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

Not Applicable

Recruiting

• Conditions: Alcohol Problem; Posttraumatic Stress Symptom; Alcohol Drinking
• Interventions: Behavioral: Cognitive restructuring; Behavioral: Activity scheduling; Behavioral: Coaching calls; Behavioral: Non-core intervention components

• Registration Number: NCT06444295
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Study Start: 2024-07-29
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-06-26
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 464

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).

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Thoughts only	Cognitive restructuring	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.
Activities only	Activity scheduling	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.
Activities, Thoughts, & Coaching	Non-core intervention components	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.
No experimental components	Non-core intervention 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.
Thoughts only	Non-core intervention components	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.
Activities + Thoughts	Cognitive restructuring	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.
Activities, Thoughts, & Coaching	Coaching calls	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.
Activities + Thoughts	Activity scheduling	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.
Activities only	Non-core intervention components	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.
Activities + Coaching	Activity scheduling	Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Activities + Thoughts	Non-core intervention components	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.
Activities + Coaching	Coaching calls	Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Activities, Thoughts, & Coaching	Activity scheduling	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.
Thoughts + Coaching	Cognitive restructuring	Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Coaching only	Non-core intervention components	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.
Activities, Thoughts, & Coaching	Cognitive restructuring	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.
Activities + Coaching	Non-core intervention components	Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Thoughts + Coaching	Non-core intervention components	Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Coaching only	Coaching calls	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.
Thoughts + Coaching	Coaching calls	Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.

Primary Outcome Measures

Name	Time	Method
Past-month number of drinks	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	Assessed via the online Timeline Followback (TLFB)
Past-month number of drinking days	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	Assessed via the online Timeline Followback (TLFB)
Past-month peak drinks	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	Assessed via the online Timeline Followback (TLFB)
Past-month frequency of heavy episodic drinking	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	Assessed via the online Timeline Followback (TLFB)
Past-month provisional diagnosis of posttraumatic stress disorder	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	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.
Past-month alcohol problems	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	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.
Past-month posttraumatic stress symptom severity	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Cannabis use & problems	Baseline, 3 months, 6 months, 9 months, 1 year	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.
Drug use & problems	Baseline, 3 months, 6 months, 9 months, 1 year	Assessed using the The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 2 (not including alcohol questions)
Anxiety	Baseline, 3 months, 6 months, 9 months, 1 year	Assessed using the Generalized Anxiety Disorder-7 scale. Minimum score = 0, maximum score = 21, higher scores indicate greater severity of generalized anxiety symptoms.
Depression	Baseline, 3 months, 6 months, 9 months, 1 year	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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States