Alcohol Abuse, Alcoholism, Alcohol Use Disorder, Screening and Brief Interventions, Suicidal Ideation, Suicide, Suicide, Attempted
Conditions
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. 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
Interventions
DEVICEWisePath for Adults
Participants assigned to this condition will receive access to the WisePath app for 12 weeks.
DEVICEActive-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.
Sponsors
Evidence-Based Practice Institute, Seattle, WA
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Injurious Thoughts and Behaviors Interview-Revised | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) | 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. |
| Change in Suicide-Related Coping Scale | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) | 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. |
| Change in the Patient-Reported Outcome Measurement Information System (PROMIS) | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App Satisfaction Survey | 12 weeks (time 4) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLinda A. Dimeff, PhD
Chief Executive Officer
Participant flow
Recruitment details
Participants were recruited through primary care clinics and a third-party organization, User Interviews.
Pre-assignment details
401 individuals completed the initial screen. Of the 176 eligible, 45 were lost to follow-up, and 4 declined to participate before completing the informed consent. 127 participants completed consent and were randomized to a condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants |
| Employment Employed | 96 Participants |
| Employment Unemployed | 31 Participants |
| Hispanic/Latinx Hispanic/Latinx | 13 Participants |
| Hispanic/Latinx Not Hispanic/Latinx | 50 Participants |
| Lifetime Suicide Attempts 1-2 | 11 Participants |
| Lifetime Suicide Attempts 3 or more | 28 Participants |
| Lifetime Suicide Attempts None | 78 Participants |
| Mental Health Treatment 2 or less hours a week | 59 Participants |
| Mental Health Treatment 3 or more hours a week | 2 Participants |
| Mental Health Treatment Not engaged in mental health treatment | 33 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 4 Participants |
| Race/Ethnicity, Customized Asian or Asian American | 7 Participants |
| Race/Ethnicity, Customized Black | 22 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Other | 13 Participants |
| Race/Ethnicity, Customized White | 32 Participants |
| Region of Enrollment United States | 64 Participants |
| Sex/Gender, Customized Female | 34 Participants |
| Sex/Gender, Customized Male | 27 Participants |
| Sex/Gender, Customized Nonbinary | 1 Participants |
| Technology Usage High Use | 124 Participants |
| Technology Usage Medium Use | 3 Participants |
| Technology Usage Minimum Use | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 63 |
| other Total, other adverse events | 36 / 64 | 35 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
None listed