Digital Intervention for Suicide Prevention

Overseen By Stephanie Stepp, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ksana Health

Disqualifiers: Manic, Psychotic, Development disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called ViraBrite, designed to prevent suicide by engaging users with safety planning and coping skills during distress. The goal is to determine if sending nudges at various times of the day can improve user interaction with the app. Participants who have recently experienced suicidal thoughts or actions and can use a smartphone daily might be a good fit for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health support through technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a smartphone app for suicide prevention, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the ViraBrite app is safe for users?

Research has shown that the BRITE suicide safety planning app, on which ViraBrite is based, effectively reduces future suicide attempts among young people hospitalized for such attempts. This suggests the app can be a useful tool for managing emotional distress and promoting safety.

Studies using similar smartphone-based tools for suicide prevention have not reported any major negative effects. These digital tools generally help users learn coping skills and manage their emotions, which are important for preventing suicide.

ViraBrite improves upon BRITE by building on these successful features. The app is designed for ease of use and aims to support users during times of high emotional distress. While specific safety data for ViraBrite is not yet available, the success of the BRITE app indicates its potential safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ViraBrite because it offers a novel digital approach to suicide prevention. Unlike traditional therapies, which often rely on in-person counseling or medication, ViraBrite uses a smartphone app to deliver timely nudges that encourage users to engage in coping and safety planning skills. This method provides continuous support and intervention opportunities, tailored to individual needs throughout the day. Additionally, the randomized timing of notifications ensures that users receive prompts at varied times, making the intervention more dynamic and potentially more effective in real-time crisis management.

What evidence suggests that the ViraBrite app is effective for suicide prevention?

Research has shown that digital tools can help reduce suicidal thoughts and behaviors. In this trial, participants will use the ViraBrite app, which studies indicate helps people engage with coping strategies and safety plans. These digital tools provide timely support during high-risk periods. Reviews have found these interventions helpful for people of different ages and genders. Overall, evidence supports that digital methods like ViraBrite can effectively prevent suicide. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adolescents struggling with mental health issues, including thoughts of suicide or anhedonia (inability to feel pleasure). Participants should be comfortable using a smartphone app designed to help with suicide safety planning. There are specific inclusion and exclusion criteria not detailed here.

Inclusion Criteria

Recent suicide attempt or ideation with a plan

English fluency and literacy

Parent or legal guardian willing and able to legally provide informed consent

Exclusion Criteria

No eligible parent or legal guardian to provide informed consent

Unable to read/understand English

Current manic or psychotic episode

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage with the ViraBrite app, receiving daily nudges to utilize coping and suicide safety planning skills

4 weeks

Daily virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ViraBrite

Trial Overview The study tests ViraBrite nudges within the BRITE app, which aims to improve engagement in coping skills and provide timely support during high-risk periods. This 4-week trial uses just-in-time adaptive interventions via smartphones to potentially prevent suicides among youth.

How Is the Trial Designed?

Group I: ViraBrite Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Ksana Health

Lead Sponsor

Trials

3

Recruited

290+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096958/

Digital Interventions for Suicide Prevention This review aimed to determine the effectiveness of digital interventions designed to address suicidal ideation and behaviors and the impacts of age, gender, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40183238/

Digital Interventions for Suicide Prevention This review aimed to determine the effectiveness of digital interventions designed to address suicidal ideation and behaviors.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06318962

Study Details | NCT06318962 | Examining the Efficacy of a ... The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ...

4. mhealth.jmir.org mhealth.jmir.org/2020/1/e12516/citations

Mobile Health Technology Interventions for Suicide Prevention Evaluating the effectiveness of the Barnet (London) suicide prevention campaign using real-time suspected suicide data. BMC Public Health ...

5. dovepress.com dovepress.com/a-scoping-review-of-digital-based-intervention-for-reducing-risk-of-su-peer-reviewed-fulltext-article-JMDH

Digital-based intervention for reducing risk of suicide | JMDH This study aims to describe a digital intervention to reduce the risk of suicidal behavior in adults.

6. nimh.nih.gov nimh.nih.gov/health/trials/suicide-prevention

Suicide Prevention - National Institute of Mental Health (NIMH) This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0890856724003617

Bridging Gaps in Care Following Hospitalization for ... The BRITE app in youth hospitalized for suicide attempt had promising outcomes in regard to future attempts. Plain language summary. This randomized clinical ...

8. mental.jmir.org mental.jmir.org/2021/12/e31367

Centering Lived Experience in Developing Digital ... The example is based on the development of a suicide prevention intervention featuring an emotion regulation and safety planning smartphone app, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9573577/

The Effectiveness of Mobile Apps for Monitoring and ... Screening for suicide risk, developing coping skills and emotional regulation strategies ... The app consists of safety plan, hope box and coping strategies.

10. researchgate.net researchgate.net/publication/378666121_Can_Your_Smartphone_Save_A_Life_A_Systematic_Review_of_Mobile-Based_Interventions_For_Suicide_Prevention

(PDF) Can Your Smartphone Save A Life? A Systematic ... Our results show that persuasive strategies are a promising tool that can be used for designing suicide prevention apps.