Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active psychosis
Location outside of the US at the time of screening
Trial design
Design model
Factorial
Treatments tested in this trial
Activity scheduling
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralAll 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
Treatment groups
464 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: No experimental componentsActive comparator 1 intervention
Group B: Activities + ThoughtsExperimental treatment 3 interventions
Group C: Activities onlyExperimental treatment 2 interventions
Group D: Thoughts onlyExperimental treatment 2 interventions
Group E: Activities, Thoughts, & CoachingExperimental treatment 4 interventions
Group F: Activities + CoachingExperimental treatment 3 interventions
Group G: Thoughts + CoachingExperimental treatment 3 interventions
Group H: Coaching onlyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 1 year2
Past-month number of drinks
Assessed via the online Timeline Followback (TLFB)
Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 1 year3
Past-month number of drinking days
Assessed via the online Timeline Followback (TLFB)
Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 1 year4
Past-month peak drinks
Assessed via the online Timeline Followback (TLFB)
Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 1 yearSecondary outcomes
1
Drug use & problems
Assessed using the The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 2 (not including alcohol questions)
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year2
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.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year3
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
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year4
Anxiety
Assessed using the Generalized Anxiety Disorder-7 scale. Minimum score = 0, maximum score = 21, higher scores indicate greater severity of generalized anxiety symptoms.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 yearOther outcomes
1
Positive mental health
Assessed using the Flourishing Scale. Minimum score = 8, maximum score = 56, higher scores indicate people with many psychological resources and strengths.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year2
Flourishing
Assessed using the Flourishing Index. Minimum score = 0, maximum score = 120, higher scores indicate greater levels of flourishing/human well-being in individuals.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year3
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.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 year4
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.
Time frame
Baseline, 3 months, 6 months, 9 months, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov