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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA030541 | 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 goal of this study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. In this trial, participants are randomly assigned to receive different versions of the THRIVE app to compare their impact. The THRIVE app is currently only available to participants in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No experimental components | Active Comparator | Participants are invited to use a version of the app for 21 days. Participants receive only the non-core intervention components and do not attend coaching calls. |
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| Activities + Thoughts | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules, but do not attend coaching calls. |
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| Activities only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module, but do not attend coaching calls. |
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| Thoughts only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module, but do not attend coaching calls. |
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| Activities, Thoughts, & Coaching | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity scheduling | Behavioral | Participants will engage in activity scheduling in the app (i.e., "Activities" module). On the first day of using the app, users will create a list of valued/important and avoided activities (e.g., spending time with friends, going to the gym), and then have the option to add alcohol protective behavioral strategies (e.g., adding ice to drinks, alternating alcoholic and nonalcoholic beverages) to activities that the user identifies as being likely to involve drinking. On subsequent days, users will be encouraged to complete at least one activity from their list. |
| Measure | Description | Time Frame |
|---|---|---|
| Past-month alcohol problems | Assessed using the 16-item Short Form Rutgers Alcohol Problem Index (S-RAPI). Minimum score = 0, maximum score = 64, higher scores mean greater severity of problems. | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month number of drinks | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month number of drinking days | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month peak drinks | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month frequency of heavy episodic drinking | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month posttraumatic stress symptom severity | Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Minimum score = 0, maximum score = 80, higher scores mean greater severity of posttraumatic stress. | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
| Past-month provisional diagnosis of posttraumatic stress disorder | Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Provisional posttraumatic stress disorder diagnosis is defined as a score greater than or equal to 31. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use & problems | Assessed using the The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 2 (not including alcohol questions) | Baseline, 3 months, 6 months, 9 months, 1 year |
| Cannabis use & problems |
| Measure | Description | Time Frame |
|---|---|---|
| Positive mental health | Assessed using the Flourishing Scale. Minimum score = 8, maximum score = 56, higher scores indicate people with many psychological resources and strengths. | Baseline, 3 months, 6 months, 9 months, 1 year |
| Flourishing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Dworkin, PhD | Contact | 206-503-3287 | edworkin@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Emily Dworkin, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules and attend coaching calls. |
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| Activities + Coaching | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls. |
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| Thoughts + Coaching | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls. |
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| Coaching only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the non-core intervention components in the app and attend coaching calls. |
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| Cognitive restructuring | Behavioral | Participants will engage in cognitive restructuring in the app (i.e., "Thoughts" activities). Users first go through an activity involving the identification of maladaptive cognitions and create a list of their maladaptive cognitions. On subsequent days, they engage in a guided in-app activity involving cognitive restructuring of maladaptive cognitions from their list. |
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| Coaching calls | Behavioral | Participants will receive 10-20 minute weekly coaching calls during the app use period (4 total, including coaching provided in the enrollment call). All coaching calls will, at minimum, include a check-in, troubleshooting of technical issues, check-in about experience with symptom self-monitoring, and offers of referrals. Coaching calls in conditions involving activity scheduling will involve assistance with the Activities module. Coaching calls in conditions involving cognitive restructuring will involve assistance with the Thoughts module. |
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| Non-core intervention components | Behavioral | All participants, regardless of condition, will receive the following non-core THRIVE components.
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| Baseline, 1 month, 3 months, 6 months, 9 months, 1 year |
Assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R). Minimum score = 0, maximum score = 32, higher scores indicate hazardous cannabis use/possible cannabis use disorder.
| Baseline, 3 months, 6 months, 9 months, 1 year |
| Depression | Assessed using the Center for Epidemiologic Studies Depression Scale - 10 item version. Minimum score = 0, maximum score = 30, higher scores mean greater depressive mood symptoms | Baseline, 3 months, 6 months, 9 months, 1 year |
| Anxiety | Assessed using the Generalized Anxiety Disorder-7 scale. Minimum score = 0, maximum score = 21, higher scores indicate greater severity of generalized anxiety symptoms. | Baseline, 3 months, 6 months, 9 months, 1 year |
Assessed using the Flourishing Index. Minimum score = 0, maximum score = 120, higher scores indicate greater levels of flourishing/human well-being in individuals.
| Baseline, 3 months, 6 months, 9 months, 1 year |
| Social support | Assessed using the Multidimensional Scale of Perceived Social Support. Minimum score = 12, maximum score = 84, higher scores indicate greater level of perceived social support. | Baseline, 3 months, 6 months, 9 months, 1 year |
| Loneliness | Assessed using the University of California Los Angeles 3-Item Loneliness Scale. Minimum score = 3, maximum score = 9, higher scores indicate greater levels of loneliness. | Baseline, 3 months, 6 months, 9 months, 1 year |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000088686 | Cognitive Restructuring |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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