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A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Primary Purpose

Suicide, Mental Health Disorder, Anhedonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vira
Treatment as Usual (TAU)
Sponsored by
Ksana Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Depression, Depressive Disorder, Mood Disorders, Mental Disorders, Suicidal Behaviors, Suicidal Thoughts, Suicidal Ideation

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old. Receiving treatment at the Intensive Adolescent and Family DBT Pgogram 13-18 years old Owns a personal smartphone (Android or iPhone 7+) Fluent in English Exclusion Criteria: Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program) Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Digitally enhanced treatment supported by the Vira platform

    Treatment as Usual (TAU)

    Arm Description

    Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.

    Intensive outpatient DBT + EARS app (passive data monitoring software)

    Outcomes

    Primary Outcome Measures

    Columbia Suicide Severity Rating Scale (C-SSRS)
    The C-SSRS is an assessment of suicidal thoughts and behaviors in clinical and research settings. The C-SSRS consists of 16 questions about suicidal thoughts and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
    Scale for Suicidal Ideation (SSI)
    The SSI consists of 19 items that evaluate three dimensions of suicide ideation: active suicidal desire, specific plans for suicide, and passive suicidal desire. Each item is rated on a 3-point scale from 0 to 2. The higher the total score, the greater the severity of suicide ideation.

    Secondary Outcome Measures

    Screen for Anxiety Related Emotional Disorders (SCARED)
    The scared is a 5-item self-report questionnaire used to screen for childhood anxiety disorders including general anxiety disorder, separate anxiety disorder, panic disorder, and social phobia. Items are rated on a 3 point Likert scale from 0 to 2 and summed to yield a total score. Total scores range from 0 to 10. Higher scores indicate greater anxiety.
    Risky Behavior Questionnaire for Adolescents (RBQ-A)
    The RBQ-A is a 20-item self-report measure that assesses frequency of engagement of risky behaviors (e.g., sexual precociousness, aggression, rule-breaking, and substance use). Items are rated on a 5-point Likert scale. Scores range from 0 to 80. Higher scores reflect greater engagement in risky behaviors.
    Pittsburgh Sleep Quality Index (PSQI)
    The PSQI is a 19-item self-report measure of sleep quality and disturbances. The 19 items are grouped into 7 component scores, each weighted equally on a 0 to 3 scale and summed to yield a global PSQI score. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.
    Mood and Feelings Questionnaire (MFQ)
    The MFQ is a 13-item self-report questionnaire used to screen for depressive in children and young people. Items are rated on a 3-point Likert scale (not true = 0; sometimes true = 1; not true = 2). Scores are calculated by summing the point values on each response. Total MFQ scores range from 0 to 26, with higher scores suggesting greater severity in depressive symptoms.
    Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)
    The ACIPS is a 17-item self-report measure of hedonic capacity of social interaction and interpersonal engagement. Items are rated on a 6-point from "very false" to "very true." Total scores are calculated by summing the ratings (after reversing one negatively worded item) and range from 17 to 102. Lower scores indicate greater social anhedonia.

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Ksana Health
    Collaborators
    New York State Psychiatric Institute, Columbia University, National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05920252
    Brief Title
    A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
    Official Title
    Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    February 28, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ksana Health
    Collaborators
    New York State Psychiatric Institute, Columbia University, National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.
    Detailed Description
    Suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people. Specifically, we will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes. Specifically, we will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Mental Health Disorder, Anhedonia
    Keywords
    Depression, Depressive Disorder, Mood Disorders, Mental Disorders, Suicidal Behaviors, Suicidal Thoughts, Suicidal Ideation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Digitally enhanced treatment supported by the Vira platform
    Arm Type
    Experimental
    Arm Description
    Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.
    Arm Title
    Treatment as Usual (TAU)
    Arm Type
    Active Comparator
    Arm Description
    Intensive outpatient DBT + EARS app (passive data monitoring software)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vira
    Intervention Description
    Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as Usual (TAU)
    Intervention Description
    Intensive outpatient DBT + EARS app (passive data monitoring software)
    Primary Outcome Measure Information:
    Title
    Columbia Suicide Severity Rating Scale (C-SSRS)
    Description
    The C-SSRS is an assessment of suicidal thoughts and behaviors in clinical and research settings. The C-SSRS consists of 16 questions about suicidal thoughts and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
    Time Frame
    6 months
    Title
    Scale for Suicidal Ideation (SSI)
    Description
    The SSI consists of 19 items that evaluate three dimensions of suicide ideation: active suicidal desire, specific plans for suicide, and passive suicidal desire. Each item is rated on a 3-point scale from 0 to 2. The higher the total score, the greater the severity of suicide ideation.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Screen for Anxiety Related Emotional Disorders (SCARED)
    Description
    The scared is a 5-item self-report questionnaire used to screen for childhood anxiety disorders including general anxiety disorder, separate anxiety disorder, panic disorder, and social phobia. Items are rated on a 3 point Likert scale from 0 to 2 and summed to yield a total score. Total scores range from 0 to 10. Higher scores indicate greater anxiety.
    Time Frame
    3 and 6 months
    Title
    Risky Behavior Questionnaire for Adolescents (RBQ-A)
    Description
    The RBQ-A is a 20-item self-report measure that assesses frequency of engagement of risky behaviors (e.g., sexual precociousness, aggression, rule-breaking, and substance use). Items are rated on a 5-point Likert scale. Scores range from 0 to 80. Higher scores reflect greater engagement in risky behaviors.
    Time Frame
    3 and 6 months
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    The PSQI is a 19-item self-report measure of sleep quality and disturbances. The 19 items are grouped into 7 component scores, each weighted equally on a 0 to 3 scale and summed to yield a global PSQI score. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.
    Time Frame
    3 and 6 months
    Title
    Mood and Feelings Questionnaire (MFQ)
    Description
    The MFQ is a 13-item self-report questionnaire used to screen for depressive in children and young people. Items are rated on a 3-point Likert scale (not true = 0; sometimes true = 1; not true = 2). Scores are calculated by summing the point values on each response. Total MFQ scores range from 0 to 26, with higher scores suggesting greater severity in depressive symptoms.
    Time Frame
    3 and 6 months
    Title
    Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)
    Description
    The ACIPS is a 17-item self-report measure of hedonic capacity of social interaction and interpersonal engagement. Items are rated on a 6-point from "very false" to "very true." Total scores are calculated by summing the ratings (after reversing one negatively worded item) and range from 17 to 102. Lower scores indicate greater social anhedonia.
    Time Frame
    3 and 6 months
    Other Pre-specified Outcome Measures:
    Title
    System Usability Scale (SUS)
    Description
    The System Usability Scale is a 10-item measure that evaluates the usability of mobile software. Items are rated on a 5-point Likert scale from 0 to 4. Total SUS scores range from 0 to 100. Higher scores reflect greater usability.
    Time Frame
    3 and 6 months
    Title
    Interpersonal Needs Questionnaire (INQ)
    Description
    The INQ is a 15-item self-report assessment of interpersonal factors thought to be associated with suicidal desire and behaviors. Items are rated on a 7-point Likert scale. Scores range from 15 to 105. Higher scores reflect greater levels of these interpersonal factors.
    Time Frame
    3 and 6 months
    Title
    National Institute of Drug Abuse (NIDA) Quick Screen V1.0
    Description
    The NIDA Quick Screen is used to screen patients for drug use in general medical settings. The tool consists of 4 items regarding frequency of past year use of alcohol, tobacco, non-medical prescription drug, and illegal drug use.
    Time Frame
    3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old. Receiving treatment at the Intensive Adolescent and Family DBT Pgogram 13-18 years old Owns a personal smartphone (Android or iPhone 7+) Fluent in English Exclusion Criteria: Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program) Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Randy Auerbach, PhD, ABPP
    Phone
    646-774-5745
    Email
    rpa2009@cumc.columbia.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nick Allen, PhD
    Organizational Affiliation
    Ksana Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We will upload de-identified data to the NIMH NDA.

    Learn more about this trial

    A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

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