Alcohol Drinking Clinical Trial
Official title:
Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
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.
Status | Not yet recruiting |
Enrollment | 464 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 26, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have reached the legal age of majority in their current state of residence - Be able to read and speak English fluently - Own a smartphone that cannot be accessed by others while the study app is installed, or agree to take steps to reduce the risk of access - Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening - Reside in the same state as the recruitment site for most of the year - Have experienced a sexual assault (i.e., unwanted and non-consensual attempted/completed sexual contact) within the past 12 weeks at the time of screening - Report =1 past-month heavy drinking episode (i.e., 5+ drinks on a given day or 15+ drinks in a given week for participants assigned male at birth and 4+ drinks on a given day or 8+ drinks in a given week for participants assigned female or intersex at birth) at the time of screening - Endorse elevated posttraumatic stress symptoms at screening (defined as a score above a pre-established cut point on a screening measure of PTSD). Exclusion Criteria: - Active psychosis - Location outside of the US at the time of screening |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Flourishing | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | Past-month number of drinks | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year | |
Primary | Past-month number of drinking days | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year | |
Primary | Past-month peak drinks | Assessed via the online Timeline Followback (TLFB) | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | Baseline, 1 month, 3 months, 6 months, 9 months, 1 year | |
Secondary | 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 | |
Secondary | Cannabis use & problems | 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 | |
Secondary | 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 | |
Secondary | 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 |
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