Recruiting

ViraSafe

Sponsor:

Ksana Health

Code:

NCT07348666

Conditions

Suicide

Mental Health Disorder

Anhedonia

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Not accepted

Interventions

ViraSafe: Treatment pushes

BRITE

Study Details

Brief summary:

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.

Conditions

Suicide

Mental Health Disorder

Anhedonia

Study ID

NCT07348666

Start date

Jun 18, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

Youth (minors):

  • 13-17 years old
  • Suicide attempt in the last year and ideation in the past month
  • English fluency and literacy
  • Parent or legal guardian willing and able to legally provide informed consent
  • Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan

Youth (adults)

  • 18-24 years old
  • Recent suicide attempt or ideation with a plan
  • English fluency and literacy
  • Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan.

Exclusion Criteria:

Youth (minors):

  • Unable to read/understand English
  • Current manic or psychotic episode
  • Development disability precluding comprehension of study procedures
  • No routine access to a mobile phone, assessed by EHR review and during phone screen
  • No eligible parent or legal guardian to provide informed consent

Youth (adults):

  • Unable to read/understand English
  • Current manic or psychotic episode
  • Development disability precluding comprehension of study procedures
  • No routine access to a mobile phone, assessed by EHR review and during phone screen

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ViraSafe

The new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform

active comparator: BRITE

The original BRITE app that promotes self-monitoring and self-management by providing strategies to avoid or cope with triggers for suicidal urges and has been rigorously tested in clinical trials

Interventions

ViraSafe: Treatment pushes

ViraSafe participants will complete a safety plan with their provider. Safety plan content will be editable and viewable throughout the intervention for both participants and their providers. Participants will be able to access the safety plan at any time in ViraSafe. Additionally, patients using ViraSafe will be prompted to complete a daily distress rating. ViraSafe uses automated algorithms (i.e., just in time adaptive intervention features) and user input from distress ratings to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).

In addition to the just-in-time reminders (i.e., nudges) pushed automatically by the system, through the Vira Pro platform, practitioners can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone to support their behavior change plan.

BRITE

The BRITE app contains the teen's safety plan, links to videos of how to use coping strategies they indicated in their safety plan that have been useful for them (like guided mediation or deep breathing), a library of evidence-based and age-appropriate coping skills and strategies that the adolescent can learn more about, photos or videos that the adolescent has uploaded to the app, and includes a question asking them to rate their distress level in the moment: "What is your distress level right now?" (1 is "Least Distressed" to 5, which is "Most Distressed"). Then, the teen is asked to identify the feeling that fits their distress level via 12 emoji images: "Which feelings fit your distress level?" Based on adolescent's distress rate, the BRITE app suggests coping skills or "activities" for the adolescent to lower their distress level.

Primary outcome measure

  • Proximal Engagement [ Time Frame: 24 hours ]
  • Engagement with the apps [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Stephanie Stepp, PhD

412-383-5051steppsd@upmc.edu

Locations

STAR Center, Western Psychiatric Institute & Clinic

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

David Brent Co-Director, MD

412-246-5619Brentda@upmc.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Stephanie Stepp, Ph.D.

412-383-5051steppsd@upmc.edu

More Information

Sponsor

Ksana Health

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • depression
  • depressive disorder
  • mood disorder
  • mental disorders
  • suicidal behavior
  • 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 2026-08-12.