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| ID | Type | Description | Link |
|---|---|---|---|
| R44AA029868 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WisePath for Adults | Device | Participants assigned to this condition will receive access to the WisePath app for 12 weeks. |
|
| 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. |
| 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. |
| 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. |
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)
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Linda A. Dimeff, PhD | Chief Executive Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidence-Based Practice Institute, Inc. | Seattle | Washington | 98126 | United States |
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.
Study data will become available after grant closeout, in perpetuity.
(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.
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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.
Participants were recruited through primary care clinics and a third-party organization, User Interviews.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants completed Baseline (Time 1).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Based on feedback from the FDA, participants aged 22 and older were eligible to participate in this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number analyzed differs between rows because of attrition over different timepoints. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) |
|
12 weeks
Participants were asked to report potential and actual adverse events, whether or not the individual considered the event resulting from the research, via online survey, to IRB, or study PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt that leads to acute hospital-based care | Psychiatric disorders | Non-systematic Assessment | Suicide attempt that leads to acute hospital-based care (e.g., ED visit) resulting from the research protocol or assigned app usage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Warm Handoff to 988 | Psychiatric disorders | Non-systematic Assessment | We use a debrief protocol to assess distress and imminent suicide risk at the end of the session. Those in high distress or reporting high suicidal ideation will be connected to the 988 Suicide and Crisis Lifeline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kelley Brimer | Evidence-Based Practice Institute, Inc. | 253-765-0455 | research@ebpi.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2025 | Jan 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2025 | Jan 26, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
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| 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. |
|
| 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) |
| 12 weeks (time 4) |
| 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were allowed to select multiple race/ethnicity identities and may therefore be included in more than one race/ethnicity category. | Count of Participants | Participants |
|
| Region of Enrollment | The region of the individuals participating | Number | Participants |
|
| Hispanic/Latinx | Count of Participants | Participants |
|
| Mental Health Treatment | The amount of time per week the participant is currently engaged in mental health treatment | Count of Participants | Participants |
|
| Employment | The employment status of the participant | Count of Participants | Participants |
|
| Lifetime Suicide Attempts | The number of suicide attempts the participant has made in their lifetime | Count of Participants | Participants |
|
| Technology Usage | Participants were asked to describe their use of technology. Minimum use of technology refers to only occasional usage of computers and smartphones. Medium use of technology refers to usage of computers and smartphones sometimes. High use of technology refers to the usage of computers and smartphones very often. | Count of Participants | Participants |
|
| OG000 |
| 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. |
| OG001 | 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. |
|
|
| Primary | 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. | The number analyzed differs between rows because of attrition over different timepoints. | Posted | Mean | Standard Deviation | Events | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) |
|
|
|
| Primary | 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. | The number analyzed differs between rows because of attrition over different timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) |
|
|
|
| Secondary | 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. | The number analyzed differs because of attrition over different timepoints. One participant in the Active-Control app + electronic wellness resources brochure condition did not complete the App Satisfaction Survey because they did not download the app, but continued their participation in the study. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks (time 4) |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Score on a scale | Eligibility Screen (Time 0) |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Score on a scale | Eligibility Screen (Time 0) |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Score on a scale | Eligibility Screen (Time 0) |
|
|
|
| Primary | 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. | The number analyzed differs between rows because of attrition over different timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 36 |
| 64 |
| EG001 | 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. | 0 | 63 | 0 | 63 | 35 | 63 |
|
| Alcohol poisoning that leads to acute hospital-based care | Psychiatric disorders | Non-systematic Assessment | Alcohol poisoning that leads to acute hospital-based care resulting from research procedures or device usage |
|
|
| Suicide attempts that do not require medical attention or hospital-based care | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide attempt that leads to acute hospital-based care (e.g., ED visit) | Psychiatric disorders | Non-systematic Assessment | Suicide attempt that leads to acute hospital-based care (e.g., ED visit) that is not resulting from the research protocol or assigned app usage |
|
| Significant increase in suicidal ideation frequency | Psychiatric disorders | Non-systematic Assessment | Significant increase in suicidal ideation frequency as characterized by a two-fold increase in SI in the past 30 days based on the Self Injury Thoughts and Behaviors Interview (SITBI) |
|
| Significant increase in suicidal ideation intensity | Psychiatric disorders | Non-systematic Assessment | Significant increase in suicidal ideation intensity as characterized by a two-point increase in SI in past 30 days based on the SITBI |
|
| Self-report of blackouts related to alcohol use | Psychiatric disorders | Non-systematic Assessment |
|
| Self-report of injuries to themselves or others related to alcohol use | Psychiatric disorders | Non-systematic Assessment |
|
| Significant increase in alcohol use | Psychiatric disorders | Non-systematic Assessment | ≥5-point raw score increase on PROMIS Alcohol Use 7a |
|
| Significant increase in negative consequences related to alcohol use | Psychiatric disorders | Non-systematic Assessment | ≥5-point raw score increase on PROMIS Alcohol Negative Consequences measure |
|
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Past 30-Day Suicidal Ideation Frequency Time 2 |
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| Past 30-Day Suicidal Ideation Frequency Time 3 |
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| Past 30-Day Suicidal Ideation Frequency Time 4 |
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| External Coping Time 2 |
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| External Coping Time 3 |
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| External Coping Time 4 |
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| Internal Coping Time 1 |
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| Internal Coping Time 2 |
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| Internal Coping Time 3 |
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| Internal Coping Time 4 |
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| Helpfulness |
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| Felt Cared About |
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| Received Help or Support |
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| Recommendation Likelihood |
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| Rating of Care |
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| Average of Satisfaction Items |
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| Alcohol Use Time 2 |
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| Alcohol Use Time 3 |
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| Alcohol Use Time 4 |
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| Negative Alcohol Use Consequences Time 1 |
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| Negative Alcohol Use Consequences Time 2 |
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| Negative Alcohol Use Consequences Time 3 |
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| Negative Alcohol Use Consequences Time 4 |
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| Emotion Self-Efficacy Time 1 |
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| Emotion Self-Efficacy Time 2 |
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| Emotion Self-Efficacy Time 3 |
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| Emotion Self-Efficacy Time 4 |
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