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

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+