RecruitingNot ApplicableNCT06444295

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

Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault

Sponsor

University of Washington

Enrollment

464 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Alcohol Drinking Posttraumatic Stress Symptom Alcohol Problem

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two different versions of a smartphone app called Thrive, designed to help college students recover from sexual assault by reducing heavy drinking and post-traumatic stress symptoms (PTSD). **You may be eligible if...** - You are a college or graduate student of legal majority age in your state - You experienced a sexual assault within the past 12 weeks - You have had at least one episode of heavy drinking in the past month - You are showing elevated PTSD symptoms on a screening questionnaire - You own a smartphone that others cannot access while the study app is installed - You reside in the same U.S. state as your university **You may NOT be eligible if...** - You are currently experiencing active psychosis - You are located outside the U.S. at the time of screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALActivity scheduling

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.

BEHAVIORALCognitive restructuring

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.

BEHAVIORALCoaching calls

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.

BEHAVIORALNon-core intervention components

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