Recruiting

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…

ClinicalTrials.gov IDNCT05920252

PhaseNA

Enrollment78

SponsorKsana Health

Age13 Years

SexALL

I'm interested View official listing

Conditions studied

Suicide, Mental Health Disorder, Anhedonia

About this study

Interventions

Behavioral: 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.
Behavioral: Treatment as Usual (TAU) — Intensive outpatient DBT + EARS app (passive data monitoring software)

Primary outcomes

Columbia Suicide Severity Rating Scale (C-SSRS) (6 months)
Scale for Suicidal Ideation (SSI) (6 months)

Eligibility information

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 locations

Columbia University, New York, New York 10032 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.