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N/A N=127 Randomized Double-blind Treatment

Drivers of Suicide Mobile App Study

Suicide · Suicide, Attempted · Suicidal Ideation · Alcohol Use Disorder · Alcoholism

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change in Self-Injurious Thoughts and Behaviors Interview-Revised — 0.92; 1.05; 0.62; 0.74 Scores on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
WisePath for Adults (Device); Active-Control app + electronic wellness resources brochure (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Evidence-Based Practice Institute, Seattle, WA
Primary completion
Nov 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Self-Injurious Thoughts and Behaviors Interview-Revised
4.98; 4.14; 3.16; 2.58; 2.13; 2.45
PRIMARY
Change in Self-Injurious Thoughts and Behaviors Interview-Revised
4.98; 4.14; 3.16; 2.58; 2.13; 2.45
PRIMARY
Change in Suicide-Related Coping Scale
19.16; 19.15; 20.47; 20.29; 21.49; 21.89
PRIMARY
Change in the Patient-Reported Outcome Measurement Information System (PROMIS)
10.05; 9.86; 7.26; 7.24; 6.29; 5.45
SECONDARY
App Satisfaction Survey
68.50; 60.08; 3.75; 3.80; 3.07; 2.84

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.

Eligibility Criteria

Inclusion Criteria

  • Resides in the United States
  • 22+ years of age
  • English speaking
  • At risk for suicide, as evidenced by at least one of the following:
  • One or more lifetime suicide attempts (ASQ item 4)
  • Endorsement of any ASQ items 1 -3 (expanded from "past few weeks" in ASQ to "past 30 days" in our measures)
  • Item 1: In the past 30 days, have you wished you were dead?
  • Item 2: In the past 30 days, have you felt that you or your family would be better off if you were dead?
  • Item 3: In the 30 days, have you been having thoughts about killing yourself?
  • Currently has a primary care provider and sought care from them in the past year
  • Possesses and is the primary user of an Android- or iPhone-based smartphone with a data plan

Given that alcohol misuse exponentially increases the risk of death by suicide, can exacerbate other problems, and interfere with effective treatment, we will over-recruit individuals who misuse alcohol to ensure relevance of the tool for them. No fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.

To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.

Exclusion Criteria

  • Severe depression (PHQ-9 score of 20 or greater)
  • Alcohol dependence (AUDIT score of 32 or greater)
  • Acutely suicidal (affirms item 5 of the Ask Suicide Screening Questions; Are you having thoughts of killing yourself right now? Followed by endorsing intent; Have you intended to act on urges to kill yourself in the past 30 days? or planning within the past 30 days; Have you made a plan to kill yourself in the past 30 days?)
  • Significant drug abuse problems (scores 6 or greater on the DAST-10)

Individuals who are excluded because of the severity of their depression, suicide acuity, and/or degree of substance use disorder will be provided with resources (i.e., the Suicide and Crisis Lifeline (988), SAMHSA's National Helpline) and encouraged to reach out to their primary care or mental/behavioral health provider.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05427734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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