Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students
- Conditions
- Alcohol Use Disorder
- Interventions
- Behavioral: Education-only control groupBehavioral: PST-APPLE Watch group
- Registration Number
- NCT06333288
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.
- Detailed Description
The aims of this study are (1) to test feasibility \& acceptability of screening for AUD symptoms/alcohol misuse and recruitment among college students, and (2) to test preliminary efficacy of PST-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Male and female college students aged 18-25 yr
- English-speaking
- Current alcohol use more than or equal to 2 days/week via phone screening
- Completion of AUDIT screening and meet criteria for (past year) mild, moderate or severe AUD during AUDADIS-5 interview
- Completion of written informed consent
- Interested in cutting back alcohol intake or changing his/her drinking
- Baseline screening study visit
- Participation in past 6 months in AUD or substance use treatment
- Current use of medications used to treat AUD (e.g., naltrexone)
- Lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Current use of psychoactive drugs
- Not currently enrolled in college
- Not interested in cutting back alcohol intake or changing his/her drinking
- Pregnancy or intention to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Education-only control group Participants assigned to Education-only control will be asked to watch "Quit Drinking Motivation," a 20-min video created by the MotivationHub. This video consists of a speech and conversation discussing the negative consequences resulting from their alcohol misuse and the importance of getting sober. The video will be followed by a 30-minute group discussion via zoom. Treatment group PST-APPLE Watch group The intervention group will receive individual PST (60 min individual sessions for 6 weeks, in addition to engaging with APPLE Watch features including fitness tracking (such as regular walks), heart rate, and sleep management on a daily basis. Throughout the final 6 individual self-engaged sessions, participants will persist in engaging and utilizing APPLE Watch features, incorporating daily fitness tracking (such as regular walks), wellness applications, and sleep management and apply PST.
- Primary Outcome Measures
Name Time Method Alcohol abstinence Up to 3 months Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
- Secondary Outcome Measures
Name Time Method Percent binge drinking days at 3 months. Baseline, 3 months. Measured by 90-day Timeline Followback (TLFB).
Percent days abstinence at 3 months. Baseline, 3 months. Measured by 90-day Timeline Followback (TLFB).
Change in AUD severity at 3 months. Baseline, 3 months. Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5(AUDADIS-5). Change in AUD severity from baseline to 3 months.
Change in AUD frequency status. Baseline, 3 months. Measured by AUDIT. Participants will be monitored for up to 3 months. This is the number of participants who screen positive for AUD.
Change in Alcohol-related negative consequences at 3 months. Baseline, 3 months. Measured by Rutgers Alcohol Problem Index (RAPI).
Change in Alcohol use at 3 months. Baseline, 3 months. Measured by 90-day Timeline Followback (TLFB).
Change in Reasons for drinking at 3 months. Baseline, 3 months Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Change in negative affect at 3 months. Baseline, 3 months Measured by Positive and Negative Affect Schedule (PANAS).
Change in positive affect at 3 months. Baseline, 3 months. Measured by Positive and Negative Affect Schedule (PANAS).
Percent heavy drinking days at 3 months. Baseline, 3 months. Measured by 90-day Timeline Followback (TLFB).
Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. Baseline, 3 months. Compensatory Measured by Compensatory Cognitive Strategies Scale
Change in the quality of life at 3 months. Baseline, 3 months. Measured by Quality of Life Scale (QOLS).
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States