Drivers of Suicide Mobile App Study

NCT05427734 | Completed Results DMC

• 1 other identifier: R44AA029868
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide, Attempted; Suicidal Ideation; Alcohol Use Disorder; Alcoholism; Suicide; Alcohol Abuse; Screening and Brief Interventions

Outcome Measures

Primary Outcomes (4)

• Change in Self-Injurious Thoughts and Behaviors Interview-Revised

  A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Peak Suicidal Ideation Intensity, Suicide Plan Forecasting, and Suicide Attempt Forecasting are scored on a 5-point scale (0=Low/Little; 4=Very much/Severe). Higher scores indicate higher intensity of suicidal ideation and greater likelihood to make a suicide plan and attempt.

  Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

• Change in Self-Injurious Thoughts and Behaviors Interview-Revised

  A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Past 30-Day Suicidal Ideation Frequency refers to the number of times in the past month the behavior occurred. A higher number indicates a greater number of suicidal thoughts experienced in the last month.

  Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

• Change in Suicide-Related Coping Scale

  17-item, with 5 items scored in reverse, psychometrically-sound self-report measure of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree). There are two subscales, internal coping (minimum of 0 and maximum of 28) and external coping (minimum of 0 and maximum of 28). Subscale items are summed to generate total scores for each. Higher subscale scores indicate higher ability to cope with suicidality.

  Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS)

  A well-validated, normed set of measures with standardized scoring. The measures of alcohol use (minimum of 0 and maximum of 28) and negative consequences related to alcohol use (minimum of 0 and maximum of 28) have 7 items. The measure of self-efficacy to manage emotions (minimum of 0 and maximum of 16) has 4 items. All measures are scored on a 5-point scale, (i.e., 0=never and 4=almost always for the alcohol use and negative consequences related to alcohol use measures; 0=I am not at all confident and 4=I am very confident for the self-efficacy to manage emotions measure), and responses are summed to create a raw total score for each measure. Higher scores for each measure indicate greater alcohol use, negative consequences related to alcohol use, and higher self-efficacy to manage emotions.

  Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

Secondary Outcomes (1)

• App Satisfaction Survey

  12 weeks (time 4)

Other Outcomes (3)

• Alcohol Use Disorders Identification Test (AUDIT)

  Eligibility Screen (Time 0)

• Drug Abuse Screening Test (DAST-10)

  Eligibility Screen (Time 0)

• Patient Health Questionnaire-9 (PHQ-9)

  Eligibility Screen (Time 0)

Study Arms (2)

WisePath for Adults

EXPERIMENTAL

WisePath is designed to help support individuals during challenging moments and while experiencing behavioral concerns. The app is designed for people who struggle with depression, sleep problems, have feelings of wanting to die, or want to harm themselves, and/or misuse alcohol. WisePath includes specific tools for those who are experiencing suicidality, including creating a safety plan and teaching skills and strategies to get through distressing moments. You have been assigned to use the WisePath app while you are in this study.

Device: WisePath for Adults

Active-Control app + electronic wellness resources brochure

ACTIVE COMPARATOR

Well-regarded 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, other 12-Step programs, Moderation Management, etc.), and phone/text information for the National Suicide Prevention Lifeline.

Device: Active-Control app + electronic wellness resources brochure

Interventions

WisePath for Adults DEVICE

Participants assigned to this condition will receive access to the WisePath app for 12 weeks.

WisePath for Adults

Active-Control app + electronic wellness resources brochure DEVICE

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.

Active-Control app + electronic wellness resources brochure

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resides in the United States
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evidence-Based Practice Institute, Seattle, WA: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Evidence-Based Practice Institute, Inc.

Seattle, Washington, 98126, United States

Location

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation; Alcoholism

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Angela Kelley Brimer
• Organization: Evidence-Based Practice Institute, Inc.

research@ebpi.org

253-765-0455

Study Officials

• Linda A. Dimeff, PhD

  Chief Executive Officer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 22, 2022
• Study Start: March 5, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study data will become available after grant closeout, in perpetuity.
• Access Criteria: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.

Locations

US (1)