SuicideNCT05920252
A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
A study testing Vira and Treatment as Usual (TAU) in people with Suicide and Mental Health Disorder, run by Ksana Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Suicide, Mental Health Disorder, Anhedonia
- What is being tested?
- Vira and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University
New York, New York, 10032
Randy Auerbach, PhD, ABPP, 646-774-5745, rpa2009@cumc.columbia.edu
About this study
Official title: Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
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.
Read the 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, it 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.
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Being tested
- Vira, Treatment as Usual (TAU)
- Keywords
- Depression, Depressive Disorder, Mood Disorders, Mental Disorders, Suicidal Behaviors, Suicidal Thoughts, Suicidal Ideation
- Medical subject headings
- Suicide, Mental Disorders, Anhedonia, Depression, Depressive Disorder, Mood Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViraBehavioural
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.
Treatment as Usual (TAU)Behavioural
Intensive outpatient DBT + EARS app (passive data monitoring software)
| Study group | Role | What they receive |
|---|---|---|
| Digitally enhanced treatment supported by the Vira platform | Experimental | 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. Receives: Behavioral: Vira |
| Treatment as Usual (TAU) | Active comparator | Intensive outpatient DBT + EARS app (passive data monitoring software) Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start14 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ksana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nick Allen, PhD, Principal investigator, Ksana Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920252
- Sponsor's protocol ID
- OV-002
- Other IDs
- R44MH128484, AAAV0626
- Status last verified
- Mar 2026
- First submitted
- 16 Jun 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be uploaded to the NIMH NDA.
Publications
Funkhouser CJ, Tse TC, Weiner LS, deLuise D, Pagliaccio D, Durham K, Cullen CC, Blumkin ZK, O'Brien CT, Allen NB, Auerbach RP. Study Preregistration: Testing a Digital Suicide Risk Reduction Platform for Adolescents: A Pragmatic Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2024 Aug;63(8):845-847. doi: 10.1016/j.jaac.2024.03.012. Epub 2024 Apr 1.
PubMed 39069372