Provision of multilayer digital therapy to users for addressing functional impairment

JP2025037828A5Pending Publication Date: 2026-04-03CLICK THERAPEUTICS INC
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Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-08-28
Publication Date
2026-04-03

AI Technical Summary

Technical Problem

Current clinical measures for treating functional dysfunction in patients with pathologies affecting social and non-social processing are limited by their face-to-face nature, which can be restrictive in terms of scheduling, accessibility, and the gap between clinical settings and real-world environments.

Method used

A digital therapy approach using a three-layer intervention system, shifting users from a psychoeducational layer to practice and response layers, and finally to real-world application, allowing users to practice skills in virtual environments before applying them in real life, with frequent and personalized digital interactions.

Benefits of technology

This approach enhances the transfer of knowledge to real-world skills, increases user confidence, and improves daily functioning, relationships, and adherence to treatment, while overcoming the limitations of traditional clinical measures.

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Abstract

To provide systems and methods for presenting interactive sessions to address functional impairment in users.SOLUTION: In system 100: a first session for a cognitive training layer associated with a skill provides a first image or audio recording and a prompt regarding a social cue depicted in a UI element; a second session of a virtual functional training layer for a user to apply the skill in a virtual environment provides a second image or audio recording and a second prompt via a mobile device of the user; and a third session of a functional training layer for the user to apply the skill by executing an activity displays the second prompt instructing the user to perform the activity, and receives a second response associated with execution of the activity. This can enhance efficacy of medication the user is taking to address a disease or disorder.SELECTED DRAWING: Figure 1
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a joint venture between U.S. Non-provisional Application No. 18 / 799,387, filed on August 9, 2024, entitled “PROVIDING A MULTILAYER DIGITAL THERAPEUTIC FOR ADDRESSING A FUNCTIONAL IMPAIRMENT” and U.S. Provisional Application No. 63 / 632,292, filed on April 10, 2024, entitled “PROVIDING A MULTILAYER DIGITAL THERAPEUTIC FOR ADDRESSING A FUNCTIONAL IMPAIRMENT” and U.S. Provisional Application No. 63 / 632,292, filed on March 7, 2024, entitled “PROVIDING A MULTILAYER DIGITAL THERAPEUTIC FOR ADDRESSING A FUNCTIONAL IMPAIRMENT” and U.S. Provisional Application No. This application claims priority to U.S. Provisional Application No. 63 / 562,589, entitled "PROVIDING A USER WITH A MULTI-LAYER DIGITAL THERAPY TO ADDRESS FUNCTIONAL DISORDERS," filed on December 12, 2023, and U.S. Provisional Application No. 63 / 609,268, entitled "PROVIDING A USER WITH A MULTI-LAYER DIGITAL THERAPY TO ADDRESS FUNCTIONAL DISORDERS," filed on August 30, 2023, the disclosures of all of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Certain conditions may cause patients to suffer from impairments in functioning, such as social processing disorders, non-social processing disorders, or both. Patients with conditions that affect their ability to understand or handle social situations may have difficulty functioning in environments such as the workplace, home, place of business, or other areas where the patient interacts with other people. The social processing disorders experienced by such patients may cause anxiety surrounding social environments, which further isolates the patient from engaging in social situations. Certain conditions may cause the patient to have difficulty discerning different social cues, such as those indicated through body language and tone of voice. This lack of social skills may cause the patient to have extreme difficulty dealing with and navigating social situations, as they are unable to understand or grasp the social cues given by those around them.

[0003] In addition, patients may suffer from non-social processing deficits, such as memory (e.g., verbal memory for storing and recalling information communicated verbally), executive functions (e.g., problem solving and planning), and other cognitive functions. These cognitive deficits may lead to a decreased ability to perceive, understand, and respond to the patient's surroundings and the people around them. In the case of verbal memory, this deficit in cognitive function may result in significant problems for the individual in many aspects of daily life, such as difficulty recalling conversations with others, impaired expressive language, and problems recalling names, dates, and other information. Impaired verbal memory may lead to feelings of frustration and helplessness. It may also affect relationships with family and friends, such as forgetting important events, conversations, or details, leading to misunderstandings.

[0004] Treating impairments in patients with conditions that affect their ability to handle and navigate social situations and respond appropriately to their environment can be difficult due to the inherent nature of the condition. For example, patients may be able to learn skills in the presence of a familiar clinician, but fear or be unable to use those skills in a real-life environment. The gap between the clinical setting and real-life environments (e.g., a busy coffee shop or a time-constrained social interaction like catching the right city bus) can be too large to bridge for many patients with impairments. As another example, patients who have difficulty processing information may be unable to follow directions or guidance from a clinician, especially after a therapy session.

[0005] Traditional face-to-face clinical approaches to improvement by clinicians who provide certain psychosocial therapies and other intervention techniques may not provide an adequate way to improve functional impairment. Patients may have difficulty in consistently adhering to treatment due to difficulties in social interactions and other deficits. Furthermore, such face-to-face clinical approaches may be limited by schedules and physical constraints. For example, there may not be specialized or trained clinicians in the vicinity of the patient (e.g., patients in rural or non-major urban areas). Furthermore, even if specialized or trained clinicians are available, such clinicians may not be able to meet with the patient frequently or quickly. This problem may be further exacerbated considering the fact that the patient may have a condition that requires prompt treatment or response. Summary of the Invention

[0006] To address these and other technical challenges, digital therapy in the form of a three-tiered intervention system (also referred to herein as Enhancing Life Skills through Cognitive Interventions (ELSCI)) can fill gaps and limitations in the current standard of care by moving users from a low-stimulation psychoeducational layer to an intermediate practice and response layer to a high-stimulation real-world application layer. Using this multimodal, multi-tiered system, users can be trained to become familiar with the use of skills related to their impairment in an intermediate virtualized environment before using the skills and knowledge in a real-world environment. Building a bridge between training and real-world use allows users to successfully transfer knowledge to skills that are acquired and used in real-world functioning. Knowledge transfer and skill use can increase users' self-confidence, aid users in their daily lives at school and work, and strengthen relationships with friends and family. Additionally, digital delivery allows patients to increase the frequency of interactions, particularly in the form of more frequent (e.g., multiple times per day) real-time feedback and proactive reminders to help users perform training tasks, compared to traditional treatments limited to infrequent face-to-face clinical settings.

[0007] Each tier can aim to improve the ability of the user with impairments through a series of exercises, building on previous sessions with more complex and real-life virtual scenarios to simulate and contextualize real-life situations. These sessions can progress to an ecological generalization of the cognitive improvement where the user can interact in a real-world environment while presenting digital cognitive improvement challenges that train the user to recognize cues (or other markers) from images displayed through the device. This ecological generalization of the cognitive improvement corresponds to the application of the treatments from other sessions to virtual or real environments. For example, to address social processing deficits that lead to impairments, these sessions can present images and prompts to the user via the end user device to train the user to recognize specific social cues and respond with specific interactions in the social environment. To address non-social processing deficits that lead to impairments, these sessions can present images and prompts via the end user device to help the user improve cognitive skills such as memory, communication, attention, and problem solving. Through a combination of cognitive improvement and ecological generalization of such improvement through sessions associated with different tiers, the user may be able to improve their impairments.

[0008] Training can include three tiers, moving from low stimulation and difficulty in a practice environment to high stimulation and difficulty in real-world functioning. To address social processing deficits, the first tier can include a set of cognitive exercises aimed at increasing the subject's cognitive abilities through repetition. For example, an application on the user's device can present a set of images, videos, or audio recordings of social cues (e.g., in the form of body language) along with a prompt asking the user to select the correct social cues depicted in the images. To address non-social processing deficits (e.g., verbal memory), in the first tier, the application can present a set of images, videos, or audio recordings followed by a prompt asking the user to select the correct object or character depicted in the images.

[0009] The second layer may include a set of virtual scenarios aimed at improving the subject's ability to use skills in a virtual social environment. In a second layer to address social processing deficits that lead to impairments, the application may present a set of images of alternative social settings accompanied by prompts instructing the user to select a response (e.g., a conversation or an action) to a character depicted in the setting to further strengthen the social skills. In a second layer to address non-social processing deficits that lead to impairments, the application may present a set of images, videos, or audio of a virtual environment with characters and objects, followed by prompts instructing the user to select a response (e.g., an action) that will help improve cognitive skills such as verbal memory or problem solving. In either case, the user may be given feedback in response to the user's selection.

[0010] Subsequently, the third layer can include a set of prompts aimed at getting the user to perform (e.g., social and non-social) skills in a real-world environment. For example, the application can prompt the user to perform activities in the user's environment, such as interacting with others to improve social processing. This multi-layered approach trains the user to develop social skills and use them for real-world functioning. As a result, the user can be conditioned to develop social skills to overcome impairments associated with the user's condition (e.g., affective disorders such as schizophrenia, depression, and bipolar disorder).

[0011] Therapeutic components can integrate cognitive improvement with additional layers in a functional improvement model that helps patients learn, practice, and utilize skills in more complex applied situations to transfer cognitive gains to functional demands. Content can be contextualized and individualized, with functional domains for improvement driving engagement. Users are presented with evidence that explicitly links cognitive improvement exercises to the two layers of ecological generalization. For example, when completing a tier 1 exercise, the exercise invites the user to perform a cognitive exercise associated with a social or non-social skill. In the tier 2, the intervention can incorporate familiar, realistic aspects of daily life into the in-app exercises. In the tier 3, users may be asked to practice real-world activities, such as observing social cues during interactions with trusted people. Activity progress can be reviewed for each practice session, along with notifications to celebrate successful execution or improvement of the skill in the user's daily life. Across these components, learning-theoretic approaches can be used to increase self-efficacy and engagement. This additional ecological generalization component optimizes the likelihood that users will transfer their cognitive improvements, which may then have a meaningful impact on their ability to function in the real world.

[0012] To provide these digital therapeutic sessions, the service can select and provide stimuli and associated prompts to the user for presentation via the end user device. For the first tier, the service can select a set of media including images, videos, audio, or a combination thereof having a character of a particular social cue along with prompts providing a set of possible social cue choices. If the response rate to each presented media in the first session is favorable, the service can provide a second session. For the second tier, the service can identify a set of virtual social environment media including one or more characters, with accompanying prompts defining a set of possible responses (e.g., conversations or actions) for the user to select when interacting with the character. The service can provide feedback based on the user's selection. If the percentage of correct responses meets a threshold, the service can decide to provide a third tier session to the user. Through this multi-session, multi-layered approach to remedial therapy for social processing disorders leading to impairments, subjects can improve their ability to identify social cues and engage in social interactions in real-world environments.

[0013] In addition, the service can also time the delivery or presentation of the layer to the user such that the user does not need to actively access the digital therapeutic application on the device while suffering from the chronic condition. The service can also time the delivery or presentation of the layer to the user after completion of a previous action associated with the session. Furthermore, as the service acquires additional data about the user, the service can select images, prompts, or text that are more targeted specifically to the user and his or her condition, and can store this data in the user's profile. The service can calculate a performance metric for the user in the session. The service can select a subsequent session based on at least previous selections or responses, performance metrics, completion of previous actions, or the user's profile, etc.

[0014] Using a multi-layered approach to improve functional impairments, users of digital therapeutic applications can learn and practice social and non-social skills and perform them in an ecologically valid real-world setting. This approach includes transitioning from less challenging sessions to more challenging and real-world functioning sessions. The synergistic incorporation of multiple psychosocial therapies offers several advantages, notably (i) extending the benefits of cognitive improvement to functional improvement, (ii) providing more ecological validity and real-time interaction than face-to-face clinical settings, and (iii) developing digital therapeutics that are more accessible.

[0015] In this manner, the user can easily receive sessions related to the condition to help alleviate the impairments related to the condition, as described herein. This can reduce or eliminate barriers to the user physically accessing their device while battling the condition. By selecting sessions sent to the user to address the subject user's impairments, the quality of human-computer interaction (HCI) between the user and the device can be improved. In addition, unnecessary consumption of computational resources (e.g., processing and memory) and network bandwidth of the service and the user device can be reduced, as compared to sending ineffective messages, since the sessions are more relevant to the user's condition.

[0016] Additionally, in the context of a digital therapeutic application, such session selection can provide user-specific interventions and improve subject adherence to treatment. Further, the multi-layered approach provided through a digital therapeutic application, as described herein, can result in potential improvements to the subject's impairment due to the user's condition (e.g., schizophrenia or affective disorder).

[0017] Aspects of the present disclosure describe a system and method for presenting an interaction session to address a functional impairment of a user. The system may include a computing system having one or more processors coupled to a memory. The computing system may identify a plurality of sessions to address an impairment associated with a pathology of the user. Each session of the set of sessions may include a corresponding layer of a set of layers for the user. The computing system may provide a first session of a cognitive training layer by displaying one or more first images that cause the user to recognize one or more of a plurality of social cues associated with a social skill. The computing system may provide a second session of a virtual functional training layer for the user to apply the social skill in a virtual environment. In the second session, the computing system may display (i) a second image of a social setting along with (a) a first prompt that identifies a query associated with a character displaying one of the plurality of social cues, and (b) a set of interaction elements that identifies a corresponding set of responses to the character. In the second session, the computing system may receive a first response of the plurality of responses selected by the user via at least one of the set of interaction elements. In the second session, the computing system can provide feedback to the user based on the query and the response regarding the social setting. The computing system can provide a third session of a functional training layer for the user to apply the social skill. The third session can include displaying by the computing system a second prompt instructing the user to perform an activity. In the third session, the computing system can receive a second response associated with performing the activity. The above can also apply to non-social cues.

[0018] In some embodiments, the computing system can generate a performance metric for the user based on the first response received from the user at a first time instance during the second session. The computing system can modify at least one of a set of parameters defining a presentation of at least one of images, prompts, and interactive elements of the virtual functional training layer based on the performance metric. The computing system can provide the second session of the virtual functional training layer at a second time instance.

[0019] In some embodiments, the computing system can provide the second session by displaying a third image of a second social setting together with (i) a third prompt identifying a second query of a second character in the second social setting, and (ii) a second set of interaction elements identifying a corresponding set of responses to the second character according to the set of parameters. In some embodiments, the set of parameters can include at least one of: (i) a type of contextual modality, (ii) a context of the social setting in the image, (iii) a number of characters in the social setting, (iv) a type of prompt, (v) a difficulty level of a response, (vi) a type of response, or (vii) a number of responses. The above can also be applied to non-social cues.

[0020] In some embodiments, the computing system may generate a performance metric for the user based on a percentage of correct selections in one or more sessions of the cognitive training layer. The computing system may determine to transition the user from the cognitive training layer to the virtual functional training layer in response to the performance metric satisfying a threshold. The computing system may determine to adjust the difficulty of the exercises in the cognitive training layer in response to the performance metric satisfying a threshold. In some embodiments, the computing system may generate a performance metric for the user based on a percentage of correct responses in one or more sessions of the virtual functional training layer. The computing system may determine to adjust the difficulty of the exercises in the virtual functional training layer in response to the performance metric satisfying a threshold. The computing system may determine to transition the user from the virtual functional training layer to the functional training layer in response to the performance metric satisfying a threshold.

[0021] In some embodiments, the computing system can provide the first session by (i) displaying a first view of social cues along with a set of interactive elements identifying the corresponding set of types of social cues associated with the first image, and (ii) receiving a user-selected one of the set of social cues via at least one of the set of interactive elements. The set of social cues for the first image in the first session of the cognitive training layer can further include at least one of (a) head movement, (b) body language, (c) gestures, or (d) eye contact. The above can also apply to non-social cues.

[0022] In some embodiments, the second session of the virtual functional training layer may include displaying a set of images of the social setting with the character according to a prescribed sequence. In some embodiments, the third session of the functional training layer may include displaying a third prompt to the user to select a time at which to provide the user with a message encouraging the user to perform the activity. In some embodiments, the computing system may identify a time at which to provide one of the set of sessions to the user according to a session schedule. In some embodiments, the condition of the user may include schizophrenia, and the user is receiving a treatment partially concurrently with at least one of the first session, the second session, or the third session. The treatment may include a psychosocial intervention or medication to address schizophrenia. The session may enhance the efficacy of the medication the user is taking to address the condition. The above may also apply to non-social cues.

[0023] Another aspect of the disclosure relates to a method for providing a user with schizophrenia with a necessary improvement in functional impairment. A computing system can obtain a first metric associated with the user prior to a plurality of sessions. The computing system can repeat providing one or more of the plurality of sessions to the user. The computing system can include providing a first session of a cognitive training layer by displaying one or more first images that cause the user to recognize one or more of a plurality of social cues associated with a social skill. The plurality of sessions can include a second session of a virtual functional training layer for the user to apply the social skill in a virtual social environment, the second session of the virtual functional training layer including: (i) displaying, together with a second image of a social setting, (a) a first prompt identifying a query associated with a character displaying one of the plurality of social cues, and (b) a second set of interaction elements identifying a corresponding plurality of responses to the character; (ii) receiving a response selected by the user from the plurality of responses via at least one of the second set of interaction elements; and (iii) providing feedback to the user based on the query regarding the setting and the response. The plurality of sessions may include a third session of a functional training layer including (i) displaying a second prompt to the user to perform an activity, and (ii) receiving a second response associated with performing the activity. The computing system may obtain a second metric associated with the user following at least one session of the plurality of sessions. Improvement in the functional impairment associated with schizophrenia may be achieved for the user when the second metric (i) decreases from the first metric by a first predetermined margin, or (ii) increases from the first metric by a second predetermined margin. The above may also apply to non-social cues.

[0024] In some embodiments, the user's schizophrenia can include (i) schizophrenia with positive symptoms including hallucinations and delusions, or (ii) schizophrenia with negative symptoms including reduced motivation or emotional expression. In some embodiments, the impairment associated with the user can include at least one of (i) reduced educational attainment, (ii) reduced quality of life, (iii) difficulty living independently, (iv) reduced social functioning, or (v) impaired occupational functioning. In some embodiments, the user is an adult at least 18 years of age or older and has been diagnosed with schizophrenia with the impairment.

[0025] In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is reduced from the first metric by the first predetermined margin. The first metric and the second metric are Multnomah Area Capability Scale (MCAS) values. In some embodiments, the improvement in the impairment associated with schizophrenia occurs when the second metric is reduced from the first metric by the first predetermined margin. The first metric and the second metric may be Lawton Instrumental Activities of Daily Living (IADL) scale values.

[0026] In some embodiments, the improvement in the impairment associated with schizophrenia occurs when the second metric is reduced from the first metric by the first predetermined margin. In some embodiments, the first metric and the second metric may be Personal and Social Performance (PSP) scale values. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is reduced from the first metric by the first predetermined margin. The first metric and the second metric are World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) scale values. In some embodiments, the improvement in the impairment associated with schizophrenia occurs when the second metric is reduced from the first metric by the first predetermined margin, and the first metric and the second metric are Columbia-Suicide Severity Rating Scale (C-SSRS) values.

[0027] In some embodiments, the plurality of sessions further includes a second session of the virtual functional training layer at a first time instance, the second session including displaying, together with a third image of a second setting, (i) a third prompt identifying a second query of a second character in the second setting, and (ii) a third set of interaction elements identifying a corresponding plurality of responses to the second character according to a plurality of parameters. In some embodiments, at least one of the plurality of parameters is modified based on a performance metric of the user with the response received from the user at a second time instance prior to the first time instance during the second session. The above may also apply to non-social cues.

[0028] In some embodiments, the plurality of parameters includes at least one of: (i) type of contextual modality, (ii) context of setting in image, (iii) number of characters in setting, (iv) type of prompt, (v) difficulty level of response, (vi) type of response, or (vii) number of responses. In some embodiments, the computing system can determine a transition from one tier to another tier for at least one of the plurality of sessions based on a performance metric of the user across one or more of the plurality of sessions.

[0029] In some embodiments, the computing system may provide the first session including (i) displaying a first view of social cues along with a set of interactive elements identifying a corresponding plurality of types of cues associated with the first image, and (ii) receiving a user-selected one of the plurality of types of social cues via at least one of the second set of interactive elements. In some embodiments, the plurality of social cues of the first image in the first session of the cognitive training layer further includes at least one of (a) head movement, (b) body language, (c) gestures, or (d) eye contact. The above may also apply to non-social cues.

[0030] In some embodiments, the second session of the virtual functional training layer may further include displaying a plurality of images of the setting with the character according to a prescribed sequence. In some embodiments, the third session of the functional training layer may further include displaying a third prompt to allow the user to select a time at which to provide a message prompting the user to perform the activity. In some embodiments, the plurality of sessions may be provided over a period ranging from two weeks to ten weeks. In some embodiments, the user may receive a therapy at least partially in parallel with at least one of the plurality of sessions. In some embodiments, the therapy may include a psychosocial intervention or medication to address schizophrenia. The session may enhance the efficacy of the medication the user is taking to address the condition. The above may also apply to non-social cues.

[0031] Another aspect of the present disclosure describes a system and method for presenting interactive sessions to address a user's cognitive association impairments as well as language learning and memory impairments. A computing system can identify a plurality of sessions for addressing impairments associated with a user's pathology, each session including a corresponding tier of a plurality of tiers for the user. The computing system can provide a first session of a cognitive training tier associated with a language memory skill by presenting one or more first audio recordings that prompt the user to recall one or more of a plurality of words. The computing system provides a second session of a virtual functional training tier for the user to apply the language memory skill in a virtual environment. The second session can include (i) presenting, together with a second audio recording of a speech sample, (a) a first prompt identifying a query associated with the speech sample and (b) a set of interaction elements identifying a corresponding plurality of responses; (ii) receiving a first response selected by the user from the plurality of responses via at least one of the set of interaction elements; and (iii) providing feedback to the user based on the query and the response regarding the speech sample. The computing system can provide a third session of a functional training layer for the user to apply the verbal memory skill, the third session including (i) displaying a second prompt to the user to perform an activity, and (ii) receiving a second response associated with performing the activity. Instead of an audio recording, a prompt, video, or image can be used in the above.

[0032] In some embodiments, the computing system can generate a performance metric for the user based on the first response received from the user at a first time instance during the second session. The computing system can modify at least one of a plurality of parameters defining the presentation of at least one of an audio recording, a prompt, and an interaction element of the virtual functional training layer based on the performance metric. The computing system can provide the second session of the virtual functional training layer at a second time instance, the second session including presenting, together with a third audio recording of a speech sample between characters in a social setting, (i) a third prompt identifying a second query associated with the speech sample of the character in the social setting, and (ii) a second set of interaction elements identifying a corresponding plurality of responses according to the plurality of parameters.

[0033] In some embodiments, the plurality of parameters can include at least one of: (i) type of contextual modality, (ii) context of the social setting in the audio recording, (iii) number of characters in the social setting, (iv) type of prompt, (v) difficulty level of the response, (vi) type of response, or (vii) number of responses. In some embodiments, the computing system can present the second audio recording according to a set of parameters. The plurality of parameters can include at least one of: (a) inclusion of distractors, (b) the ability to repeat the second audio recording, (c) speed modification, (d) time between each word, (e) number of words in each sentence, (f) length of the audio recording, or (g) the ability to control the distractors.

[0034] In some embodiments, the computing system can generate a performance metric for the user based on a percentage of correct selections in one or more sessions of the cognitive training tier. The computing system can determine to transition the user from the cognitive training tier to the virtual functional training tier in response to the performance metric satisfying a threshold. In some embodiments, the computing system can generate a performance metric for the user based on a percentage of correct responses in one or more sessions of the virtual functional training tier. The computing system can determine to transition the user from the virtual functional training tier to the functional training tier in response to the performance metric satisfying a threshold.

[0035] In some embodiments, the computing system can provide the first session by identifying a set of recordings for presentation to the user from a plurality of recordings, each recording corresponding to one or more words; presenting the set of recordings to the user according to a format that defines a context in which the one or more words in each of the set of recordings are presented; displaying an interface that prompts the user to select at least one of a plurality of words presented in the set of recordings; and receiving a selection of at least one word or image by the user via the interface.

[0036] In some embodiments, the third session of the functional training layer further includes displaying a third prompt to the user to select a time to provide a message to the user encouraging the user to perform the activity. In some embodiments, the computing system is capable of identifying a time to provide one of the plurality of sessions to the user according to a session schedule. In some embodiments, the condition of the user may include schizophrenia. The user may be receiving a therapy partially concurrently with at least one of the first session, the second session, or the third session. The therapy may include at least one of a psychosocial intervention or a medication to address schizophrenia.

[0037] Another aspect of the disclosure relates to a method for providing a user with schizophrenia with a necessary improvement in impairments associated with verbal memory. A computing system can obtain a first metric associated with the user prior to a plurality of sessions. The computing system can repeat providing one or more of the plurality of sessions to the user. The computing system can provide a first session of a cognitive training layer associated with a verbal memory skill by presenting one or more first audio recordings that prompt the user to recall one or more of a plurality of words. The plurality of sessions can include a second session of a virtual functional training layer for the user to apply the verbal memory skill in a virtual social environment, the second session of the virtual functional training layer including: (i) presenting, together with the second audio recording, (a) a first prompt identifying a query associated with a speech sample and (b) a set of interaction elements identifying a corresponding plurality of responses; (ii) receiving, via at least one of the set of interaction elements, a first response selected by the user from the plurality of responses; and (iii) providing feedback to the user based on the query and the response regarding the speech sample. The plurality of sessions may include a third session of the functional training layer for the user to apply the verbal memory skill, the third session including (i) displaying a second prompt to the user to perform an activity, and (ii) receiving a second response associated with performing the activity. The computing system may obtain a second metric associated with the user following at least one session of the plurality of sessions. Improvement in the functional impairment associated with schizophrenia may be achieved for the user when the second metric (i) decreases from the first metric by a first predetermined margin, or (ii) increases from the first metric by a second predetermined margin.

[0038] The schizophrenia further includes schizophrenia with negative symptoms including reduced motivation or emotional expression. In some embodiments, the impairment associated with the user can include an impairment including at least one of: (i) reduced educational attainment, (ii) reduced quality of life, (iii) difficulty in independent living, (iv) reduced social functioning, or (v) impaired occupational functioning. In some embodiments, the user is an adult at least 18 years of age or older and has been diagnosed with the schizophrenia with the impairment. In some embodiments, the multiple sessions can be provided over a period ranging from 2 weeks to 10 weeks.

[0039] In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is decreased from the first metric by the first predetermined margin, and the first metric and the second metric are Multnomah Community Ability Scale (MCAS) values. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is increased from the first metric by the second predetermined margin, and the first metric and the second metric are Clinical Rating Scale (CRS) values.

[0040] In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is decreased by the first predetermined margin from the first metric, and the first metric and the second metric are Patient Global Impression of Improvement (PGI-I) scale values. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is decreased by the first predetermined margin from the first metric, and the first metric and the second metric are Clinical Global Improvement (CGI-I) scale values. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is decreased by the first predetermined margin from the first metric, and the difference between the first metric and the second metric is a PGI-I or CGI-I scale value. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is increased by the second predetermined margin from the first metric, and the first metric and the second metric are Medication Adherence Rating Scale (MARS-a) values. In some embodiments, the improvement in the impairment associated with schizophrenia may occur when the second metric is decreased from the first metric by the first predetermined margin, and the first metric and the second metric are Columbia-Suicide Severity Rating Scale (C-SSRS) values.

[0041] In some embodiments, the computing system may determine, for at least one of the plurality of sessions, a transition from one tier to another tier based on a performance metric of the user across one or more of the plurality of sessions. In some embodiments, the second session may include a presentation of the second audio recording according to a plurality of parameters. The plurality of parameters may include at least one of: (a) inclusion of a distractor; (b) the ability to repeat the second audio recording; (c) speed modification; (d) time between each word; (e) number of words in each sentence; (f) length of the audio recording; or (g) the ability to control the distractor.

[0042] In some embodiments, the session may include identifying a set of recordings for presentation to the user from a plurality of recordings, each of which corresponds to one or more words; presenting the set of recordings to the user according to a format that defines a context in which the one or more words in each of the set of recordings are presented; displaying an interface that prompts the user to select at least one of the plurality of words presented in the set of recordings; and receiving a selection of at least one word or image by the user via the interface. In some embodiments, the user may receive a therapy at least partially in parallel with at least one of the plurality of sessions. The therapy may include at least one of a psychosocial intervention or a medication for addressing schizophrenia. [Brief description of the drawings]

[0043] The above and other objects, aspects, features, and advantages of the present disclosure will become better understood with reference 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 interaction session to address a user's impairment, in accordance with an illustrative embodiment. [Diagram 2]FIG. 2 illustrates a block diagram of a process for identifying a set of sessions to address a user's impairment and providing a first session of a cognitive training layer of the set of sessions in accordance with an illustrative embodiment. [Diagram 3] 3A-3H show a set of exemplary user interface screenshots for providing a first session, according to an exemplary embodiment. [Figure 4] FIG. 4 illustrates a block diagram of a process for providing a second session of a virtual functional training layer for a user to apply social skills in a virtual social environment, according to an exemplary embodiment. [Diagram 5] 5A-5G show a set of exemplary user interface screenshots for providing a second session, according to an exemplary embodiment. [Figure 6] FIG. 6 illustrates a block diagram of a process for providing a third session of the virtual functional training layer for a user to use social skills, according to an illustrative embodiment. [Figure 7] 7A-7E show a set of exemplary user interface screenshots for providing a third session, according to an exemplary embodiment. [Figure 8] 8A-8C show block diagrams of a method for presenting an interaction session to address a user's impairment, according to an exemplary embodiment. [Figure 9] FIG. 9 illustrates a flowchart of a method for improving functional impairment in a user with schizophrenia, according to an exemplary embodiment. [Figure 10] Figure 10 shows the reduction in WHO-DAS 2.0 disability ratings after 4 weeks of interaction with the CT-156 mobile app. The WHO-DAS 2.0 assesses disability based on 36 individual items with scores ranging from 1 (none) to 5 (extreme). The change in WHO-DAS screening from the beginning to the end of the study showed a significant reduction in disability ratings, indicating that participants experienced improvements in ability across multiple domains of functioning. [Figure 11]FIG. 11 is a block diagram of a server system and a client computer system according to an exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] In reading the following description of the various embodiments, the descriptions and respective contents listed following each section of the specification should be helpful.

[0045] Section A describes systems and methods for presenting an interaction session to address a user's impairments.

[0046] Section B describes how to improve functional impairments in users with schizophrenia.

[0047] Section C is a description of network and computing environments that may be useful in implementing the embodiments described herein.

[0048] A. Systems and methods for presenting an interaction session to address a user's impairments Referring now to FIG. 1, a block diagram of a system 100 for presenting an interaction session to address a user's impairment (e.g., social or non-social processing) is depicted. In general, 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, among others, at least one session manager 140, an interaction handler 145, a performance evaluator 150, or at least one feedback provider 155. The session management service 105 includes or can access at least one database 160. The database 160 may store, maintain, or otherwise include, among other things, one or more user profiles 165A-N (hereinafter generally referred to as user profiles 165), one or more layer configurations 170A-N (hereinafter generally referred to as layer configurations 170 or layers 170), one or more images 180A-N (hereinafter generally referred to as images 180), or one or more audio recordings 185A-N (hereinafter generally referred to as audio recordings 185). The functionality of the application 125 may be executed in part on the session management service 105. Conversely, the functionality of the application 125 may incorporate operations executed on the session management service 105. The user device 110 and the session management service 105 may collectively be part of a computing system that provides the application 125.

[0049] 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 tasks described herein. The session management service 105 may communicate with one or more user devices 110 and a database 160 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 client devices 110. Some components of the session management service 105 may be located in a server group and some may be located in a client device. For example, the session manager 140 may run on or be located on the user device 110, and the interaction handler 145 may run on or be located on the server group.

[0050] Within the session management service 105, the session manager 140 can identify a set of sessions from the layer configuration 170 to be presented to the user via the applications 125 on each user device 110. The session manager 140 can provide a set of sessions to address a user impairment and can present one or more of the stimuli (e.g., images 180) according to any of the set of sessions. The interaction handler 145 can also monitor responses by the user on the user interface 130 in the sessions provided via the user device 110. The performance evaluator 150 can identify a performance metric for the user in each session. The feedback provider 155 can provide performance-based feedback to be presented to the user via the applications 125 running on the user device 110.

[0051] The 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 tasks described herein. The user device 110 may communicate with the session management service 105 and the database 160 via a network 115. The user device 110 may be a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), or laptop computer. The user device 110 may be used to access the application 125. In some embodiments, the application 125 may be downloaded (e.g., via a digital distribution platform) and installed on the user device 110. In some embodiments, the application 125 may be a web application with resources accessible via the network 115.

[0052] The application 125 running on the user device 110 may be a digital therapeutic application and may provide sessions (sometimes referred to herein as therapy sessions) to address impairments associated with a medical condition. A user of the application 125 may be an individual who suffers from, has been diagnosed with, or is at risk for a medical condition. The medical condition may include any number of impairments that cause a user to have impairments in functioning. The impairments may include social or non-social processing impairments across any number of domains. The social processing impairments may correspond to limitations or constraints on the user in performing daily activities such as social interactions with others. For example, the impairments may include reduced educational attainment, reduced quality of life, difficulty living independently, reduced social functioning, or impaired occupational functioning.

[0053] Additionally, non-social processing disorders can correspond to difficulties or limitations in cognitive processes, such as mental processes related to attention, memory, language processing, executive function, or sensory processing. Conditions can include, for example, neurological disorders (e.g., schizophrenia with positive or negative symptoms, or multiple sclerosis), or affective disorders (e.g., major depressive disorder, anxiety disorder, bipolar disorder, or post-traumatic stress disorder (PTSD)). Such conditions can impede or impair social skills, such as socially appropriate behavior or expressing feelings or needs. In some embodiments, the processing disorder can include a deficit in verbal memory on the part of the user. Verbal memory can correspond to the user's ability to encode, store, and retrieve information related to language and verbal communication. Verbal memory can include, for example, memory recall and cognitive association. Memory recall can refer to the user's ability to retrieve information after it has been provided (e.g., within 5-10 minutes). Cognitive association can refer to a user's ability to make connections or links between information received verbally and other information (eg, in the form of cues).

[0054] The application 125 may be used to present a session to the user prompting them to perform actions to reduce impairments associated with the user's condition. These actions may be presented to the user as a result of sending a session initiation request, user detection measurements received from the client device, or the passage of a scheduled time or period, among others. Behaving socially appropriate includes engaging in normal everyday interactions without undue stress or awkwardness. In some cases, social interactions that are understandable to a person without a condition such as schizophrenia may be very difficult, stressful, or disruptive to a person with a condition such as schizophrenia. For example, purchasing coffee in a socially appropriate manner may cause stress or discomfort to a subject experiencing schizophrenia. The appropriate tone of voice, word patterns, and physicality associated with interacting with a barista to purchase coffee may initially be unknown to the subject. This may lead to difficulty for the subject functioning in public or social settings, disrupting the subject's lifestyle. Other behaviors may cause or be associated with the user's condition. Digital therapeutic sessions can be provided to the user through the application 125 to address limitations in social and non-social skills due to impairments resulting from the condition.

[0055] The user may be receiving a treatment to address the condition at least partially concurrently with the session via the application 125. The user may be receiving a treatment at least partially concurrently with the first session, the second session, the third session, or any combination thereof. The treatment may include taking a medication. The medication may be at least orally administered, intravenously administered, or topically applied. For example, for schizophrenia, typical antipsychotics (e.g., haloperidol, chlorpromazine, fluphenazine, perphenazine, loxitane, thioridazine, or trifluoperazine) or atypical antipsychotics (e.g., aripiprazole, risperidone, clozapine, quetiapine, olanzapine, ziprasidone, lurasidone, paliperidone, or iclepertine). For affective disorders (e.g., PTSD or depression), medications such as serotonin reuptake inhibitors (SRIs) or mood stabilizers (e.g., lithium, valproate, divalproex sodium, carbamazepine, lamotrigine) can be used. The application 125 can enhance the efficacy of medications the user is taking to address the condition. Treatments include psychosocial interventions such as psychoeducation, group therapy, cognitive behavioral therapy (CBT), early intervention for first onset psychosis (FEP), cognitive rehabilitation, and educational planning.

[0056] 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 a 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 therapeutic sessions) to address a user's impairment via the user interface 130.

[0057] The application 125 can receive instructions for presenting a session to the user. The session can include or be defined by a corresponding tier configuration 170 provided from the database 160. The tier configuration 170 can correspond to or include tiers, therapeutic techniques, images, prompts, or other indications for presentation to the user via the application 125 during the session. The session can include an interactive interface to engage the user, via the user interface 130, with one or more therapies designed to improve the user's cognitive function associated with a pathological condition. For example, the user can play a game on the user device 110 presented by the application 125 that incorporates one or more therapies to address a functional impairment. Each session can correspond to a tier. In some embodiments, each session corresponds to a tier. A tier can refer to a difficulty level or type of content presented during a session. For example, a first session can include a first tier. The first tier can be configured to display a set of first images corresponding to a first therapeutic technique. The tier can include instructions for the presentation of images 180, audio recordings 185, prompts, UI elements 135, or other visual indications associated with the session.

[0058] In some embodiments, the application 125 may present three sessions to address the impairments associated with the user's condition, with each session corresponding to a respective tier. Each tier associated with a respective session may increase the difficulty of the prompted actions, queries, etc. The first tier may include a prompt and an image 180 or audio recording 185 for presentation to the subject via the subject's mobile device, such as the user device 110. To address social processing impairments, for example, the image 180 may be an image of a character, and the prompt may instruct the subject to select a social cue of the character depicted in the image 180 (or audio recording 185) to train the subject to recognize the social cue. To address non-social processing impairments, for example, the image 180 (or audio recording 185) may be of an object, and the prompt may instruct the subject to select which object is depicted to address the subject's attention and memory. The first tier may be a cognitive training tier that provides cognitive exercises to teach the subject social skills through repetition. The subject may be presented with a first image 180A of the images 180 depicting a social setting, character, or social cue. In some embodiments, the first tier may be a cognitive training tier associated with a non-social skill, such as verbal memory, in which the user is presented with one or more audio recordings 185 and is tasked with recalling one or more of a plurality of words presented in the audio recordings 185.

[0059] A first session associated with the first tier may provide a prompt regarding a first image 180A (or an audio recording 185A, or both the first image 180A and the audio recording 185A) and social cues depicted on the UI elements 135. The subject may select one or more of the UI elements 135 based on the depicted social environment or cues. One or more of the UI elements 135 may be associated with a correct selection and one or more of the UI elements 135 may be associated with an incorrect selection. In some cases, each selection may include various degrees of correctness. For example, the first session may include two images. The first image 180A may depict a person actively cooking and the second image 180B may depict a person simply sitting on a couch. The subject may be prompted to select the image depicting a person who appears busy. In this example, the correct selection would be the first image 180A depicting a person cooking. By including a series of images 180 (or audio recordings 185) and prompts such as the examples above in the first tier, knowledge of social and non-social skills can be reinforced through repetition.

[0060] The second of the three layers may correspond to a second session. The second session may provide a second image 180B (or an audio recording 185B, or both the second image 180B and the audio recording 185B) and a second prompt via the user's mobile device. The second session may include a set of interaction elements, such as UI elements 135. The second image 180B may present a social setting as a virtual environment. For example, the second image 180B may present a virtual social setting through the application 125. In this manner, the second layer may provide virtual training incorporating familiar and realistic aspects of everyday life with the goal of addressing the impairment. The second session may include a prompt indicating a question associated with a character depicted in the social setting and exhibiting social cues.

[0061] As an example of social processing, the second tier may include the presentation of text depicting a social setting in which a character is standing in a doorway, unknowingly and unintentionally blocking the subject from leaving the room. The second prompt may include a question such as, "How do I get out of the room?" In this example, the interaction element may include text such as, "1. Politely ask the person to move," "2. Push past the person," or "3. Say nothing and wait for the person to move." A correct response by the subject may include a choice through the interaction element that indicates an appropriate social interaction based on the depicted social situation. In this example, the correct choice is choice 1.

[0062] To address non-social processing, for example, the images 180B can be images of multiple characters in a setting and prompts can instruct the subject to select a response, for the purpose of training the user to exercise executive functions (e.g., planning and problem solving) in a virtual environment. In another example, the user can be presented with an audio recording 185 of a conversation and be prompted to provide a response related to information conveyed in the conversation, for the purpose of training the user to exercise verbal memory.

[0063] The third tier can correspond to a third session in which a third image 180C (or an audio recording 185C, or both the image 180C and the audio recording 185C) is presented to the user. The third session can include only a prompt, not the third image 180C. The third image 180C can include a third prompt regarding an activity (e.g., an act) for the user to perform in the real world. For example, to address social processing deficits that lead to impairments, the third prompt can instruct the user to smile at a stranger or ask a librarian where a book is located. The third session can prompt the subject for a response associated with performing the activity. For example, the third session can prompt the subject for instructions for completing a task, such as an evaluation of how the activity was performed or whether the subject completed the activity. To address non-social processing deficits that lead to impairments, the prompt can instruct the subject to perform the activity while planning to perform the activity by a specified time, with the goal of training executive functions (e.g., planning) in a real-world environment. As an example, to train verbal memory in a real-world environment, prompts could ask the user to follow instructions in a how-to video, such as how to make a sandwich, or to have a conversation and later recall the person's name.

[0064] The images 180 may be or include a display shown to the user as an image, video, or other visual presentation. The images 180 may be subdivided into sets, such as a first set of images 180A or a second set of images 180B. In some embodiments, the set of images 180N may include still images, video, text, or a combination thereof. One or more images 180 may be repeated between the sets. The images 180 may include live, pre-recorded, or generated video or animation, such as a video recording, a short animated piece, or an animated image. The images 180 may include audio or haptic presentations. For example, the images 180 may include sounds, phrases, words, or other auditory noises to be presented to the user. The images 180 may be of any size or orientation actionable by the user interface 130. The images 180 may include text, such as words or sentences, presented to the user via the user interface 130. The images 180 may include instructions to have the user take some action as part of the ecologically valid cognitive improvement. For example, the images 180 may include text, graphics, or audio instructions that depict an action that the user should take or perform in connection with the session. The images 180 may depict a social environment, a person, an animal, an object, or a combination thereof, etc. The images 180 may also be coupled with or correspond to one or more prompts.

[0065] The audio recordings 185 may be or include one or more files corresponding to audio content presented to the user. The audio recordings 185 may include live, pre-recorded, or generated audio, such as an audio recording of an utterance from an individual or a conversation between two or more individuals. For example, each audio recording 185 may be a recording of one or more words, one or more sentences, or a set of sentences in a conversational format by two or more individuals, spoken by a single speaker. In some embodiments, the audio recordings 185 may include audio generated using a speech synthesizer or a generated voice. In some embodiments, at least one audio recording 185 may be associated with the image 180. In some embodiments, at least one audio recording 185 may be associated with or correspond to one or more prompts. Files used for the audio recordings 185 may include, for example, a waveform audio file format (WAV), an MPEG file format (MP3), an audio interchange file format (AIFF), or an Ogg Vorbis (OGG), etc.

[0066] The prompt may include instructions or indications for the user to take an action or make a selection to address the impairment associated with the condition. The prompt may be associated with the image 180 (or audio recording 185, or both the image 180 and the audio recording 185). The prompt may be displayed, for example, within the image 180, overlaid on the image 180, or adjacent to the image 180. The prompt may include a query related to one or more of the images 180 displayed via the application 125 operating on the user device 110A. The prompt may include text that instructs the user to interact or interact with one or more UI elements 135. For example, the prompt may present a query to the user based on the image 180 displayed on the user interface 130 by the application 125 and may instruct the user to make a selection of the UI element 135 based on the image 180 and the query. The prompt may include instructions for an action or task to be performed by the user according to the session.

[0067] Actions associated with a session can be included in the tier configuration 170. The actions can include interacting or not interacting with the user device 110. For example, the actions can include tilting the user interface 130 or selecting a UI element 135 presented by the user device 110. The actions can include a physical task performed by the user. For example, the actions can include the user leaving the house, talking to a cashier, or buying milk. The actions can include instructions for the user to address a condition. The actions can be included in a session to address a functional impairment associated with the user's condition. For example, a prompt can instruct the user to perform an action outside of the virtual environment, such as physically going to a coffee shop to buy coffee. One or more actions can be associated with the tier configuration 170 stored in the database 160.

[0068] The database 160 may store and maintain various resources and data associated with the session management service 105 and the applications 125. The database 160 may include a database management system (DBMS) for organizing and arranging the data maintained on the database. The database 160 may communicate with the session management service 105 and one or more user devices 110 via the network 115. While performing various operations, the session management service 105 and the applications 125 may access the database 160 to retrieve identified data therefrom. The session management service 105 and the applications 125 may also write data to the database 160 from the performance of such operations.

[0069] Such operations may include maintaining a user profile 165 (sometimes referred to herein as a subject profile). The user profile 165 may include information related to the user's condition, as described herein. For example, the user profile 165 may include information related to, among other things, the severity of the condition, the occurrence of the condition (such as the occurrence of symptoms associated with the condition that affect the user's cognitive function), medications or treatments the user is taking for the condition, and / or the duration of the condition. The user profile 165 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), or in response to a clinician (e.g., a doctor or nurse) addressing the user's condition, among other things.

[0070] The user profile 165 can store and maintain information related to a user of the application 125 via the user device 110. Each user profile 165 can be associated with or correspond to a subject or user of the application 125. The user profile 165 can include or store information for each session performed by the user. The information for a session can include various parameters, actions, images 180, prompts, layer configurations 170, or selections or actions of previous sessions performed by the user, or can be initially blank. The user profile 165 can simplify communication to the user by presenting the user with sessions that are most likely to assist the user in alleviating impairments or improving cognitive function based at least on the user profile 165. This directional approach can reduce the need for multiple communications with the user, thereby reducing bandwidth and increasing the benefits of user-computer interaction.

[0071] In some embodiments, the user profile 165 may identify or include information regarding a treatment regimen undertaken by the user, such as the type of treatment (e.g., therapy, medication, or psychotherapy), duration (e.g., day, week, or year), and frequency (e.g., daily, weekly, quarterly, yearly). The user profile 165 may be stored and maintained in the database 160 using one or more files (e.g., Extensible Markup Language (XML), Comma Separated Values ​​(CSV) delimited text files, or Structured Query Language (SQL) files). The user profile 165 may be iteratively updated as the user provides responses, makes selections, and performs actions in connection with a session, layer configuration 170, or image 180, etc.

[0072] The layer configuration 170 may specify or include a set of instructions that define each layer provided as a session via the user interface 130 for the application 125 on the user device 110. The layer configuration 170 may correspond to or include layers, therapy techniques, images, prompts, or other indications for presentation to the user via the application 125 during a session. In some embodiments, the layer configuration 170 may be for social skills training. For example, for a first layer, the layer configuration 170 may specify a file corresponding to an image 180 of a character and define prompts for possible choices of social cues detected in the image 180. For a second layer, the layer configuration 170 may specify a file corresponding to an image 180 of a social environment with one or more characters and define prompts for possible choices of responses to the setting depicted in the image 180. For a third layer, the layer configuration 170 may specify prompts to instruct a user of the application 125 to perform an activity (e.g., interact with others) in the user's surroundings.

[0073] In some embodiments, the layer configuration 170 may be for non-social skills training, such as verbal memory training to address cognitive association impairments as well as language learning and verbal memory impairments. For example, for a first tier, the layer configuration 170 may identify files corresponding to images 180 and audio recordings 185 and define prompts for choice options for one or more words presented in the audio recordings 185. For a second tier, the layer configuration 170 may identify files corresponding to images 180 or audio recordings 185 of a conversation between individuals in a virtual environment and define prompts for choice options for responses associated with information presented in the conversation. For a third tier, the layer configuration 170 may identify prompts to instruct a user of the application 125 to perform an activity (e.g., interact with others) in the user's surroundings. The layer configuration 170 may be persisted in the database 160 using one or more files (e.g., Extensible Markup Language (XML), Comma Separated Values ​​(CSV) delimited text files, or Structured Query Language (SQL) files).

[0074] Identification of the images 180, audio recordings 185, layer configurations 170, actions, or prompts may be stored and maintained in database 160. For example, database 160 may use one or more data structures or files to maintain images 180 and audio recordings 185. Each of the images 180 may prompt a user via application 125 to perform an action or make a selection via application 125. For example, application 125 may receive instructions to present a layer including one or more images 180. The layers and sessions may be used to provide therapy to improve cognitive functions, such as social or non-social skills, symptoms of a medical condition, or other cognitive or behavioral effects of a medical condition. The sessions may be presented as games, activities, or actions performed by a user via user interface 130. For example, one or more sessions may be presented as a series of images 180 accompanied by a prompt including a query. The query is for the user to select an interaction element (e.g., of UI element 135) associated with the query and the image 180.

[0075] Referring now to FIG. 2, a block diagram of a process 200 for identifying a set of sessions to address a user's impairment and providing a first session of a cognitive training layer of the set of sessions is depicted. The process 200 may include or correspond to operations performed on the system 100 to present an interaction session to address a user's impairment. Under the process 200, the session manager 140 executing on the session management service 105 may access the database 160 to retrieve, fetch, or otherwise identify a user profile 165 of a user 210 (sometimes referred to herein as a subject, patient, or person) of the application 125 on the user device 110. The user profile 165 may identify or define information associated with the user 210, the instance of the application 125 on the user device 110, the user device 110, and the like. For example, the user profile 165 may identify that the user 210 has an impairment, a symptom associated with a condition, or other cognitive or behavioral consequence resulting from the condition. The user profile 165 may, among other things, identify that the user 210 is taking medication to address the user's 210 medical condition or symptoms associated with the medical condition.

[0076] The session manager 140 can determine or identify a set of sessions for the user 210 to address the impairments associated with the condition. Each session can correspond to a respective tier for addressing the impairments associated with the condition of the user 210. Each tier can correspond to one or more cognitive remediation exercises to help the user 210 overcome or improve the impairments. For example, each tier can include a different therapy designed to teach the user 210 social skills or recognizing social cues. The session manager 140 can identify sessions to the impairments associated with the condition of the user 210 associated with the user profile 165.

[0077] The user profile 165 may include information such as images 180, layer configurations 170, previous sessions (e.g., previous selections identified for the user 210), performance associated with sessions already identified for the user 210, or taking of medication by the user 210 to address the user's condition. The user profile 165 may also identify or include information regarding the recorded performance of the impairment, such as the number of occurrences of failed social interactions, symptoms associated with the condition, the number of occurrences of participation or engagement in social settings, the duration of previous occurrences, and taking of medication, among others. The user profile 165 may initially lack information regarding previous sessions and may build up information as the user 210 participates in or engages in sessions via the application 125. The user profile 165 may be utilized to select one or more sessions to provide to the user 210 via the application 125 in a session.

[0078] The session manager 140 may initiate a session in response to receiving a request from the user 210 via the application 125. The user 210 may provide a request to initiate a session via the user interface 130 executing via the application 125. The request may include information related to the impairment. The request may include, among other things, an identity of the user 210 or a user profile 165, symptoms associated with the user's 210 condition, a time of the request, or attributes associated with the condition, such as the severity of the condition. The application 125 running on the user device 110 may generate a session initiation request to send to the session management service 105 in response to the user's 210 interacting with the application 125, such as by the user 210 selecting one or more selections 205 via the UI elements 135. In some embodiments, the session manager 140 may initiate or identify a session in response to a scheduled session time, in response to the completion of a previous session, or based on the user's 210 taking medication prescribed to address the condition, among other things.

[0079] In some embodiments, the session manager 140 may identify the sessions based on a predefined schedule of sessions. For example, the session manager 140 may identify a first session to include a cognitive training skill layer associated with a condition according to a predefined schedule of challenges. In this illustrative example, the session manager 140 may identify a second session based on a subsequent session of the predefined schedule. For example, the predefined schedule of sessions may include a first, second, and third session corresponding to different psychosocial therapies. The session manager 140 may define a schedule or time for identifying or providing sessions, or a schedule or time for marking sessions for presentation. In some embodiments, the session manager 140 may identify sessions based on a set of rules. The rules may be configured to provide sessions that target the underlying causes of a condition or provide sessions that train the user 210 to improve the user's 210 social and non-social skills in a systematic, objective, and therapeutically effective manner. The rules may be set based on the completion time of actions or selections 205 associated with a session, a user profile 165, a prompt, or other attributes of the system 100.

[0080] Once one or more sessions are identified, the session manager 140 can provide, route, or otherwise transmit the sessions to the user device 110. In some embodiments, the session manager 140 can send instructions to the application 125 on the user device 110 to present the sessions and their corresponding images and prompts via the user interface 130. The instructions can include, for example, a specification of which UI elements 135 should be used and can specify content to be displayed on the UI elements 135 of the user interface 130. The instructions can further specify or include images 180. The instructions can be code, data packets, or control means for presenting the sessions to the user 210 via the application 125 executing on the user device 110.

[0081] For the identified session 220, the session manager 140 can create, write, or otherwise generate instructions for the session 220 according to the tier configuration 170. The session 220 can be a first session and can include a cognitive training tier as stored in the tier configuration 170A. For the session 220, the session manager 140 can select or identify a set of images 180A-N (hereinafter generally referred to as images 180), a set of audio recordings 185A-N (hereinafter generally referred to as audio recordings 185), and prompts 230A-N (hereinafter generally referred to as prompts 230) for display during the session 220. The session manager 140 can select the images 180 and prompts 230 based on the tier configuration 170A, the user profile 165, or previous sessions, etc. For example, the session manager 140 can select the images and prompts 230 to address verbal memory, social skills, or other areas in which the user may be struggling with impairments. The session manager 140 can identify or select images 180 and prompts 230 as part of a session to provide a layer of cognitive training to a user 210 experiencing an impairment associated with a pathological condition.

[0082] In some embodiments, the session manager 140 can select or identify a set of audio recordings 185 for the session 220. The selection can be based on the tier configuration 170A, the user profile 165, or previous sessions, among others. Each recording 185 can correspond to or be associated with one or more words. For example, the set of selected recordings 185 can correspond to a list of words to be presented to the user 210. The session manager 140 can also identify or specify a format in which the set of audio recordings 185 is presented. The format can identify or define a context in which the words of each audio recording 185 are presented. For example, the format can include a list of words or a sentence, etc.

[0083] The session manager 140 can provide instructions for the session 220 for displaying the images 180, the audio recording 185, and the prompts 230 on the application 125. The session manager 140 can transmit the session 220 to the user device 110 for execution via the application 125. The session manager 140 can provide the images 180 or the audio recording 185 (or both) as part of the session 220. The session manager 140 can provide the prompts 230A-N as part of the session 220 at least partially contemporaneous with the presentation of the images 180 or the audio recording 185. The instructions can also include a prompt that instructs the user 210 to make a selection 205 or perform an activity in connection with the session. For example, the prompt 230 may display a message instructing the user 210 to make the selection 205 of the UI element 135. The images 180 can include text, images, audio, or video presented by the user device 110 via the application 125. For example, the images 180 may include a presentation of images that instruct the user 210 to interact with the application 125 via the user interface 130 .

[0084] Session manager 140 may provide prompts 230 as part of session 220, at least partially concurrently with the presentation of images 180 or audio recordings 185. The instructions may also include prompts 230 instructing user 210 to make selections 205 indicating which one or more words were presented during the presentation of audio recordings 185. For example, prompt 230 may display a message instructing user 210 to make selections 205 of UI elements 135. At least some of images 180 may correspond to words presented in audio recordings 185, and at least some of images 180 may not correspond to any of the words presented via audio recordings 185. For example, if at least one of audio recordings 185 presented the word "banana," images 180 may depict several different fruits.

[0085] An application 125 on a user device 110 can render, display, or otherwise present one or more sessions. The session 220 can be presented via one or more UI elements 135 of a user interface 130 of the application 125 on the user device 110. The presentation of the UI elements 135 can be according to instructions provided by a session manager 140 for presenting the session 220 to a user 210 via the application 125. In some embodiments, the application 125 can render, display, or otherwise present aspects of the session 220, such as images 180, audio recordings 185, or prompts, independent of the session management service 105.

[0086] The application 125 can render, display, or otherwise present images 180 and audio recordings 185 for the session 220. The images 180 can include one or more cues to teach or train the user 210 to recognize such cues 235 for social skill acquisition. The cues 235 can relate to or include social cues. As described herein, a social cue can be an indication of a social behavior exhibited by a character or person. In some embodiments, a neurotypical person (e.g., a person not experiencing a pathology associated with the user 210) can easily recognize social cues and can make social decisions or interactions based on observed social cues. For example, a user 210 experiencing a pathology may have difficulty understanding social cues.

[0087] The cues 235 may include at least one of head movements (e.g., nodding, shaking, tilting, or other head gestures), body language (e.g., facial expressions, general body posture, and proximity to other characters), gestures (e.g., pointing with a finger or expressing an emotion through a hand or fingers), or eye contact (e.g., directing eyes toward another person to indicate engagement or emotion), among others. For example, an image 180 displayed on the user interface 130 via the application 125 may depict social cues 235 such as a character nodding their head, smiling, making eye contact, declining to make eye contact, folding their arms, waving, frowning, speaking with their hands, or shaking their head. In some embodiments, the social cues 235 may be textually described in the image. For example, the image 180 may include text describing the character's body language. In some embodiments, the presented image 180 may lack cues 235. For example, when the application 125 plays a set of recordings 185, the image 180 displayed by the application 125 may lack social cues 235.

[0088] In this regard, the application 125 can present prompts 230A-N associated with the session 220. The prompts 230 can include text or images associated with the image 180. The prompts 230 can indicate choices 205 for the user 210 to choose from. In some embodiments, the prompts 230 can include or be coupled with UI elements 135A-N. The UI elements 135A-N can identify one or more types of social cues 235 depicted in the image 180. These types of social cues 235 can include the physicality of the cue 235 (e.g., head movement, body language, gestures, or eye contact, etc.) or the context of the cue 235 (e.g., a cue 235 indicating that a character is busy, annoyed, in a hurry, not paying attention, etc.). The application 125 can share or have the same functionality as the session manager 140, the interaction handler 145, the performance evaluator 150, or other components of the session management service 105, as described above. For example, the application 125 may maintain a timer that tracks the amount of time that has elapsed since the presentation of a previous session.

[0089] In some embodiments, the application 125 may display, render, or otherwise present the images 180 or prompts for different time periods. The application 125 may present a first image 180A for a first time period and a second image 180B for a second time period. For example, the application 125 may present the first image 180A during a first time period and then present the second image 180B during a second time period. In some cases, the application 125 may delay the presentation of the second image 180B after displaying the first image 180A. The application 125 may present the images 180A and 180B or prompts simultaneously. The simultaneous presentation of the images 180 or prompts may refer to displaying the images 180 or prompts during the same time period or at the same display location on the user interface 130. In this regard, the application 125 may display prompts 230A-N to instruct the user 210 to interact with the display. The image 180 or UI elements 135A-N may include a prompt for the user 210 to make an action or selection 205 associated with the session 220. The selection 205 may include an action such as physically manipulating the user device 110, activating a UI element 135, or viewing a video or image of the image 180, among others.

[0090] In some embodiments, the session manager 140 can provide a series of images 180 (or audio recordings 185) and a prompt 230 that prompts the user 210 to make a selection 205 based on a cue 235 depicted on the images 180. The user 210 can make a selection that indicates the cue 235 via a UI element 135. For example, the images 180 can include an image of a person shaking their head. The prompt 230 can be combined or separate from the UI element 135 to instruct the user 210 to select one or more of the UI elements 135 based on the cue 235 depicted on the images 180 (e.g., shaking their head, audio, etc.). For example, a first prompt 230A can be combined with a first UI element 135A and can include text that reads, "If she says 'yes', choose this," and a second prompt 230B can be combined with a second UI element 135B that includes text that reads, "If she says 'no', choose this." With such prompted selections based on cues 235 associated with the presented image 180 , the user 210 can perform iterative training exercises to teach the user 210 to recognize the social cues 235 .

[0091] In some embodiments, the application 125 can play or present a set of audio recordings 185 to the user 210 (e.g., via speakers or headphones). The audio recordings 185 can be presented according to a specified format that defines the context in which the words are presented. For example, the application 125 can play the set of audio recordings 185 sequentially if the format specifies that the words corresponding to the audio recordings 185 are a list of words. The application 125 can also play a single audio recording 185 if the format specifies that the words constitute a sentence to be presented to the user 210. In combination with or following the presentation of the audio recordings 185, the application 125 can present or display a prompt 230 on the user interface 130 for the user 210. The prompt 230 can enable the user 210 to make a selection 205 to identify at least one of the set of words presented in the set of recordings 185. The words may be presented in the form of text or images 180 representing objects. The prompt 230 may include any number of questions, such as whether a word was presented, which words were presented, which words were not presented, which of these words were presented, one word from the list, one word from not, n words from the list, one word from the list, and one word from the list and one word not from the list. The prompt 230 may be presented in combination with or following the presentation of the audio recording 185. In some embodiments, the application 125 may present at least one UI element 135 to allow the user 210 to play back the audio recording 185.

[0092] In some embodiments, an audio recording 185 may be attached to one or more images 180 to teach the user 210 to understand, comprehend, and remember auditory information, such as words, sentences, and stories. As an illustrative example, the third prompt 230C may be coupled to multiple UI elements, such as UI element 135. The third prompt 230C may instruct the user to select a UI element 135 that corresponds to an audio cue that is played for the user via a speaker coupled to the client device. For example, the audio cue may play the word "cat," and the third prompt 230C may ask the user 210 to select a UI element 135 that corresponds to the audio cue. The UI elements 135C-E may include respective text, such as "horse," "dog," or "cat," and the user may select the UI element 135 that is believed to correspond to the third prompt 230C that includes the word "cat." With such prompt selection based on the cue 235 associated with the presented images 180, the user 210 may perform repetitive training exercises that aid the user.

[0093] The application 125 can monitor at least one selection 205 by a UI element 135A-N. The application 125 can do so during a session in response to presentation of an image 180, in response to presentation of a prompt 230, or in response to receiving a selection 205. The application 125 can monitor for receipt of the selection 205. The application 125 can monitor for the selection 205, for example, via the user interface 130 or via a sensor associated with the user device 110. The application 125 can receive multiple selections 205 during a session. For example, the application 125 can monitor a series of selections 205 made by the user 210 during a session. The application 125 can monitor and record information related to the received selections 205. For example, the application 125 may monitor and record the time of the selection 205, the duration of the selection 205, the order of the selection 205, the prompt 230 or image 180 associated with the selection 205, and / or the delay between the presentation of the prompt 230 or image 180 and the selection 205, etc.

[0094] Once the user 210 makes the selection 205, the application 125 generates at least one response 225. The response 225 may identify the selection 205. The response 225 may include information about the selection 205, such as a duration of the selection 205, a time of the selection 205, an image 180 or a prompt 230 associated with the selection 205, and / or a delay between presentation of the image 180 or prompt 230 and the selection 205. The application 125 may generate the response 225 for transmission to the session management service 105. The response 225 may 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.

[0095] The interaction handler 145 may receive, identify, or otherwise detect a response 225 identifying the selection 205. The interaction handler 145 may receive the response 225 from the application 125. The interaction handler 145 may receive the response 225 at scheduled time intervals or once the selection 205 is made during a session. The interaction handler 145 may query or ping the application 125 for the response 225. The interaction handler 145 may receive multiple responses 225 during one period. For example, the interaction handler 145 may receive a first response 225 indicating a first selection 205 and a second response 225 indicating a second selection 205.

[0096] The interaction handler 145 can store and maintain the response 225, including the selection 205, in the database 160. The interaction handler 145 can store information related to the response 225, including a time of the response 225, an action associated with the selection 205, a user profile 165 associated with the response 225, and an image 180 or prompt 230 associated with the response 225, etc. The response 225 can include or identify the selection 205 made by the user 210 using the UI element 135. The response 225 can identify a type of social cue 235 depicted in the image 180. In some embodiments, the response 225 can identify one or more words presented via the audio recording 185. The response 225 may include a time taken to complete the task. For example, the response 225 can include that the user spent four minutes performing an action associated with the presentation of the session 220.

[0097] The response 225 may include a total time for the session 220 to complete, and may also include a start time of the session 220 and a completion time of the session 220. The response 225 may include UI elements 135 that were interacted with during the presentation of the session 220. For example, the response 225 may include a list of buttons, toggles, or other UI elements 135 that were selected by the user 210 at a specified time during the presentation of the session 220. The response 225 may 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 include measurements, such as measurements of time, location, or user data.

[0098] In some embodiments, the performance evaluator 150 can generate a performance metric 215 based at least on the selections 205, the responses 225, the user profile 165, or previous sessions, etc. The performance metric 215 can be a qualitative (e.g., “poor,” “average,” “good”) or quantitative (e.g., numerical) score indicative of the performance of the user 210 during the session 220 or series of sessions. The performance evaluator 150 can generate the performance metric 215 based on a percentage of correct selections 205 of the cognitive training layer. For example, the user 210 can be provided with a series of images 180 (or audio recordings 185) and prompts 230 as part of the session 220. The user 210 can make one or more selections 205 during the session 220. In some cases, the selections 205 made by the user 210 can correctly identify the social cue 235 depicted in the image 180, while in other cases, the selections 205 made by the user 210 can not correctly identify the social cue 235. In some embodiments, the selections 205 by the user 210 may identify (e.g., correctly or incorrectly) words presented via the audio recording 185. The performance evaluator 150 may determine a performance metric 215 based on a ratio of correct selections 205 to incorrect selections 205, a ratio of correct selections 205 to the total selections 205, a ratio of incorrect selections 205 to the total selections 205, a percentage of correct or incorrect selections 205 during a period of time, a percentage of correct or incorrect selections 205 during a session 220, etc.

[0099] The performance evaluator 150 may determine whether the user 210 is performing at or above the threshold performance. The performance evaluator 150 may compare the determined performance metric 215 to the threshold performance. If the performance evaluator 150 determines the performance metric 215 to be below the threshold performance, the performance evaluator 150 may instruct the session manager 140 to maintain the current session 220. Conversely, if the performance evaluator 150 determines the performance metric 215 to be at or above the threshold performance, the session 220 is considered completed or passed. Upon completing or passing the session 220, the session manager 140 may determine to present a second session to the user 210 via the application 125. For example, if the performance metric 215 meets a threshold, the session manager 140 may determine to transition the user 210 from a cognitive training tier associated with the session 220 to another tier, such as a virtual functional training tier.

[0100] Additionally, the feedback provider 155 may generate, output, or otherwise generate feedback for receipt by the user 210 via the application 125 operating on the user interface 130. The feedback provider 155 may generate the feedback based on at least the performance metrics 215, the responses 225, the prompts 230 including queries, the user profile 165, or historical sessions, images 180, audio recordings 185, or prompt presentations. 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 a presentation of the performance metrics. The feedback may display messages such as motivational messages, suggestions to improve performance, congratulatory messages, or comforting messages. In some embodiments, the feedback provider 155 may generate such feedback during a session being performed by the user 210. In some embodiments, the feedback may include an indication of a correct response to a query in the prompt 230.

[0101] The feedback provider 145 may provide, transmit, or otherwise send feedback to the application 125 for display on the user interface 130. The feedback provider 145 may provide instructions for rendering or displaying the feedback. The feedback provider 145 may send a data packet, signal, or other instruction to the application 125 indicating the presentation of the feedback. Upon receiving this, the application 125 may present the feedback to the user 210 via the user interface 130. The presentation of the feedback may include a UI element 135. For example, the user 210 may make a selection associated with the feedback, such as to increase the difficulty of the session or to restart the session 220. In some embodiments, the application 125 may also present the feedback to indicate a correct response. For example, if the user's selection is incorrect, the application 125 may set the color of the UI element 135 corresponding to the user's selection to indicate that the user's selection is incorrect (e.g., set it to red). The application 125 may also set the color of the UI element 135 corresponding to the correct response to a different color (e.g., set it to green). Alternatively, if the user's selection is correct, the application 125 may set the color of the UI element 135 that corresponds to the user's selection to indicate that the user's selection is correct (eg, set it to green).

[0102] 3A-3H, a set of exemplary user interfaces 300A-H for providing a first session are depicted. The user interfaces of the set 300 may be presented via an application 125. The application 125 may be displayed on a user interface or display, such as the user interface 130 of the user device 110, in association with a first tier. The first session depicted by the user interfaces of the set 300 may be associated with a cognitive training tier as depicted with reference to FIG. 2. In the user interfaces of the set 300A-B, a user (e.g., the user 210) may interact with the user interfaces 305A-310B. The user interfaces 305A-310B may include one or more user elements, such as the UI element 135, to accept input by the user 210 using at least one hand 525. The interfaces 305A and 305B may be prompts to inform the user how to perform a subsequent task. The interfaces 310A and 310B can include a pair of images 315A and 315B or a single image 303 with characters along with prompts encouraging the user to select a character with particular social cues (e.g., busy, conversation flow state, and attention).

[0103] In the user interface of set 300C, user interface 305C may include a play button 306 to initiate playback of the set of audio recordings 185 corresponding to the list of words. When this button is pressed, application 125 may present user interface 309 along with playback of set of audio recordings 185. Once playback of the audio recordings is complete, application 125 may present user interface 310C to prompt user 210 to respond whether a particular word (e.g., "milk") was presented. User interfaces of set 300D may be a continuation of set 300C above. Through the user interface, application 125 may continue to prompt user 210 to select whether a word was played or not. Application 125 may also present a user interface prompting user 210 if a word was not played. Additionally, application 125 may present a user interface prompting user 210 to select whether a word was played or not using images showing various words (e.g., yogurt and banana as depicted). The user interfaces shown in sets 300E-H can guide the user through similar exercises: for example, the user interface in set 300E can prompt the user to indicate whether a word has been presented, and the user interface in set 300F can prompt the user to indicate whether a word has been presented in a particular position in a list of played words.

[0104] Referring now to FIG. 4, a block diagram of a process 400 for providing a second session of a virtual functional training layer for a user to apply social skills in a virtual social environment is depicted. The process 400 may include or correspond to operations performed in the system 100 or the process 200. Under the process 400, the session manager 140 may provide a session 420 corresponding to the virtual functional training layer. The interaction handler 145 may receive a response 425 from the user 210 indicating a set of selections 205′. The performance evaluator 150 may generate or identify a performance metric 415 for the session 420. The feedback provider 155 may generate feedback 450 to provide to the user 210 based on performance during the session 420. The interaction handler 145 may send the feedback 450 to the application 125 for presentation to the user 210.

[0105] Session manager 140 may provide session 420 for presentation to user 210 via application 125. Session manager 140 may provide session 420 using operations similar to process 200 described in connection with session 220 of FIG. 2. Session 420 may include images 180'AN (hereinafter generally referred to as images 180'), audio recordings 185'AN (hereinafter generally referred to as audio recordings 185'), and prompts 430A-N (hereinafter generally referred to as prompts 430). Images 180' and prompts 430 may be the same as or similar to images 180' and prompts 230.

[0106] The session 420 may be a second session corresponding to a virtual functional training layer. The virtual functional training layer may provide a virtual setting 435 including one or more characters 440 for presentation to the user 210 in the image 180'. The virtual functional training layer may serve to provide a virtual, artificial, or otherwise generated environment for display via the user interface 130 to train the user 210 to identify and react to the virtual setting 435. In some embodiments, the second session may be a virtual functional training layer for the user 210 to utilize social skills (e.g., social perception) or non-social skills (e.g., verbal memory). In this manner, by providing a second session having a virtual setting 435, the session management service 105 may further build on the teachings of the previous session 220.

[0107] The virtual setting 435 may correspond to or refer to a virtual social setting. A social setting may include an environment in which one or more persons or characters 440 socially interact or converse with one another. For example, a social setting may include a party, a store, a school, an office, a workplace, a park, or other settings in which interactions with other characters 440 are common or expected. Interactions with other characters 440 may include conversations, written communication, physical actions (e.g., handshakes or hugs), or other forms of verbal or non-verbal communication. In some embodiments, an image 180' may depict a virtual setting 435, such as an office, a store, a party, etc., including one or more characters 440, via the user interface 130 as part of a session 420. In some embodiments, the virtual setting 435 may be presented via a set of audio recordings 185' of a conversation between two or more individuals. The virtual setting 435 may be devoid of an image 180' or may be devoid of a depiction of a character 440 within the image 180'.

[0108] The one or more characters 440 may include people depicted in the image 180'. The characters 440 may include people one might encounter in a social setting, such as a librarian, a cashier, a passerby, a coworker, a child, police, a store clerk, a waiter, a mailman, or the like. The image 180' may depict the character 440 interacting with the virtual setting 435. For example, the image 180' may depict the character 440 purchasing coffee, talking to a police officer, or passing other characters in a store. The image 180' may depict the character 440 performing or exhibiting a social cue, such as the cue 235 depicted in connection with FIG. 2.

[0109] The session manager 140 can provide the session 420 including a prompt 430. The prompt 430 can correspond to the image 180' or an aspect thereof, such as a virtual setting 435 or a character 440. In some embodiments, the prompt 430 can include a query or question. The query or question can be displayed as an image with text or symbols or presented as audio via the user device 110. The query can correspond to the image 180'. The query can be associated with a character 440 depicted in the virtual setting 435. In some embodiments, the query identified by the prompt 430 can relate to a cue depicted by the character 440 in the image 180'. For example, the prompt 430 can include a query such as "What should the character say to order a coffee?" or "Is the barista busy?" The prompt can include any query related to the character 440 depicted in the virtual setting 435 for the user 210 to identify an appropriate or correct response based on the image 180'.

[0110] In some embodiments, the session manager 140 can provide images 180' (or audio recordings 185') for presentation via the user interface 130 of the application 125 in a prescribed sequence. The session manager 140 can present one or more images 180' during the session 420. The images 180' in the prescribed sequence may include the same character 440, the same virtual setting 435, different characters 440, different virtual settings 435, or a combination thereof. In some embodiments, the sequence of images 180' may depict a set of sequential or causal social cues or interactions. For example, a first image 180A' may depict a character ordering a coffee, and a second image 180B' may depict the character subsequently receiving the coffee. As another example, a first image 180A' may depict a character blocking the path of another character, and a second image 180B' may depict the character moving out of the way of the other character. In some embodiments, the order of images 180′ may be determined by session manager 140 according to a defined set of images 180′, or session manager 140 may determine the order of images 180′ based on user profile 165, responses 425 from user 210, or performance metrics 415 associated with user 210 during session 420.

[0111] In some embodiments, the session manager 140 may provide instructions for the session 420 to present the image 180', the audio recording 185', and the prompt 430 on the application 125. The session manager 140 may provide the image 180' or the audio recording 185' (or both) as part of the session 420. The session manager 140 may provide the prompt 430 as part of the session 420 at least partially contemporaneous with the presentation of the image 180' or the audio recording 185'. In some embodiments, the session manager 140 may provide one or more audio recordings 185' of speech samples from at least one speaker in association with the virtual setting 435. The speech samples may correspond to one or more sentences by the speaker, such as a statement, a question, an exclamation, a request, a command, or a suggestion, among others. In some embodiments, the recording may be a conversation between two or more speakers. The conversation may be a conversation between characters in the virtual setting 435. In some embodiments, session manager 140 can provide instructions to include one or more images 180' associated with a set of audio recordings 185'. For example, images 180' can include a representation of a virtual setting 435 and avatars corresponding to speakers in a conversation presented through audio recordings 185'. In some embodiments, images 180' can include a representation of virtual setting 435 that does not include characters. For example, audio recording 185' can be a conversation about filling up a car with gas, and image 180' accompanying the presentation of audio recording 185' can be at a gas station.

[0112] In some embodiments, the instructions may also include a prompt 430 instructing the user 210 to make a selection 205' indicating what information was presented during the presentation of the audio recording 185. The information may be inferred from or associated with words presented during the session 420. For example, the prompt may display a message instructing the user 210 to make a selection 205' of a UI element 135. At least some of the images 180 may correspond to information presented in the audio recording 185, and at least some of the images 180 may not correspond to any of the information presented via the audio recording 185. In some embodiments, the prompt 430 may identify or include a query associated with the conversation presented in the audio recording 185'. The query of the prompt 430 may be to recall, in a virtual setting 435, information conveyed in the speech sample of the audio recording 185.

[0113] Once presented with one or more images 180' including a virtual setting 435 and a character 440, the user 210 can make a selection based on the prompt 430. The user 210 can make a selection 205' via a UI element 135 to answer a prompt including a query related to the image 180'. In some embodiments, the UI element 135 can include other prompts 430. The user 210 selects one of the UI elements 135 in response to presentation of a prompt 430 including a query, an image 180', a character 440, a virtual setting 435, or a combination thereof.

[0114] The application 125 can monitor one or more selections 205' via the UI element 135. The application 125 can monitor one or more selections 205' in a manner similar to that described in connection with the selection 205 of FIG. 2. Upon detecting a selection 205', the application 125 can generate at least one response 425. The response 425 can identify the selection 205'. The response 425 can include information related to the selection 205, such as a duration of the selection 205, a time of the selection 205, an image 180 or a prompt 430 associated with the selection 205', and / or a delay between the presentation of the image 180' or the prompt 430 and the selection 205. The application 125 can generate the response 425 for transmission to the session management service 105. The response 425 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.

[0115] In some embodiments, the application 125 may play or present (e.g., via speakers or headphones) a set of audio recordings 185' to the user 210 as part of the session 420. The set of audio recordings 185' may include recordings of speech samples from at least one speaker associated with a social setting. In some embodiments, the recordings may be recordings of a conversation between two or more speakers. The speech samples may include one or more pieces of information about which the user 210 is quizzed following or in combination with the presentation of the audio recordings 185'. In some embodiments, the application 125 may display one or more images 180' in combination with the presentation of the audio recordings 185'. The images 180' may depict the social setting in which the characters are conversing.

[0116] In combination with or following the presentation of the audio recordings 185', the application 125 can present or display a prompt 430 on the user interface 130 for the user 210. The prompt 430 may enable the user 210 to make a selection 205 to identify information presented in the conversation from the set of audio recordings 185'. This information may correspond to semantic content inferred from or otherwise associated with one or more words presented in the set of audio recordings 185'. The prompt 430 may, for example, ask the user 210 to indicate whether a particular statement is true about the content presented in the audio recordings 185'. The prompt 430 may be presented in combination with or following the presentation of the audio recordings 185'. In some embodiments, the application 125 can present at least one UI element 135 to enable the user 210 to play back the audio recordings 185'.

[0117] The interaction handler 145 may receive, identify, or otherwise detect a response 425 identifying the selection 205'. The interaction handler 145 may receive the response 425 from the application 125. The interaction handler 145 may receive the response 425 at scheduled time intervals or once the selection 205' is made during a session. The interaction handler 145 may query or ping the application 125 as to whether there was a response 425. The interaction handler 145 may receive multiple responses 425 during one period. For example, the interaction handler 145 may receive a first response 425 indicating a first selection 205' and a second response 425 indicating a second selection 205'.

[0118] The interaction handler 145 can store the response 425, including the selection 205′, in the database 160. The interaction handler 145 can store information related to the response 425, including a time of the response 425, an action associated with the selection 205, a user profile 165 associated with the response 425, and an image 180, audio recording 185′, or prompt 430 associated with the response 425, etc. The response 425 can include or identify a selection 205 made by the user 210 with a UI element 135. In some embodiments, the response 425 can identify a type of social cue depicted in the image 180, an appropriate social interaction to take given the virtual setting 435, or a social cue associated with the character 440. In some embodiments, the response 425 can indicate information presented in the set of audio recordings 185′. The response 425 can include a time taken to complete the task. For example, the response 425 can include that the user 210 spent four minutes performing an action associated with the presentation of the session 420.

[0119] In some embodiments, the response 425 may include a total time for the session 420 to complete, and may also include a start time of the session 420 and a completion time of the session 420. The response 425 may also include UI elements 135 that were interacted with during the presentation of the session 420. For example, the response 425 may include a list of buttons, toggles, or other UI elements 135 that were selected by the user 210 at a specified time during the presentation of the session 420. The response 425 may 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 425 may include measurements such as measurements of time, location, or user data.

[0120] The performance evaluator 150 may calculate, generate, or otherwise determine a performance metric 415 associated with the session 420 based on the response 425. The performance metric 415 may be or include the performance metric 215 depicted in FIG. 2. In some embodiments, the performance evaluator 150 may determine the performance metric 415 based on previous performance metrics 415. In some embodiments, the performance evaluator 150 may maintain separate performance metrics for each session or may generate a combined performance metric. In some embodiments, a high performance metric 415 may correspond to a user performing well in the session 420 (e.g., selecting the correct choice 205′).

[0121] The correct choice 205' may refer to a choice indicating a correct response to a query presented by the prompt 430 with respect to the virtual setting 435 and character 440. The correct response 425 may be associated with a socially acceptable or polite, behaviorally normal, moral, or emotionally stable social interaction for the presented virtual setting 435. For example, a correct response to the query "How do I order coffee" in the virtual setting 435 may be indicated by a UI element 135A showing the words "I say, 'I'd like a medium black coffee, please.'" In some embodiments, the correct response 425 may correspond to a selection of information inferable from a conversation in a set of audio recordings 185' presented to the user 210. For example, in a conversation in which two interlocutors are discussing which item to buy at a grocery store, the correct response 425 may be associated with an act related to buying the item discussed in the conversation.

[0122] Conversely, an incorrect response may be indicated by a UI element 135B depicting the words "I say 'Give me a coffee'" or a UI element 135C depicting the words "I'll take someone else's coffee." In this manner, an incorrect response may be associated with socially inappropriate, immoral, behaviorally abnormal, or emotionally unstable behavior. Examples of incorrect responses include yelling, stealing, physical fighting, lying, or being rude. In some embodiments, an incorrect response 425 may correspond to a selection of information that cannot be inferred from a conversation of a set of audio recordings 185' presented to the user 210. For example, in a conversation in which two individuals are discussing vacation plans, an incorrect response 425 may be associated with an incorrect amount for the vacation budget.

[0123] Based on whether the response 425 is correct or incorrect, the performance evaluator 150 can calculate, generate, or otherwise evaluate a performance metric 415 for the user 210 based on the selection 205′ associated with the response 425. For example, the performance evaluator 150 can set the performance metric 415 for a given response 425 as “1” if correct and “−1” if incorrect. In some embodiments, the performance evaluator 150 can determine a response time or correctness of the user 210 in choosing the selection 205′. For example, the performance evaluator 150 can determine from the response 225 that the user 210 has not performed one or more actions indicated by the prompt 430 or image 180′, or that the user 210 has not performed an action within a threshold time. The threshold time can correspond to or be defined as an amount of time that the user 210 is expected to make a selection 205′ on one of the UI elements 135, and can range from 5 seconds to 10 minutes. This determination may cause the performance evaluator 150 to modify or adjust the performance metric 415 using the response time compared to the threshold time.

[0124] In some embodiments, the performance evaluator 150 may calculate, generate, or otherwise identify a performance metric 415 associated with an increase in cognitive functioning or a decrease in impairment (e.g., social processing or non-social processing) of the user 210. The performance evaluator 150 may determine the performance metric 415 based on a delay time between the presentation of the image 180' and the receipt of the interaction 425. For example, the delay time between the subsequent presentation of the image 180' (or audio recording 185') and the receipt of the interaction 205' may decrease. This decrease in delay time may indicate an increase in cognitive functioning or a decrease in impairment of the user 210.

[0125] The session manager 140 may modify the session 420 (e.g., including the presentation of images 180′, audio recordings 185′, and prompts 430) based on the performance metrics 415. In some embodiments, the performance evaluator 150 may generate the performance metrics 415 during the first time period based on the responses 425. The session manager 140 may modify tier parameters 445A-N associated with a tier of the session 420. The tier parameters 445A-N (hereinafter generally referred to as tier parameters 445 or parameters 445) may define the presentation of the session 420. The parameters 445 may correspond to the presentation of images 180′, audio recordings 185′, prompts 430, or UI elements 135.

[0126] The parameters 445 can include a type of modality of the content. The type of modality of the content can include the manner in which the session 420 is presented, such as auditory, visual, tactile, or textual. For example, the session manager 140 can modify the image 180' to include an auditory reading of the text shown therein. The parameters 445 can include a context for the social setting in the image. The context of the social setting in the image can be related to information provided about the virtual setting 435 during the session, such as the location of the virtual setting 435 or the social interactions displayed in the image 180'. The parameters 445 can include a number of characters 440 in the virtual setting 435. For example, the session manager 140 can add characters 440 to the virtual setting 435 or remove characters 440 from the virtual setting 435. The parameters 445 can include a type of prompt. The type of prompt can include a query, an action, or an instruction, etc.

[0127] In some embodiments, the session manager 140 can modify the prompt 430 to display alternative text or images or to be associated with an alternative UI element 135. The session manager 140 can change the type of the prompt from a query to an action or reword the type of query. The parameters 445 can include a difficulty level of the response. The difficulty level can relate to how often a set of users make a correct selection for a given prompt. For example, a first prompt that elicits more incorrect responses than a second prompt may be more difficult than a second prompt. The parameters 445 can include a type of response. The type of response can refer to the UI element 135 selected by the user 210 or can refer to a classification of the response. For example, a first response can be classified as an "aggressive" response based on the selection of the UI element 135 and a second response can be classified as a "calm" response. The parameters 445 can include multiple responses. For example, the session manager 140 can modify the presentation of the prompt 430 to include more prompts based on the number of responses received so far by the session manager 140.

[0128] In some embodiments, the session manager 140 can modify the presentation of the audio recording 185' according to a set of parameters 445. The set of parameters 445 can include a set of controls or constraints that apply to the presentation of the audio recording 185'. In some embodiments, the session manager 140 can use the constraints defined by the set of parameters 445 when selecting a new audio recording 185' for a subsequent session. The parameters 445 can also include distractions. For example, the distractions can include adding noise (e.g., Gaussian noise) or including interrupting speech in the speech sample of the audio recording 185'. The parameters 445 can include the ability to repeat the presentation of the audio recording 185'. For example, a constraint may limit the number of times the user 210 can repeatedly press (e.g., one of the UI elements 135) to listen to the audio recording 185'. The parameters 445 can also include speed modifications. For example, a constraint may specify the playback speed of the audio in the audio recording 185'. The parameters 445 may include the volume (or intensity) of the sound in the sound recording 185'.

[0129] Additionally, the parameters 445 may specify the time between each word (or sentence) in the audio recording 185'. For example, the parameters 445 may define the amount of time between the presentation of one phrase and the presentation of a subsequent phrase while presenting the audio recording 185'. The parameters 445 may include the number of words in each sentence. For example, the constraint may specify a minimum or maximum number of words to be presented in each sentence of the audio recording 185'. The parameters 445 may include the length of the audio recording 185'. The length may specify a minimum or maximum duration of the audio recording 185'. The parameters 445 may include functionality to control distractors. For example, the user interface 130 may include a UI element 135 for including or excluding distractors in the presentation of the audio recording 185'.

[0130] The session manager 140 can present the modified session at a second time instance. The session manager 140 can provide the modified session including a modified image 180′, a modified voice recording 185′, a modified prompt 430, a modified UI elements 135, or any combination thereof. In some embodiments, the providing of the session 420 at the second time instance can include displaying a third image 180C′. The third image 180C′ can include a second virtual setting 435, a second prompt 430B, or a second set of UI elements 135B. The second prompt 430B can specify a second query related to a second character depicted in the second virtual setting 435. For example, the session manager 140 can modify the prompt to display a second or different query related to a second or different character 440 during the session 420 by modifying the layer parameter 445. The set of UI elements 135 can specify a set of corresponding responses related to the second character. In some embodiments, session manager 140 can provide a modified session having prompts 430 that configure, set, or otherwise modify parameters 445 applied to the presentation of audio recording 185'. For example, session manager 140 can specify that prompts 430 include options such as reducing distractions, slowing down speech, or increasing the volume.

[0131] According to the parameters 445, the application 125 can display UI elements 135 corresponding to a set of selections 205' associated with the second character in the second virtual setting. The application 125 can present the audio recording 185' with one or more constraints defined by the parameters 445 applied. For example, the application 125 can remove the UI elements 135 corresponding to the play button and increase the playback speed of the audio recording 185'. By modifying the parameters 445 of the session 420, the session manager 140 can provide a tailored session to the user 210 based on the user's performance as indicated by the performance metrics 415. This approach to cognitive improvement can reduce computational resources allocated to non-critical sessions and can further improve adherence to the digital therapeutic regimen. In some embodiments, the application 125 can present a prompt 430 via the UI elements 135 to allow the user 130 to modify the parameters 445 applied to the presentation of the audio recording 185'. For example, the user interface 130 of the prompt 430 may include UI elements 135 for reducing distractions, increasing the volume, decreasing the speed, and repeating at least a portion of the conversation.

[0132] Additionally, the feedback provider 155 may generate, output, or otherwise generate feedback 450 for receipt by the user 210 via the application 125 running on the user interface 130. The feedback provider 155 may generate the feedback 450 based on at least the performance metrics 415, the responses 425, the prompts 430 including queries, the user profile 165, or historical sessions, images 180, audio recordings 185', or prompt presentations. The feedback 450 may include a presentation of the performance metrics 415. The feedback 450 may display messages such as motivational messages, suggestions for improving performance, congratulatory messages, or comforting messages. In some embodiments, the feedback provider 155 may generate such feedback 450 during a session being performed by the user 210. In some embodiments, the feedback provider 155 may generate feedback that provides text including an explanation of a correct response. The explanatory text may be maintained and stored in a database 160 (eg, using one or more files) and may be retrieved from the database 160 for feedback 450 .

[0133] The feedback provider 145 can provide, transmit, or otherwise send the feedback 450 to the application 125 for display on the user interface 130. The feedback provider 145 can provide instructions for rendering or displaying the feedback 450. The feedback provider 145 can send a data packet, signal, or other instruction to the application 125 indicating the presentation of the feedback 450. Upon receiving this, the application 125 can present the feedback 450 to the user 210 via the user interface 130. The presentation of the feedback 450 can include UI elements 135. For example, the user 210 can make a selection associated with the feedback 450, such as to increase the difficulty of the session or to restart the session 420. In some embodiments, the application 125 can present the feedback 450 to display explanatory text for the correct response.

[0134] The performance evaluator 150's determination of the performance metric 415 may cause the session manager 140 to determine to transition to a third session. The session manager 140 may determine to transition the user 210 from the virtual training tier associated with the session 420 to a training tier associated with another session. The session manager 140 may provide the third session in response to the performance evaluator 150 determining that the performance metric 415 is equal to or greater than the threshold. The performance evaluator 150 may determine that the performance metric 415 is equal to or greater than the performance threshold for the session 420. Conversely, upon determining that the performance metric 415 is equal to or greater than the performance threshold for the session, the session manager 140 may provide the other session. The performance evaluator 150 may also determine that the performance metric 415 falls below the performance threshold for the session 420. Upon determining that the performance metric 415 falls below the performance threshold, the session manager 140 may maintain the session 420.

[0135] 5A-5G, a set of exemplary user interfaces 500A-G for providing a second session are depicted. The user interfaces of the set 500A can include user interfaces 505-520. In some embodiments, the user interfaces of the set 500A can be part of or included in the second session providing a virtual functional training layer. The user interfaces 505-520 can depict an exemplary virtual setting, such as the virtual setting 435 depicted with reference to FIG. 4. The user interface 520 can include feedback 525 regarding the user's selection in a previous interface. The feedback 525 can be presented by the service in response to receiving a response by the user at the interface 515.

[0136] Through the suite 500A interfaces provided in the second session (e.g., session 420), the user can be trained in social or non-social skills. Social skills can include performing social interactions in social situations, such as ordering coffee at a store, asking a stranger for directions, reaching or reaching for an object if someone is blocking the way, etc. Non-social skills can include memory skills, such as time management and verbal memory skills, such as remembering spoken words and associating images from spoken words. Social settings can include interactions observed between one or more individuals or interactions in which the subject participates together with one or more others. For example, the subject can read or observe a social setting in which a customer is arguing with a cashier. The subject can also participate in and engage in interactions, such as transactions, conversations, exchanges of items, meals, and other social interactions, with various individuals, such as cashiers, tellers, neighbors, friends, coworkers, and other individuals.

[0137] Social settings include parties, offices, public spaces, transportation, or other settings or environments in which the subject observes or participates in social interactions. Social interactions and social environments do not necessarily require speech and may include written or written communication, non-verbal communication, or sign language, among others. Social interactions and social settings may include social cues such as an individual's body language, tone of voice, volume of voice, eye contact, facial expression, and the like. In some cases, appropriate social interactions in a social setting may be identified by the subject through social cues presented by individuals in that social setting. In sessions provided by the service, the subject may be readily trained to identify or select social interactions based on the social cues of the social situation. For example, as depicted in user interfaces 505-520, upon successfully completing a regimen of sessions, the subject may decide to politely draw the cashier's attention toward the subject if the cashier's body language, eye contact, and facial expression indicate to the subject that the cashier is not busy.

[0138] In the set 500B of user interfaces, the application 125 can display a user interface 525A having a play button to initiate playback of a set of audio recordings 185' corresponding to conversations related to the social setting. The conversations can be about obtaining products at a supermarket. When the button is pressed, the application 125 can play the audio recordings 185'. Following playback, the application 125 can display a user interface 530A having an image 180' of a supermarket to prompt the user 210 about the information communicated in the conversation. In the depicted example, the application 125 can include a question about which shelf aisle the user 210 should go to to obtain the products mentioned in the conversation.

[0139] In the set 500C of user interfaces, the application 125 can display a user interface 525B having a play button to initiate playback of a set of audio recordings 185′ corresponding to a conversation associated with the social setting. The conversation can include obtaining ingredients to make the salad as well as instructions for making the salad. When the button is pressed, the application 125 can play the audio recordings 185′. Following playback, the application 125 can display a user interface 530B to prompt the user 210 for responses to information communicated in the conversation. In the depicted example, the application 125 can include a question about which step came first in the instructions for making the salad.

[0140] In the user interface of the set 500D, the application 125 can display a user interface 535A having a play button to initiate playback of the set of audio recordings 185' corresponding to the conversation associated with the social setting. After the user presses the "tap to continue" button, the application 125 can present a user interface 540A to prompt the user 210 to listen to the conversation. The application 125 can then display a user interface 545A that prompts the user to recall information about the conversation presented via the audio recordings 185'. Once the user presses continue, the application 125 can display a user interface 550A to instruct the user 210 to get as many correct answers as possible. The application 125 can proceed to play the set of audio recordings 185'.

[0141] The user interface of the set 500E can be similar to that presented in the user interface of the set 500D, with the addition of parameters 445 that apply to the presentation of the audio recordings 185'. In the user interface of the set 500E, the application 125 can display a user interface 535B having a play button to initiate playback of the set of audio recordings 185' corresponding to the conversation associated with the social setting. After the user presses the "tap to continue" button, the application 125 can present a user interface 540B to prompt the user 210 to listen to the conversation and inform the user 210 that it may contain distractions, including noise and other speech. The application 125 can then display a user interface 545B that informs the user about the ability to reduce distractions during the conversation. Once the user presses continue, the application 125 can display a user interface 550A to instruct the user 210 to get as many correct answers as possible. The application 125 can proceed to play the set of audio recordings 185' with the added distractions.

[0142] In the user interface of the set 500F, the application 125 can display a user interface 555A having a play button to initiate playback of the set of audio recordings 185' corresponding to the conversation. After the user presses the button, the application 125 can play the audio recordings 185' with one or more parameters 445, such as noise, low volume, or fast speech. Following presentation of the audio recordings 185', the application 125 can present a user interface 560A that prompts the user 210 regarding the parameters 445 for modifying the presentation of the conversation in the set of audio recordings 185'. Once one of the options is selected, the application 125 can present a user interface 565A to provide feedback 450 regarding the selection by the user 210.

[0143] In the set 500G of user interfaces, the application 125 can display a user interface 555B having a play button to initiate playback of a set of audio recordings 185' corresponding to the conversation. When the user presses the button, the application 125 can play the audio recordings 185'. Following presentation of the audio recordings 185', the application 125 can present a user interface 560A that prompts the user 210 regarding information conveyed in the conversation and provides a list of options related to that information. Once one of the options is selected, the application 125 can present a user interface 565B to provide feedback 450 regarding the selection by the user 210.

[0144] 6 shows a block diagram of a process 600 for providing a third session of a functional training layer for a user to use social skills. The process 600 may include or correspond to operations performed in the system 100, the process 200, or the process 400. Under the process 600, the session manager 140 may provide a session 620 corresponding to the functional training layer. The interaction handler 145 may receive a response 625 indicating the performance of an act of the functional training layer. The performance evaluator 150 may identify a performance metric 615 based on the response 625. The feedback provider 155 may provide feedback to the user 210 based on the performance metric 615.

[0145] The session manager 140 can provide a session 620 to the application 125. The session 620 can be a third session 620 and can correspond to a third tier. The third tier can be a functional training tier. The functional training tier can be a treatment tier in which one or more prompts 630 are displayed to the user via the user interface 130 to instruct the user on an activity. The activity can include an activity in a real-world environment different from the virtual setting 435 of FIG. 4. The activity can include the user 210's engagement in a social setting such as a library, a store, a park, etc. For example, the activity can include the user 210 buying coffee in person at a coffee shop, asking a librarian in person for help finding a book in a library, or having a conversation in person on a bus. By participating in an activity in a real-world environment, the user 210 can practice social skills in the real world, combining multiple teachings from previous sessions to reduce functional impairments. The functional training tier can also further improve non-social skills such as verbal memory in previous tiers, such as following recipe instructions in a tutorial video on how to bake a cake or recalling contact details of a person through a conversation.

[0146] The user interface 130 can display one or more prompts 630A-N instructing the user 210 to perform one or more activities. When the session 620 is presented, the user 210 can choose to act now or can choose to postpone the activity until a later time. In some embodiments, upon presentation of the prompts 630A-N, the user 210 can use the UI element 135 to select a time to act. For example, the user 210 can make a selection 605 using the UI element 135 to indicate a time to act. The response 625 can be sent at a first time T1. The response 625 can indicate a second time T2 at which the user chooses to act. In some embodiments, the second time T2 can indicate a time at which the user 210 will act. In some embodiments, the second time T2 can indicate a time at which the session management service 105 will send a reminder message 635 instructing the user 210 to act.

[0147] The interaction handler 145 may send the reminder message 635 at the time T2 indicated by the user 210 in the response 625. The interaction handler 145 may automatically send the reminder message 635 when the time T2 is reached. The time T2 may be a countdown (e.g., a delay of one hour or one day) or the time T2 may be a specific time or date (e.g., 6 p.m. on Friday). The interaction handler 145 may send the reminder message 635 including a prompt 630 for an activity to be performed. The reminder message 635 may be displayed on the user interface 130. The user 210 may snooze the reminder message 635 (e.g., delay it until a later time). In some cases, the reminder message 635 may be snoozed a threshold number of times. If the number of snoozes exceeds a threshold number, the user 210 may not be able to snooze the reminder message 635.

[0148] The user 210 may perform the activity indicated in the prompt 630 or the reminder message 635. Upon performing the activity, the user 210 may make one or more selections 605 indicating the performance of the activity. In some cases, the session management service 105 or application 125 may prompt the user 210 to perform the activity regardless of whether the user 210 indicates completion of the activity. The session management service 105 or application 125 may prompt the user 210 to perform the activity in response to the passage of a period of time, in response to the selection 605 by the user 210, or in response to a schedule of prompts. Prompting the user 210 to perform the activity may include displaying a UI element 135 on the user interface 130. In some embodiments, the user 210 may be provided with multiple possible choices of UI elements 135 corresponding to the user 210 performing the activity. For example, user interface 130 may display a first UI element 135A indicating the activity was successful, a second UI element 135B indicating the activity was unsuccessful, or a third UI element 135C indicating that user 210 did not perform the activity. In some embodiments, UI element 135 may include a text box in which user 210 may dictate or type a response indicating the performance of the activity.

[0149] The activity performance can identify the state of the user 210 during the performance of the activity (e.g., emotional state, reaction, or difficulty of a challenge). For example, the activity performance can include whether the user performed the activity, the length of time the activity was performed, challenges encountered during the activity, general feelings or reflections regarding the activity, or a numerical rating of how the performance of the activity made the user 210 feel, etc. The user 210 can indicate their performance of the activity through a selection 605 of a UI element 135. The application 125 can detect the selection 605 and send a response 625 to the interaction handler 145 indicating the performance of the activity.

[0150] The performance evaluator 150 can determine a performance metric 615 for the session 620 based on the response 625. The performance evaluator 150 can determine the performance metric 615 in the same or similar manner as described in connection with the performance metric 215 of FIG. 2 or the performance metric 415 of FIG. 4. The performance evaluator 150 can determine the performance metric 615 based on the response 625 that includes an instruction to perform an activity. The performance evaluator 150 can determine the performance metric 615 based on the instruction to perform. In some embodiments, the user 210 can indicate that the activity was successful. When the user 210 indicates that the activity was successful, the performance evaluator 150 can determine a high performance metric 615. Conversely, when the user 210 indicates that the activity was unsuccessful or that the user 210 did not perform the activity, the performance evaluator 150 can determine a low performance metric 615.

[0151] The session management service 105 may repeat the above-mentioned functions (e.g., processes 200, 400, and 600) over multiple sessions. The number of sessions may span a set number of days, weeks, or years, or may have no clear end point. By repeatedly providing different sessions corresponding to different tiers based on at least the performance metrics 215, 415, and 615, the user profile 165, and the responses 225, 425, and 625, the user 210 may receive training to improve impairments (e.g., social or non-social processing impairments) associated with the condition. This may alleviate symptoms faced by the user 210 even when suffering from a condition that may otherwise inhibit the user from seeking treatment or even physically accessing the user device 110. Additionally, the quality of human-computer interaction (HCI) between the user 210 and the user device 110 may be improved from participating in sessions presented via the user interface 130 of the application 125.

[0152] Because these sessions can build on one another to provide a comprehensive and manageable regimen, the user 210 is more likely to participate in the sessions when presented via the user device 110. This reduces unnecessary consumption of the service and the computational resources (e.g., processing and memory) of the user device 110 and reduces network bandwidth usage compared to transmitting unnecessary or unimportant sessions. Furthermore, in the context of digital therapeutic applications, the tailored selection of sessions, including such images and prompts, can provide a user-specific intervention and improve the subject's adherence to the treatment. This can result in higher adherence to the therapeutic intervention as well as potential improvement of the user's condition or cognitive or functional impairment.

[0153] 7A-7E show screenshots of exemplary sets 700A-E of user interfaces for providing a third session. In the set 700A of user interfaces, the application 125 can present user interfaces 705-730. The set 700A of user interfaces can be part of or included in a third session providing a functional training layer. The user interfaces 705-730 show activities for the user to perform, such as activities described herein. The user interface 705 can be a prompt instructing the user to perform a particular activity (e.g., observing and performing a gesture). The second interface 710 can include information for the user to recognize social cues in a real-world setting. The third interface 715 can include a prompt for selecting what time to send a reminder.

[0154] In the set of user interfaces 700B, the application 125 can present user interfaces 720-730. The user interface 720 can allow the user 210 to specify a time to send a reminder message. The user interface 725 can prompt the user 210 to indicate feedback regarding a particular activity taking place around the user 210. The user interface 730 can send feedback to the user 210 regarding the response in the user interface 725. In the set of user interfaces 700C, the application 125 can present a user interface 735 to indicate to the user 210 the start of a new activity to utilize language memory-based skills in the user's surroundings. When an interaction with the start button is detected, the application 125 can present a user interface 740 to provide clues regarding the activity to the user 210. Subsequently, the application 125 can present a user interface 745 to provide instructions regarding the listening skill activity. The application 125 can present a user interface 750 to explain a specific purpose of the listening skill activity.

[0155] In set 700D of user interfaces, application 125 may present user interface 755 to instruct user 210 to perform a task in the surrounding area (e.g., the user's home). If the user presses continue, application 125 may present user interface 760 to provide additional instructions regarding the task to be performed. Application 125 may also display user interface 765 to allow user 210 to select a time to perform the activity. Upon continuing, application 125 may display user interface 770 to provide hints regarding the performance of the action. Application 125 may display user interface 775 to inform the user to return to application 125 to perform the task and record via application 125. In set 700E of user interfaces, after the activity is completed, application 125 may display user interfaces 780 and 785 to inform user 210 of successful completion of the task.

[0156] 8A-8C are flow charts of a method 800 of presenting an interaction session to address a user's impairment. The method 800 can be implemented or performed using any or a combination of components detailed herein, such as the session management service 105 and the user device 110. Under the method 800, a service (e.g., the session management service 105) can identify a set of sessions (805). Each session can correspond to a respective tier and can include one or more images and prompts. The service can provide a first session of the set of sessions to a user device (e.g., the user device 110) (810). Providing the first session can include providing an image and a prompt associated with the first session. The user device can present the first image and the first prompt using a display device of the user device (815). Upon presenting the first image and the first prompt, an application running on the user device can detect and transmit a first selection associated with a cue presented in the first session (825). The cue can be or include the cue 235 shown in FIG. 2. The service may receive a first selection of the cue (820). Upon receiving the first selection of the cue, the service may determine whether a selection rate is above a threshold (830). The selection rate may refer to a rate of correct selections received by the service from the user device. If the selection rate is below the threshold, the service may return to providing the first session (810). If the selection rate is equal to or greater than the threshold, the service may provide a second session (835). The second session may include a virtual functional training layer. The user device may present a second image, a second prompt, and an interaction element associated with the second session (840).

[0157] Continuing with the method 800 in FIG. 8B, in response to presenting the second image, the second prompt, and the interactive element (840), an application operating on the user device can detect a selection of a response via the interactive element (850). In some embodiments, the user 210 can use the interactive element to select a first response corresponding to the second image or the second prompt. In some embodiments, the application can detect the selection of the interactive element and can generate a response based on the selection to send to the service. The service can receive the first response (845). The service can receive the first response indicating the selection associated with the second session. The service can generate a performance metric (855). The service can generate a performance metric based at least on the first response. The service can provide feedback (860). The service can provide feedback to the user device via the application. The feedback can be generated by the service based on at least one of the first response, the performance metric, the selection, the second image, or the second prompt. The user device can present the feedback (865). The user device may present the feedback via an application operating on the user device.

[0158] Upon providing the feedback, the service may determine whether the performance metric is above a threshold (870). If the performance metric is not above the threshold, the service may modify the presentation of the session (875). If the performance metric is at or above the threshold, the service may provide a third session (880). The third session may include or correspond to a functional training tier and may include one or more third prompts. The user device may present the third prompt (885).

[0159] Continuing with the method 800 of FIG. 8C , the user device may present a third prompt (885). Presenting the third prompt may include presenting a prompt instructing the user to perform an activity. The user device may send a response (895). The response may include instructions for a behavioral activity, or the response may include a time to remind the user to perform the activity. The service may receive a second response (890). Upon receiving the second response, the service may send a reminder message at the time indicated in the second response, store the response, or generate performance metrics for the user based on the response.

[0160] B. How to improve functional impairment in users with schizophrenia Referring now to FIG. 9, a flow chart of a method 900 for providing a required improvement to a functional impairment of a user with schizophrenia is depicted. The method 900 may be performed by any of the components or actors described herein, such as the session management service 105, the user device 110, or the user 210. The method 900 may be used in combination with any of the functions or operations described in the examples of Sections A and B herein. The method 900 may include a method for providing a required improvement to a functional impairment of a user with schizophrenia. The functional impairment may include, among others, social processing (e.g., social perception and emotional processing) or non-social processing (e.g., verbal memory, mentalizing, theory of mind, and problem solving). In general terms, the method 900 may include obtaining a baseline metric (905). The method 900 may include identifying a tier for the session (910). The method 900 may include providing a session for the tier (915). The method 900 may include determining whether to move to a next tier (920). The method 900 may include identifying a next tier if the decision is to transition (925). Otherwise, the method 900 may include maintaining the current tier if the decision is not to transition (930). The method 900 may include obtaining a session metric (935). The method 900 may include determining whether to continue (940). The method 900 may include determining whether the session metric is an improvement over a baseline metric (945). The method 900 may include determining that an improvement is indicated if the session metric is determined to be an improvement over the baseline metric (950). The method 900 may include determining that an improvement is not indicated if the session metric is determined to not be an improvement over the baseline metric (955).

[0161] In further detail, the method 900 can include retrieving, identifying, or otherwise obtaining a baseline metric (905). The baseline metric can be associated with a user (e.g., user 210) having or diagnosed with schizophrenia. The user's schizophrenia may further include positive symptoms including hallucinations and delusions, or negative symptoms including reduced motivation or emotional expression. The user's schizophrenia can lead to impairments in functioning (e.g., social or non-social processing). For example, impairments associated with the user can include one or more of reduced educational attainment, reduced quality of life, difficulty living independently, reduced social functioning, or impaired occupational functioning, or the like.

[0162] The baseline metrics may be obtained (e.g., by a computing system such as the session management service 105 or the user device 110, or both) prior to providing any session to the user via a digital therapeutic application (e.g., application 125 or a research app described herein). The baseline metrics may indicate the severity of the user's impairment due to schizophrenia. The baseline metrics may include, for example, a Multnomah Area Capacity Scale (MCAS) value, a Lawton Instrumental Activities of Daily Living (Lawton IADL) value, a Personal and Social Performance (PSP) scale value, a Time Use Survey value, a Patient Global Impression of Improvement (PGI-I) scale value, a Clinical Global Improvement (CGI-I) scale value, or a World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) value, or the like. Other metrics, such as Clinical Rating Scale (CRS) values, Medication Adherence Rating Scale (MARS) values, Columbia Suicide Severity Rating Scale (C-SSRS) values, etc., can be used to indicate other related effects (e.g., to indicate medication adherence or as an exclusion criterion). The scales used to measure the severity of the functional impairment may differ depending on whether they correspond to social or non-social processing. For social processing (e.g., social perception), the metrics can include MCAS, Lawton IADL, PSP, or WHO-DAS 2.0 scale values, etc. For non-social processing (e.g., verbal memory), the metrics can include MCAS, CRS, CGI-I, or MARS-a, etc. Additional explanations of the scales are provided below.

[0163] Multnomah Community Competence Scale (MCAS): The Multnomah Community Competence Scale is used to assess the functioning of adults with mental disorders living in the community. Both scales (clinician-rated and self-report) are based on standard methodologies for scale development. In this study, the clinician-rated version of the Multnomah Community Competence Scale was used and will be referred to hereafter. We also used an expanded version that includes behavioral anchors and additional interview probes that have been standardized in patients with schizophrenia and other serious mental illnesses. Trained non-clinicians can also serve as raters and have been shown to have high reliability. The Multnomah Community Competence Scale measures the degree of functional ability over the past month through 17 indicators. These indicators are rated on a 5-point scale ranging from 5 (no impairment) to 1 (extreme impairment). A maximum score of 85 indicates a high level of functioning. The trainer-rated Multnomah Community Competence Scale takes an average of 20 minutes to complete.

[0164] Lawton Instrumental Activities of Daily Living Scale: The Lawton Instrumental Activities of Daily Living (Lawton IADL) Scale assesses an individual's ability to live independently across eight categories: using the telephone, shopping, cooking, housework, doing laundry, using transportation, taking medication as prescribed, and managing finances. Each category has a list of tasks and is rated with a score of 0 (low functioning, dependent) or 1 (high functioning, independent). A total score ranges from 0 (low functioning, dependent) to 8 (high functioning, independent) for women and 0 (low functioning, dependent) to 5 (high functioning, independent) for men.

[0165] Scale of Personal and Social Functioning (PSP): The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work, study), personal and social relationships, self-care, and disruptive and aggressive behaviors. Each domain is rated from 0-100 with anchors at 10-point intervals. A total score is calculated out of 10.

[0166] World Health Organization Disability Assessment Scale (WHO-DAS 2.0): The WHODAS 2.0 is a 36-item self-rating scale that measures participants' functioning and disability across six areas of life: cognition (understanding and communicating), mobility (moving around and getting around), self-care (hygiene, dressing, eating, being alone), social (interacting with others), daily activities (household chores, leisure, work, school) and participation (community and society).

[0167] Clinical Rating Scale (CRS): The CRS is a one-item scale that allows clinicians to rate the level of adherence to medication or treatment observed by the patient. This item is rated on a scale of 1-7, with 1 indicating complete refusal to adhere to medication or treatment and 7 indicating active participation in treatment.

[0168] Medication Adherence Rating Scale (MARS): The MARS is a 10-item scale in which patients are asked about their adherence, or compliance, to their psychiatric medications. For each item, patients are asked questions about their medication-related behaviors and attitudes over the past week. Patients are asked to answer each item with a "yes" or "no." Items are summed to obtain a final score ranging from 0 (poor adherence to psychiatric treatment) to 10 (good adherence to psychiatric treatment).

[0169] Time Use Survey: The time use survey is a semi-directive interview to assess how the patient has used their time during the past month. Patients are asked about work, education, voluntary work, leisure, sports, hobbies, socializing, rest, household chores / daily chores, child care, and sleep. The time spent on each activity is calculated as the number of hours per week allocated to that activity during the past month. The interview takes approximately 30-45 minutes.

[0170] Columbia-Suicide Severity Scale (C-SSRS): The Columbia-Suicide Severity Scale (C-SSRS) is an assessment tool that assesses suicidal ideation and behavior. The scale has been successfully administered in many settings, including schools, college campuses, the military, fire departments, the justice system, primary health care, and scientific research. The scale is intended to be used by individuals who have been trained in its administration. The questions included in the Columbia-Suicide Severity Scale are the recommended probes for determining suicide risk. Ultimately, the determination of the presence or absence of suicidal ideation or behavior depends on the judgment of the individual administering the scale.

[0171] Patient Global Impression of Improvement (PGI-I): The PGI-I is a single-item patient-reported outcome that measures participatory subjective improvement on a 7-point scale in the severity of experienced negative symptoms. Higher scores on the PGI-I indicate subjective reports of worsening illness during treatment. Response options are: 1=very much better, 2=much ​​better, 3=slightly better, 4=no change, 5=slightly worse, 6=much ​​worse, 7=very worse.

[0172] Clinical Global Improvement Indicator (CGI-I): The CGI-I is a one-item standardized clinician-rated scale that assesses how much a patient's illness has improved or worsened in the past 7 days since enrollment in a study or treatment. The scale uses a 7-point Likert scale with higher scores indicating worsening illness. Response options are: 1 = very improved, 2 = much improved, 3 = mildly improved, 4 = no change, 5 = mildly worse, 6 = much worse, 7 = very worse.

[0173] Clinical Global Impression-Severity (CGI-S): The CGI-S is a single-item standardized clinician-rated global rating scale that measures the severity of experienced negative symptoms over the past 7 days using a 7-point Likert scale. Higher scores on the CGI-S represent greater severity of illness. Response options are: 0=not rated; 1=normal, not ill at all; 2=borderline psychosis; 3=mild; 4=moderate; 5=markedly ill; 6=severe; and 7=most severely ill participants.

[0174] Medication Adherence Rating Scale-a (MARS-a): The MARS-a is a 10-item scale in which patients are asked about their adherence, or compliance, to their psychiatric medications. For each item, patients are asked questions about their medication-related behaviors and attitudes over the past week. Patients are asked to answer each item with a "yes" or "no." Items are summed to obtain a final score ranging from 0 (poor adherence to psychiatric treatment) to 10 (good adherence to psychiatric treatment).

[0175] Benefit Assessment: Study participants may directly benefit from an interactive, software-based intervention featuring cognitive training and messaging. CT-156 is an adaptation of cognitive remediation training, supplemented by ecological generalization of cognitive training, a well-validated treatment option for treating functional impairments in people diagnosed with schizophrenia. It integrates multiple psychosocial treatment techniques to collaboratively treat functional impairments associated with schizophrenia, as described in the symptom-psychological model.

[0176] The users can have any demographic or characteristics, such as by age (e.g., adult (18 years or older) or late adolescent (between 18-24 years old)) or gender (e.g., male, female, or non-binary). The users may be receiving treatment for schizophrenia at least partially concurrently with one or more sessions. The treatment may include psychosocial interventions or medications to address schizophrenia. Psychosocial interventions may include psychoeducation, group therapy, cognitive behavioral therapy (CBT), or early intervention for first-episode psychosis (FEP). For example, the medication may be a typical antipsychotic (e.g., haloperidol, chlorpromazine, fluphenazine, perphenazine, loxitane, thioridazine, or trifluoperazine) or an atypical antipsychotic (e.g., aripiprazole, risperidone, clozapine, quetiapine, olanzapine, ziprasidone, lurasidone, paliperidone, or iclepertine).

[0177] The method 900 can include selecting, identifying, or otherwise specifying at least one of a set of tiers of one or more sessions (e.g., sessions 220, 420, or 620) for a user (910). A computing system (e.g., session management service 105 or user device 110, or both) can execute a digital therapeutic application (e.g., application 125) to provide improved life skills through cognitive intervention (ELSCI). The computing system can identify the tier of the session based on a schedule or a user profile (e.g., user profile 165). The tiers can include, among others, a first tier for cognitive training, a second tier for virtual functional training, and a third tier for ecological functional training. The schedule or profile can identify which tier the user is currently working on. The user can start with the first tier and progress to the second and third tiers after completion of the previous tier. From the schedule or profile, the computing system can identify the tier for the user.

[0178] The method 900 can include providing or presenting sessions for the identified tier (915). The computing system can provide instructions for the sessions according to the identified tier. Each session can correspond to an identified tier that trains the user in a particular social or non-social skill aimed at addressing impairments due to schizophrenia. The instructions can define images (e.g., images 180) and prompts according to a configuration of the tier (e.g., tier configuration 170). Once received, the application can present the images and prompts via one or more elements of a user interface (e.g., user interface 130).

[0179] For the first tier session, the computing system may display one or more images (e.g., image 180) that prompt the user to recognize one or more of a plurality of social cues associated with the social skill. In some embodiments, the computing system may display an image of the social cue (e.g., cue 235) and a prompt (e.g., prompt 230) that includes a set of interaction elements that identify a plurality of corresponding types of cues related to the image. The computing system may receive a user-selected one of the plurality of types of social cues via at least one of the set of interaction elements. The cues may include, among others, head movements (e.g., nodding, shaking, tilting, or other head gestures), body language (e.g., facial expressions, overall body posture, and proximity to other characters), gestures (e.g., pointing with a finger or expressing emotion via hands or fingers), or eye contact (e.g., eye direction toward another person to indicate engagement, involvement, or emotion).

[0180] In some embodiments, for a first tier session associated with a non-social skill, such as verbal memory, the computing system can present the user with one or more first audio recordings (e.g., audio recording 185) that evoke one or more of the plurality of words. The computing system can identify a set of audio recordings to present to the user. Each audio recording corresponds to one or more words. Once the set of audio recordings is identified, the computing system can present the set of audio recordings according to a format. The format can define a context in which the words of the audio recordings are presented. The computing system can display a user interface that prompts the user to select at least one of the words presented in the audio recordings. The computing system can receive a selection of words from the user.

[0181] For a second tier session, the computing system may display an image (e.g., image 180') of a social setting (e.g., virtual setting 435). The image may be presented with a prompt (e.g., prompt 430) that identifies a query associated with a character (e.g., character 440) exhibiting one of a plurality of social cues, and a set of interaction elements that identify a corresponding plurality of responses to the character. In some embodiments, the computing system may display the image of the set of settings with the character according to a defined order. The computing system can receive a response (e.g., response 425) selected by the user from the plurality of responses via at least one of the second set of interaction elements. The computing system can provide feedback (e.g., feedback 450) to the user based on the query and the response regarding the setting.

[0182] In some embodiments, the computing system can present the second tier according to a set of parameters (e.g., parameters 445). These parameters can include, for example, a type of contextual modality, a context of the setting in the image, a number of characters in the setting, a type of prompt, a difficulty level of the response, a type of response, or a number of responses, etc. In some embodiments, the computing system can, in one instance, modify the presentation of the second tier session using responses from the user in a previous instance of the second tier session. For example, the computing system may display an image of a social setting having a prompt that identifies a query of a character in the setting and a set of interaction elements that identifies a corresponding number of responses to the second character according to a number of parameters.

[0183] In some embodiments, for the second tier session to utilize language memory skills in a virtual social setting, the computing system can present audio recordings of speech samples (e.g., audio recordings 185'). The speech samples can be from at least one speaker and correspond to one or more sentences by the speaker, such as a statement, a question, an exclamation, a request, a command, or a suggestion. In some embodiments, the computing system can modify the presentation or selection of the audio recordings 185' in the second tier according to a set of parameters. The set of parameters can include inclusion of distractors, the ability to repeat the presentation, modifying the speed, the volume of speech in the audio recording, the time between each word or sentence, the number of words in each sentence, the length of the audio recording, and the ability to control the inclusion or exclusion of distractors. Additionally, the computing system can present a prompt identifying a query associated with the speech sample and a set of interaction elements identifying a set of responses. The query can ask the user to recall information regarding at least a portion of the speech sample. The computing system can receive a response selected by the user from the set of responses via at least one of the user interface elements. The computing system can generate and provide feedback to the user based on the queries and responses.

[0184] For a Tier 3 session, the computing system may display a prompt instructing the user to perform an activity in the user's surroundings or environment. The computing system may then receive a response (e.g., response 625) associated with performing the activity. Additionally, the computing system may present the user with a prompt to select a time to provide a message (e.g., reminder message 635) encouraging the user to perform the activity.

[0185] The method 900 may include determining whether to transition to the next tier (920). The computing system may generate, calculate, or otherwise determine a performance metric (e.g., performance metric 215 or 415) for the user in the current session. Once this determination is made, the computing system may compare the performance metric to a threshold. The threshold may define or identify a value of the performance metric that transitions the user to the next tier (e.g., from the first tier to the second tier, or from the second tier to the third tier). The method 900 may include identifying the next tier if the decision is to transition (925). If the performance metric meets the threshold (e.g., is equal to or greater than the threshold), the computing system may decide to transition the user to the next tier. Otherwise, the method 900 may include maintaining the current tier if the decision is not to transition (930). If the performance metric does not meet the threshold (e.g., is less than the threshold), the computing system may decide not to transition the user to the next tier and to maintain the user in the current tier.

[0186] The method 900 can include obtaining, identifying, or otherwise acquiring a session metric (935). The session metric can be obtained (e.g., by a computing system) after providing at least one session to the user via the digital therapeutic application. The session metric can indicate the severity of the user's impairment due to schizophrenia after providing at least one session in one or more tiers. The session metric can include, for example, a Multnomah Community Ability Scale (MCAS) value, a Lawton Instrumental Activities of Daily Living (Lawton IADL) value, a Personal and Social Performance (PSP) scale value, a Time Use Survey value, a Patient Global Impression of Improvement (PGI-I) scale value, a Clinical Global Improvement (CGI-I) scale value, or a World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) value, or the like. Other metrics can be used (e.g., to indicate adherence or as exclusion criteria), such as Clinical Rating Scale (CRS) values, Medication Adherence Rating Scale (MARS) values, Columbia-Suicide Severity Rating Scale (C-SSRS) values, etc. The session metric can be the same type of metric or measure as the baseline metric.

[0187] Method 900 may include a step of determining or judging whether to continue (940). This decision may be based on a set length of the study (e.g., days, weeks, or years), a set number of time instances to perform one or more sessions, or a set number of sessions to be provided to the user. For example, the set number of time instances may range from 2 weeks to 30 weeks relative to obtaining baseline metrics or initiating an initial session by the user. If the amount of time since obtaining baseline metrics exceeds the set length, the decision may be to stop providing additional tasks. In contrast, if the amount of time does not exceed the set length, the decision may be to continue providing additional tasks and repeat from step (910).

[0188] The method 900 may include determining or judging whether the session metric is an improvement over a baseline metric (945). The improvement may correspond to an improvement in the severity of the user's impairment due to schizophrenia. The impairment may include social processing (e.g., social perception) or non-social processing (e.g., verbal memory). The improvement may 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 a difference in values ​​between the baseline metric and the session metric for determining that the user has shown an improvement in the severity of the impairment due to schizophrenia. Whether the improvement is shown by an increase or a decrease may depend on the type of metric used to measure the user with respect to the severity of the impairment due to schizophrenia. The margin may also depend on the type of metric used, and may generally correspond to a difference in values ​​that indicate a noticeable difference by a clinician or user with respect to the severity of the impairment due to schizophrenia, or a statistically significant result in the difference between the values ​​of the baseline metric and the session metric.

[0189] The method 900 may include determining that improvement is indicated if the session metric is determined to be an improvement over the baseline metric (950). In some embodiments, improvement may be determined (e.g., by a computing system or a clinician testing the user) when the session MCAS metric decreases from the baseline MCAS metric by a first predetermined margin. In some embodiments, improvement may be determined when the session Lawton IADL metric increases from the baseline Lawton IADL metric by a second predetermined margin. In some embodiments, improvement may be determined when the session PSP metric increases from the baseline PSP metric by a second predetermined margin.

[0190] Continuing, in some embodiments, improvement may be determined when the session WHO-DAS 2.0 metric decreases by a first predefined margin from the baseline WHO-DAS 2.0 metric. In some embodiments, compliance may be determined to have improved when the session CRS metric increases by a second predefined margin from the baseline CRS metric. In some embodiments, compliance may be determined to have improved when the session MARS metric increases by a second predefined margin from the baseline CMARSRS metric.

[0191] In some embodiments, the impairment associated with the user with schizophrenia may be determined to have improved when the session MCAS metric is decreased by a first predetermined margin from the baseline MCAS metric. In some embodiments, the impairment associated with the user with schizophrenia may be determined to have improved when the session CRS metric is increased by a second predetermined margin from the baseline CRS metric. In some embodiments, the impairment associated with the user with schizophrenia may be determined to have improved when the session PGI-I metric is decreased by a first predetermined margin from the baseline PGI-I metric. In some embodiments, the impairment associated with the user with schizophrenia may be determined to have improved when the session MARS-a metric is increased by a second predetermined margin from the baseline MARS-a metric.

[0192] The method 900 may include determining that no improvement is indicated if the session metric is determined not to be an improvement over the baseline metric (955). In some embodiments, no improvement may be determined (e.g., by a computing system or a clinician testing the user) when the session MCAS metric does not decrease from the baseline MCAS metric by a first predetermined margin. In some embodiments, no improvement may be determined when the session Lawton IADL metric increases from the baseline Lawton IADL metric by a second predetermined margin. In some embodiments, no improvement may be determined when the session PSP metric does not increase from the baseline PSP metric by a second predetermined margin.

[0193] Continuing, in some embodiments, it may be determined that no improvement has been made when the session WHO-DAS 2.0 metric has not decreased by a first predetermined margin from the baseline WHO-DAS 2.0 metric. In some embodiments, it may be determined that no improvement has been made when the session CRS metric has not increased by a second predetermined margin from the baseline CRS metric. In some embodiments, it may be determined that no improvement has been made when the session MARS metric has not increased by a second predetermined margin from the baseline MARS metric. In some embodiments, it may be determined that no improvement has been made when the session time usage survey metric has not increased by a second predetermined margin from the baseline time usage survey metric. In some embodiments, it may be determined that no improvement has been made when the session C-SSRS metric has not decreased by a first predetermined margin from the baseline C-SSRS metric.

[0194] In some embodiments, a functional impairment associated with a user with schizophrenia may be determined to not have improved when the session MCAS metric does not decrease by a first predetermined margin from the baseline MCAS metric. In some embodiments, a functional impairment associated with a user with schizophrenia may be determined to not have improved when the session CRS metric does not increase by a second predetermined margin from the baseline CRS metric. In some embodiments, a functional impairment associated with a user with schizophrenia may be determined to not have improved when the session PGI-I metric does not decrease by a first predetermined margin from the baseline PGI-I metric. In some embodiments, a functional impairment associated with a user with schizophrenia may be determined to not have improved when the session MARS-a metric does not increase by a second predetermined margin from the baseline MARS-a metric.

[0195] Example 1: Using ELSCI in a digital therapeutic targeting social perception In one example, the CT-156 mobile app (e.g., Application 125) was administered to individuals with schizophrenia according to the International Classification of Diseases, Eleventh Revision (ICD-11) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), experiencing mild to moderate impairment as indicated by WHO-DAS 2.0, and prescribed antipsychotic medication. Treatment duration was 2-30 weeks. Users of the CT-156 mobile app were expected to experience improvement in impairment during their use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0196] This is a multicenter, exploratory, double-arm study evaluating the overall efficacy of an abbreviated version of CT-156 as a treatment for mild to moderate functional impairment in participants aged 18 years or older who have been diagnosed with schizophrenia. Eligibility required participants to be diagnosed with schizophrenia according to the International Classification of Diseases, 11th Revision (ICD-11) or Diagnostic and Statistical Manual of Mental Disorders, 5th Revision (DSM-5) and to be experiencing mild to moderate functional impairment based on the WHO-DAS 2.0.

[0197] Participants who met the eligibility criteria were enrolled in the study and were offered the option to select one of the study arms (CT-156 or CT-156+UXR) at the screening visit. Participants in both study arms used the same study app. The difference between the study arms was a qualitative interview versus a survey.

[0198] Screening Period: All participants entered a screening period of up to 7 days to determine eligibility after the informed consent procedure. At the screening visit, participants who met all applicable inclusion criteria and none of the exclusion criteria were introduced to the digital mobile application by downloading and installing the application on their personal iPhone® trademark or Android smartphone device. Approximately 50 eligible participants were enrolled at approximately 12 study centers in the United States during the in-person clinic visit on Day 1. A portion of participants (up to 15 people) were offered the opportunity to participate in the UXR group, which received the same treatment plus additional user research interviews and surveys. Approximately 35 people were enrolled in the CT-156 group.

[0199] Baseline Visit: Participant eligibility was confirmed at the baseline visit on Day 1. Participants were considered eligible to activate the study app if they met all inclusion criteria and did not meet any exclusion criteria.

[0200] Intervention period: Assessments and activities during this period were conducted either in-person at the clinic or via remote telephone visits.

[0201] Follow-up period: Participants entered a follow-up period of up to 1 week during which they attended a visit to complete follow-up assessments. Participants did not engage in any activity within the application.

[0202] Inclusion criteria: Participants were eligible to take part in the study if they met all of the following criteria: 1. Are willing and able to provide written informed consent to participate in this study, attend study visits, and comply with study-related requirements and assessments. 2. Age 18 or older at the time of informed consent. 3. Fluent in written and spoken English and able to read and understand the informed consent form. 4. You are a resident of the United States. 5. Meet diagnostic criteria for a primary diagnosis of schizophrenia as defined by the International Classification of Diseases, 11th edition (ICD-11) or Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for at least 6 months prior to screening. 6. Receiving outpatient treatment at the time of screening and no history of psychiatric hospitalization within the 13 weeks (3 months) prior to screening. 7. Currently prescribed at least one typical and / or atypical antipsychotic and have been taking the same antipsychotic for at least 13 weeks (3 months) prior to the enrollment date (Day 1). Dose adjustments during the study are permitted as described in the package insert for each medication. 8. A mean score of 2.2 in at least two of the following domains on the WHO-DAS 2.0: understanding and communication, getting along with others, activities of daily living - household chores, and social participation. 9. Participant agrees to be the sole user of an iPhone with iPhone Operating System (iOS) version 15 or later, or an Android Operating System (OS) version 12 or later, and to download and use the digital mobile application as required by the Protocol. 10. Be willing and able to receive Short Message Service (SMS) text and push messages on your smartphone. 11. You are the owner of the email address or have regular access to the email address. 12. Have regular access to the Internet via a cellular data plan and / or Wi-Fi. 13. Have stable housing, have been residing in the same residence for at least 13 weeks (3 months) prior to screening, and have no plans to change residence during the study period. 14. Understand the use of the study app during the screening period and at the baseline visit, as determined by the investigator.

[0203] Exclusion Criteria: Participants who met any of the following criteria were deemed ineligible to participate in the study. 1. The subject has positive symptoms of schizophrenia and the investigator determines that treatment cannot be effectively administered to improve functional impairment. 2. Currently receiving or have received within the 3 months (13 weeks) prior to screening concurrent therapy, defined as individual or group-based structured treatment (e.g., cognitive behavioral therapy, social skills training, motivational interviewing, occupational / occupational therapy), as assessed by the investigator. 3. Currently receiving treatment with two or more antipsychotics (including two or more dosage forms). 4. Meet ICD-11 or DSM-5 criteria for a diagnosis not under investigation that would affect protocol adherence, including schizophreniform disorder, schizoaffective disorder, or psychotic nonspecific disorder (posttraumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorder). 5. Meet ICD-11 or DSM-5 criteria for a current episode of depression, mania, or hypomania. 6. Meet ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) that, in the investigator's judgment, would interfere with compliance with the protocol. Diagnoses classified as in sustained remission will be accepted. 7. In the investigator's judgment, currently requires or is likely to require prohibited concomitant medications and / or concurrent therapies for the duration of the study. 8. Individuals at moderate to high risk of suicide who meet any of the following criteria: a. A "yes" response to either item 4 or 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 13 weeks (3 months) prior to screening or at baseline (Day 1). b. Response of "yes" to the suicidal behavior item on the C-SSRS within the past 26 weeks (6 months) prior to screening or at baseline (Day 1). c. In the opinion of the investigator, there is a significant risk of suicide. 9. Have participated in any other clinical research study (interventional or observational study) within the past 13 weeks (3 months). 10. Have previously participated in any of the following studies: CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, CT-155-A-001, CT-155-R-001, CT-156-D-001, CT-156-C-001, CT-156-P-00x.

[0204] Primary Endpoint: The primary endpoint was the degree of participants' engagement with the study app using predefined engagement metrics. * Number of days the study app was opened out of the total number of treatment days * Number of times the study app was opened during the treatment period * Number of medication checks completed during the treatment period (out of total allocated) * Number of assigned tasks completed during treatment * Average duration of each app usage session

[0205] Exploratory Endpoints: * Change from baseline to week 8 in MCAS - expanded version * Change from screening to week 8 in WHO-DAS 2.0 * Change from baseline to week 8 in CRS * Change from baseline to week 8 in MARS-a * PGI-I at week 8 * CGI-I Week 8 * Change in CGI-S from baseline to week 8 * Change in strength of digital collaboration from baseline to week 8 as assessed by mARM * Participant's assessment of the quality and satisfaction of the study app as measured by the MARS-b at Week 8 / ET visit * Participant feedback from qualitative user research interviews

[0206] Schedule of activities and evaluations: [Table 1] JPEG2025037828000003.jpg9471JPEG2025037828000004.jpg6670

[0207] A study was conducted using the CT-156 mobile app in adults (ages 18 and over) diagnosed with schizophrenia who were taking antipsychotics with functional impairment, as shown in Figure 10. The results showed that self-reported impairment (WHO DAS 2.0) improved significantly and the primary efficacy endpoint (MCAS) trended in the right direction.

[0208] Example 2: Using ELSCI in digital therapeutics targeting problem solving In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0209] Example 3: Using ELSCI in digital therapy targeting verbal memory In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0210] Example 4: Using ELSCI in digital therapeutics targeting mentalizing / theory of mind In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0211] Example 5: Using ELSCI in digital therapeutics targeting emotion processing In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0212] Example 6: Using ELSCI in digital treatments targeting social perception and verbal memory In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to the International Classification of Diseases, Eleventh Revision (ICD-11) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0213] Example 7: Using ELSCI in digital therapeutics targeting social perception, verbal memory, problem solving, and emotional processing In one example, the CT-156 mobile app (e.g., application 125) is administered to an individual who has schizophrenia according to the International Classification of Diseases, Eleventh Revision (ICD-11) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), is experiencing mild to moderate impairment as indicated by the WHO-DAS 2.0, and is prescribed an antipsychotic medication.

[0214] In one embodiment, subjects are first surveyed prior to entering treatment. Subjects may undergo a values ​​and goals assessment in addition to a cognitive assessment to ascertain the subject's values ​​and goals. These values ​​and goals determinations are then used through the app to maintain motivation and engagement. A combination and sequence of interventions including social perception, verbal memory, problem solving, and emotion processing is determined. Subjects are informed of the initial intervention recommendation and are given the option to accept the recommended initial intervention or choose an alternative option.

[0215] Treatment duration will be 2-30 weeks. Subjects will receive each of the four interventions. Users of the CT-156 mobile app are expected to experience improvements in functional impairment during their use, as measured by MCAS, Lawton IADL, PSP Scale, WHO-DAS 2.0, C-SSRS, or Time Use Survey.

[0216] Example 8: Using ELSCI in digital therapeutics targeting social perception, verbal memory, emotional processing, and problem solving In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0217] Through use of the CT-156 mobile app, a subject with schizophrenia performs the method illustrated in FIG. 9, sequentially utilizing interventions for social perception, verbal memory, emotion processing, and problem solving. The CT-156 mobile app can be used in combination with any of the features or operations described in the illustrative examples of Sections A and B herein. The subject first obtains a baseline metric of social perception, then a tier of sessions is identified and a session of that tier is provided. The subject using the CT-156 app then determines the next tier by deciding whether to transition from the current tier or remain in the current tier. Finally, a session metric of social perception is obtained that may or may not show improvement from the baseline metric.

[0218] If there is improvement over the baseline metrics, subjects are moved onto the next intervention, verbal memory; the process described above is repeated for verbal memory. Next, subjects are moved onto the emotion processing intervention; the process described above is repeated for emotion processing. Finally, subjects are moved onto the problem solving intervention; the process described above is repeated for problem solving.

[0219] After completing the four interventions in sequence, users can expect to see improvements in functional impairment as measured by MCAS, Lawton IADL, PSP Scale, WHO-DAS 2.0, C-SSRS, or Time Use Survey scores over the course of their CT-156 mobile app use.

[0220] Example 9: Using ELSCI in digital therapeutics targeting verbal memory, social perception, problem solving, and emotional processing In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0221] Through use of the CT-156 mobile app, a subject with schizophrenia performs the method provided in FIG. 9, sequentially utilizing interventions for verbal memory, social perception, problem solving, and emotion processing. The CT-156 mobile app can be used in combination with any of the features or operations described in the illustrative examples of Sections A and B herein. The subject first obtains a baseline metric of verbal memory, then a tier of sessions is identified and sessions at that tier are provided. The subject using the CT-156 app then determines the next tier by deciding whether to transition from the current tier or remain at the current tier. Finally, a session metric of verbal memory is obtained that may or may not show improvement from the baseline metric.

[0222] If there is improvement over baseline measures, subjects are moved onto the next intervention, social perception, and the process described above is repeated for social perception. Next, subjects are moved onto the problem-solving intervention, and the process described above is repeated for problem solving. Finally, subjects are moved onto the emotion processing intervention, and the process described above is repeated for emotion processing.

[0223] After completing the four interventions in sequence, users can expect to see improvements in functional impairment as measured by MCAS, Lawton IADL, PSP Scale, WHO-DAS 2.0, C-SSRS, or Time Use Survey scores over the course of their CT-156 mobile app use.

[0224] Example 10: Using ELSCI in digital therapeutics targeting emotional processing, verbal memory, social perception, and problem solving In one example, the CT-156 mobile app (e.g., application 125) is administered to individuals who have schizophrenia according to ICD-11 or DSM-5, experience mild to moderate impairment as indicated by WHO-DAS 2.0, and are prescribed antipsychotic medication. Treatment duration is 2-30 weeks. Users of the CT-156 mobile app are expected to experience improvement in impairment during use, as measured by MCAS scores, Lawton IADL scores, PSP scale scores, WHO-DAS 2.0 scores, C-SSRS scores, or time use survey scores.

[0225] Through use of the CT-156 mobile app, a subject with schizophrenia performs the method provided in FIG. 9, sequentially utilizing interventions for emotion processing, verbal memory, social perception, and problem solving. The CT-156 mobile app can be used in combination with any of the features or operations described in the illustrative examples of Sections A and B herein. The subject first obtains a baseline metric of emotion processing, then a tier of sessions is identified and sessions at that tier are provided. The subject using the CT-156 app then determines the next tier by deciding whether to transition from the current tier or remain at the current tier. Finally, a session metric of emotion processing is obtained that may or may not show improvement from the baseline metric.

[0226] If there is improvement over the baseline measures, subjects are moved onto the next intervention, verbal memory; the process described above is repeated for verbal memory. Next, subjects are moved onto the social perception intervention, and the process described above is repeated for social perception. Finally, subjects are moved onto the problem solving intervention, and the process described above is repeated for problem solving.

[0227] After completing the four interventions in sequence, users can expect to see improvements in functional impairment as measured by MCAS, Lawton IADL, PSP Scale, WHO-DAS 2.0, C-SSRS, or Time Use Survey scores over the course of their CT-156 mobile app use.

[0228] C. Network and Computing Environment Various operations described herein may be performed on a computer system. FIG. 11 shows a simplified block diagram of a representative server system 1000, a client computer system 1014, and a network 1026 that may be used to implement certain embodiments of the present disclosure. In various embodiments, the server system 1000 or a similar system may implement the services or servers described herein, or portions thereof. The client computer system 1014 or a similar system may implement the clients described herein. The system 100 described herein may be similar to the server system 1000. The server system 1000 may have a modular design incorporating many modules 1002 (e.g., blades in a blade server embodiment), and although two modules 1002 are shown, any number may be provided. Each module 1002 may include one or more processing units 1004 and local storage 1006.

[0229] The one or more processing units 1004 may include a single processor, which may have one or more cores, or multiple processors. In some embodiments, the one or more processing units 1004 may include a general-purpose primary processor as well as one or more special-purpose co-processors, such as a graphics processor, digital signal processor, etc. In some embodiments, some or all of the processing units 1004 may be implemented using customized circuitry, such as an application specific integrated circuit (ASIC) or a customer programmable grid array (FPGA). In some embodiments, such integrated circuits execute instructions stored within the circuitry itself. In other embodiments, the one or more processing units 1004 may execute instructions stored in a local storage device 1006. Any combination of any type of processor may be included in the one or more processing units 1004.

[0230] The local storage 1006 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) and / or non-volatile storage media (e.g., magnetic or optical disks, flash memory, etc.). The storage media incorporated in the local storage 1006 may be fixed, removable, or upgradeable, as desired. The local storage 1006 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 readable / writeable memory device, or a volatile readable / writeable memory, such as a dynamic random access memory. The system memory may store some or all of the instructions and data required by the one or more processing units 1004 during execution. The ROM may store static data and instructions required by the one or more processing units 1004. The permanent storage may be a non-volatile readable / writeable memory device that may store instructions and data even when the module 1002 is powered down. As used herein, the term "storage medium" includes any medium that is capable of storing data indefinitely (albeit through overwriting, electrical disturbance, power loss, etc.) and does not include carrier waves or ephemeral electronic signals propagated over wireless or wired connections.

[0231] In some embodiments, the local storage device 1006 may store one or more software programs executed by the one or more processing devices 1004, such as an operating system and / or programs that implement various server functions, such as the functionality of system 100 or any other system described herein, or any other server(s) associated with system 100 or any other system described herein.

[0232] "Software" generally refers to a sequence of instructions that, when executed by one or more processing units 1004, cause the server system 1000 (or portions thereof) to perform various operations, thus defining one or more specific machine embodiments that execute and perform the operations of the software program. The instructions may be stored as firmware resident in a read-only memory for execution by the one or more processing units 1004, and / or as program code stored in a non-volatile storage medium that can be loaded into a 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 1004 may retrieve program instructions to execute and data to process from the local storage device 1006 (or non-local storage device, described below).

[0233] In some server systems 1000, multiple modules 1002 may be interconnected via a bus or other interconnect 1008 to form a local area network that supports communication between the modules 1002 and other components of the server system 1000. The interconnect 1008 may be implemented using a variety of technologies, including server racks, hubs, routers, etc.

[0234] A wide area network (WAN) interface 1010 may provide data communication capabilities between a local area network (e.g., via interconnect 1008) and a network 1026, such as the Internet. Other technologies may be used to communicatively couple the server system to the network 1026, including wired technologies (e.g., Ethernet, IEEE 802.3 standard) and / or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standard).

[0235] In some embodiments, the local storage device 1006 is intended to provide working memory for one or more processing devices 1004, providing fast access to programs and / or data being processed while reducing traffic on the interconnect 1008. Storage for larger amounts of data can be provided on a local area network by one or more mass storage subsystems 1008 connectable to the interconnect 1012. The mass storage subsystems 1012 can be based on magnetic, optical, semiconductor, or other data storage media. Direct attached storage, storage 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 the mass storage subsystem 1012. In some embodiments, additional data storage resources are accessible via the WAN interface 1010 (albeit potentially with increased latency).

[0236] The server system 1000 may operate in response to requests received via the WAN interface 1010. For example, one of the modules 1002 may implement management functions and assign individual tasks to other modules 902 in response to received requests. Work allocation techniques may be used. Once a request has been processed, results may be returned to the requester via the WAN interface 1010. Typically such operations may be automated. Additionally, in some embodiments, the WAN interface 1010 may connect multiple server systems 1000 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 collaborating with one another) may be used, including dynamic resource allocation and reallocation.

[0237] The server system 1000 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 11 as client computing system 1014. The client computing system 1014 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, glasses), desktop computer, laptop computer, etc.

[0238] For example, the client computing system 1014 may communicate over a WAN interface 1010. The client computing system 1014 may include computer components such as one or more processing units 1016, storage devices 1018, a network interface 1020, user input devices 1022, and user output devices 1024. The client computing system 1014 may be computing devices implemented in a variety of form factors, such as desktop computers, laptop computers, tablet computers, smartphones, other computing devices, wearable computing devices, etc.

[0239] The processing unit 1016 and storage device 1018 may be similar to the one or more processing units 1004 and local storage device 1006 described above. Appropriate devices may be selected based on the demands placed on the client computing system 1014. For example, the client computing system 1014 may be implemented as a "thin" client having limited processing capabilities or as a high performance computing device. The client computing system 1014 may comprise program code executable by the one or more processing units 1016 to enable various interactions with the server system 1000.

[0240] The network interface 1020 may provide a connection to a network 1026, such as a wide area network (e.g., the Internet) to which the WAN interface 1010 of the server system 1000 is also connected. In various embodiments, the network interface 1020 may include a wired interface (e.g., Ethernet) and / 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.).

[0241] User input device 1022 may include any device (or devices) by which a user can send signals to client computing system 1014, which can be interpreted by client computing system 1014 as indicating a particular user request or information. In various embodiments, user input device 1022 may include any or all of a keyboard, a touchpad, a touchscreen, a mouse or other pointing device, a scroll wheel, a click wheel, a dial, a button, a switch, a keypad, a microphone, and the like.

[0242] The user output device 1024 may include any device by which the client computing system 1014 can provide information to a user. For example, the user output device 1024 may include a display-to-display shared image generated by the client computing system 1014 or transmitted to the client computing system 914. The display may incorporate a variety of image generating 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 converters, signal processors, etc.). Some embodiments may include devices such as a touch screen that function as both an input and output device. In some embodiments, other user output devices 1024 may be provided in addition to or instead of a display. Examples include indicator lights, speakers, tactile "display" devices, printers, etc.

[0243] 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 a process 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 in the program instructions. Examples of program instructions or computer code include machine code produced by a compiler, or files containing higher level code that are executed by a computer, electronic component, or microprocessor using an interpreter. With appropriate programming, the one or more processing devices 1004 and 1016 can provide various functions to the server system 1000 and the client computing system 1014, including any of the functions described herein as being performed by a server or client, or other functions.

[0244] It will be understood that the server system 1000 and the client computing system 1014 are exemplary 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 1000 and the client computing system 1014 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 be located in the same facility, in the same server rack, or on the same motherboard, but need not be so located. Additionally, 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 the various blocks may be reconfigurable or non-reconfigurable depending on how the initial configuration is obtained. The embodiments of the present disclosure may be realized in a variety of apparatuses, including electronic devices implemented using any combination of circuitry and software.

[0245] Although the present disclosure has been described with respect to specific embodiments, those skilled in the art will recognize that many variations are possible. The 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. The embodiments of the present disclosure can be implemented using any combination of dedicated components and / or programmable processors and / 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 an electronic circuit 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 and / or software components can also be used, and that a particular operation described as being implemented in hardware can also be implemented in software, or vice versa.

[0246] A computer program incorporating various features of the present disclosure can be encoded and stored on various computer-readable storage media. Suitable media include magnetic disks or tapes, optical storage media such as compact disks (CDs) or digital versatile disks (DVDs), flash memory, and other non-transitory media. A computer-readable medium encoded with a 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).

[0247] Thus, although the disclosure has been described in terms of specific embodiments, it will be understood that the disclosure is intended to cover all modifications and equivalents that come within the scope of the following claims.

Claims

1. A method of presenting an interaction session to address user dysfunction: A step in which a computing system identifies multiple sessions to address disorders associated with the user's medical condition, wherein each of the multiple sessions includes a corresponding layer among a plurality of layers for the user; The steps include: providing a first session of the cognitive training layer by the computing system by displaying one or more first images that cause the user to recognize one or more of several social cues associated with social skills; The calculation system provides a second session of a virtual functional training layer for the user to apply the social skills in a virtual social environment: (i) a step of displaying, together with a second image of the social setting, (a) a first prompt that identifies a query associated with a character that displays one of the plurality of social cues, and (b) a set of interaction elements that identify a plurality of corresponding responses to the character; (ii) receiving a first response selected by the user from the plurality of responses via at least one of the pair of interacting elements; (iii) Providing a second session which includes the step of providing feedback to the user based on the query and the first response regarding the social setting; A method comprising the step of providing a third session of a functional training layer for the user to apply the social skills, the calculation system providing the third session, the step of (i) displaying a second prompt instructing the user to perform an activity, and (ii) receiving a second response associated with performing the activity.

2. The steps include: generating the user's performance metrics by the computing system based on the first response received from the user in the first time instance during the second session; A step of modifying, by the computational system, at least one of a plurality of parameters that define the presentation of at least one image, prompt, and interaction element of the virtual functional training layer, based on the performance metric; The method according to claim 1, further comprising the step of providing the second session of the virtual functional training layer in a second time instance by the computing system, the step of providing the second session, which includes displaying, together with a third image of a second social setting, (i) a third prompt that identifies a second query for a second character in the second social setting, and (ii) a second set of interaction elements that identify a plurality of corresponding responses to the second character according to a plurality of parameters.

3. The method according to claim 2, wherein the plurality of parameters include at least one of (i) the modality of the context, (ii) the context of the social setting in the image, (iii) the number of characters in the social setting, (iv) the type of prompt, (v) the difficulty level of the response, (vi) the type of response, or (vii) the number of responses.

4. The steps include: generating the user's performance metrics using the calculation system based on the percentage of correct choices in one or more sessions of the cognitive training layer; The method according to any of the prior claims, further comprising the step of causing the user to decide to move from the cognitive training layer to the virtual functional training layer in response to the performance metric satisfying a threshold.

5. The steps include: generating the user's performance metrics using the computing system based on the percentage of correct responses in one or more sessions of the virtual functional training layer; The method according to any of the prior claims, further comprising the step of deciding to move the user from the virtual functional training layer to the functional training layer in response that the performance metric satisfies a threshold.

6. The step of providing the first session includes (i) displaying a set of interaction elements that identify a plurality of corresponding types of social cues associated with the first image, together with a first screen of social cues, and (ii) receiving one of the plurality of social cues selected by the user through at least one of the set of interaction elements, The method according to any of the preceding claims, wherein the plurality of social cues of the first image in the first session of the cognitive training layer further comprises at least one of (a) head movement, (b) body language, (c) gesture, or (d) eye contact.

7. The method according to any of the preceding claims, further comprising the second session of the virtual functional training layer displaying a plurality of images of the social setting with characters in a predetermined order.

8. The method according to any of the prior claims, further comprising displaying a third prompt causing the user to select a time to give the user a message prompting them to perform the activity.

9. The method according to any of the preceding claims, further comprising the step of determining by the calculation system a time for providing one of the plurality of sessions to the user in accordance with the session schedule.

10. The user's condition includes a neurological disorder or an emotional disorder, and the user is receiving treatment in part concurrently with at least one of the first session, the second session, or the third session, and the treatment includes at least one of psychosocial interventions or medications to address the condition. The method according to any of the preceding claims, wherein the drug comprises at least one of haloperidol, chlorpromazine, fluphenazine, perphenazine, roxitan, thioridazine, trifluoperazine, aripiprazole, risperidone, clozapine, quetiapine, olanzapine, ziprasidone, lurasidone, paliperidone, or iclepertin.

11. A system that presents interaction sessions to address user dysfunction: A computing system having one or more processors coupled to memory, wherein the computing system: Identifying multiple sessions for addressing disorders associated with a user's medical condition, each session including a corresponding layer among multiple layers for the user; The first session of the cognitive training layer is provided by displaying one or more first images that cause the user to recognize one or more of several social cues associated with social skills; The provision of the second session of the virtual functional training layer for the user to apply the social skills in the virtual social environment includes: (i) displaying a second image of the social setting, along with (a) a first prompt that identifies a query associated with a character that displays one of the multiple social cues, and (b) a set of interaction elements that identify multiple corresponding responses to the character; (ii) receiving a first response selected by the user from the plurality of responses via at least one of the pair of interacting elements; (iii) Provide feedback to the user based on the social setting and the query relating to the first response; The system is configured to provide a third session of a functional training layer for the user to apply the social skills, the provision of which includes (i) displaying a second prompt instructing the user to perform an activity, and (ii) receiving a second response associated with the performance of the activity.

12. The aforementioned computing system further: In the second session, the first instance generates performance metrics for the user based on the first response received from the user; Based on the performance metrics, modify at least one of a plurality of parameters that define the presentation of at least one image, prompt, or interaction element of the virtual functional training layer; The system according to claim 11, configured to provide the second session of the virtual functional training layer in a second time instance, wherein providing the second session includes displaying, together with a third image of a second social setting, (i) a third prompt identifying a second query of a second character in the second social setting, and (ii) a second set of interaction elements identifying a plurality of corresponding responses to the second character according to a plurality of parameters.

13. The system according to claim 12, wherein the plurality of parameters include at least one of (i) the modality of the context, (ii) the context of the social setting in the image, (iii) the number of characters in the social setting, (iv) the type of prompt, (v) the difficulty level of the response, (vi) the type of response, or (vii) the number of responses.

14. The aforementioned computing system further: Based on the percentage of correct choices in one or more sessions of the cognitive training layer, the user's performance metrics are generated; The system according to any one of claims 11-13, configured to decide to move the user from the cognitive training layer to the virtual functional training layer in response to the performance metric satisfying a threshold.

15. The aforementioned computing system further: Based on the percentage of correct responses in one or more sessions of the virtual functional training layer, the user's performance metrics are generated; The system according to any one of claims 11-14, configured to decide to move the user from the virtual functional training layer to the functional training layer in response to the performance metric satisfying a threshold.

16. The provision of the first session further includes (i) displaying a second set of interaction elements that identify a plurality of corresponding social cues associated with the first image, along with a first screen of social cues, and (ii) receiving one of the plurality of social cues selected by the user through at least one of the second set of interaction elements. The system according to any one of claims 11-15, wherein the plurality of social cues for the first image in the first session of the cognitive training layer further include at least one of (a) head movements, (b) body language, (c) gestures, or (d) eye contact.

17. The system according to any one of claims 11-16, wherein the second session of the virtual functional training layer further comprises displaying a plurality of images of the social setting with characters in a predetermined order.

18. The system according to any one of claims 11-17, further comprising displaying a third prompt that allows the user to select a time to give the user a message prompting them to perform the activity.

19. The system according to any one of claims 11-18, wherein the calculation system is further configured to determine the time at which to provide one of the plurality of sessions to the user in accordance with a session schedule.

20. The system according to any one of claims 11-19, wherein the user's condition includes a neurological disorder or an emotional disorder, the user is receiving treatment in part concurrently with at least one of the first session, the second session, or the third session, and the treatment includes at least one of psychosocial interventions or medications to address the condition.

21. A method for providing necessary improvements to the functional impairment of a user suffering from a neurological or emotional disorder: The steps include: obtaining a first metric associated with the user before multiple sessions using a computing system; The calculation system repeatedly provides one or more of the aforementioned sessions to the aforementioned user, wherein the aforementioned sessions are: A first session of the cognitive training layer, by displaying one or more first images that cause the user to recognize one or more of several social cues associated with social skills; A second session of a virtual functional training layer for the user to apply the social skills in a virtual social environment, comprising: (i) displaying a second image of a social setting, (a) a first prompt that identifies a query associated with a character that displays one of the plurality of social cues, and (b) a second set of interaction elements that identify a plurality of responses corresponding to the character, (ii) receiving a first response selected by the user from the plurality of responses via at least one of the second set of interaction elements; and (iii) providing feedback to the user based on the query regarding the social setting and the first response; A repeating step includes (i) displaying a second prompt instructing the user to perform an activity, and (ii) receiving a second response associated with performing the activity; The steps include obtaining a second metric associated with the user by the computing system, following at least one of the aforementioned multiple sessions, A method wherein the improvement of the functional impairment associated with the neurological disorder or the emotional disorder is brought to the user when the second metric decreases by (i) a first predetermined margin from the first metric, or (ii) increases by a second predetermined margin from the first metric.

22. The method according to claim 21, wherein the user's neurological disorder or emotional disorder includes schizophrenia, and the schizophrenia includes at least one of (i) schizophrenia having positive symptoms including hallucinations or delusions, or (ii) schizophrenia having negative symptoms including reduced motivation or emotional expression.

23. The method according to claim 21 or 22, wherein the impairment associated with the user further includes at least one of (i) reduced educational attainment, (ii) reduced quality of life, (iii) difficulty living independently, (iv) reduced social functioning, or (v) impaired occupational functioning.

24. The method according to any one of claims 21-23, wherein the user is an adult at least 18 years of age and has been diagnosed with the neurological disorder or emotional disorder having the functional impairment.

25. The method according to any one of claims 21-24, wherein the improvement in the functional impairment associated with the neurological disorder or the emotional disorder is brought about when the second metric decreases by a first predetermined margin from the first metric, and the first metric and the second metric are Maltonoma Regional Competency Scale (MCAS) values.

26. The method according to any one of claims 21-24, wherein the improvement in the functional impairment associated with the neurological disorder or the emotional disorder is brought about when the second metric increases by a second predetermined margin from the first metric, and the first and second metrics are Lawton's Instrumental Activities of Daily Living (IADL) scale values.

27. ​​The method according to any one of claims 21-24, wherein the improvement in the functional impairment associated with the neurological disorder or the emotional disorder is brought about when the second metric increases by a second predetermined margin from the first metric, and the first and second metrics are personal and social functioning performance (PSP) scale values.

28. The method according to any one of claims 21-24, wherein the improvement in the functional impairment associated with the neurological disorder or the emotional disorder is brought about when the second metric decreases by a first predetermined margin from the first metric, and the first metric and the second metric are World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) scale values.

29. The method according to any one of claims 21-24, wherein the improvement in the functional impairment associated with the neurological disorder or the emotional disorder is brought about when the second metric decreases by a first predetermined margin from the first metric, and the first metric and the second metric are Columbia Suicide Severity Rating Scale (C-SSRS) values.

30. The plurality of sessions further include the second session of the virtual functional training layer in the first time instance, the second session including, together with a third image of the second setting, (i) a third prompt that identifies a second query for a second character in the second setting, and (ii) a third set of interaction elements that identify a plurality of corresponding responses to the second character according to a plurality of parameters. The method according to any one of claims 21-29, wherein at least one of the plurality of parameters is modified based on the user's performance metrics using the first response received from the user in the second time instance prior to the first time instance in the second session.

31. The method according to claim 30, wherein the plurality of parameters include at least one of (i) the modality of the context, (ii) the context of the setting in the image, (iii) the number of characters in the setting, (iv) the type of prompt, (v) the difficulty level of the response, (vi) the type of response, or (vii) the number of responses.

32. The method according to any one of claims 21-31, further comprising the step of determining, for at least one of the plurality of sessions, a transition from one tier to another tier, by the computing system based on the user's performance metrics across one or more of the plurality of sessions.

33. The provision of the first session includes (i) displaying a set of interaction elements that identify a plurality of corresponding types of cues associated with the first image, along with a first screen of social cues, and (ii) receiving one of the plurality of types of social cues selected by the user through at least one of the second set of interaction elements. The method according to any one of claims 21-32, wherein the plurality of social cues for the first image in the first session of the cognitive training layer further include at least one of (a) head movement, (b) body language, (c) gesture, or (d) eye contact.

34. The method according to any one of claims 21-33, wherein the second session of the virtual functional training layer further comprises displaying a plurality of images of the social setting with characters in a predetermined order.

35. The method according to any one of claims 21-34, further comprising displaying a third prompt that causes the user to select a time to give the user a message prompting them to perform the activity.

36. The method according to any one of claims 21-35, wherein the aforementioned multiple sessions are provided over a period ranging from two weeks to ten weeks.

37. The user is receiving treatment at least partially in parallel with at least one of the multiple sessions, and the treatment includes at least one of psychosocial interventions or medications to address the neurological disorder or the emotional disorder. The method according to any one of claims 21 to 36, wherein the drug comprises at least one of haloperidol, chlorpromazine, fluphenazine, perphenazine, roxitan, thioridazine, trifluoperazine, aripiprazole, risperidone, clozapine, quetiapine, olanzapine, ziprasidone, lurasidone, paliperidone, or iclepertin.

38. The method according to any one of claims 1 to 10, further comprising the step of having the computing system present other interaction sessions to address the user's impairments in language memory, language learning, and cognitive association, and further to address the user's impairments in problem-solving or a combination thereof.

39. The calculation system further: The system according to any one of claims 11-20, further configured to present other interaction sessions to address the user's impairments in language memory, language learning, and cognitive association, and to further address the user's impairments in problem-solving or a combination thereof.

40. The method according to any one of claims 21-37, further comprising the step of having the computing system present other interaction sessions to address impairments in the user's language memory, language learning, and cognitive association, and further to address impairments in the user's problem-solving or a combination thereof.