onset of the behavior associated with the substance use, and may initiate, by the one or more processors, the instruction of an activity to address the maladaptive behavior associated with the substance use of the user in response to receiving the request. The one or more processors may determine a time to provide the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words, and providing, by the one or more processors, the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further includes providing the instruction at the determined time.

[0035] In various implementations, the user may be administered an effective amount of a medication including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist. In various implementations, the substance use includes at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

[0036] Another aspect of the present disclosure relates to a system including one or more processors for providing instructions for an activity to address maladaptive behaviors associated with a user's substance use. The one or more processors can identify a profile for a user with a substance use disorder, the profile including a plurality of substance use words. The one or more processors can present a plurality of memory words unrelated to the substance use and instructions for memorizing the plurality of memory words. The one or more processors can also provide instructions for performing an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. The one or more processors can update the profile of the user using the user's performance of the activity.

[0037] In some implementations, the one or more processors may provide instructions for performing an activity that provides information about a future event. The future event may be related to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, gratitude for the future, a challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use. Before providing the instructions for performing the activity, the one or more processors may provide instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, gratitude for the future, a challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use. The one or more processors may also provide instructions for the user to select a category of the future event before providing the instructions for performing the activity. The category of the future event may be selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, gratitude for the future, a challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0038] In various implementations, the one or more processors can provide instructions for selecting a time frame for the future event. The future event can occur less than one month in the future. The future event can occur more than one month in the future. The one or more processors can instruct the user to generate one or more visual cues based on the information about the future event provided by the user. The visual cues can be images or text, including free text, provided by the user. The one or more processors can provide subsequent instructions for performing an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words, including a prompt including the visual cues related to the information about the future event and instructions for performing an activity related to the visual cues. The prompt can be a timeline identifying multiple visual cues. The timeline can automatically update based on times tagged to the visual cues. The activity can include an audio recording or a text description. The one or more processors can provide a prompt related to the information about the future event following performance of the information-providing activity. The act of refraining from selecting one or more of the plurality of memory words may be performed simultaneously with the act of refraining from selecting one or more of the plurality of substance use words.

[0039] In various embodiments, the one or more processors can provide subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words. The one or more processors can also provide subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words, and the performance of the activity of refraining from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words can be followed by providing the prompt related to the information regarding the future event. The one or more processors can provide instructions to perform an activity of selecting all of the memory words from a plurality of words. The one or more processors can provide instructions to perform an activity of selecting one or more of the memory words from a plurality of words. The one or more processors can calculate a score indicative of a percentage of correct interactions with the memory words and select the plurality of memory words based on the score.

[0040] In various embodiments, the one or more processors can calculate a score indicative of correct interactions, speed of user selection, or both, during performance of one or more activities and select a plurality of subsequent substance use words, a plurality of subsequent memory words, or both, based on the score. The score can be calculated by the number of correct interactions, speed of user selection, or both, during performance of the activity of selecting all of the memory words from a plurality of words. The one or more processors can calculate a score indicative of correct interactions, speed of user selection, or both, during performance of the activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words and, in response to the score meeting a threshold, determine an increase in the number of words for the subsequent activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words. The one or more processors may calculate a score indicative of correct interaction, speed of the user selection, or both, during the activity of selecting all memory words from a plurality of words, and in response to the score meeting a threshold, determine an increase in the number of words for a subsequent activity of refraining from selecting multiple memory words, refraining from selecting multiple substance use words, or selecting all memory words from a plurality of words.

[0041] In various embodiments, the one or more processors display the score indicating at least one of a percentage of correct interactions, a speed of user selection, or both during one or more activities. The one or more processors can generate one or more cue words or images based on the information about the future event provided by the user, and the prompts associated with the information about the future event include the one or more cue words or images. Providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or one or more of the plurality of memory words can further include the one or more processors providing instructions to perform an activity in which the user selects one or more neutral words unrelated to substance use and different from the memory words. Providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words or one or more of the plurality of memory words can include presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or more than 10 seconds.

[0042] In various embodiments, the instructions to perform an activity are provided to the user at least daily, at least once every two days, at least once every five days, or at least once a week. The user may be administered an effective amount of a medication including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist. The one or more processors may receive a request from the user indicating the onset of a behavior associated with the substance use, and may initiate the instructions for an activity to address the user's maladaptive behavior associated with substance use in response to receiving the request. The one or more processors can determine a time for providing the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words, and providing the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further comprises providing the instruction at the determined time. The one or more activities can be performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. The substance use can include at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse. The prompt can be provided at least 1 day, 5 days, 1 week, or 1 month following providing the instruction to perform an activity that provides information about a future event. The one or more processors can provide the instruction to refrain from selecting one or more of the plurality of substance use words before the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and one or more of the plurality of substance use words.

[0043] Another aspect of the present disclosure relates to a method for providing necessary treatment or remission for a substance use disorder (SUD) in a user. The method includes administering a treatment to the user, the treatment including a digital therapeutic. In some implementations, the digital therapeutic includes identifying a profile for the user with a substance use disorder, the profile including a plurality of substance use words. In some implementations, applying the digital therapeutic includes presenting a plurality of mnemonic words unrelated to the substance use and instructions for memorizing the plurality of mnemonic words. In some embodiments, applying the digital therapeutic includes providing instructions for performing an activity to refrain from selecting one or more of the plurality of mnemonic words and one or more of the plurality of substance use words.

[0044] In some implementations, applying the digital therapeutic includes providing instructions to perform an activity that provides information about a future event. The future event may be related to the user's health, relationships, values, finances, enjoyment, charitable contributions, moderation, or lifestyle. The future event may be at least one day, one week, one month, one year, or more into the future. Applying the digital therapeutic may include providing instructions to the user prior to the instructions to perform the activity, prompting the user to select a category of the future event. The category of the future event may be selected from the user's health, relationships, values, finances, enjoyment, charitable contributions, moderation, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use. In various implementations, applying the digital therapeutic includes providing instructions to select a time frame for the future event. The future event may occur less than one month in the future. The future event may occur more than one month in the future. Applying the digital therapeutic can include providing instructions to the user for generating one or more visual cues based on the information about the future event provided by the user. The visual cues can be images or text, including free text, provided by the user. Applying the digital therapeutic can include providing a prompt including the visual cues related to the information about the future event and instructions for performing an activity associated with the visual cues. The prompt can be a timeline identifying multiple visual cues. The timeline can automatically update based on times tagged to the visual cues. The activity can include an audio recording or a text description.

[0045] Applying the digital therapeutic can include providing subsequent instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; providing a prompt including the one or more visual cues related to the information about the future event; and providing instructions to perform an activity related to the one or more visual cues. The prompt can be a timeline identifying a plurality of visual cues. The timeline can be automatically updated based on times tagged to the visual cues. The activity can include an audio recording or a text description.

[0046] In some implementations, applying the digital therapeutic can include providing subsequent instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. Applying the digital therapeutic can include providing the prompt related to the information about the future event following the performance of the activity to refrain from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words. Applying the digital therapeutic can include providing instructions to perform an activity to refrain from selecting one or more of the plurality of substance use words prior to the instructions to perform the activity to refrain from selecting one or more of the plurality of memory words and one or more of the plurality of substance use words.

[0047] In various embodiments, applying the digital therapeutic can include providing instructions for performing an activity of selecting all of the memory words from a plurality of words. Applying the digital therapeutic can include providing instructions for performing an activity of selecting one or more of the memory words from a plurality of words. Applying the digital therapeutic can include calculating a score indicative of a percentage of correct interactions with the memory words, and then selecting the plurality of memory words with the digital therapeutic based on the score. In various embodiments, applying the digital therapeutic can include calculating a score indicative of a correct interaction, a speed of the user selection, or both, during the activity of selecting all of the memory words from a plurality of words. Applying the digital therapeutic can include determining, in response to the score meeting a threshold, an increase in the number of words for a subsequent activity of refraining from selecting a plurality of memory words, an activity of refraining from selecting a plurality of memory words, or an activity of selecting all of the memory words from a plurality of words. Applying the digital therapeutic can include displaying the score indicative of at least one of a percentage of correct interactions, a speed of user selection, or both, during one or more activities.

[0048] Applying the digital therapeutic may include calculating a score indicative of correct interactions, speed of user selection, or both, during performance of one or more activities, and selecting, by the one or more processors, a plurality of subsequent substance use words, a plurality of subsequent memory words, or both, based on the score. The score may be calculated by the number of correct interactions, speed of user selection, or both, during performance of the activity of selecting all of the memory words from a plurality of words. Applying the digital therapeutic may include calculating a score indicative of correct interactions, speed of user selection, or both, during performance of the activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words. Applying the digital therapeutic may include determining, in response to the score meeting a threshold, an increase in the number of words for the subsequent activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words.

[0049] Applying the digital therapeutic can include generating one or more cue words or images based on the information about the future event provided by the user, and the prompt associated with the information about the future event includes the one or more cue words or images.

[0050] In various implementations, applying the digital therapeutic can include providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or one or more of the plurality of memory words, which can include providing instructions to perform an activity in which the user selects one or more neutral words unrelated to substance use and different from the memory words, via the digital therapeutic. Applying the digital therapeutic can include providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words or memory words, which can include presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or 10 seconds or more. The instructions to perform an activity can be provided to the user at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week. The one or more activities can be performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. The prompt may be provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

[0051] Applying the digital therapeutic can include receiving a request from the user indicating an onset of the behavior associated with the substance use, and initiating, by the digital therapeutic, the instruction of an activity to address the maladaptive behavior associated with the substance use of the user in response to receiving the request. Applying the digital therapeutic can include determining a time to provide the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words, and providing, by the digital therapeutic, the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further includes providing the instruction at the determined time.

[0052] In various implementations, the user may be administered an effective amount of a medication including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist. In various implementations, the substance use may include at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

[0053] In various implementations, the user's substance use disorder (SUD) is in remission when, following application of the digital therapeutic, the user experiences a decrease in an Obsessive-Compulsive Drug Use Scale (OCDUS) metric. The user's SUD may be in remission when, following application of the digital therapeutic, the user experiences an improvement in a Drug Withdrawal Self-Efficacy Scale (DASES) metric. The user's SUD may be in remission when, following application of the digital therapeutic, the user experiences an improvement in a Modified Visual Analog Scale (MVAS) craving rating. The user's SUD may be in remission when, following application of the digital therapeutic, the user experiences a decrease in self-reported substance use. The user's SUD may be in remission when, following application of the digital therapeutic, the user experiences an improvement in an Opioid Substitution Therapy Quality of Life (OSTQOL) metric. The user may receive treatment for substance use at least partially concurrently with the digital therapeutic. The user may be prescribed medication for substance use. The user's substance use may be reduced following application of the digital therapeutic. The user's SUD may be in remission when, following application of the digital therapeutic, the user demonstrates improvement in at least one of the following: Resilience Enhancement Scale, Perceived Stress Scale, OSTQOL, MVAS, or self-reported overall substance use via the Timeline Follow-Back (TLFB) method. The digital therapeutic may be applied at least daily, every other day, or weekly. The digital therapeutic may be applied for at least one week, one month, or three months. Applying the digital therapeutic may include updating the user's profile using the user's performance of the activity.

[0054] 1. Overview Referring now to FIG. 1 , a block diagram of a system 100 for presenting interactive sessions to address maladaptive behaviors associated with a user's substance use is shown. Generally, the system 100 may include at least one session management service 105 and a set of user devices 110A-N (hereinafter generally referred to as user devices 110) communicatively coupled to each other via at least one network 115. At least one user device 110 (e.g., the illustrated first user device 110A) may include at least one application 125. The application 125 may include or provide at least one user interface 130 having one or more user interface (UI) elements 135A-N (hereinafter generally referred to as UI elements 135). The session management service 105 may include at least a session handler 140, a word generator 145, an activity selector 150, a response handler 155, a performance evaluator 160, a feedback generator 165, etc. The word generator 145 can include words provided in a database or words selected from an indication-specific lexicon. In some embodiments, a user can input related words related to the user's particular substance use. In other embodiments, a user can evaluate the appropriateness of words from a potential list of words provided by the word generator 145. In yet another embodiment, eye tracking or biometrics can be measured by a user device to determine which words are most salient to the user for inclusion in the database selected by the word generator. In another embodiment, the word generator 145 can generate new words in real time, possibly using generative AI machine learning models, without using pre-generated words or requiring a database to store such words.

[0055] The session management service 105 includes or has access to at least one database 170. The database 170 may store, maintain, or otherwise include one or more user profiles 175A-N (hereinafter generally referred to as user profiles 175). The user device 110 and the session management service 105 may collectively be part of a computing system that provides the application 125.

[0056] More specifically, the session management service 105 (sometimes generally referred to herein as a service) may be any computing device including one or more processors coupled with memory and software, capable of performing the various processes and activities described herein. The session management service 105 may communicate with one or more user devices 110 and a database 170 via a network 115. The session management service 105 may be located, collocated, or otherwise associated with at least one server group. The server group may correspond to a data center, branch office, or campus where one or more servers corresponding to the session management service 105 are located. The session management service 105 may be located, collocated, or otherwise associated with one or more user devices 110. Some components of the session management service 105 may be located within a server group, and some may be located within a client device. For example, the session management service 105 may run on or be located on the user device 110, and the activity selector 150 may run on or be located on the server group.

[0057] Within the session management service 105, a session handler 140 can initiate a session for a user through an application 125. A word generator 145 can generate words for session instructions from a database 170. An activity selector 150 can select an instruction activity for the user. A response handler 155 can receive a response from the user in response to the instruction and activity. A performance evaluator 160 can evaluate the user's performance based on the response. A feedback generator 165 can provide feedback to the user through the application 125 based on the results of the performance evaluator 160.

[0058] User device 110 (sometimes referred to herein as an end-user computing device or client device) may be any computing device including one or more processors coupled with memory and software capable of performing the various processes and activities described herein. User device 110 may communicate with session management service 105 and database 170 via network 115. User device 110 may be a smartphone, other mobile phone, tablet computer, wearable device (e.g., smart watch, glasses), or laptop computer. User device 110 may be used to access application 125. In some embodiments, application 125 may be downloaded (e.g., via a digital distribution platform) and installed on user device 110. In some embodiments, application 125 may be a web application with resources accessible via network 115.

[0059] The application 125 running on the user device 110 can be a digital therapeutic application and can provide sessions (sometimes referred to herein as therapy sessions) to address substance use disorders (SUDs). A user of the application 125 can be an individual diagnosed with or at risk for SUDs. For example, the user may experience increased substance use frequency or quantity, respiratory or other health issues, or withdrawal symptoms. The causes of SUDs include genetic, behavioral, environmental, physiological, and psychological factors. For example, individuals with a family history of SUDs may be more vulnerable to substances and at higher risk for developing addiction. In another example, socioeconomic status, such as financial hardship or poverty, may contribute to substance use as a coping mechanism.

[0060] Examples of SUDs include opioid use disorder, alcohol use disorder, and drug use disorder. SUDs can lead to physical health, mental health, social and economic problems, and other issues. Physical health effects include heart disease (e.g., hypertension, arrhythmia, and cardiomyopathy), decreased lung function, lung damage, brain damage (e.g., neurotoxicity), and immunosuppression. These conditions can impair or disrupt relationships, resulting in social embarrassment, and can also lead to economic losses such as job loss.

[0061] The application 125 can be used to provide sessions to reduce a user's substance use. Sessions are presented to the user as a result of the user's input of information (e.g., substance use, lifestyle, work schedule). Sessions can include a variety of activities targeted at reducing substance use, such as inhibitory control training, working memory training, and thinking about future events. Sessions can include any number of activities in any order and can be generated based on the information input by the user. Providing a digital treatment (e.g., intervention) to a user through the application 125 can address the negative effects of SUD.

[0062] The user may be receiving, at least in part, a treatment to address the condition or a side effect of the condition at least partially concurrently with the intervention provided by application 125. For example, the user may be receiving treatment for a severe unhealthy lifestyle (SUD). The user may receive the treatment at least partially concurrently with any number of sessions, or any combination thereof. The treatment may include taking medication. Such medication may be administered orally, intravenously, or topically. For example, the medication may include, among others, medications for treating a severe unhealthy lifestyle (SUD) (e.g., naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist). Application 125 may enhance the effectiveness of the medication the user is taking to address the condition. Treatment may include cognitive behavioral therapy (CBT), contingency management, therapy, rehabilitation programs, or support groups.

[0063] The application 125 may include, present, or otherwise provide a user interface 130 having one or more UI elements 135 to a user of the user device 110 according to configuration on the application 125. The UI elements 135 may correspond to visual components of the user interface 130, such as command buttons, text boxes, check boxes, radio buttons, menu items, and sliders. In some embodiments, the application 125 may be a digital therapeutic application and may provide one or more sessions (sometimes referred to herein as therapy sessions) for addressing a user's substance use disorder via the user interface 130.

[0064] Database 170 may store and maintain various resources and data associated with session management service 105 and applications 125. Database 170 may include a database management system (DBMS) for organizing and arranging data maintained on the database. Database 170 may communicate with session management service 105 and one or more user devices 110 via network 115. While performing various operations, session management service 105 and applications 125 may access database 170 to retrieve identified data therefrom. Session management service 105 and applications 125 may also write data to database 170 from the performance of such operations.

[0065] Such operations may include maintaining a user profile 175 (sometimes referred to herein as a subject profile). The user profile 175, as described herein, may include information related to the user's condition (e.g., SUD). For example, the user profile 175 may include information related to the severity of the condition, the occurrence of the condition (e.g., the occurrence of symptoms associated with the condition), medications or treatments the user is using for the condition, and / or the duration of the condition. The user profile 175 may be updated periodically (e.g., daily, weekly) in response to a schedule, in response to changes in user information (e.g., entered by the user via the user interface 130 or learned from the user device 110), in response to a clinician's (e.g., a doctor or nurse's) addressing of the user's condition, etc.

[0066] The user profile 175 can store and maintain information related to a user of the application 125 via the user device 110. Each user profile 175 can be associated with or correspond to a user of the application 125. The user profile 175 can include or store information for each session performed by the user. The information for a session can include various parameters, actions, images, prompts, or selections or actions of previous sessions performed by the user, and can be initially blank. The user profile 175 can simplify communication to the user by presenting the user with sessions that are most likely to assist the user in addressing the user's SUD based at least on the user profile 175. This directed approach can reduce the need for multiple communications with the user, thereby reducing bandwidth and increasing the benefits of user-computer interaction.

[0067] In some embodiments, user profile 175 may identify or include information about the treatment regimen the user practices, such as the type of treatment (e.g., therapy, medication, or psychotherapy), duration (e.g., daily, weekly, or yearly), and frequency (e.g., daily, weekly, quarterly, or yearly). User profile 175 may be stored and maintained in database 170 using one or more files (e.g., Extensible Markup Language (XML), Comma Separated Values (CSV) delimited text files, or Structured Query Language (SQL) files). User profile 175 may be iteratively updated as the user provides responses, makes selections, and performs actions in connection with a session. User profile 175 may also be updated based on words generated by word generator 145 and activities performed by the user selected by activity selector 150. For example, responses received by response handler 155 may update user profile 175.

[0068] Database 170 may store substance use words 180A-N (hereinafter generally referred to as user profile 180). Substance use words 180 may be words associated with substance use. For example, substance use words 180 may include needle, drug, or opioid. User profile 175 may include substance use words 180 based on information associated with the user. Database 170 may also store memory words 185A-N (hereinafter generally referred to as memory words 185). Memory words 185 include words not associated with substance use. For example, memory words 185 may include dog, whale, ball, apple, or computer. Database 170 may store neutral words.

[0069] 2. Selection Activities A block diagram of process 200 by system 100 for providing a session for a user 210 to perform an activity is depicted. Process 200 can include or correspond to operations performed by system 100 to receive and process data provided by user 210. Referring first to FIG. 2A , under process 200, word generator 145 can generate words from database 170 for use in an activity selected by activity selector 150. In this session, substance use word activities and memory word activities are combined into a single selection activity. That is, sometimes substance use words are presented to the user, and sometimes memory words are presented to the user. Combining substance use word activities and memory word activities can target overlapping neural network substrates and function to simultaneously train two subdomains of executive control (e.g., inhibitory control and working memory), thereby simulating a critical period of brain development and preparing the prefrontal cortex and limbic regions of the brain for plastic change. Activities involving both substance use words and memory words can keep the user 210 focused and induce brain plasticity. For example, the instructions to the user 210 can include a message instructing the user 210 to refrain from selecting both memory words 185 and / or substance use words 180 in the same activity, even though they do not necessarily appear on the same screen. In this case, the user may be presented with one screen displaying memory words, followed by a subsequent screen displaying substance use words, and the user would receive a correct score by making no selection on either screen. The instructions can also include instructing the user 210 to select one or more from a set of neutral words. The set of neutral words is unrelated to substance use and is different from the memory words 185 used in the instructions. For example, the user 210 can withhold interaction with the user interface 130 (e.g., selection) when presented with either the memory words 185 or the substance use words 180, and can select the neutral word to receive a correct score.

[0070] This choice activity trains the user 210 to strengthen inhibitory control and break the stimulus-action schema that triggers the user 210 to use drugs. The substance use language activity breaks the user 210's associations with drugs and allows new stimulus-action associations to form. The substance use language activity also prepares the brain for plastic changes in the prefrontal cortex and limbic regions.

[0071] The substance use word activity may also be selected by the activity selector 150 in combination with the mnemonic word activity as a single activity. However, the activity selector 150 may also select the substance use word activity as a single activity for the user to perform, meaning that only the substance use words are displayed to the user, not the mnemonic words. For example, this may be done to introduce the user to treatment or to guide the user to a subsequent activity that combines substance use words and mnemonic words. Similarly, the activity selector 150 may select the mnemonic word activity as a single activity for the user to perform, meaning that only the mnemonic words are displayed to the user, not the substance use words. In response to the activity selector 150 selecting the selected activity, the session handler 140 generates instructions 215. The instructions 215 may include both the substance use words 180 and the mnemonic words 185 generated by the word generator 145. The instructions 215 may include a message to perform the substance use word and mnemonic word activity and to refrain from selecting one or more of the substance use words 180 and / or the mnemonic words 190.

[0072] In some embodiments, an activity or session can include multiple rounds, each containing multiple trials. Each trial displays a single word. For example, the first trial displays a substance use word, followed by a memory word in the second trial, followed by a neutral word in the third trial. However, in some embodiments, a trial can include multiple words, including multiple substance use words, multiple memory words, and / or multiple neutral words. An activity can include 1-20 rounds, 2-10 rounds, or 3-5 rounds per session. An activity can include 10-200 trials, 20-150 trials, 50-100 trials, or 70-80 trials per round. The number of trials per round or rounds per session depends on the amount of time given to the trial, round, or session and the particular user, such as 1, 2, 3, 5, 7, 10, or more minutes per round. This is because the time it takes to complete a trial, round, and / or session can vary for each user.

[0073] To generate the substance use words, the session handler 140 may first identify the user's SUD based on the user profile 175. The user profile 175 may include a set of substance use words 180 based on the user's SUD. Prior to generating the instructions 215, the word generator 145 may identify the words based on at least one of the user profile 175 or past sessions stored in the database 170. For example, the user profile 145 may include conditions the user has had in the past and / or currently has that can be used to determine interventions. At the time of generating the instructions 215, the user may be receiving an effective amount of a medication to inhibit a SUD, including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist. The word generator 145 may also generate words based on the medication being administered to the user.

[0074] To generate the mnemonic word, the word generator 145 may select a mnemonic word 185 associated with the user profile 175. Instructions 215 may present the mnemonic word 185 to the user 210. The mnemonic word 185 may be unrelated to substance use. The instructions 215 may include a message for memorizing the mnemonic word 185.

[0075] To generate the neutral words, the word generator 145 may select the neutral words based on the user profile 175, words unrelated to substance use, and / or words that differ from the memory words 185, among other factors.

[0076] 3. Visualization Activities A block diagram of a process 300 by the system 100 for providing a session for the user 210 to perform a visualization activity is depicted. After completing a selection activity as described above, the process 300 can provide a session for the user to perform the visualization activity. The process 300 can include or correspond to operations performed by the system 100 to receive and process data provided by the user 210. Referring first to FIG. 3A , under the process 300, the activity selector 150 can select a visualization activity, and the session handler 140 can generate visualization instructions 505 for the user 210 to perform the visualization activity. The visualization activity can provide the user 210 with a goal-related context to leverage the user's 210 improvements in executive control from the selection activity. The visualization activity can connect improvements from the selection activity to real-world context, for example, to facilitate the user's 210 maintaining and updating associations with substance use words 185.

[0077] In response to the activity selector 150 selecting a visualization activity, the session handler 140 generates visualization instructions 305. The visualization instructions 305 can instruct the user 210 to perform a visualization activity, including prompting the user to provide information 310 about a future event. The visualization instructions 305 can be a text or audio description of the activity. The visualization instructions 305 can be generated, sent, and received in a manner similar to other instructions described herein. The future event can be related to health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with the user's 210 substance use. The future event can be generally positive, such as a birthday, celebration, wedding, graduation, goal, objective, or the like. The future event can be at least one day, one week, one month, one year, or more in the future. The future event can be less than one week, one day, one 12 hours, or one hour in the future. The visualization instructions 305 can present the user 210 with UI elements 135 for inputting event information 310, such as when a future event is likely to occur. For example, the user 210 can input an upcoming future event, a graduation ceremony, and the date of the graduation ceremony. The event information 310 can then be stored in the database 170.

[0078] In some embodiments, before the session handler 140 generates the visualization instructions 305, the session handler 140 can provide instructions to the user 210 to select a type of future event selected from at least one of the user's health, relationships, values, financial status, fun, charitable contributions, abstinence, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use. In some embodiments, the session handler 140 can provide instructions to the user 210 to select a category of the future event. The category can be selected from at least one of the user's health, relationships, values, financial status, fun, charitable contributions, abstinence, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use. The future event can be tagged by category. In some embodiments, the session handler 140 provides instructions to perform visualization activities based on the category after the user 210 has performed a certain number of visualization activities. In various embodiments, the visualization instructions 405 can include a request to select a time frame for the future event. The future event can occur less than one month in the future or more than one month in the future. Future events may be tagged with a time frame. In some embodiments, the session handler 140 provides instructions to perform a visualization activity based on a time frame after the user 210 has performed a certain number of visualization activities.

[0079] Following performance of the visualization activity, the session handler 140 can generate a prompt 330 related to the event information 310. The prompt 330 can be used by the user in subsequent sessions to visualize future events from previous sessions. The prompt 330 can encourage the user 210 and remind the user 210 of the cognitive improvements made via the system 100. The prompt 330 can be provided to the user by the session handler 140 at least one day, five days, one week, or one month after providing the visualization instructions 305 to the user 210, particularly after the user performs one or more subsequent sessions of the selected activity.

[0080] The prompt 330 may include one or more cue words or images based on the event information 310 provided by the user to remind the user 210 of the upcoming event. For example, in response to event information 310 including information about a graduation, the cue may include the words "graduation" or "mortarboard" or an image of a graduation cap and robe. The user 210 may also input one or more self-generated cue words or images via the UI element 130, and these cue words and images may also be recorded. In some embodiments, the session handler 140 may prompt the user 210 to generate one or more visual cues based on information about the future event provided by the user. In some embodiments, the session handler 140 may provide the user 210 with one or more visual cues to select from and store the visual cue selected by the user 210.

[0081] The prompt 330 can be a timeline that identifies multiple visual cues. For example, the prompt 330 can include an image of a birthday cake with the words "in one month" to represent a family member's birthday and an image of an airplane with the words "in two months" to represent a trip to visit a friend. The timeline can be automatically updated based on the times tagged to the visual cues. For example, the session handler 140 can request the user 210 to tag a time to a selected visual cue and generate a timeline based on the visual cues and the current time.

[0082] In some embodiments, the session handler 140 can send a request to the user to input information to generate the prompt 330. For example, the session handler 140 can request the user to provide a textual reminder (e.g., a cue word), a date and / or time frame for the future event, and a category for the future event and / or prompt 330. For example, the prompt 330 can be categorized as at least one of the user's health, relationships, values, financial status, fun, charitable contributions, moderation, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0083] In some embodiments, the session handler 140 stores the prompts 330 following their generation. The session handler 140 can store the prompts 330 following each visualization activity. A collection of prompts 330 can be displayed on the user device 110 for the user 210 to visualize various future events at once. For example, a collection of prompts 330 may be displayed on the user device 110 as a future vision board.

[0084] 3A-3B , a prompt 330 can be provided to the user following process 200 and / or process 300. For example, session handler 140 may instruct user 210 to perform an activity to refrain from selecting one or more memory words 185 and / or one or more substance use words 180. Following performance of the selection activity, session handler 140 can send prompt 330 to user device 110 for presentation to user 210. Prompt 330 can include one or more visual cues. The one or more visual cues can be descriptions of future events or pictorial depictions of future events. Such cues can also be in other formats, such as audio. Prompt 330 can enhance activity-induced brain plasticity and enhance changes in the brain's executive control system.

[0085] Following the prompt 330, the session handler 140 can generate a subsequent activity for the user 210 to perform. The subsequent activity can be associated with the visual cue. The subsequent activity can include an audio / video recording or a text description. The audio / video recording or text description can be associated with the visual cue. The application 125 can record the user's 210 interaction 315 with the activity.

[0086] In some embodiments, the prompt 330 is provided following the performance of the selection activity. In some embodiments, the prompt 330 is provided before the performance of the selection activity. In some embodiments, the prompt 330 is provided during the performance of the selection activity. As another example, the user 210 may first be provided with the visualization activity, be provided with the prompt 330, and then be instructed to perform the selection activity. In some aspects, the user may be instructed to perform the selection activity, then be instructed to perform the visualization activity, then receive subsequent instructions to perform the selection activity, and then be provided with the prompt 330.

[0087] 4. Repeat the cycle of selection and visualization activities For maximum benefit, the session handler 140 may initiate a selection activity, then initiate a visualization activity involving storing a prompt, then initiate a subsequent selection activity, then initiate a subsequent visualization activity involving showing that prompt to the user, and this cycle may be repeated multiple times over 1-24 hours, 1-7 days, 1-4 weeks, 1-12 months, or over a year.

[0088] In other embodiments, the execution of these three activities may be performed in different orders, different times, and in multiple combinations based on the user profile 175. Each activity may be performed at a fixed frequency and / or number of times (per second, per minute, etc.).

[0089] For example, during a given week, the user 210 may be provided with instructions for the substance use words and mnemonic words on certain days of the week to perform a selection activity that combines the substance use words and mnemonic words. This activity may be performed a certain number of times depending on the user profile 175. The visualization instructions 305 may be provided to the user 210 on a certain number of days that the substance use word and mnemonic word instructions are also delivered. The visualization activity may be performed a certain number of times based on the user profile 175. On days that the user 210 is provided with instructions for the substance use words and mnemonic words, the prompt 330 may be provided to the user 210 before, during, or after performing the substance use word and mnemonic word activity.

[0090] To implement this cycle, the activity selector 150 can select a selection or visualization activity for the user 210 to perform. The activity selector 150 can also select the length of time for the activity to be performed, such as 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. The time at which the session handler 140 sends the session can be at least once a day, at least once every two days, at least once every five days, or at least once a week.

[0091] Sessions generated by the session management service 105 described herein can mimic periods of adult plasticity typically limited to childhood. For example, an activity selector 150 that alternates substance use and memory word activities can mimic that period. By providing sessions with a variety of activities and words, the session handler 140 can mimic important learning principles observed during periods when experience shapes habits and behaviors develop (e.g., plasticity). For example, substance use word activities with predominance responses, short response times, and indication-specific words directed by the session handler 140 and / or feedback generator 165 can create a challenging and salient learning environment for users to focus their attention and adapt quickly under given conditions.

[0092] 5. Memory Quiz A block diagram of a process 200 by the system 100 for providing a session for a user 210 to perform an activity is depicted. The process 400 may include or correspond to operations performed by the system 100 to receive and process data provided by the user 210. Referring first to FIG. 4A , under the process 400, the activity selector 150 may select a memory quiz, and the session handler 140 may create, write, or otherwise generate memory quiz instructions 405 based on the words. The memory quiz instructions 405, which instruct the user 210 to perform the memory quiz activity, may reinforce learning from the selected activity. For example, the selected activity may include a subset of the memory words 185, and the memory quiz activity may include all of the memory words 185.

[0093] The session handler 130 may generate memory quiz instructions 405 in response to the activity selector 150 selecting a memory quiz activity for the user 210 to perform. The memory quiz instructions 405 may include a message for performing the memory quiz activity by interacting with (e.g., selecting) all of the memory words 185 from a set of words. The set of words may include both memory words 185 and neutral words. The set of neutral words is different from the memory words 185 and the substance use words 180 and is unrelated to substance use. For example, the memory words 185 may be presented along with the neutral words, and the memory quiz instructions 405 may instruct the user 210 to select only the memory words 185. In some embodiments, the memory quiz instructions 405 may instruct the user 210 to select one or more of the memory words 185. For example, the memory quiz activity need not include all of the memory words 185. The memory quiz instructions 405 may include a subset of the memory words 185 for the user 210 to select. Memory quiz instructions 405 can be generated, sent, and received in the same manner as other instructions described herein.

[0094] 4B , upon receiving the memory quiz instruction 405, the application 125 on the user device 110 can display, render, or otherwise present the memory quiz instruction 405 via the user interface 130. The application 125 can then prompt or instruct the user 210 to provide a response 415 to the memory quiz instruction 405, such as by performing a memory quiz activity. The response 415 can be provided by the user 210 performing an interaction 410 with a UI element 135 on the user interface 130 that displays the mnemonic word 185 and the neutral word. In response to the mnemonic word 185 being displayed on the screen, the user 210 can select the mnemonic word 185, which can be included in the interaction 410. The interaction 410 can be recorded by the application 125 and transmitted as the response 415. The interaction 410 can also record the user's 210 interaction with the neutral word. The interaction 410 can be recorded, received, and identified in the same manner as other interactions described herein.

[0095] In response to the response score 420 meeting a threshold, the feedback generator 165 may increase the number of words for the subsequent activity. The feedback generator 165 may instruct the word generator 145 to generate more memory words 185' for the subsequent activity. The memory words 185' may include memory words 185 or may be different from the memory words 185 used in the previous session.

[0096] 6. Examples In one example, a user interface can be presented through an application. The user interface can indicate which activity the user is instructed to perform. The user interface can provide instructions to the user regarding the activity. The user interface can provide mnemonics for the user to remember and refrain from selecting.

[0097] The user interface can also memorize the memory words and provide instructions to the user to refrain from selecting the memory words during the selection activity. The memory words may be displayed on the screen of the user interface along with instructions to refrain from selecting the memory words. The user interface may provide instructions to refrain from selecting the substance use words. The user interface can instruct the user to refrain from selecting both the substance use words and the memory words. The user interface can present either the substance use words or the memory words in one area of the user interface. After the user interacts with the substance use word or the memory word, the user interface can remove the substance use word or the memory word and then present the subsequent memory word or substance use word in an area of the screen different from the previous memory word or substance use word. In some embodiments, the substance use word is presented before the presentation of the memory word. In some embodiments, the memory word is presented before the presentation of the substance use word. In some embodiments, a neutral word unrelated to substance use is presented in the same or a different area of the user interface as the previous substance use word or memory word. The substance use words, memory words, or neutral words may be presented on the user interface for a period of time and then removed before a subsequent word is presented. Alternatively, the substance use words, memory words, and / or neutral words may be presented on a single screen on the user interface. The presentation time of the memory words, substance use words, or neutral words may be less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or 10 seconds or more. The user interface may indicate to the user that the activity is complete. The user interface may display a score to the user based on the user's performance during the activity.

[0098] In one example, a user interface for a memory quiz activity can present a set of words, including mnemonic words, for a user to select from. The user interface can present the set of mnemonic words alongside neutral words, along with instructions for the user to select the mnemonic words. In some embodiments, the user interface can include instructions for refraining from selecting the neutral words. The mnemonic words can be displayed for a set period of time. The mnemonic words and neutral words may be displayed together on a single screen. The presentation time for the mnemonic words can be less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or 10 seconds or more. The user interface can present a result based on the interaction to the user and can present a score to the user based on the results of the activity.

[0099] In some examples, a user interface showing an activity score can be presented to the user after performance of, for example, a memory quiz activity and / or a substance use word and memory word activity. The user interface can present the user with an explanation of what the score is based on, including the percentage, number, and / or timing of correct interactions and / or selections. In addition to the score, the user interface may also display metrics related to the score to the user, such as accuracy, timing of selections, and the number and / or percentage of correct interactions and / or selections. The user interface can also indicate the challenge or difficulty of the activity and how these affect the user's score. In some embodiments, the user interface indicates areas for improvement for the user, including activities where the user can improve their performance. The user interface can indicate words involved in incorrect interactions and / or selections.

[0100] FIG. 5 shows a flowchart of a visualization activity, according to an example embodiment. A set of user interfaces 500 can be part of an application and can be presented via user interface 130. User interface 505 can be a home page (e.g., a start page) from which a user begins a visualization activity. User interface 510 can introduce the visualization activity and any subsequent activities (e.g., selection activities). User interface 515 can display the visualization activity for the user to perform. User interface 520 can be an ending screen for the visualization activity and / or subsequent activities.

[0101] In some examples, the user interface can present a visualization activity and indicate to the user which activity the user is instructed to perform. The user interface can present instructions to the user to engage in the visualization activity. The user interface can provide instructions for the user to imagine a future event. The user interface can provide instructions to the user to input information about the future event. The user interface can present the user with specific questions about the future event, such as the timing of the event, the location of the event, who will be present at the event, and how the user will feel when the event is accomplished. The user interface can present the user with questions or requests to input information about the event, such as a description or image of the event.

[0102] In another example of a user interface for a visualization activity, the user interface may provide a user with a choice of time frame for future events in the visualization activity (e.g., one day, one week, one month, or more than one year, etc.). The user interface may present the user with a choice of selecting a topic or category for the future events (i.e., health, relationships, values, finances, fun, charitable giving, moderation, small progress, achievements, future gratitude, challenges, lifestyle, etc.) and instructions for visualizing events related to the category. In some aspects, the user interface may present the user with instructions for selecting upcoming challenges in the user's life and how the user intends to handle the future events or challenges. The user interface may present a choice for selecting a time frame for the future events or challenges. For example, the user interface may present a choice of a particular time frame for the future events or challenges (e.g., one day, one week, one month, or more than one year, etc.).

[0103] In one example, the user interface can include inputs for a user to create a prompt for the visualization activity, which can include a reminder or image related to the future event and the date of the future event. The user interface can request the user to select a category (i.e., health, relationships, values, finances, fun, charitable giving, moderation, small gains, achievements, future gratitude, challenges, lifestyle). The user interface can include instructions for the user to input information related to the future event, such as a description and image of the event.

[0104] In some examples, the user interface may include inputs for a user to create cues and / or reminders related to future events. The cues may be text, image, or audio-based content. The user interface may include inputs or instructions for a user to provide reminders of the events and descriptions or images related to the events. The user interface may require a user to input the timing of the future events.

[0105] When the user provides input related to the clue, the user interface may indicate to the user that a new clue has been created. The user interface may display a future board and notify the user that the clue has been added to the user's future board. The clue may be presented on the user's future board on a timeline showing the date or time of the event (e.g., a period of one day, one week, one month, or more than one year). The user interface may display a screen indicating the completion of the visualization activity and / or a start screen for a subsequent activity (e.g., a substance use word activity).

[0106] In one example, the user interface may present a future board after a user performs a visualization activity. The user interface may present a future board including multiple clues entered by the user. The user interface may present a future board after a user performs additional selection and / or visualization activities. The future board may be segmented by time frame (e.g., one day, one week, one month, or more than one year) in which future events occur and / or by clue category (i.e., health, relationships, values, finances, fun, charitable contributions, sobriety, small progress, achievements, future gratitude, challenges, lifestyle). The clues may be provided along a timeline and presented in chronological order or within groups of clues that occur within a similar time frame (e.g., one day, one week, one month, or more than one year). Clues associated with visualization activities may be removed from the future board or moved to another location or grouping upon completion or passage of the future events. The user interface may include instructions for interacting with one or more cues displayed on the future board, including instructions for indicating that a future event has been completed or passed. The cues may be textual, audio, or visual-based content related to the future event.

[0107] 9. Process 1-4B, instructions 215 can take a variety of forms associated with application 125. In some embodiments, instructions 215 can be displayed, rendered, or otherwise presented to user 210 via user interface 130 of application 125. In some embodiments, instructions 215 can include a short message service (SMS) (e.g., a text message) or a multimedia message service (MMS) (e.g., an audio message, a video message). For example, instructions 215 can include a link to open application 125 that instructs the user to perform an activity.

[0108] Interaction 220 may include actions such as physically manipulating user device 110, manipulating UI elements 135, or viewing substance use words 180 or memory words 185 or neutral words 190, among others. Interaction 220 may include actions such as moving, tapping, sliding, tilting, shaking, tilting, or orienting user device 110 toward a side of user device 110. A side of user device 110 may refer to a boundary created by user interface 130 associated with user device 110, such as one side of a rectangular screen.

[0109] The interactions 220 may include actions such as touching, pressing, or otherwise activating UI elements 135 of the user interface 130 associated with at least one of the substance use words 180, memory words 185, or neutral words 190. For example, the user 210 may perform one or more interactions 220 through an application 125 running on the user device 110 by activating one or more of the UI elements 135 as described herein. The user 210 may perform the interactions 220 by pressing a button associated with the application 125 and displayed via the user interface 130. In some embodiments, one or more first UI elements 135A may be associated with the substance use words 180, one or more second UI elements 135B may be associated with the memory words 185, and one or more third UI elements 190 may be associated with the neutral words 190. In some embodiments, the interaction 220 can include the user refraining from selecting or activating one or more UI elements 135 for a period of time during the selection activity while the substance use words 180, memory words 185, or neutral words 190 are presented by the user interface 135. The period during which the words are presented and the user refrains from selecting the words can be 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or 10 seconds or more.

[0110] The application 125 may monitor for the occurrence of at least one interaction 220 with the substance use words 180, memory words 185, and / or neutral words 190. The application 125 may perform the monitoring during a session in response to the presentation of the substance use words 180, memory words 185, and / or neutral words 190 or in response to receiving the interaction 220. The application 125 may monitor the receipt of the interaction 220. The application 125 may monitor the interaction 220, for example, via the user interface 130 or via a sensor associated with the user device 110. The application 125 may receive multiple interactions 220 during a session. For example, the application 125 may monitor a series of interactions 220 made by the user 210 during a session. The application 125 may monitor and record information related to the received interactions 220. For example, application 125 may monitor and record the time of interaction 220, the duration of interaction 220, the order of interaction 220, the substance use words 180 and / or memory words 185 and / or neutral words 190 associated with interaction 220, and / or the delay between presentation of substance use words 180, memory words 185, neutral words 190 and selection of those words.

[0111] When the user 210 engages in an interaction 220, the application 125 can generate at least one response 225. The response 225 can identify the interaction 220. The response 225 can include information about the interaction 220, such as the duration of the interaction 220, the time of the interaction, the substance use words 180 and / or memory words 185 and / or neutral words 190 associated with the interaction 220, and / or the delay between the presentation of the substance use words 180, memory words 185, and / or neutral words 190 and the selection of those words. The application 125 can generate the response 225 for transmission to the session management service 105. The response 225 can be in a format readable by the session management service 105, such as an electronic file readable by the session management service 105 or a data packet readable by the session management service 105.

[0112] The response handler 155 can receive, identify, or otherwise detect a response 225 identifying the interaction 220. The response handler 115 can receive the response 225 from the application 125. The response handler 155 can receive the response 225 at scheduled time intervals or when the interaction 220 occurs during a session. The response handler 155 can query or ping the application 125 for a response 225. The response handler 155 can receive multiple responses 225 during a single period. For example, the response handler 140 can receive a first response 225 indicating a first interaction 220 and a second response 225 indicating a second interaction 220.

[0113] The response handler 155 can store the response 225, including the interaction 220, in the database 170. The response handler 155 can store information related to the response 225, including the time of the response 225, the action associated with the interaction 220, the user profile 175 associated with the response 225, and the substance use word 180 and / or memory word 185 and / or neutral word 190 associated with the response 225. The response 225 can include or identify the user's 210 interaction 220 with the substance use word 180 and / or memory word 185 and / or neutral word 190. The response 225 may include the time it took to complete the activity or the number of activities it took to complete the activity. For example, the response 225 can include the number of activities the user completed or the number of minutes it took to perform the action associated with the presentation of the substance use word 180 and / or memory word 185 and / or neutral word 190. The response 225 may include the total number of attempts or rounds to complete the session, the total time to complete the session, and may also include the start time of the session and the completion time of the session. The response 225 may include UI elements 135 interacted with during the presentation of the substance use words 180 and / or memory words 185 and / or neutral words 190. For example, the response 225 may include a list of buttons, toggles, or other UI elements 135 selected by the user 210 at a particular time during the presentation of the substance use words 180 and / or memory words 185 and / or neutral words 190. The response 225 may also include other information, such as the location of the user 210 while performing the session, such as geolocation, IP address, GPS location, or triangulation with cellular towers. The response 225 may also include measurements, such as measurements of time, location, or user data.

[0114] The performance evaluator 160 can calculate, generate, or otherwise determine a response score 230 associated with a response 225 based on the interaction 220 with the substance use words 180 and / or memory words 185 and / or neutral words 190. The response score 230 can indicate a level of correctness, or conversely, a level of error, associated with the response 225. A high response score 230 can correlate with a high level of correctness by selecting a neutral word 190 and / or refraining from selecting a substance use word 180 and / or memory word 185. A low response score 230 can correlate with a low level of correctness (e.g., a high level of error). For example, a low response score 230 can indicate that the user 210 selected a substance use word 180 and / or memory word 185.

[0115] In determining the response score 230, the performance evaluator 160 may evaluate the responses 225 based on the interactions 220. The performance evaluator 160 may determine the response score 230 based on the percentage of correct interactions 220 with the memory words 185 and / or substance use words 180 and / or neutral words 190. The percentage of correct interactions may be based on the number of times, the rate, etc., that the user 210 interacts with the memory words 185 and / or substance use words 180 and / or neutral words 190 based on the interactions 220. For example, the performance evaluator 160 may calculate the response score 230 based on the number of interactions with the substance use words 180, the number of deferred selections for the substance use words 180, the number of interactions with the memory words 185, the number of deferred selections for the memory words 185, the number of interactions with the neutral words 190, and / or the number of deferred selections for the neutral words 190.

[0116] In some embodiments, the response score 230 is determined based on correct interactions, speed of user selection, or both during the interaction 220. Correct interactions indicate, for example, the number, rate, or percentage of times the user 210 correctly interacts with the neutral word 190 and refrains from selecting the substance use word 180 and the memory word 185. The application 125 can record speeds between interactions that can be used to calculate the response score 230. For example, the time between when the memory word 185 is displayed on the user interface 130 and when the user 210 incorrectly interacts with the memory word 185 can be used to calculate the response score 230. The response score 230 can also be displayed on the user interface 130 and indicate at least one of the percentage of correct interactions, speed of user selection, or both during the interaction 220.

[0117] The feedback generator 165 may also generate, output, or otherwise generate feedback for receipt by the user 210 via the application 125 operating on the user interface 130. The feedback generator 165 may generate the feedback based on at least the response score 230, the user profile 175, the responses 225, or the presentation history of the memory words 185 and the substance use words 180 and neutral words 190. The feedback may include text, video, or audio presented to the user 210 via the application 125 displayed via the user interface 130. The feedback may include presentation of the response score 230. The feedback may display messages such as motivational messages, suggestions for improving performance, congratulatory messages, comforting messages, etc. In some embodiments, the feedback generator 165 may generate such feedback during a session being performed by the user 210. The feedback may include the response score 230 for display on the user interface 1430, which may include at least one of the percentage of correct interactions during the interaction 220, the speed of user selections, or both.

[0118] Based on the response score 230, the feedback generator 165 can generate and select subsequent substance use words 180′, mnemonic words 185′, and neutral words 190 for use in subsequent sessions. The subsequent substance use words 180′, mnemonic words 185′, and neutral words 190 can be associated with the user profile 175 and used in subsequent activities. The user profile 175 can also be updated based on the response score 230 by the feedback generator 165. The interactions 220 are recorded in the user profile 175, and subsequent activities and words can be generated by the session handler 140 based on at least one of the response score 230 and the interactions 220. The updates to the user profile 175 reflect the progress and performance of the user 210 and can instruct the session management service 105 to increase the difficulty of subsequent instructions or decrease the difficulty of subsequent instructions.

[0119] In some embodiments, the feedback generator 165 may also determine whether to increase the number of substance use words and / or memory words and / or neutral words (e.g., increase the difficulty) of subsequent activities of the session management service 105 based on the response score 230. For example, in response to the response score 230 meeting a threshold, the feedback generator 165 may update the user profile 175 to include the response score 230 in response to receiving the response score 230 from the performance evaluator 160. The feedback generator 165 may determine whether the response score 230 meets a threshold. The user profile 175 may then instruct the session handler 140 to increase the number of memory words in subsequent sessions. The feedback generator 165 may also display the response score 230 on the user device 110.

[0120] Based on the response score 230, the feedback generator 165 can instruct the session handler 140 to generate instructions for a subsequent session to refrain from selecting subsequent memory words 185′ and / or to take action to refrain from selecting substance use words 180′. The memory words 185′ can include memory words 185 or can be different from the memory words 185 used in the previous session. The words generated by the word generator 145 for a subsequent session can be determined by the response scores of the first session, the second session, etc., particularly the response scores of the memory quiz. The feedback generator 165 can also update the user profile 175 based on the response score 230. The feedback generator 165 can store the response score 230 in the user profile 175, which can be used for subsequent sessions initiated by the session management service 105. The feedback generator 165 can also increase the number of words the user 210 must memorize in subsequent sessions. For example, the amount of words in memory vocabulary 185' may be greater than the amount of words in memory vocabulary 185 to increase the difficulty of the memory vocabulary activity for the subsequent session. Also, feedback generator 165 may decrease the number of words that user 210 must memorize in the subsequent session to decrease the difficulty of the activity for the subsequent session.

[0121] The progressive difficulty factors determined by the performance evaluator 160 and feedback generator 165 for memory word training replicate how skills are naturally acquired during sensitive periods of development (e.g., childhood plasticity). For example, the word generator 145 can increase the number of words generated in response to scores generated by the performance evaluator 160. The visualization activities selected by the activity selector 150 and generated by the session handler 140 can leverage neuroplasticity, which supports episodic memory formation throughout a user's lifespan. Pairing visualizations with substance use words and memory words by the session handler 140 can support neuroplasticity across relevant brain regions and enhance the clinical effectiveness of digital therapeutic applications. For example, the session handler 140 can generate sessions as directed by the activity selector 150. The session handler 140 can then provide words generated by the word generator 145 to sessions selected by the activity selector to support neuroplasticity.

[0122] FIG. 6 shows a flowchart of a method 600 for providing a user with activities to address substance use disorders, according to an exemplary embodiment. Method 600 can be performed by any component of system 100, such as session management service 105, user device 110, or user 210. In method 600, one or more processors can identify a profile (605). The profile can be of user 210 and can identify the user's 210 specific substance use disorder and prior treatment. One or more processors can select an activity based on the profile (610). The activity can be based on the user's 210 substance use disorder. One or more processors can present substance use word instructions to user 210 (615). The substance use word instructions can include a substance use word and instructions for refraining from selecting the substance use word. One or more processors can receive a response to the substance use word instructions (620). The response can include user 210's interaction with the substance use word, the memory word, and / or a neutral word. The one or more processors may present memory word instructions (625). The memory word instructions may request the user 210 to interact with the memory word presented to the user 210. The one or more processors may then receive a response to the memory word instructions (630). The response may include the user 210's interaction with the memory word, the substance use word, and / or the neutral word. The one or more processors may provide visualization instructions to the user 210 (635). The visualization instructions may prompt the user 210 to think about a future event that will occur to the user 210. The one or more processors may then receive event information (640). The event information may relate to a future event and may be entered by the user 210. The one or more processors may provide a prompt regarding the event (645). The prompt may be based on the event information and may be provided after, before, or during performance of an activity (e.g., a selection activity). The one or more processors may then receive a response based on the prompt (650).The one or more processors can present the user with subsequent substance use word instructions and / or memory word instructions, and then present subsequent visualization instructions including prompts, and this cycle can be repeated one or more times over a period of 1-24 hours, 1-7 days, 1-4 weeks, 1-12 months, or greater than one year. The response can be based on the user's performance in response to receiving the prompts. The one or more processors can then update the profile based on the response (655). The response can include a score based on the user's performance 210.

[0123] 11. Dynamic Content Delivery In some implementations, the system can include dynamic content delivery that sends requests to user devices.

[0124] For example, the activity selector 150 can select an activity based on an optimal time to send the activity to the user 210. The activity selector 150 is configured to select an activity and instruct the session handler 140 to send instructions 215 with "just-in-time intervention (JITI)" to reinforce the training provided by the activity. For example, the activity selector 150 can select both the activity and the time to send the session to the user 210 based on the user profile 175 and past sessions stored in the database 170. The activity selector 150 can also select the length of time the activity will run based on the user profile 175 and past sessions stored in the database 170.

[0125] In some embodiments, activity selector 150 can select and / or initiate an activity based on physiological changes in the user measured by the wearable technology. For example, in response to a biological signature indicative of an increased risk of substance use measured by the user's wearable technology (e.g., a smartwatch, a smartphone), application 125 can initiate a session 210 to address maladaptive behaviors related to substance use. Activity selector 150 can select an activity based on the biological signature provided by the wearable technology. In this manner, application 125 and activity selector 150 can adjust the timing and type of instructions and activities based on the user's physiological changes measured by the wearable technology to provide an individualized intervention and activity schedule to address substance use.

[0126] In some embodiments, the session handler 140 can provide instructions in response to receiving a request from the user 210 indicating the onset of behavior associated with substance use. For example, the user 210 can feel an urge to use a substance and make a request to the session management service 105 to initiate a session. The session handler 140 can then begin prescribing activities to address the user's 210 maladaptive behavior associated with substance use. These activities can include, for example, selection activities and visualization activities to reinforce the user's 210 learning from previous sessions. The sessions can be provided as needed (i.e., just-in-time) in response to the user's 210 request.

[0127] In some embodiments, the session handler 140 provides a session for a predetermined period of time. Based on the user profile 175, the session management service 105 can determine a schedule of activities for the user 210. For example, the session management service 105 can set a selection activity to be sent at a first time and a visualization activity to be sent one day later. This schedule can be adjusted based on responses received from the user 210 based on their interactions with the activities. The session handler 140 can also determine a time to provide instructions to the user 210.

[0128] In some embodiments, the session handler 140 provides sessions based on just-in-time intervention (JITI). For example, the session handler 140 can provide a session to the user 210 at a time determined based on the user profile 175, the user's 210 response score, and the user's 210 request. The session handler 140 can determine the optimal time to provide a session to the user 210. For example, the session handler 140 can determine, based on the user's previous activity, times of the day when a response is more likely than other times. The session handler 140 can then determine to consistently provide sessions to the user 210 at times of the day when a response is more likely.

[0129] B. Systems and Methods for Remission of a User's Substance Use Through the Application of Digital Therapeutics FIG. 8 shows a flowchart of a method 800 for remission of a user's substance use. Method 800 can be performed by any component of system 100, such as session management service 105, user device 110, or user 210. Under method 800, one or more processors can apply a digital therapeutic to a user (805). The digital therapeutic can be targeted to address the user's substance use. One or more processors can provide instructions to the user (810). The instructions can instruct the user to perform an activity. One or more processors can receive a response (815). The response can be based on the user's performance of the activity. One or more processors can determine a score (820). The score can be based on the response. One or more processors can identify an activity based on the score (825). The score can determine subsequent activities to be provided to the user by one or more processors. One or more processors can decide whether to continue the digital therapeutic (830). This can be based on the effectiveness of the intervention, the length of time of the intervention, etc. The one or more processors may determine whether the session metrics indicate improvement relative to the baseline metrics (835). Method 800 may include determining that remission is indicated if the session metrics are determined to have improved from the baseline metrics (840). Method 800 may include determining that remission is not indicated if the session metrics are determined not to have improved from the baseline metrics (845).

[0130] More specifically, method 800 can include applying a digital therapeutic to a user. The digital therapeutic can be associated with a user (e.g., user 210) with a SUD. A SUD can be the result of genetics, brain chemistry (e.g., altered levels of neurotransmitters such as dopamine), mental health disorders (e.g., anxiety, depression, attention deficit hyperactivity disorder (ADHD)), personality traits (e.g., impulsive behavior), coping mechanisms (e.g., lack of effective coping strategies), or early exposure (e.g., exposure during adolescence when the brain is still developing). The impact of a SUD on a user can include physical health effects (e.g., cardiovascular disease, pulmonary disease, etc.) as well as mental health effects (e.g., depression, anxiety, etc.).

[0131] The user may have any demographic characteristics, such as by age (e.g., adult (over 18 years old) or late adolescent (between 18-24 years old)) or gender (e.g., male, female, or non-binary). At least partially concurrent with the time instance or session in which the user performs the activity, the user may be receiving medication to address their medical condition. For example, the medication may include naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, lofexidine, or a GLP-1 agonist. The medication may be in an effective amount (e.g., dosage or frequency) sufficient to result in a positive outcome or symptom relief (e.g., weight loss). The effectiveness of medications in addressing a user's SUD may be improved or enhanced through combined interventions implemented and monitored through digital therapeutic applications.

[0132] In some embodiments, users of a digital therapeutic application experience or are provided with user-executed sessions via the digital therapeutic application (e.g., application 125 described herein or a research app). As described herein, a session can include repeated cycles of selection activities and visualization activities described herein. A second group can include another set of users who serve as a control group. The second group of users can be exposed to or receive a control treatment (sometimes referred to herein as a placebo or standard of care).

[0133] The control therapy may exclude activities implemented via the digital therapeutic application that are intended to address a SUD. In some embodiments, the control therapy may include an intervention implemented via an application on the computing device that does not affect a SUD or related symptoms. In some embodiments, the control therapy may include a non-active type of intervention that is not related to a SUD. Such a non-active type of intervention may not be suitable for generating a user-specific intervention.

[0134] In some embodiments, the control therapy can include a care as usual (CAU) treatment regimen. The CAU treatment regimen may not include the digital therapeutic application described herein. For example, the CAU treatment regimen can have the user take medication for the SUD on a schedule (e.g., 1-3 times per day) and can include an assessment of the SUD conducted in person or via a web application to evaluate symptoms. Baseline metrics (e.g., pre-intervention metrics) can be obtained (e.g., via a computing device) from users in both the treatment and control groups (e.g., receiving a non-effective type of intervention or CAU).

[0135] Method 800 can include providing instructions (810) to a user. The instructions can relate to at least one or a combination of a selection activity and a visualization activity. For example, instructions regarding substance use words and / or memory words and / or neutral words, and instructions regarding information about future events, can be provided in a recurring cycle. The user can also be prescribed medication for substance use. The user can also be receiving substance use treatment at least partially concurrently with method 800.

[0136] The method 800 can include receiving 815 a response. The response can be a user interaction with the activity. For example, the response can include a user interaction with a word presented on the user's user device, an instance where the user reserves a selection with a word, and an instance where the user provides information about a future event.

[0137] The method 800 can include determining (820) a score based on the response. The score can be based on the number of correct interactions, the percentage of correct interactions, the speed of selection, or any combination thereof. A correct interaction indicates the number of times the user correctly selected a word or refrained from selecting a word. For example, in a selection activity, a correct interaction can be the user selecting a neutral word, refraining from selecting a substance use word, and / or refraining from selecting a memory word. As another example, for a memory quiz, a correct interaction would be the user selecting a memory word and not selecting a neutral word. Selection speed can indicate the time between a word being displayed on the user device and the user selecting the word.

[0138] The method 800 can include identifying an activity based on the score (825). The score can indicate the user's performance and progress. The score can meet a threshold and indicate increasing the word count and / or difficulty of subsequent activities. The score can also indicate the type of activity to provide to the user, such as a selection activity or a visualization activity.

[0139] Baseline metrics can be obtained (e.g., by a computing device) prior to user-initiated intervention activities via a digital therapeutic application (e.g., an application 125 described herein or a research app). The baseline metrics can be indicative of the user's condition with respect to the severity of their SUD. These baseline metrics can include, for example, substance use frequency, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis, Obsessive Compulsive Drug Use (OCDUS) metrics, Drug Abstinence Self-Efficacy Scale (DASES) metrics, Modified Visual Analogue Scale (MVAS) assessments, self-reported substance use, Opioid Substitution Treatment Quality of Life (OSTQOL) scale, Recovery Empowerment Scale, Perceived Stress Scale, impact on daily functioning, tolerance, withdrawal, duration of use, and the like. Prior to implementing the intervention, the user may have an initial baseline metric that meets a baseline threshold. The threshold may define, or identify the value of the initial metric at which the user is identified as suitable or eligible to perform an activity via the digital therapeutic application. The initial metric may be, for example, a DSM-5 metric that meets four or more criteria.

[0140] Session metrics can be associated with a user (e.g., user 210) with respect to a SUD. The session metrics can be obtained (e.g., by a computing device) after performing at least one time instance or session in which an activity is performed by the user via the digital therapeutic application. The baseline criteria can be indicative of the user's condition with respect to the severity of the SUD and can indicate the associated impact on the user's daily life and activities as a result of performing the intervention. Session metrics can include, for example, substance use frequency, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnoses, Obsessive Compulsive Drug Use (OCDUS) metrics, Drug Abstinence Self-Efficacy Scale (DASES) metrics, Modified Visual Analogue Scale (MVAS) ratings, self-reported substance use, Opioid Substitution Treatment Quality of Life (OSTQOL) scales, Recovery Empowerment Scales, Perceived Stress Scales, impact on daily functioning, tolerance, withdrawal, duration of use, etc. Session metrics can be from the same types of measures as baseline metrics. Session metrics can be obtained from both treatment and control groups.

[0141] Method 800 can include determining or deciding whether to continue (830). This decision can be based on a set length of the trial (e.g., day, week, or year), a set number of time instances to perform one or more activities, a set amount of time to perform the activities, or a set number of activities provided to the user. For example, the set number of time instances can range from one week to six months relative to obtaining the baseline metrics. For example, the digital therapeutic can be applied at least daily, every other day, every three days, or weekly. If the amount of time since obtaining the baseline metrics exceeds the set length, the decision can be to stop providing additional activities.

[0142] In contrast, if the amount of time since obtaining the baseline metric has not exceeded the set length, the decision may be to continue providing additional interventions and repeat from step (805). The selection or modification of instructions for the next time instance or session may be based on the performance of the activity in a previous time instance or session. In some embodiments, the next instructions may be modified based on response data from the user while performing the activity in a previous time instance or session. In some embodiments, the next instructions may be modified based on scores determined from the performance of the activity in a previous time instance or session. For example, the instructions may be modified by order of execution (e.g., relative to other interventions), the length of time to complete the intervention, the difficulty of performing the intervention, etc. The selection or modification of instructions for the next time instance or session may be based on the performance of the intervention in a previous time instance or session.

[0143] The method 800 can include identifying or determining whether the session metric is an improvement over a baseline metric (835). The improvement can correspond to a decrease in substance use or a decrease in the intensity of side effects associated with SUD. The improvement can occur when the session metric increases by a first predetermined margin compared to the baseline metric, or when the session metric decreases by a second predetermined margin compared to the baseline metric. The margin identifies or defines the difference in values between the baseline metric and the session metric for determining that the user has exhibited a decrease in the intensity of side effects associated with SUD. Whether improvement is indicated by an increase or a decrease can depend on the type of metric used to measure the user for SUD. The margin can also depend on the type of metric used and can generally correspond to a difference in values that indicates a notable difference in terms of SUD or a statistically significant result in the difference between the values of the baseline metric and the session metric.

[0144] In some embodiments, at least one of the first predetermined margin or the second predetermined margin can be calculated, generated, or otherwise determined (e.g., by a computing device). The first predetermined margin or the second predetermined margin can be based on baseline metrics and session metrics obtained from users in a treatment group or a control group. The margin can also correspond to a statistically significant difference between the change in baseline metrics and session metrics in the treatment group and the change in baseline metrics and session metrics in a control group (e.g., receiving a control therapy). The difference can be based on any number of statistical tests, such as a t-test, a z-test, a chi-squared test, etc.

[0145] Method 800 may include determining that remission is indicated when the session metric is determined to be an improvement over the baseline metric (840). In some embodiments, remission may be determined (e.g., by a computing system or a clinician examining the user) when the DSM-5 metric is reduced by a first predetermined margin from the baseline DSM-5 metric. In some embodiments, remission may be determined when the session OSTQOL metric is reduced by a second predetermined margin from the baseline OSTQOL metric. In some embodiments, remission may be determined when the session abstinence metric is reduced by a second predetermined margin from the baseline abstinence metric. In some embodiments, remission may be determined when the session impact on daily living percentage metric is reduced by a first predetermined margin from the baseline impact on daily living percentage metric. Following administration of the digital therapeutic, the user's substance use may be reduced.

[0146] Method 800 may include determining that remission is not indicated if the session metric is determined not to be an improvement over the baseline metric (845). In some embodiments, remission may be determined (e.g., by a computing system or a clinician examining the user) when the DSM-5 metric is not reduced by a first predetermined margin from the baseline DSM-5 metric. In some embodiments, remission may be determined when the session OSTQOL metric is not reduced by a second predetermined margin from the baseline OSTQOL metric. In some embodiments, remission may be determined when the session abstinence metric is not reduced by a second predetermined margin from the baseline abstinence metric. In some embodiments, remission may be determined when the session impact on daily living percentage metric is not reduced by a first predetermined margin from the baseline impact on daily living percentage metric.

[0147] Example 1: Effectiveness of cognitive activities in digital treatments targeting SUB In one example, the CT-102 mobile app (e.g., App 125) will be administered to individuals with a self-reported diagnosis of moderate to severe opioid use disorder (OUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. The DSM-5 includes a criteria list, with moderate to severe OUD identified as meeting four to five criteria and severe OUD as meeting six or more criteria. The treatment duration will be 2-52 weeks. This is a single-arm study to examine the feasibility and acceptability of the abbreviated CT-102 app in participants aged 18 years or older with OUD. Each arm will have at least 20 participants.

[0148] Enroll at least 20 participants to achieve at least 10 completers, assuming an early discontinuation (ET) rate of 33%. This estimate reflects the 50% ET rate established in randomized controlled trials with treatment durations ranging from 2 to 52 weeks. Within this group, there will be a subcohort of approximately 5-10 individuals who will voluntarily agree to participate in designated user experience research (UXR) surveys and interviews.

[0149] Users will perform the activities disclosed herein, such as choice activities, visualization activities, memory quizzes, etc. Users will be assessed based on a number of clinical endpoints, including:

[0150] Screening Period: All participants will be screened for up to 7 days. Assessments during this period will be conducted according to the Schedule of Activities and Assessments (SoA). Participants will be considered eligible if they meet all inclusion criteria and no exclusion criteria, based on the investigator's assessment. Screening and baseline visits may be conducted on the same day.

[0151] Baseline Visit: After the screening period, eligible participants will be enrolled. The baseline assessment will be conducted according to the SoA. Participants will download and activate the study app (e.g., abbreviated CT-102) on their primary iPhone or Android smartphone. Participants will be instructed to access and engage with the study app daily.

[0152] Engagement Period: Participants will interact with the study app and complete activities as prompted by the study app daily. During the engagement period, participants will complete oral fluid drug tests approximately twice weekly. These tests are administered to support the mechanism of treatment delivered by the study app and are not considered study endpoints. Oral fluid drug testing includes remote application of point-of-care tests twice weekly and remote provision of an additional oral fluid specimen for confirmatory lab testing (shipped by mail) once weekly. Participants will be assessed as described in the SoA. Approximately 6 participants will be interviewed virtually at the end of Week 2 (Days 9-15). Approximately 10 participants will participate in a weekly user engagement survey.

[0153] Follow-up Period: At the end of engagement, participants will have a one-week post-treatment follow-up. Participants will be assessed as outlined in the SoA. Participants who choose to participate in UXR will participate in a final UXR interview.

[0154] Primary endpoint: ● Involvement level ○ Number of days involved in the app during the involvement period ○ Number of lessons completed during the engagement period ○ Number of DiNaMo® sessions completed during the engagement period ● Therapeutic alliance Changes in the Mobile Agnew Relationship Measure (mARM) during the engagement period Changes in the mobile version of the Agnew Relationship Scale during the engagement period Changes in delay discounting metrics obtained from the Monetary Choice Questionnaire over the course of the engagement period Changes in drug demand metrics derived from the Hypothetical Purchase Task over the course of the engagement period Changes in objective working memory function obtained from a digit span task during the engagement period Changes in subjective working memory function during the engagement period as measured by a metamemory questionnaire Changes in subjective inhibitory control measured by the Barratt Impulsiveness Scale (BIS-11) during the engagement period Maximum working memory challenge condition achieved through DiNaMo during the engagement period Active working memory task condition in DiNaMo during the engagement period Maximum response latency achieved through DiNaMo during the engagement period. Active response latency task conditions in DiNaMo during the engagement period ● App usefulness and perception Patient Global Impression of Change (PGI-C single item) during the intervention period Opioid use and craving management Changes in the Obsessive-Compulsive Drug Use Scale (OCDUS) during the intervention period Changes in drug abstinence self-efficacy (Drug Abstinence Self-Efficacy Scale (DASES)) during the intervention period Changes in Modified Visual Analogue Scale (MVAS) craving ratings during the intervention period ● Participant feedback Customer Satisfaction (CSAT) during engagement (single item) Digital Intervention Barriers Scale (DIBS-7) during the engagement period Changes in the resilience enhancement scale during the engagement period Changes in perceived stress scales during the period of involvement

[0155] Exploratory endpoints: Changes in self-reported opioid use during the engagement period using the timeline follow-back (TLFB) method Changes in self-reported substance use during the involvement period using the TLFB method ● Changes in resilience enhancement measures during the engagement period Changes in perceived stress scales during the involvement period Changes in Opioid Substitution Therapy Quality of Life (OSTQOL) during participation

[0156] Correlations between user engagement metrics, the Psychological Change Scale (PGI-C), and customer satisfaction (CSAT), as well as correlations between treatment-related changes in OCDUS, DASES, MVAS, delay discounting (Monetary Choice Questionnaire), cognitive assessment measures (BIS-11, Metamemory Questionnaire, Digit Span), and the TLFB Schedule of Activities and Assessment (SoA). Studies conducted using the CT-102 mobile app with adults (ages 18 and older) with substance use-related disorders can follow a study schedule 700, as shown in Figure 7.

[0157] Screening Period ● All participants will undergo a screening period of up to 7 days to determine eligibility for enrollment. Assessments during this period will be conducted according to the Schedule of Activities and Assessments (SoA). • Participants may complete the screening and baseline visits on the same day if all required assessments are completed according to protocol.

[0158] Baseline visit (Day 1) ● At the end of the screening period, eligible participants will be enrolled. • Participants will also undergo a baseline assessment as outlined in the Schedule of Activities and Assessments. ● Site staff will assist eligible participants in downloading and installing the study app on their personal primary smartphone. The study app will be activated using a unique activation code. ● Participants will be instructed to access and engage with the study app daily. • Participants will complete the screening and baseline visits on the same day if all required assessments are completed according to protocol.

[0159] Duration of involvement ● Each day, participants will interact with the study app and complete activities according to the instructions in the study app. ● During the engagement period, participants will complete oral fluid drug tests approximately twice weekly. These tests will be conducted to support the mechanism of treatment delivered by the study app and are not considered study endpoints. Oral fluid drug testing will involve the remote application of point-of-care tests twice weekly and the remote provision of an additional oral fluid specimen for confirmatory lab testing (shipped by mail) once weekly. ● Participants will be assessed as outlined in the SoA. ● Approximately six participants will have a virtual interview at the end of the second week. ● Approximately 10 participants will take part in weekly user engagement surveys.

[0160] Follow-up period (1 week) ● At the end of the engagement, participants will undergo post-treatment follow-up. Participants will be assessed as outlined in the SoA. ● Participants who choose to participate in UXR will participate in a final UXR interview.

[0161] At least 20 participants will be enrolled. Approximately 10 sites will participate in the study.

[0162] Research Evaluation Financial Choice Questionnaire The Monetary Choice Questionnaire (MCQ) is a self-report assessment tool for assessing delay discounting behavior, measuring the tendency to devalue rewards as the delay to receiving them increases. Participants choose between a smaller immediate reward and a larger delayed reward through a series of 27 hypothetical decision-making prompts. The rate at which individuals discount future rewards indicates preferences for immediate gratification and delayed benefits, providing insight into decision-making processes related to financial decisions, impulsivity, and health behaviors. This delay discounting rate can be calculated from MCQ responses.

[0163] Virtual Purchasing Challenge The hypothetical purchasing task (HPT) is a tool for measuring hypothetical drug demand for opioids and other substances. In the HPT, participants report the amount of drug they would purchase across nine price ranges. This method helps researchers construct demand curves and assess drug-demand behavior. Previous studies have found correlations between these demand measures and clinical variables such as substance use and treatment outcomes, including prediction of future opioid use in patients with OUD.

[0164] Bharat Impulsivity Scale (BIS-11) The BIS-11 was designed to assess impulse control across attention (e.g., difficulty concentrating), motor (e.g., routine behavior), and planning-related (e.g., inability to plan ahead) domains. The BIS-11 is intended to be an improvement over previous versions of the BIS. The BIS-11 has previously demonstrated treatment-related change in response to psychological interventions in individuals with OUD.

[0165] Thirty items are rated on a 4-point scale (1 = never / almost never, 2 = sometimes, 3 = often, 4 = almost always / always). The BIS-11 has three subscales:

[0166] Attentional impulsivity assesses task focus, intrusive thoughts, and agitation.

[0167] Motor impulsivity assesses the tendency to act impulsively and the consistency of lifestyle habits.

[0168] Non-Planning Impulsivity values careful thought, planning, and the enjoyment of challenging mental activities.

[0169] Drug Withdrawal Self-Efficacy Scale (DASES) The DASES is a 20-item self-report survey that measures confidence in one's ability to abstain from drug use in specific situations. The DASES is a psychometrically validated adaptation of the Abstinence Self-Efficacy Scale.

[0170] Customer Satisfaction (CSAT) Single Item CSAT is a single-item assessment of customer satisfaction with a product or service. The survey is intentionally simple in design, encouraging user engagement and authentic feedback. Participants are asked to rate their satisfaction on a 5-point scale, with 1 representing "very dissatisfied" and 5 representing "very satisfied." This format allows for an easy-to-understand, quantitative assessment of customer satisfaction and can provide valuable insights into the effectiveness and usability of digital interactions and interventions.

[0171] Metamemory Questionnaire (MMQ) The Metamemory Questionnaire (MMQ; also known as the Multifactorial Memory Questionnaire) is a self-report instrument designed to assess three subjective aspects of memory: overall satisfaction with one's memory (MMQ-Satisfaction), perception of everyday memory ability (MMQ-Ability), and use of memory strategies and aids (MMQ-Strategies). The MMQ focuses on clinically relevant aspects of memory, including memory-related emotions, and avoids items unrelated to everyday functioning. The questionnaire contains a total of 57 self-report items and takes approximately 10 minutes to complete. The MMQ has good psychometric properties and has also demonstrated responsiveness to brief cognitive training interventions in clinical populations.

[0172] Digital Intervention Barriers Scale (DIBS-7) The DIBS-7 is a 10-item, unidimensional scale designed to capture commonly encountered barriers in digital mental health interventions. The DIBS-7 demonstrated strong criterion-related validity, with mean scores robustly correlated with established variables related to engagement in digital mental health interventions (DMHIs), including treatment expectancies, behavioral indicators of engagement, and satisfaction. These associations were stronger than those observed for user characteristics regarding engagement, suggesting broad applicability across various user populations. Furthermore, the DIBS-7 was shown to significantly moderate treatment response, highlighting its validity in assessing factors affecting the effectiveness of DMHIs.

[0173] Mobile Agnew Relationship Scale (mARM) The mARM is a validated patient-rated scale assessing the digital occupational alliance (DWA) with mobile health interventions for mental health conditions. The scale was adapted from the well-validated Agnew Relationship Scale and consists of 25 items rated on a 7-point scale ranging from "strongly disagree" to "strongly agree."

[0174] System Usability Scale (SUS) The System Usability Scale (SUS) is a widely used scale for quantifying the usability of many software and hardware products. SUS scores are expressed as a percentage ranging from 0 to 100, with a perfect score of 100% representing perfect usability and an exceptionally good user experience.

[0175] Patient Global Impression Scale (PGI-C) The Patient Global Impression of Change (PGI-C) is a self-reported, 7-point rating scale that represents the patient's assessment of their overall improvement. The PGI-C has been validated in many other episodic disorders against established measures of pain intensity, pain interference with daily life, and treatment effectiveness. Importantly, it assesses change from baseline, not change since the last visit.

[0176] Obsessive-Compulsive Drug Use Scale (OCDUS) The Obsessive-Compulsive Drug Use Scale (OCDUS) measures three components: thoughts and interference with substances, cravings and control, and thoughts and resistance to will.

[0177] Self-reported substance use via timeline follow-back (TLFB) The TLFB retrospectively collects data on substance use for each day during the reporting period, providing detailed information on patterns of use. Originally developed to assess self-reported alcohol use (Sobell & Sobell, 1992), it has since been adapted and validated for assessing other substance use, including opioids.

[0178] Resilience Enhancement Scale The Resilience Empowerment Scale (RES) is a 20-item self-report instrument designed to assess empowerment in individuals recovering from substance use disorders. Seven items are adapted from the Women in Recovery Empowerment Scale. The RES assesses four dimensions of empowerment: emotional, cognitive, behavioral, and relational. Specifically, the RES includes four items for emotional empowerment, four items for cognitive empowerment, three items for behavioral empowerment, and nine items for relational empowerment. Respondents rate items on a 7-point Likert scale ranging from "almost never" to "almost always," with higher scores indicating higher levels of empowerment. This scale is applicable to both men and women and provides a thorough and reliable measure of empowerment across different populations.

[0179] Perceived Stress Scale The Perceived Stress Scale is a 14-item assessment instrument designed to measure the degree to which various situations in an individual's life are perceived as stressful. The scale also includes several direct questions about the level of stress currently experienced.

[0180] Brief Trauma Questionnaire (BTQ) The BTQ is a 10-item self-report questionnaire designed to assess traumatic exposure according to DSM-IV, but only includes severe injuries, particularly life-threatening ones, due to the difficulty in accurately assessing subjective responses.

[0181] The BTQ was originally developed to assess traumatic exposure in line with DSM-IV guidelines, but focused only on criterion A.1 (life threat / serious injury) due to the difficulty of accurately measuring criterion A.2 (subjective response) using a brief self-report format. Since criterion A.2 was removed from the PTSD diagnostic criteria in DSM-5, the BTQ can now comprehensively assess criterion A.

[0182] Opioid Substitution Therapy Quality of Life (OSTQOL) The Opioid Substitution Therapy Quality of Life Scale (OSTQOL) is a specialized assessment instrument developed to assess the quality of life (QOL) of patients receiving opioid substitution therapy (OST). The scale was developed through a rigorous process involving focus groups with OST patients to identify key QOL themes. The final scale consists of 38 items across six subscales capturing various aspects of QOL, including items uniquely relevant to patients with OUD, such as personal growth, psychological distress, social contact, material well-being, satisfaction with opioid substitution therapy, and experiences of embarrassment and discrimination. This assessment instrument has demonstrated good internal consistency reliability, strong convergent and discriminant validity, as well as favorable response to treatment in a large clinical trial in OUD patient populations. The OSTQOL is a multidimensional tool designed to comprehensively assess the QOL of OST patients while minimizing responder and administrator burden.

[0183] Modified Visual Analogue Scale (MVAS) The modified VAS for craving is a two-dimensional representation for assessing both the intensity and frequency of craving (expressed as the percentage of time per day craving is experienced). Unlike the standard VAS, which is typically a single line with endpoints representing "no pain" and "worst imaginable pain," the MVAS includes additional markers or descriptors along the scale, allowing participants to more precisely describe their pain level by distinguishing between mild, moderate, and severe pain. Use of the MVAS reduces ambiguity and improves the reliability of pain ratings.

[0184] Columbia-Suicide Severity Rating Scale (C-SSRS) The Columbia-Suicide Severity Rating Scale (C-SSRS) is a scale assessing suicidal ideation and behavior that assesses an individual's level of suicidal ideation on a scale ranging from "I want to die" to "active suicidal ideation with specific plans, intentions, and actions." The assessment consists of a baseline assessment that assesses participants' lifetime experiences with suicidal events and suicidal ideation, and a post-baseline assessment that focuses on suicidality since the previous study visit.

[0185] UXR Interview Some participants will participate in qualitative user interviews via video conference with members of the Click Therapeutics product development team. Approximately six participants will participate in a UXR interview in week two (days nine through fifteen), and ten participants will participate in a final visit interview. These interviews will gather additional information about users' experiences with the app, such as preferred app features, ease of use of those features, difficulties related to the intervention, or other feedback gained from regular interaction with the app.

[0186] User engagement surveys User engagement surveys will be conducted to understand participants' experience with the research app during the engagement phase. These questionnaires will ask questions related to perceived enjoyment, difficulties, and related user experiences. These questionnaires will be completed electronically by participants once a week and will take approximately 10 minutes to complete.

[0187] Example 2: Clinical evaluation of the safety and efficacy of digital therapeutic applications This study will evaluate the efficacy and safety of CT-102 as an adjunctive treatment for OUD in participants aged 18 years and older who are receiving treatment with an FDA-approved medication for the treatment of OUD (MOUD). Treatment duration will range from 2 to 52 weeks. This digital therapeutic application will be evaluated as an adjunctive treatment for OUD. Users will complete activities disclosed herein, including choice activities, visualization activities, and memory quizzes. Users will be evaluated based on a number of clinical endpoints, including:

[0188] Users of the CT-102 application are evaluated against one or more controls for statistically significant differences in the primary and secondary clinical endpoints described herein. The one or more controls include a control group not participating in the CT-102 group, or a user not participating in one or more of the selection, visualization, or memory quiz activities. Changes from baseline in the primary and secondary clinical endpoints are evaluated for the CT-102 group and the control group, and these values are evaluated for clinically significant changes in the CT-102 group versus the control group.

[0189] Study Objective: The objective of this study was to evaluate the efficacy and safety of CT-102 as adjunctive therapy in patients with OUD aged 18 years or older who were taking MOUD during the treatment period.

[0190] Primary endpoint: Biochemically verified non-prescription opioid abstinence defined by ≥80% negative samples during the evaluation period.

[0191] Secondary endpoints: Self-reported change in non-opioid substance use during the intervention period (timeline follow-back method) Self-reported change in opioid substance use during the intervention period (timeline follow-back method) Change in Recent Overdose Experiences Scale (RODES) during the intervention period Changes in personal opioid overdose risk (Personal Opioid Overdose Risk Survey: PORS) during the intervention period Changes in opioid substitution therapy quality of life (OSTQOL) during the intervention period Changes in the Short Form Health Survey (SF-36) during the intervention period Change in the Obsessive-Compulsive Drug Use Scale (OCDUS) during the involvement period Changes in Drug Abstinence Self-Efficacy Scale (DASES) during the intervention period Biochemically confirmed changes in non-opioid substance use during the period of involvement Changes in MOUD retention during participation, as reported by study participants with appropriate clinical documentation (provided to the research team upon request) • Assess overall improvement via the Patient Global Impression-Change Scale (PGI-C) during the engagement period. Durability of effect will be measured by biochemical confirmation of non-prescription opioid abstinence during the intervention period.

[0192] Exploratory endpoints: ● The degree of participant engagement with the trial digital treatment, as measured by key engagement metrics. • Durability of effects will be measured by self-reported opioid substance use during and / or after the engagement period (timeline follow-back method). • Durability of effects will be measured by self-report of non-opioid substance use during and / or after the engagement period (timeline follow-back method).

[0193] Safety Endpoints: Frequency and severity of adverse events, serious adverse events, and study discontinuations due to adverse events Prevalence of suicidal behavior and suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

[0194] The study design is a multicenter, randomized, double-blind, digitally controlled study to evaluate the efficacy and safety of CT-102 as an adjunct treatment to MOUD for OUD in participants aged 18 years and older.

[0195] Screening Period: ● All participants will undergo a screening period of up to 14 days to determine eligibility for enrollment. ● During the screening period, participants will be asked to complete various tasks within the onboarding software module to confirm their digital literacy and interest in research. ● Evaluation during this period will be conducted in accordance with the Schedule of Activities and Evaluation (SoA).

[0196] Run-in Period: Participants then enter a 28-day run-in period to establish a baseline of use.

[0197] Baseline Visit: After the 28-day run-in period, the investigator will verify that participants continue to meet all inclusion criteria and do not meet any exclusion criteria. Participants will be randomized to CT-102 or digital control on Day 1.

[0198] Treatment duration: ● Participants will follow the protocol's treatment assignment for up to 365 days. ● Each day, participants will interact with the study app and complete tasks according to the instructions in the study app. During the treatment period, participants will undergo oral fluid drug testing approximately twice weekly. Responders with 16 or more negative samples out of 20 during the treatment period will be considered abstinent. ● Oral fluid drug testing involves the remote application of point-of-care testing twice weekly and the remote provision of an additional oral fluid specimen for confirmatory laboratory testing (shipped by mail) twice weekly. • Biospecimen results will be further cross-referenced with self-reported opioid use (assessed using a timeline follow-back method).

[0199] Follow-up Period: After completing their assigned treatment, participants will be monitored for up to 12 weeks and undergo post-treatment follow-up. Participants will be assessed as described in the SoA. Statistical analysis: The equivalence of treatment conditions with respect to key baseline variables is assessed. This includes comparing treatment conditions with respect to baseline levels of demographic information and moderators that may affect treatment (e.g., sex and age). Following the intention-to-treat principle, all randomized participants are included in the analysis. The null hypothesis for the primary endpoint is that there is no difference in success rates between the two groups, and the alternative hypothesis is that there is a difference. A test of proportions is used to evaluate this hypothesis. The main goal is to obtain a stable estimate of the effect size and adjust the sample size to show a statistically significant difference between the treatment groups for the primary endpoint.

[0200] C. Network and Computing Environment Various operations described herein may be performed on a computer system. FIG. 9 illustrates a simplified block diagram of a representative server system 900, a client computing system 914, and a network 926 that may be used to implement certain embodiments of the present disclosure. In various embodiments, the server system 900 or a similar system may implement the services or servers described herein, or portions thereof. The client computing system 914 or a similar system may implement the clients described herein. The system 900 described herein may be similar to the server system 900. The server system 900 may have a modular design incorporating many modules 902 (e.g., blades in a blade server embodiment); although two modules 902 are shown, any number may be provided. Each module 902 may include one or more processing units 904 and local storage 906.

[0201] The one or more processing units 904 can include a single processor, which can have one or more cores, or multiple processors. In some embodiments, the one or more processing units 904 can include a general-purpose primary processor as well as one or more special-purpose coprocessors, such as a graphics processor, digital signal processor, etc. In some embodiments, some or all of the one or more processing units 904 can be implemented using customized circuitry, such as an application-specific integrated circuit (ASIC) or a field programmable gate array (FPGA). In some embodiments, such integrated circuits execute instructions stored on the circuitry itself. In other embodiments, the one or more processing units 904 can execute instructions stored on local storage 906. Any combination of any type of processor can be included in the one or more processing units 904.

[0202] The local storage device 906 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) or nonvolatile storage media (e.g., magnetic or optical disks, flash memory, etc.). The storage media incorporated in the local storage device 906 may be fixed, removable, or upgradeable, as desired. The local storage device 906 may be physically or logically divided into various subunits, such as system memory, read-only memory (ROM), and permanent storage. The system memory may be a read / write memory device or a volatile read / write memory, such as dynamic random access memory. The system memory may store some or all of the instructions and data needed by the one or more processing units 904 during execution. The ROM may store static data and instructions needed by the one or more processing units 904. The permanent storage device may be a nonvolatile read / write memory device that can store instructions and data even when the module 902 is powered down. As used herein, the term "storage medium" includes any medium capable of storing data indefinitely (albeit through overwriting, electrical disturbance, power loss, etc.), and does not include carrier waves or ephemeral electronic signals propagated wirelessly or via wired connections.

[0203] In some embodiments, local storage 906 may store one or more software programs executed by one or more processing units 904, such as an operating system or programs that implement the functionality of system 900 or any other system described herein, or various server functions, such as any one or more servers associated with system 900 or any other system described herein.

[0204] "Software" generally refers to sequences of instructions that, when executed by one or more processing units 904, cause the server system 900 (or portions thereof) to perform various operations, and thus define one or more specific machine implementations that execute and carry out the operations of the software program. The instructions may be stored as firmware resident in read-only memory for execution by the one or more processing units 904, or as program code stored on a non-volatile storage medium that can be loaded into volatile working memory. The software may be implemented as a single program or a collection of separate programs or program modules that interact as desired. To perform the various operations described above, the one or more processing units 904 may retrieve program instructions to execute and data to process from the local storage device 906 (or non-local storage device, as described below).

[0205] In some server systems 900, multiple modules 902 may be interconnected via a bus or other interconnect 908 to form a local area network that supports communication between the modules 902 and other components of the server system 900. The interconnect 908 may be implemented using a variety of technologies, including server racks, hubs, routers, etc.

[0206] A wide area network (WAN) interface 910 may provide data communication functionality between a local area network (e.g., via interconnect 908) and a network 926, such as the Internet. Other technologies may be used to communicatively couple the server system to the network 926, including wired technologies (e.g., Ethernet, IEEE 802.3 standard) or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standard).

[0207] In some embodiments, local storage 906 is intended to provide working memory for one or more processing units 904, providing fast access to programs or data being processed while reducing traffic on interconnect 908. Storage for larger amounts of data can be provided on a local area network by one or more mass storage subsystems 908 connectable to interconnect 912. Mass storage subsystem 912 can be based on magnetic, optical, semiconductor, or other data storage media. Direct-attached storage, storage area networks, network-attached storage, etc. can be used. Any data storage mechanism or other collection of data described herein as generated, consumed, or maintained by a service or server can be stored in mass storage subsystem 912. In some embodiments, additional data storage resources are accessible (albeit potentially with increased latency) via WAN interface 910.

[0208] The server system 900 may operate in response to requests received via the WAN interface 910. For example, one of the modules 902 may implement a management function and assign individual activities to other modules 902 in response to received requests. Work allocation techniques may be used. Once a request is processed, a result may be returned to the requestor via the WAN interface 910. Typically, such operations may be automated. Furthermore, in some embodiments, the WAN interface 910 may connect multiple server systems 900 together to provide a scalable system capable of managing large volumes of activity. Other techniques for managing server systems and server farms (collections of server systems cooperating with each other) may be used, including dynamic resource allocation and reallocation.

[0209] The server system 900 can interact with a variety of user-owned or user-operated devices over a wide area network, such as the Internet. An example of a user-operated device is shown in Figure 9 as client computing system 914. The client computing system 914 can be implemented as a consumer device, such as, for example, a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, eyeglasses), desktop computer, laptop computer, etc.

[0210] For example, client computing system 914 may communicate over WAN interface 910. Client computing system 914 may include computer components such as one or more processing units 916, storage devices 918, network interfaces 920, user input devices 922, and user output devices 924. Client computing system 914 may be computing devices implemented in a variety of form factors, such as desktop computers, laptop computers, tablet computers, smartphones, other mobile computing devices, wearable computing devices, etc.

[0211] The processing unit 916 and storage unit 918 may be similar to the one or more processing units 904 and local storage unit 906 described above. Suitable devices may be selected based on the demands placed on the client computing system 914. For example, the client computing system 914 may be implemented as a "thin" client having limited processing power or as a high-performance computing device. The client computing system 914 may comprise program code executable by the one or more processing units 916 to enable various interactions with the server system 900.

[0212] The network interface 920 may provide a connection to a network 926, such as a wide area network (e.g., the Internet), to which the WAN interface 910 of the server system 900 is also connected. In various embodiments, the network interface 920 may include a wired interface (e.g., Ethernet) or a wireless interface implementing various wireless data communication standards, such as Wi-Fi, Bluetooth, or cellular data network standards (e.g., 3G, 4G, LTE, etc.).

[0213] User input device(s) 922 may include any device (or devices) that allows a user to send signals to client computing system 914, which can be interpreted by client computing system 914 as indicating a particular user request or information. In various embodiments, user input device(s) 922 may include any or all of a keyboard, touchpad, touchscreen, mouse or other pointing device, scroll wheel, click wheel, dial, button, switch, keypad, microphone, etc.

[0214] The user output device(s) 924 may include any device(s) that enable the client computing system 914 to provide information to a user. For example, the user output device(s) 924 may include a display-to-display shared image generated by or transmitted to the client computing system 914. The display may incorporate various image generation technologies, such as, for example, a liquid crystal display (LCD), a light emitting diode (LED) display including an organic light emitting diode (OLED), a projection system, a cathode ray tube (CRT), etc., along with supporting electronics (e.g., digital-to-analog or analog-to-digital converter, a signal processor, etc.). Some embodiments may include devices such as a touchscreen that function as both an input and output device. In some embodiments, other user output device(s) 924 may be provided in addition to or instead of a display. Examples include indicator lights, speakers, tactile "display" devices, printers, etc.

[0215] Some embodiments include electronic components, such as a microprocessor, storage devices, and memory, that store computer program instructions on a computer-readable storage medium. Many of the features described herein can be implemented as processes specified as a set of program instructions encoded on a computer-readable storage medium. These program instructions, when executed by one or more processing units, cause the one or more processing units to perform various operations indicated by the program instructions. Examples of program instructions or computer code include machine code produced by a compiler and files containing higher-level code that are executed by a computer, electronic component, or microprocessor using an interpreter. With appropriate programming, one or more processing devices 904 and 916 can provide various functions to the server system 900 and the client computing system 914, including any of the functions described herein as being performed by a server or client, or other functions.

[0216] It will be understood that the server system 900 and the client computing system 914 are illustrative and that variations and modifications are possible. Computer systems used in connection with embodiments of the present disclosure may have other functionality not specifically described herein. Additionally, while the server system 900 and the client computing system 914 are described with reference to certain blocks, it should be understood that these blocks are defined for convenience of explanation and are not intended to imply a particular physical arrangement of components. For example, different blocks may, but need not, be located in the same facility, in the same server rack, or on the same motherboard. Furthermore, the blocks need not correspond to physically separate components. The blocks may be configured to perform various operations, for example, by programming a processor or providing appropriate control circuitry, and various blocks may be reconfigurable or non-reconfigurable depending on how the initial configuration is obtained. Embodiments of the present disclosure may be realized in a variety of apparatuses, including electronic devices implemented using any combination of circuitry and software.

[0217] While the present disclosure has been described with reference to specific embodiments, those skilled in the art will recognize that numerous variations are possible. Embodiments of the present disclosure can be implemented using a variety of computer systems and communication technologies, including but not limited to the specific examples described herein. Embodiments of the present disclosure can be implemented using any combination of dedicated components or programmable processors or other programmable devices. The various processes described herein can be performed by any combination of the same or different processors. Where a component is described as being configured to perform a particular operation, such configuration can be achieved, for example, by designing electronic circuitry to perform the operation, by programming a programmable electronic circuit (such as a microprocessor) to perform the operation, or by any combination thereof. Furthermore, while the above-described embodiments may refer to specific hardware and software components, those skilled in the art will recognize that different combinations of hardware or software components can also be used, and that certain operations described as being implemented in hardware can also be implemented in software, or vice versa.

[0218] A computer program incorporating various features of the present disclosure may be encoded and stored on a variety of computer-readable storage media. Suitable media include magnetic disks or tapes, optical storage media such as compact discs (CDs) or digital versatile discs (DVDs), flash memory, and other non-transitory media. A computer-readable medium encoded with program code may be packaged with a compatible electronic device, or the program code may be provided separately from the electronic device (e.g., via internet download or as a separately packaged computer-readable storage medium).

[0219] Thus, while the present disclosure has been described in terms of specific embodiments, it will be understood that the present disclosure is intended to cover all modifications and equivalents that fall within the scope of the following claims.

[0220] Embodiments: 1. A method of providing instruction for activities to address maladaptive behaviors associated with a user's substance use, comprising: identifying, by one or more processors, a profile for a user having a substance use disorder, the profile including a plurality of substance use terms; presenting, by the one or more processors, a plurality of memory words not related to substance use and instructions for memorizing the plurality of memory words; providing, by the one or more processors, instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; and updating, by the one or more processors, the profile of the user using the performance of the activity by the user.

[0221] 2. The method of claim 1, further comprising providing, by the one or more processors, instructions to perform an activity that provides information about future events.

[0222] 3. The method of claim 2, wherein the future event relates to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0223] 4. The method of claim 3, further configured by the one or more processors to, before providing the instructions to perform the activity, provide instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0224] 5. The method of claim 2, further comprising providing, by the one or more processors, instructions to the user prior to the instructions to perform the activity, for selecting a category of the future event.

[0225] 6. The method of claim 5, wherein the categories of future events are selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0226] 7. The method of claim 2, further comprising providing, by the one or more processors, instructions for selecting a time frame for the future event.

[0227] 8. The method of claim 7, wherein the future event may occur in less than one month.

[0228] 9. The method of claim 7, wherein the future event may occur more than one month in the future.

[0229] 10. The method of claim 2, further comprising prompting the user to generate one or more visual cues based on the information about the future event provided by the user.

[0230] 11. The method of claim 10, wherein the visual cue is an image or text, including free text, provided by the user.

[0231] 12. providing, by the one or more processors, subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 12. The method of claim 1, further comprising providing, by the one or more processors, a prompt including the visual cue associated with the information regarding the future event and instructions for performing an activity associated with the visual cue.

[0232] 13. The method of claim 12, wherein the prompt is a timeline that identifies a plurality of visual cues.

[0233] 14. The method of claim 12, wherein the timeline is automatically updated based on times tagged to the visual cues.

[0234] 15. The method of claim 12, wherein the activity includes an audio recording or a text description.

[0235] 16. The method of any of claims 2-15, further comprising the step of providing, by said one or more processors, a prompt related to said information regarding said future event following performance of said activity that provides information.

[0236] 17. The method of any of claims 2-16, wherein the activity of refraining from selecting one or more of the presentations of the plurality of memory words is performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

[0237] 18. The method of any of claims 1-17, further comprising providing, by the one or more processors, subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words.

[0238] 19. providing, by the one or more processors, subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 19. The method of any of claims 16-18, further comprising: providing, by the one or more processors, the prompt related to the information regarding the future event following the execution of the activity of refraining from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words.

[0239] 20. The method of any of claims 1-19, further comprising providing instructions by said one or more processors to perform the activity of selecting all of said memory words from a plurality of words.

[0240] 21. The method of any of claims 1-20, further comprising providing instructions for performing, by said one or more processors, an activity of selecting one or more of said memory words from a plurality of words.

[0241] 22. calculating, by said one or more processors, a score indicative of a percentage of correct interactions with said memory words; 22. The method of claim 20 or claim 21, further comprising selecting, by the one or more processors, the plurality of memory words based on the scores.

[0242] 23. calculating, by the one or more processors, a score indicative of correct interaction, speed of selection, or both, during performance of one or more activities; 23. The method of any of claims 1-22, further comprising selecting a plurality of subsequent substance use words, a plurality of subsequent memory words, or both based on the score.

[0243] 24. The method of claim 23, wherein the score is calculated based on the number of correct interactions, the speed of selection, or both, during the activity of selecting all of the memory words from a plurality of words.

[0244] 25. calculating, by the one or more processors, a score indicative of correct interaction, speed of selection, or both, during performance of the activity of refraining from selection of the plurality of memory words and / or the plurality of substance use words; and determining, by the one or more processors, in response to the score meeting a threshold, an increase in word count for a subsequent activity that refrains from selecting the plurality of memory words and / or the plurality of substance use words.

[0245] 26. calculating, by the one or more processors, a score indicative of correct interaction, speed of selection, or both, during performance of the activity of selecting all memory words from a plurality of words; The method of any of claims 1-24, further comprising determining, by the one or more processors, in response to the score meeting a threshold, an increase in the number of words for a subsequent action of refraining from selecting multiple memory words, refraining from selecting multiple substance use words, or selecting all memory words from a plurality of words.

[0246] 27. The method of any of claims 22-26, further comprising displaying the score indicative of at least one of the percentage of correct interactions, the speed of selection, or both, during one or more activities.

[0247] 28. Still further comprising generating, by said one or more processors, one or more cue words or images based on said information regarding said future event provided by said user; 28. The method of claim 2, wherein the prompt associated with the information about the future event includes the one or more cue words or images.

[0248] 29. The method of any of claims 2-29, wherein providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the one or more of the plurality of memory words comprises providing, by the one or more processors, instructions to perform an activity in which the user selects one or more from a plurality of neutral words unrelated to substance use and different from the memory words.

[0249] 30. The method of any of claims 1-29, wherein providing the instruction to perform an activity to refrain from selecting one or more of the plurality of substance use or memory words comprises presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or more than 10 seconds.

[0250] 31. The method of any of claims 1-30, wherein the instructions to perform an activity are provided to the user at least once a day, at least once every two days, at least once every five days, or at least once a week.

[0251] 32. The method of any of claims 1-31, wherein the user is administered an effective amount of a medication comprising at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist.

[0252] 33. receiving, by the one or more processors, a request from the user indicating the onset of a behavior associated with the substance use; and initiating, by the one or more processors, the instruction of an activity to address maladaptive behaviors associated with the user's substance use in response to receiving the request.

[0253] 34. The method further includes determining, by the one or more processors, a time for providing the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words; 34. The method of any of claims 1-33, wherein providing the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further comprises providing the instruction at the determined time.

[0254] 35. The method of any of claims 1-34, wherein the one or more activities are performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer.

[0255] 36. The method of any of claims 1-35, wherein the substance use comprises at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

[0256] 37. The method of any of claims 1-36, wherein the prompt is provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

[0257] 38. A system for providing activity instructions to address maladaptive behaviors associated with a user's substance use, the system comprising: one or more processors, the processors: Identifying profiles containing multiple substance use terms for users with substance use disorders; presenting a plurality of memory words unrelated to substance use and instructions for memorizing the plurality of memory words; providing instructions for performing an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; The system is configured to use the performance of the activity by the user to update the profile of the user.

[0258] 39. The one or more processors: 39. The system of claim 38, further configured to provide instructions for performing an activity that provides information about a future event.

[0259] 40. The system of claim 39, wherein the future event relates to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0260] 41. The one or more processors: 41. The system of claim 40, further configured to, before providing the instructions to perform the activity, provide instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0261] 42. The one or more processors: 40. The system of claim 39, further configured by the one or more processors to provide instructions to the user prior to the instructions to perform the activity, for selecting a category of the future event.

[0262] 43. The system of claim 42, wherein the categories of future events are selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0263] 44. The one or more processors: 40. The system of claim 39, further configured to provide, by the one or more processors, instructions for selecting a time frame for the future event.

[0264] 45. The system of claim 44, wherein the future event may occur in less than one month.

[0265] 46. The system of claim 44, wherein the future event can occur more than one month in the future.

[0266] 47. The one or more processors: 40. The system of claim 39, further configured to prompt the user to generate one or more visual cues based on the information about the future event provided by the user.

[0267] 48. The system of claim 47, wherein the visual cue is an image or text, including free text, provided by the user.

[0268] 49. The one or more processors: providing subsequent instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 49. The system of any of claims 38-48, further configured to provide a prompt including the visual cue associated with the information regarding the future event and instructions for performing an activity associated with the visual cue.

[0269] 50. The system of claim 49, wherein the prompt is a timeline that identifies multiple visual cues.

[0270] 51. The system of claim 49, wherein the timeline is automatically updated based on times tagged to the visual cues.

[0271] 52. The system of claim 49, wherein the activity includes an audio recording or a text description.

[0272] 53. The one or more processors: 53. A system according to any of claims 39-52, further configured to provide a prompt related to the information regarding the future event following performance of the activity that provides information.

[0273] 54. The system of any of claims 38-53, wherein the activity of refraining from selecting one or more of the plurality of memory words is performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

[0274] 55. The one or more processors: 55. The system of any of claims 38-54, further configured to provide subsequent instructions for performing an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words.

[0275] 56. The one or more processors: providing subsequent instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 56. The system of any of claims 53-55, further configured to provide the prompt related to the information regarding the future event following performance of the activity of refraining from selecting one or more of the plurality of memory words and presentation of one or more of the plurality of substance use words.

[0276] 57. The one or more processors: 57. The system of any of claims 38-56, further configured to provide instructions for performing an activity of selecting all of the memory words from a plurality of words.

[0277] 58. The one or more processors: 58. The system of any of claims 38-57, further configured to provide instructions for performing an activity of selecting one or more of the memory words from a plurality of words.

[0278] 59. The one or more processors: calculating a score indicative of the percentage of correct interactions with said memory word; 59. The system of claim 57 or claim 58, further configured to select the plurality of mnemonic words based on the score.

[0279] 60. The one or more processors: calculating a score indicating correct interactions, speed of selection, or both during performance of one or more activities; 60. The system of any of claims 38-59, further configured to select a plurality of subsequent substance use words, a plurality of subsequent memory words, or both based on the score.

[0280] 61. The system of claim 60, wherein the score is calculated based on the number of correct interactions, the speed of selection, or both, during the activity of selecting all of the memory words from a plurality of words.

[0281] 62. The one or more processors: calculating a score indicative of correct interaction, speed of selection, or both, during performance of the activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words; 62. The system of any of claims 38-61, further configured to, in response to the score meeting a threshold, determine an increase in word count for a subsequent activity that refrains from selecting the plurality of memory words and / or the plurality of substance use words.

[0282] 63. The one or more processors: calculating a score indicative of correct interactions, speed of selection, or both, during performance of the activity of selecting all memory words from a plurality of words; 63. The system of any of claims 38-62, further configured to, in response to the score meeting a threshold, determine an increase in the number of words for a subsequent activity of refraining from selecting multiple memory words, refraining from selecting multiple substance use words, or selecting all memory words from a plurality of words.

[0283] 64. The one or more processors: 64. The system of any of claims 59-63, further configured to display the score indicative of at least one of a percentage of correct interactions, a speed of selection, or both, during one or more activities.

[0284] 65. The one or more processors: further configured to generate one or more cue words or images based on the information about the future event provided by the user; 65. The system of any of claims 38-64, wherein the prompt associated with the information regarding the future event includes the one or more cue words or images.

[0285] 66. The system of any of claims 2-29, wherein providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the one or more of the plurality of memory words comprises providing, by the one or more processors, instructions to perform an activity in which the user selects one or more from a plurality of neutral words unrelated to substance use and different from the memory words.

[0286] 67. The system of any of claims 38-66, wherein providing the instruction to perform an activity to refrain from selecting one or more of the plurality of substance use words and / or memory words comprises presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or more than 10 seconds.

[0287] 68. The system of any of claims 38-67, wherein the instructions to perform an activity are provided to the user at least once a day, at least once every two days, at least once every five days, or at least once a week.

[0288] 69. The system of any of claims 38-68, wherein the user is administered an effective amount of a medication comprising at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist.

[0289] 70. The one or more processors: receiving a request from the user indicating an onset of a behavior associated with the substance use; 70. The system of any of claims 28-69, further configured to, in response to receiving the request, initiate instruction of an activity to address maladaptive behaviors associated with the user's substance use.

[0290] 71. The one or more processors: further configured to determine a time period for providing the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words; 71. The system of any of claims 38-70, wherein providing the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further comprises providing the instruction at the determined time.

[0291] 72. The system of any of claims 38-71, wherein the one or more activities are performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer.

[0292] 73. The system of any of claims 38-72, wherein the substance use includes at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

[0293] 74. A system as described in any of claims 38-73, wherein the prompt is provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

[0294] 75. A method for providing necessary treatment or remission for a substance use disorder (SUD) in a user, comprising: applying a treatment to the user comprising a digital treatment, the digital treatment comprising: Identifying profiles containing multiple substance use terms for users with substance use disorders; presenting a plurality of memory words unrelated to substance use and instructions for memorizing the plurality of memory words; and providing instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words.

[0295] 76. The step of applying the digital therapy comprises: 76. The method of claim 75, further comprising providing instructions for performing an activity that provides information about a future event.

[0296] 77. The method of claim 76, wherein the future event relates to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0297] 78. The step of applying the digital therapy comprises: 78. The method of claim 77, further comprising, before providing the instructions to perform the activity, providing instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0298] 79. The step of applying the digital therapy comprises: 77. The method of claim 76, further comprising providing instructions to the user to select a category of the future event prior to the instructions to perform the activity.

[0299] 80. The method of claim 79, wherein the categories of future events are selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future appreciation, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

[0300] 81. The step of applying the digital therapy comprises: 77. The method of claim 76, further comprising providing instructions for selecting a time frame for the future event.

[0301] 82. The method of claim 81, wherein the future event may occur in less than one month.

[0302] 83. The method of claim 81, wherein the future event may occur more than one month in the future.

[0303] 84. The step of applying the digital therapy comprises: 77. The method of claim 76, further comprising prompting the user to generate one or more visual cues based on the information about the future event provided by the user.

[0304] 85. The method of claim 84, wherein the one or more visual cues are images or text, including free text provided by the user.

[0305] 86. The step of applying the digital therapy comprises: providing subsequent instructions to perform an activity that refrains from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 86. The method of any of claims 75-85, further comprising providing a prompt including the one or more visual cues associated with the information regarding the future event and instructions for performing an activity associated with the one or more visual cues.

[0306] 87. The method of claim 86, wherein the prompt is a timeline that identifies a plurality of visual cues.

[0307] 88. The method of claim 87, wherein the timeline is automatically updated based on times tagged to the visual cues.

[0308] 89. The method of claim 86, wherein the activity includes an audio recording or a text description.

[0309] 90. The step of applying the digital therapy comprises: 90. The method of any of claims 78-89, further comprising the step of providing a prompt related to the information regarding the future event following performance of the information-providing activity.

[0310] 91. The method of any of claims 75-90, wherein the activity of refraining from selecting one or more of the plurality of memory words is performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

[0311] 92. The step of applying the digital therapy comprises: 92. The method of any of claims 75-91, further comprising providing subsequent instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words.

[0312] 93. The step of applying the digital therapy comprises: providing subsequent instructions to perform an activity that refrains from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 93. The method of any of claims 90-92, further comprising: providing the prompt related to the information regarding the future event following the performance of the activity of refraining from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words.

[0313] 94. The step of applying the digital therapy comprises: 94. The method of any of claims 75-93, further comprising providing instructions for performing an activity of selecting all of the memory words from a plurality of words.

[0314] 95. The step of applying the digital therapy comprises: 95. The method of any of claims 75-94, further comprising providing instructions for performing an activity of selecting one or more of the memory words from a plurality of words.

[0315] 96. The step of applying the digital therapy comprises: calculating a score indicative of the percentage of correct interactions with the memory word; and selecting the plurality of memory words based on the score.

[0316] 97. The step of applying the digital therapy comprises: calculating a score indicative of correct interactions, speed of selection, or both, during performance of one or more activities; and selecting a plurality of subsequent substance use words, a plurality of subsequent memory words, or both based on said score.

[0317] 98. The method of claim 97, wherein the score is calculated based on the number of correct interactions, the speed of selection, or both, during the activity of selecting all of the memory words from a plurality of words.

[0318] 99. The step of applying the digital therapy comprises: calculating a score indicative of correct interaction, speed of selection, or both, during performance of the activity of refraining from selection of the plurality of memory words and / or the plurality of substance use words; and in response to the score meeting a threshold, determining an increase in word count for a subsequent activity that refrains from selecting the plurality of memory words and / or the plurality of substance use words.

[0319] 100. The step of applying the digital therapy comprises: calculating a score indicative of correct interaction, speed of selection, or both, during the activity of selecting all memory words from a plurality of words; 98. The method of any of claims 94-97, further comprising: in response to the score meeting a threshold, determining an increase in the number of words for a subsequent activity of refraining from selecting multiple memory words, refraining from selecting multiple substance use words, or selecting all memory words from a plurality of words.

[0320] 101. The step of applying the digital therapy comprises: 101. The method of any of claims 96-100, further comprising displaying the score indicative of at least one of the percentage of correct interactions, the speed of selection, or both, during one or more activities.

[0321] 102. Still further comprising generating one or more cue words or images based on said information about said future event provided by said user; 102. The method of any of claims 76-101, wherein the prompt associated with the information about the future event includes the one or more cue words or images.

[0322] 103. The method of any of claims 75-102, wherein providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the one or more of the plurality of memory words further comprises providing instructions to perform an activity of the user selecting one or more from a plurality of neutral words unrelated to substance use and different from the memory words.

[0323] 104. The method of any of claims 75-103, wherein the step of providing the instructions to perform an activity to refrain from selecting one or more of the plurality of substance use or memory words includes presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or more than 10 seconds.

[0324] 105. The method of any of claims 75-104, wherein the instructions to perform an activity are provided to the user at least once a day, at least once every two days, at least once every five days, or at least once a week.

[0325] 106. The method of any of claims 75-105, further comprising administering an effective amount of a drug comprising at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist.

[0326] 107. The step of applying the digital therapy comprises: receiving a request from the user indicating the onset of a behavior associated with the substance use; and initiating said instruction of an activity to address maladaptive behaviors associated with the user's substance use in response to receiving said request.

[0327] 108. The step of applying the digital therapy comprises: determining a time for providing the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words; 108. The method of any of claims 75-107, wherein providing the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further comprises providing the instruction at the determined time.

[0328] 109. The method of any of claims 75-108, wherein the one or more activities are performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer.

[0329] 110. The method of any of claims 75-109, wherein the substance use includes at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

[0330] 111. The method of any of claims 75-110, wherein the prompt is provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

[0331] 112. The method of any of claims 75-111, wherein the user's substance use disorder (SUD) is remitted when, following application of the digital therapeutic, the user experiences a decrease in an Obsessive-Compulsive Drug Use Scale (OCDUS) metric.

[0332] 113. The method of any of claims 75-112, wherein the user's SUD is remitted when, following application of the digital therapeutic, the user experiences an improvement in a Drug Withdrawal Self-Efficacy Scale (DASES) metric.

[0333] 114. The method of any of claims 75-113, wherein the user's SUD is ameliorated when, following administration of the digital therapeutic, the user experiences an improvement in a modified visual analog scale (MVAS) craving rating.

[0334] 115. The method of any of claims 75-114, wherein the user's SUD is remitted when, following administration of the digital therapeutic, the user experiences a reduction in self-reported substance use.

[0335] 116. The method of any of claims 75-115, wherein the user's SUD is remitted when, following administration of the digital therapeutic, the user experiences an improvement in an Opioid Substitution Therapy Quality of Life (OSTQOL) measure.

[0336] 117. The method of any of claims 75-116, wherein the user is receiving treatment for substance use at least partially concurrently with the digital treatment.

[0337] 118. The method of any of claims 75-117, wherein the user is prescribed medication for substance use.

[0338] 119. The method of any of claims 75-118, wherein the user experiences a decrease in substance use following administration of the digital therapeutic.

[0339] 120. The method of any of claims 75-119, wherein the user's SUD is remitted when, following administration of the digital therapeutic, the user shows improvement in at least one of the Enhanced Resilience Scale, Perceived Stress Scale, OSTQOL, MVAS, or self-reported total substance use via a timeline follow-back (TLFB) method.

[0340] 121. The method of any of claims 75-120, wherein the digital therapy is applied at least daily, every two days, or weekly.

[0341] 122. The method of claim 121, wherein the digital therapy is applied for at least one week, one month, or three months.

[0342] 123. The method of claims 75-122, further comprising using the performance of the activity by the user to update the profile of the user.

Claims

1. 1. A method of providing activity instructions for addressing maladaptive behaviors associated with a user's substance use, comprising: identifying, by one or more processors, a profile for a user having a substance use disorder, the profile including a plurality of substance use terms; presenting, by the one or more processors, a plurality of memory words not related to substance use and instructions for memorizing the plurality of memory words; providing, by the one or more processors, instructions to perform an activity of refraining from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; and updating, by the one or more processors, the profile of the user using the performance of the activity by the user.

2. 1. A system for providing activity instructions to address maladaptive behaviors associated with a user's substance use, comprising: one or more processors, the processors: Identifying profiles containing multiple substance use terms for users with substance use disorders; presenting a plurality of memory words unrelated to substance use and instructions for memorizing the plurality of memory words; providing instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; The system is configured to use the performance of the activity by the user to update the profile of the user.

3. The system of claim 2 , wherein the one or more processors are further configured to provide instructions for performing an activity that provides information about a future event.

4. 4. The system of claim 3, wherein the future events relate to at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

5. The one or more processors:

5. The system of claim 4, further configured to, before providing the instructions to perform the activity, provide instructions for the user to select a type of future event selected from at least one of the user's health, relationships, values, financial status, enjoyment, charitable contributions, moderation, small progress, achievement, future gratitude, challenge, lifestyle, or overcoming maladaptive behaviors associated with substance use.

6. The one or more processors:

4. The system of claim 3, further configured by the one or more processors to provide instructions to the user prior to the instructions to perform the activity, for selecting a category of the future event.

7. 7. The system of claim 6, wherein the categories of future events are selected from the user's health, relationships, values, financial status, enjoyment, charitable contributions, abstinence, small progress, achievement, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors associated with substance use.

8. The one or more processors: The system of claim 3 , further configured to provide, by the one or more processors, instructions for selecting a time frame for the future event.

9. 9. The system of claim 8, wherein the future event may occur in less than one month.

10. The system of claim 8 , wherein the future event can occur more than one month in the future.

11. The one or more processors: The system of claim 3 , further configured to prompt the user to generate one or more visual cues based on the information about the future event provided by the user.

12. The system of claim 11 , wherein the visual cue is an image or text, including free text, provided by the user.

13. The one or more processors: providing subsequent instructions to perform an activity that refrains from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 13. The system of claim 2, further configured to provide a prompt including the visual cue associated with the information regarding the future event and instructions for performing an activity associated with the visual cue.

14. The system of claim 13 , wherein the prompt is a timeline that identifies a plurality of visual cues.

15. The system of claim 13 , wherein the timeline is automatically updated based on times tagged to the visual cues.

16. The system of claim 13 , wherein the activity comprises an audio recording or a text description.

17. The one or more processors:

17. The system of any of claims 3-16, further configured to provide a prompt related to the information regarding the future event following performance of the information-providing activity.

18. 18. The system of claim 2, wherein the activity of refraining from selecting one or more of the plurality of memory words is performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

19. The one or more processors:

19. The system of any of claims 2-18, further configured to provide subsequent instructions for performing an activity of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words.

20. The one or more processors: providing subsequent instructions to perform an activity that refrains from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; 20. The system of claim 17, further configured to provide the prompt related to the information regarding the future event following the performance of the activity of refraining from selecting one or more of the plurality of memory words and the presentation of one or more of the plurality of substance use words.

21. The one or more processors:

21. The system of claim 2, further configured to provide instructions for performing an activity of selecting all of the memory words from a plurality of words.

22. The one or more processors:

22. The system of claim 2, further configured to provide instructions for performing an activity of selecting one or more of the memory words from a plurality of words.

23. The one or more processors: calculating a score indicative of the percentage of correct interactions with said memory word; 23. The system of claim 21 or claim 22, further configured to select the plurality of mnemonic words based on the score.

24. The one or more processors: calculating a score indicative of correct interactions, speed of selection, or both during performance of one or more activities; 24. The system of any of claims 2-23, further configured to select a plurality of subsequent substance use words, a plurality of subsequent memory words, or both based on the score.

25. 25. The system of claim 24, wherein the score is calculated based on the number of correct interactions, the speed of selection, or both, during the activity of selecting all of the memory words from a plurality of words.

26. The one or more processors: calculating a score indicative of correct interaction, speed of selection, or both, during performance of the activity of refraining from selecting the plurality of memory words and / or the plurality of substance use words; 26. The system of any of claims 2-25, further configured to, in response to the score meeting a threshold, determine an increase in word count for a subsequent activity that refrains from selecting the plurality of memory words and / or the plurality of substance use words.

27. The one or more processors: calculating a score indicative of correct interactions, speed of selection, or both, during performance of the activity of selecting all memory words from a plurality of words; 27. The system of any of claims 2-26, further configured to, in response to the score meeting a threshold, determine an increase in the number of words for a subsequent activity of refraining from selecting multiple memory words, refraining from selecting multiple substance use words, or selecting all memory words from a plurality of words.

28. The one or more processors:

28. The system of any of claims 23-27, further configured to display the score indicative of at least one of a percentage of correct interactions, a speed of selection, or both, during one or more activities.

29. The one or more processors: further configured to generate one or more cue words or images based on the information about the future event provided by the user; 29. The system of claim 2, wherein the prompt associated with the information about the future event includes the one or more cue words or images.

30. 30. The system of any of claims 2-29, wherein providing the instructions to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the one or more of the plurality of memory words includes providing instructions by the one or more processors to perform an activity in which the user selects one or more neutral words from a plurality of neutral words unrelated to substance use and different from the memory words.

31. 31. The system of claim 2, wherein providing the instruction to perform an activity to refrain from selecting one or more of the plurality of substance use words and / or memory words comprises presenting the one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or more than 10 seconds.

32. 32. The system of any of claims 2-31, wherein the instructions to perform an activity are provided to the user at least once a day, at least once every two days, at least once every five days, or at least once a week.

33. 33. The system of any of claims 2-32, wherein the user is administered an effective amount of a medication comprising at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorpine, levallorphan, nalodeine, alvimopan, methylnatrexone, naloxegol, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine, or a GLP-1 agonist.

34. The one or more processors: receiving a request from the user indicating an onset of a behavior associated with the substance use; 34. The system of any of claims 2-33, further configured to, in response to receiving the request, initiate the instruction of an activity to address maladaptive behaviors associated with the user's substance use.

35. The one or more processors: further configured to determine a time period for providing the instruction to perform the activity of refraining from selecting one or more of the plurality of memory words and / or the plurality of substance use words; 35. The system of claim 2, wherein providing the instruction to perform the activity of refraining from selecting one or more of the plurality of substance use words and / or the plurality of memory words further comprises providing the instruction at the determined time.

36. 36. The system of any of claims 2-35, wherein the one or more activities are performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer.

37. 37. The system of any of claims 2-36, wherein the substance use includes at least one of alcohol abuse disorder (AUD), opioid abuse disorder (OUD), or drug abuse.

38. 38. The system of claim 2, wherein the prompt is provided at least one day, five days, one week, or one month following providing the instruction to perform an activity that provides information about a future event.

39. 1. A method for providing needed treatment or remission for a substance use disorder (SUD) in a user, comprising: applying a treatment to the user comprising a digital treatment, the digital treatment comprising: Identifying profiles containing multiple substance use terms for users with substance use disorders; presenting a plurality of memory words unrelated to substance use and instructions for memorizing the plurality of memory words; and providing instructions to perform an activity to refrain from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words.