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

University of Washington

Status: Enrolling

Conditions: Posttraumatic Stress Symptom; Alcohol Problem; Alcohol Drinking

Treatments: Behavioral: Activity scheduling; Behavioral: Non-core intervention components; Behavioral: Coaching calls; Behavioral: Cognitive restructuring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06444295

STUDY00016193

R01AA030541 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 464 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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464 participants in 8 patient groups

No experimental components

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-core intervention components

Activities + Thoughts

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive restructuring

Behavioral: Non-core intervention components

Behavioral: Activity scheduling

Activities only

Experimental group

Description:

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.

Treatment:

Behavioral: Non-core intervention components

Behavioral: Activity scheduling

Thoughts only

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive restructuring

Behavioral: Non-core intervention components

Activities, Thoughts, & Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive restructuring

Behavioral: Coaching calls

Behavioral: Non-core intervention components

Behavioral: Activity scheduling

Activities + Coaching

Experimental group

Description:

Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.

Treatment:

Behavioral: Coaching calls

Behavioral: Non-core intervention components

Behavioral: Activity scheduling

Thoughts + Coaching

Experimental group

Description:

Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.

Treatment:

Behavioral: Cognitive restructuring

Behavioral: Coaching calls

Behavioral: Non-core intervention components

Coaching only

Experimental group

Description:

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.

Treatment:

Behavioral: Coaching calls

Behavioral: Non-core intervention components