Clinical trial NCT05427734: Drivers of Suicide Mobile App Study
Official title: Drivers of Suicide Mobile App Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Alcohol Use Disorder
Alcoholism
Alcohol Abuse
Screening and Brief Interventions
Lead sponsor: Evidence-Based Practice Institute, Seattle, WA
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. Participants will be compensated $60 for completion of each of the follow-up assessments (4-, 8-, and 12-week); no payment will be provided for completion of the baseline assessment, however participants will receive a $60 bonus for completing all assessments (including baseline). Participants who complete each assessment (including baseline) within 72 hours of the scheduled appointment will earn a chance to win one of 12 $100 Amazon gift cards that will be raffled at the end of the study (i.e., those who complete all four assessments on time will have four raffle entries). If a participant decides to withdraw or end participation prior to completing their trial or if they are administratively withdrawn by the researchers, they will be compensated the total amount for the assessments they have completed.

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

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.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: Eligibility Screening (time 0), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
measure: Change in Self-Injurious Thoughts and Behaviors Interview-Revised
timeFrame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
measure: Change in Suicide-Related Coping Scale
timeFrame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS)
timeFrame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Secondary outcomes:
measure: Change in Suicide Attempt Self-Injury Interview
timeFrame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
measure: App Satisfaction Survey
timeFrame: 12 weeks (time 4)
Other outcomes:
measure: Demographics Questionnaire
timeFrame: Eligibility Screening (time 0)
measure: Ask Suicide Screening Questions
timeFrame: Eligibility Screening (time 0)
measure: Alcohol Use Disorders Identification Test
timeFrame: Eligibility Screening (time 0)
measure: Drug Abuse Screening Test
timeFrame: Eligibility Screening (time 0)
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Eligibility Screening (time 0)
measure: Eligibility Screen
timeFrame: Eligibility Screening (Time 0)
Locations:
city: Seattle
country: United States
facility: Evidence-Based Practice Institute, Inc.
state: Washington
Study officials:
affiliation: Chief Executive Officer
name: Linda A. Dimeff, PhD
role: PRINCIPAL_INVESTIGATOR
References: