Clinical trial NCT06333288: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students
Official title: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students (PRO-APPLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol abstinence
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in AUD severity at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in AUD frequency status.
timeFrame: Baseline, 3 months.
measure: Change in Alcohol-related negative consequences at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Alcohol use at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Reasons for drinking at 3 months.
timeFrame: Baseline, 3 months
measure: Change in negative affect at 3 months.
timeFrame: Baseline, 3 months
measure: Change in positive affect at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.
timeFrame: Baseline, 3 months.
measure: Change in the quality of life at 3 months.
timeFrame: Baseline, 3 months.
measure: Percent heavy drinking days at 3 months.
timeFrame: Baseline, 3 months.
measure: Percent binge drinking days at 3 months.
timeFrame: Baseline, 3 months.
measure: Percent days abstinence at 3 months.
timeFrame: Baseline, 3 months.
Other outcomes:
measure: Intervention Acceptability
timeFrame: 3 months.
measure: Intervention Fidelity
timeFrame: 3 months.
measure: Participant Retention
timeFrame: 3 months.
measure: Protocol Acceptability
timeFrame: 3 months.
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Department of Medicine, University of Illinois at Chicago
name: Hallihan Hagar, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: