Trials / Completed

CompletedNCT05427734

Drivers of Suicide Mobile App Study

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 127 (actual)

Sponsor: Evidence-Based Practice Institute, Seattle, WA · Industry
Sex: All
Age: 22 Years
Healthy volunteers: Not accepted

Summary

The central purpose of this project is to evaluate and facilitate access to evidence-based best practices for individuals struggling with suicidal ideation and co-occurring behavioral problems, including alcohol misuse, and provide assistance to the patients while they are waiting to receive care, as they are receiving care, and after they return home. While WisePath is highly innovative in how it delivers these best practices, the content is well-established and known to reduce suicidality and alcohol misuse. We will conduct a 12-week intent-to-treat RCT with 120 suicidal adults 22 years and older who may also be experiencing alcohol misuse. Participants will be randomly assigned to WisePath (n=60) or an active control condition (n=60) including a control suicide prevention self-help app plus an electronic wellness resources brochure containing links to health and wellness materials, psychoeducation about suicide, depression, self-help recovery-focused resources (e.g., Alcoholics Anonymous and other 12-Step programs, Moderation Management, etc.), and phone/text information for the 988 Suicide \& Crisis Lifeline. Participants will be assessed at baseline, 4, 8 and 12 weeks.

Detailed description

This study will test the newly developed WisePath for Adults ("WisePath"), a robust digital technology developed under NIAAA SBIR Fast-Track award (R44AA029868; Drs. Dimeff \& Jobes, Co-PIs) that is developed to efficiently and reliably aid delivery of recommended best-practices for the treatment of suicidal ideation in adults, including suicidal individuals who also misuse alcohol. WisePath includes techniques for prevention of suicidal behaviors (ideation, planning, attempts) while providing access to support resources in the moment via a mobile app. WisePath will include evidence-based practices for suicide prevention, including for those who are suicidal and also experience other behavioral health concerns such as depressed mood, sleep problems, and misuse of alcohol. This study will test WisePath with individuals who are experiencing these problems and recently sought treatment from a primary care provider. WisePath includes: psychoeducation, behavioral skills training, crisis stabilization planning, lethal means management, brief interventions for the treatment of suicidal ideation, depressed mood, sleep problems, alcohol misuse, and messages of hope, wisdom, and insights from people with lived experience (PLE). We will conduct a randomized controlled trial (RCT; N=120) comparing WisePath (n=60) to an active control condition (a well-regarded suicide prevention self-help app + electronic wellness resources brochure; n=60) in adults experiencing suicidal ideation. To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% (n=42) of the sample will be comprised of individuals who experience a harmful or hazardous level of alcohol use. Participants will be randomly assigned to a condition utilizing a minimization randomization procedure to match participants across condition on suicide severity, depression severity, and alcohol misuse. Participants will be assessed at baseline, 4, 8, and 12 weeks. We hypothesize that in comparison to the active control condition, WisePath participants will show significantly better outcomes from baseline to the 4-, 8-, and 12-week assessment points such that: 1. WisePath participants will report significantly greater decreases in suicidal and alcohol misuse behaviors compared to controls 2. WisePath participants will report greater increases in self-efficacy and coping with suicidal thoughts and distress, as well as use of suicide prevention strategies compared to study controls 3. WisePath participants will report a higher degree of satisfaction with their respective app compared to controls

Conditions

Interventions

Type	Name	Description
DEVICE	WisePath for Adults	Participants assigned to this condition will receive access to the WisePath app for 12 weeks.
DEVICE	Active-Control app + electronic wellness resources brochure	Participants assigned to this condition will receive access to Virtual Hope Box, a well-regarded suicide prevention self-help app, for 12 weeks plus an electronic wellness resources brochure.

Timeline

Start date: 2025-03-05
Primary completion: 2025-11-10
Completion: 2025-11-10
First posted: 2022-06-22
Last updated: 2026-04-17
Results posted: 2026-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05427734. Inclusion in this directory is not an endorsement.