ClinicalTrials.gg
CompletedNCT06665620Updated Aug 12, 2026

Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

An interventional study of ViraBrite nudges in Suicide, Mental Health Disorder and Anhedonia, sponsored by Ksana Health. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Primary conditionSuicide(the registry's first term)UnverifiedIs this wrong?Suicide is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Ksana Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
13 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Suicide
  • Mental Health Disorder
  • Anhedonia

Keywords

  • depression
  • depressive disorder
  • mood disorder
  • mental disorders
  • suicidal behaviors
  • suicidal thoughts
  • suicidal ideation
03

In context

Suicide Unverified

607 studies on the registry are indexed under Suicide; 162 are open to participants now.

This study's enrollment of 24 is below the median of 104 across 490 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Ksana Health is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Compared within Suicide, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recent suicide attempt or ideation with a plan
  • English fluency and literacy
  • Parent or legal guardian willing and able to legally provide

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    ViraBrite

    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.

    Behavioral: ViraBrite nudges

Interventions

  • BehavioralViraBrite nudges

    Each day, participants will receive prompts via smartphone notifications that encourage them to access the ViraBrite app and utilize suicide safety planning skills.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

  2. 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

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

  4. 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.

    Time frame: 4 weeks

  5. 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).

    Time frame: Weekly

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06665620
Lead sponsor
Ksana Health
Collaborators
University of Pittsburgh Medical Center, National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Oct 30, 2024
Start date
Jul 16, 2025
Primary completion
Feb 1, 2026
Completion
Feb 1, 2026
Last update
Aug 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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