Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06444295
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • Alcohol Problem
  • Posttraumatic Stress Symptom

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.
  • Non-core intervention components — BEHAVIORAL
    All participants, regardless of condition, will receive the following non-core THRIVE components. * 21 days of brief self-report surveys in the app assessing their PTSD symptoms and alcohol use in the prior 24 hours. * A banner in their app displaying rotating non-personalized encouraging messages from other users. All app users will have the option of submitting encouraging statements to be displayed to all other users. Statements will be vetted by study staff before posting. * Lists of referral options specific to each recruitment site via the "Resources" section of the app. * Answers to frequently asked questions about the study, the study consent form, and contact information for the study team via the "Information" section of the app. * One call with a study "point person" within the first week following randomization to ensure they were able to access the app and troubleshoot access issues

Study Details

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.

Key Dates

Start date
Jul 29, 2024
Status verified
Feb 2025
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
464 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: No experimental components
    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.
  • Experimental: Activities + Thoughts
    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.
  • Experimental: Activities only
    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.
  • Experimental: Thoughts only
    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.
  • Experimental: Activities, Thoughts, & Coaching
    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.
  • Experimental: Activities + Coaching
    Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
  • Experimental: Thoughts + Coaching
    Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
  • Experimental: Coaching only
    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.

Primary Outcome Measure

Past-month alcohol problems [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195-

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