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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Alcohol Problem; Posttraumatic Stress Symptom
• Intervention / Treatment: Behavioral: Non-core intervention components; Behavioral: Activity scheduling; Behavioral: Cognitive restructuring; Behavioral: Coaching calls

• Study Type: Interventional
• Enrollment (Estimated): 464
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Dworkin, PhD; Phone Number: 206-503-3287; Email: edworkin@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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).

Exclusion Criteria:

• Active psychosis
• Location outside of the US at the time of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Non-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
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.	Behavioral: Non-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; Behavioral: Activity 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.; Behavioral: Cognitive 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.
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.	Behavioral: Non-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; Behavioral: Activity 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.
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.	Behavioral: Non-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; Behavioral: Cognitive 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.
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.	Behavioral: Non-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; Behavioral: Activity 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.; Behavioral: Cognitive 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.; Behavioral: Coaching 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.
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.	Behavioral: Non-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; Behavioral: Activity 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.; Behavioral: Coaching 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.
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.	Behavioral: Non-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; Behavioral: Cognitive 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.; Behavioral: Coaching 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.
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.	Behavioral: Non-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; Behavioral: Coaching 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Emily Dworkin, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Sexual assault; Mobile health intervention
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol Drinking; Alcohol-Related Disorders
• Other Study ID Numbers: STUDY00016193; R01AA030541 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No