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Behavioral Intervention
THRIVE App for Alcohol Use and PTSD
N/A
Recruiting
Led By Emily Dworkin, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine the best version of the THRIVE app, which has been shown to help reduce alcohol misuse and posttraumatic stress in individuals who have experienced sexual assault. Participants in the study
Who is the study for?
This trial is for adults who can read and speak English, are students at a recruitment site, have recently experienced sexual assault, show signs of posttraumatic stress, own a private smartphone, live in the same state as the recruitment site most of the year, and report recent heavy drinking.
What is being tested?
The study tests different versions of the THRIVE app to see which one best reduces alcohol misuse and posttraumatic stress after sexual assault. Participants will be randomly assigned to use various features like activity scheduling or cognitive restructuring.
What are the potential side effects?
Since this intervention involves an app with psychological exercises and coaching calls rather than medication or medical procedures, side effects may include emotional discomfort or distress related to addressing traumatic experiences.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Past-month alcohol problems
Past-month frequency of heavy episodic drinking
Past-month number of drinking days
+4 moreSecondary study objectives
Anxiety
Cannabis use & problems
Depression
+1 moreOther study objectives
Flourishing
Loneliness
Positive mental health
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Thoughts onlyExperimental Treatment2 Interventions
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.
Group II: Thoughts + CoachingExperimental Treatment3 Interventions
Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Group III: Coaching onlyExperimental Treatment2 Interventions
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.
Group IV: Activities, Thoughts, & CoachingExperimental Treatment4 Interventions
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.
Group V: Activities onlyExperimental Treatment2 Interventions
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.
Group VI: Activities + ThoughtsExperimental Treatment3 Interventions
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.
Group VII: Activities + CoachingExperimental Treatment3 Interventions
Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Group VIII: No experimental componentsActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive restructuring
2014
N/A
~300
Coaching calls
2022
Completed Phase 2
~170
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,913,919 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,306 Total Patients Enrolled
Emily Dworkin, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
41 Total Patients Enrolled
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