Recruiting

Observational Study

Sponsor:

Ksana Health

Code:

NCT05920252

Conditions

Suicide

Mental Health Disorder

Anhedonia

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Vira

Treatment as Usual (TAU)

Study Details

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.

Conditions

Suicide

Mental Health Disorder

Anhedonia

Study ID

NCT05920252

Start date

Aug 14, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Digitally enhanced treatment supported by the Vira platform

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.

active comparator: Treatment as Usual (TAU)

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

Interventions

Vira

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)

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

Primary outcome measure

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
  • Scale for Suicidal Ideation (SSI) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Randy Auerbach, PhD, ABPP

646-774-5745rpa2009@cumc.columbia.edu

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Randy Auerbach, PhD, ABPP

646-774-5745rpa2009@cumc.columbia.edu

More Information

Sponsor

Ksana Health

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Depression
  • Depressive Disorder
  • Mood Disorders
  • Mental Disorders
  • Suicidal Behaviors
  • Suicidal Thoughts
  • Suicidal Ideation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ksana Health on 2026-03-04.