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

NCT ID: NCT06333288

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-11-30

Brief Summary

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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

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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).

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment 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.

Group Type OTHER

PST-APPLE Watch group

Intervention Type BEHAVIORAL

PST combined APPLE Watch is a tailored behavioral intervention that enables college students with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake and teach problem-solving skills.

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.

Group Type OTHER

Education-only control group

Intervention Type BEHAVIORAL

Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.

Interventions

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PST-APPLE Watch group

PST combined APPLE Watch is a tailored behavioral intervention that enables college students with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake and teach problem-solving skills.

Intervention Type BEHAVIORAL

Education-only control group

Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Hagar Hallihan

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hallihan Hagar, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2024-0268

Identifier Type: -

Identifier Source: org_study_id