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
2 other identifiers
interventional
464
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedStudy Start
First participant enrolled
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2027
February 11, 2025
February 1, 2025
3 years
May 30, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Secondary Outcomes (4)
Drug use & problems
Baseline, 3 months, 6 months, 9 months, 1 year
Cannabis use & problems
Baseline, 3 months, 6 months, 9 months, 1 year
Depression
Baseline, 3 months, 6 months, 9 months, 1 year
Anxiety
Baseline, 3 months, 6 months, 9 months, 1 year
Other Outcomes (4)
Positive mental health
Baseline, 3 months, 6 months, 9 months, 1 year
Flourishing
Baseline, 3 months, 6 months, 9 months, 1 year
Social support
Baseline, 3 months, 6 months, 9 months, 1 year
- +1 more other outcomes
Study Arms (8)
No experimental components
ACTIVE COMPARATORParticipants 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.
Activities + Thoughts
EXPERIMENTALParticipants 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.
Activities only
EXPERIMENTALParticipants are invited to use a version of the app for 21 days. Participants receive the Activities app module, but do not attend coaching calls.
Thoughts only
EXPERIMENTALParticipants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module, but do not attend coaching calls.
Activities, Thoughts, & Coaching
EXPERIMENTALParticipants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules and attend coaching calls.
Activities + Coaching
EXPERIMENTALParticipants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Thoughts + Coaching
EXPERIMENTALParticipants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Coaching only
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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 they agree to take steps to reduce the risk that someone else will access the study app
- Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening, or if they are on summer break, plan to be enrolled in the upcoming fall term
- 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).
You may not qualify if:
- Active psychosis
- Location outside of the US at the time of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Dworkin, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Study Start
July 29, 2024
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
July 15, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share