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

NCT05920252 | Recruiting DMC

• 3 other identifiers: OV-002R44MH128484AAAV0626
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  6 months

Secondary Outcomes (5)

• Screen for Anxiety Related Emotional Disorders (SCARED)

  3 and 6 months

• Risky Behavior Questionnaire for Adolescents (RBQ-A)

  3 and 6 months

• Pittsburgh Sleep Quality Index (PSQI)

  3 and 6 months

• Mood and Feelings Questionnaire (MFQ)

  3 and 6 months

• Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)

  3 and 6 months

Other Outcomes (3)

• System Usability Scale (SUS)

  3 and 6 months

• Interpersonal Needs Questionnaire (INQ)

  3 and 6 months

• National Institute of Drug Abuse (NIDA) Quick Screen V1.0

  3 and 6 months

Study Arms (2)

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.

Behavioral: Vira

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

Interventions

Vira BEHAVIORAL

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.

Digitally enhanced treatment supported by the Vira platform

Treatment as Usual (TAU) BEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• years old
• Owns a personal smartphone (Android or iPhone 7+)
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Ksana Health: lead
• Columbia University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Mental Disorders; Anhedonia; Depression; Depressive Disorder; Mood Disorders; Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Allen, PhD

  Ksana Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randy Auerbach, PhD, ABPP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: August 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)