SuicideViraSafeRCTNCT07348666
A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
A study testing ViraSafe: Treatment pushes and BRITE in people with Suicide and Mental Health Disorder, run by Ksana Health at 3 sites 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 24 years
- Conditions the study is for
- Suicide, Mental Health Disorder, Anhedonia
- What is being tested?
- ViraSafe: Treatment pushes and BRITE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Ksana Health Inc
Eugene, Oregon, 97405
Nick Allen Co-Founder & CEO, PhD, 206-745-9419, nick.allen@ksanahealth.com
- Recruiting
STAR Center, Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213
David Brent Co-Director, MD, 412-246-5619, Brentda@upmc.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Stephanie Stepp, Ph.D., 412-383-5051, steppsd@upmc.edu
About this study
Official title: BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents (ViraSafe RCT (SBIR Phase 2))
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.
Read the detailed description
ViraSafe is an augmented version of the BRITE app that integrates the BRITE coping skills and safety planning content into a module within the Vira behavior change platform. Vira, a digital behavior change platform developed by Ksana Health, consists of a smartphone app for patients, along with integrated web portals for practitioners and for healthcare administrators and supervisors. The platform collects self-report and passive data on smartphone usage patterns, such as language use, physical activity, sleep, social interactions, and screen time, and uses these insights to provide objective and continuous measurements of mental health indicators.
Upon downloading the Vira app and accessing the ViraSafe module, 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.
After undergoing study screening procedures and providing informed consent/assent, participants will complete the baseline assessment (60 minutes) which will occur virtually over video conference software or phone call.
Additional self-reports collected at patient visit will be requested through informed consent process as some overlap with what research team plans to administer. Self-reports will be retrieved for data analysis at the timepoints that align with the study timepoints. Self-reports will be administered by research staff if not available from a clinic's measurement-based care system.
Following Baseline assessments, participants will be randomized in a 1:1 allocation to receive ViraSafe or BRITE (50 in each arm). Randomization will be based on age, sex, and suicide symptoms. At a scheduled patient visit in their clinical settings, onboarding to assigned app will occur. Onboarding involves downloading their assigned app from Google Play Store or Apple App Store. Each app involves a trained clinician from their clinic setting collaboratively completing a safety plan. If a mental health clinician is not available for onboarding after Baseline, a research clinician will assist with onboarding.
At 1-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures with additional items assessing acceptability, usability, and satisfaction using the Technology Acceptance Model (TAM) and System Usability Scale (SUS) (total assessment duration: 60 minutes). At the 3-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures (total duration: 60 minutes).
20 adolescent participants or as many that are needed to reach saturation who received ViraSafe intervention arm will be selected to complete a qualitative exit interview to provide additional feedback on the intervention (60 minutes). The interview guide will be developed closer to the time of first exit interview and submitted for approval to the IRB prior to completing interviews.
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Being tested
- ViraSafe: Treatment pushes, BRITE
- Keywords
- depression, depressive disorder, mood disorder, mental disorders, suicidal behavior, 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.
ViraSafe: Treatment pushesBehavioural
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.
BRITEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ViraSafe | Experimental | The new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform Receives: Behavioral: ViraSafe: Treatment pushes |
| BRITE | Active comparator | 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 Receives: Behavioral: BRITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Engagement
Engagement with the ViraSafe app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) and BRITE app (daily dose rating, post rating after accessing coping skill, editing coping skill content)
Measured: 24 hours
Engagement with the apps
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used.
Measured: 3 months
Secondary outcomes (3)
Technology Acceptance
Mixed methods feedback on acceptability, usability, and satisfaction, including the System Usability Scale and items adapted from the Technology Acceptance Model (TAM).
System Usability Scale: 10 items -- Brooke, J(1996) Technology Acceptance Model: 12 Items - Adapted from Davis, (1989)
Participants rate the extent to which they agree with each statement by circling a number from one to seven arranged horizontally beneath anchor point descriptions "Strongly Agree," "Neutral," and "Strongly Disagree.
Measured: 3 months
Suicide Risk Factors: Columbia Suicide Severity Rating Scale (CSSRS)
Changes in suicide risk factors from baseline to 3 months assessed through the Columbia Suicide Severity Rating Scale (CSSRS).
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: 3 months
Suicidal Risk Factors: Reason 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: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Jun 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ksana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348666
- Sponsor's protocol ID
- STUDY25040094
- Other IDs
- R44MH135605
- Acronym
- ViraSafeRCT
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents (ViraSafe RCT (SBIR Phase 2))
- ClinicalTrials.gov ID
- NCT07348666
- Acronym / sponsor ID
- ViraSafeRCT / STUDY25040094
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Keywords
- depression, depressive disorder, mood disorder, mental disorders, suicidal behavior, suicidal thoughts, suicidal ideation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ksana HealthIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh Medical Center
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ViraSafe is an augmented version of the BRITE app that integrates the BRITE coping skills and safety planning content into a module within the Vira behavior change platform. Vira, a digital behavior change platform developed by Ksana Health, consists of a smartphone app for patients, along with integrated web portals for practitioners and for healthcare administrators and supervisors. The platform collects self-report and passive data on smartphone usage patterns, such as language use, physical activity, sleep, social interactions, and screen time, and uses these insights to provide objective and continuous measurements of mental health indicators.
Upon downloading the Vira app and accessing the ViraSafe module, 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.
After undergoing study screening procedures and providing informed consent/assent, participants will complete the baseline assessment (60 minutes) which will occur virtually over video conference software or phone call.
Additional self-reports collected at patient visit will be requested through informed consent process as some overlap with what research team plans to administer. Self-reports will be retrieved for data analysis at the timepoints that align with the study timepoints. Self-reports will be administered by research staff if not available from a clinic's measurement-based care system.
Following Baseline assessments, participants will be randomized in a 1:1 allocation to receive ViraSafe or BRITE (50 in each arm). Randomization will be based on age, sex, and suicide symptoms. At a scheduled patient visit in their clinical settings, onboarding to assigned app will occur. Onboarding involves downloading their assigned app from Google Play Store or Apple App Store. Each app involves a trained clinician from their clinic setting collaboratively completing a safety plan. If a mental health clinician is not available for onboarding after Baseline, a research clinician will assist with onboarding.
At 1-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures with additional items assessing acceptability, usability, and satisfaction using the Technology Acceptance Model (TAM) and System Usability Scale (SUS) (total assessment duration: 60 minutes). At the 3-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures (total duration: 60 minutes).
20 adolescent participants or as many that are needed to reach saturation who received ViraSafe intervention arm will be selected to complete a qualitative exit interview to provide additional feedback on the intervention (60 minutes). The interview guide will be developed closer to the time of first exit interview and submitted for approval to the IRB prior to completing interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViraSafe | Experimental | Behavioral: ViraSafe: Treatment pushesThe new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform |
| BRITE | Active comparator | Behavioral: BRITEThe 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 |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViraSafe: Treatment pushesViraSafe 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. | Behavioural | ViraSafe |
| BRITEThe 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. | Behavioural | BRITE |
Primary outcome
Proximal Engagement
Time frame: 24 hours
Engagement with the ViraSafe app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) and BRITE app (daily dose rating, post rating after accessing coping skill, editing coping skill content)
Engagement with the apps
Time frame: 3 months
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used.
3 secondary outcomes
Technology Acceptance
Time frame: 3 months
Suicide Risk Factors: Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: 3 months
Suicidal Risk Factors: Reason for Living
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViraSafe: Treatment pushes and BRITE in people with Suicide and Mental Health Disorder, run by Ksana Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Stepp, PhD (412-383-5051, steppsd@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Engagement (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.