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

Alcohol Drinking Clinical Trial

Official title:

Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444295
• Other study ID #: STUDY00016193
• Secondary ID: R01AA030541
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Emily Dworkin, PhD
• Phone: 206-503-3287
• Email: edworkin[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. completion date: June 30, 2028
• Est. primary completion date: June 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 agree to take steps to reduce the risk of access

• Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening

• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Problem
• Alcohol-Related Disorders

Intervention

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	Past-month number of drinks	Assessed via the online Timeline Followback (TLFB)	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Primary	Past-month number of drinking days	Assessed via the online Timeline Followback (TLFB)	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Primary	Past-month peak drinks	Assessed via the online Timeline Followback (TLFB)	Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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