SuicideNCT06665620
Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
A study testing ViraBrite nudges 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 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. 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?
- ViraBrite nudges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 1 Feb 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
- Recent suicide attempt or ideation with a plan
- English fluency and literacy
- Parent or legal guardian willing and able to legally provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
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 need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) 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).
Read the detailed description
The goal of the MRT is to optimize the ViraBrite intervention by randomly assigning participants to various combination of notification timing (e.g., morning, midday, evening). Participants will download the ViraBrite suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) 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). The MRT will last for 4 weeks for each participant. Each day, participants will receive prompts ("nudges") according to a micro-randomized pattern that encourage them to access the ViraBrite app and utilize suicide safety planning skills. One decision point will occur per day. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening. The MRT will also investigate the impact of estimated emotional distress as a moderator of responding to the nudge. Specifically, measures of distress including 1. Self-report of daily mood, 2. Linguistic markers of distress (i.e., first person pronoun use) and 3. Geolocation will be explored as moderators of engagement with nudges.
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Being tested
- ViraBrite nudges
- Keywords
- depression, depressive disorder, mood disorder, 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.
ViraBrite nudgesBehavioural
Each day, participants will receive prompts via smartphone notifications that encourage them to access the ViraBrite app and utilize suicide safety planning skills.
| Study group | Role | What they receive |
|---|---|---|
| ViraBrite | Experimental | Each day, participants will receive nudges according to a micro-randomized pattern that encourage them to access the ViraBrite app and utilize coping and suicide safety planning skills. One decision point will occur per day. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening. Receives: Behavioral: ViraBrite nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal engagement with ViraBrite
Engagement with the ViraBrite app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) between the current and next randomization
Measured: 24 hours
Engagement with ViraBrite
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used
Measured: 4 weeks
Secondary outcomes (5)
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: 4 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS is a 14-item scale that measures anhedonia. The items cover the domains of social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14. Higher scores indicate greater anhedonia.
Measured: 4 weeks
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: 4 weeks
Reasons for Living
The Reasons for Living (RFL) Inventory is a 48-item instrument that measures a range of beliefs potentially important as reasons for not committing suicide. The items are rated on 6-point Likert type scales based on how important each reason would be for living if suicide was contemplated (1 = not at all important; 6 = extremely important). The total score is calculating by calculating the mean of the item scores and multiplying the result by 48. Total scores can only be calculated if a participant answers at least 38 items.
Measured: 4 weeks
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: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start16 Jul 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- At each decision point (once per day), participants will be randomized to receive a n nudge encouraging them to access the ViraBrite app and utilize suicide safety planning skills vs. no nudge. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ksana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665620
- Sponsor's protocol ID
- OV-003
- Other IDs
- R44MH135605
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No