Clinical trial NCT06444295: Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
Official title: Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Symptom
Alcohol Drinking
Alcohol Problem
Keywords: Sexual assault
Mobile health intervention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-06-05
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Past-month alcohol problems
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month number of drinks
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month number of drinking days
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month peak drinks
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month frequency of heavy episodic drinking
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month posttraumatic stress symptom severity
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Past-month provisional diagnosis of posttraumatic stress disorder
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Secondary outcomes:
measure: Drug use & problems
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Cannabis use & problems
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Depression
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Anxiety
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
Other outcomes:
measure: Positive mental health
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Flourishing
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Social support
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
measure: Loneliness
timeFrame: Baseline, 3 months, 6 months, 9 months, 1 year
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Emily Dworkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: