Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedDecember 13, 2024
December 1, 2024
6 months
March 20, 2024
December 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Alcohol abstinence
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
Up to 3 months
Secondary Outcomes (12)
Change in AUD severity at 3 months.
Baseline, 3 months.
Change in AUD frequency status.
Baseline, 3 months.
Change in Alcohol-related negative consequences at 3 months.
Baseline, 3 months.
Change in Alcohol use at 3 months.
Baseline, 3 months.
Change in Reasons for drinking at 3 months.
Baseline, 3 months
- +7 more secondary outcomes
Other Outcomes (4)
Intervention Acceptability
3 months.
Intervention Fidelity
3 months.
Participant Retention
3 months.
- +1 more other outcomes
Study Arms (2)
Treatment group
OTHERThe 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.
Control group
OTHERParticipants 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.
Interventions
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.
Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hallihan Hagar, PhD, RN
Department of Medicine, University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 27, 2024
Study Start
April 15, 2024
Primary Completion
September 30, 2024
Study Completion
November 30, 2024
Last Updated
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- After analyzing.
We will adhere to the University of Illinois Chicago (UIC) Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of UIC Research Grants. Data from this research will be shared and the results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with typical scientific practices. All publications will be made publicly available consistent with UIC policies.