Drivers of Suicide Mobile App Study

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism; Suicidal Ideation; Suicide, Attempted; Suicide; Alcohol Use Disorder; Alcohol Abuse; Screening and Brief Interventions
• Intervention / Treatment: Device: Active-Control app + electronic wellness resources brochure; Device: WisePath for Adults

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

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98126
      • Evidence-Based Practice Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active-Control app + electronic wellness resources brochure; 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; 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.
Experimental: WisePath for Adults; 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; Participants assigned to this condition will receive access to the WisePath app for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Satisfaction Survey	An eight-item survey used in EBPI's earlier research, which focuses on an app's ease of use and helpfulness. The initial six items use a five-point rating scale (1=poor; 5=excellent). Users also provide an overall satisfaction rating for their condition app using a 100-point scale (1=the worst; 100=the best) and indicate whether they would recommend using the app to others in their situation. The scores for the initial six items were also summed and averaged to generate the Average of Satisfaction Items score. Higher scores indicate the app has greater ease of use and helpfulness, and the respondent felt more cared about, supported, likely to recommend the app, and greater satisfaction with the app.	12 weeks (time 4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test (AUDIT)	A 10-item psychometrically sound self-report measure (minimum 0 and maximum 40) used to assess alcohol intake, potential dependence on alcohol, and experience of alcohol-related harm. Items 1-8 are scored on a 5-point scale (0=Never to 4=Daily or almost daily; 0=Never to 4=4 or more times a week; 0=1 or 2 to 4=10 or more). Items 9 and 10 are scored on a 3-point scale (0=No; 2=Yes, but not in the last year; 4=Yes, during the last year). Items are summed to generate a total score. A score of 0 suggests no experience with problems related to alcohol use; 1 to 7 suggests low-risk consumption; 8 to 14 suggest hazardous or harmful alcohol consumption; and 15 or more indicates the likelihood of alcohol dependence.	Eligibility Screen (Time 0)
Drug Abuse Screening Test (DAST-10)	A 10-item psychometrically validated self-administered screening tool (minimum of 0 and maximum of 10) for drug-related problems. Items are scored on a binary scale. (No=0; Yes=1), except for item 3 which is reverse scored. Items are summed to generate a total score. Higher scores indicate a greater degree of problems related to drug use.	Eligibility Screen (Time 0)
Patient Health Questionnaire-9 (PHQ-9)	The nine-item questionnaire assesses recent depressive symptoms, and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. Scores of 1-9 indicate minimal to mild depression; 10-14, moderate depression; and 15-19, moderate to severe depression.	Eligibility Screen (Time 0)

Collaborators and Investigators

• Sponsor: Evidence-Based Practice Institute, Seattle, WA
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Linda A. Dimeff, PhD, Chief Executive Officer

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Self-Injurious Behavior; Alcohol-Related Disorders; Behavior; Suicide; Suicidal Ideation; Alcoholism; Suicide, Attempted
• Other Study ID Numbers: R44AA029868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@jasprhealth.com.

The final dataset will include self-reported demographic and behavioral data from participants in the randomized controlled trial. The dataset will include sensitive data from participants regarding suicidal behavior and substance use. Even though the final dataset will be stripped of identifiers prior to release for sharing, investigators believe that there remains the possibility of deductive disclosure of participants. Thus, the de-identified dataset will be distributed by Drs. Dimeff and Jobes to those that request it and only under a data-sharing agreement that includes: (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.

• IPD Sharing Time Frame: Study data will become available after grant closeout, in perpetuity.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No