MedPath

Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students

Not Applicable
Completed
Conditions
Alcohol Use Disorder
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Primary Outcome Measures
NameTimeMethod
Alcohol abstinenceUp to 3 months

Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.

Secondary Outcome Measures
NameTimeMethod
Change in the quality of life at 3 months.Baseline, 3 months.

Measured by Quality of Life Scale (QOLS).

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 Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.Baseline, 3 months.

Compensatory Measured by Compensatory Cognitive Strategies Scale

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 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).

Trial Locations

Locations (1)

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States

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