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

December 9, 2024 updated by: Hagar Hallihan, University of Illinois at Chicago

Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students (PRO-APPLE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol abstinence
Time Frame: Up to 3 months
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alcohol-related negative consequences at 3 months.
Time Frame: Baseline, 3 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Baseline, 3 months.
Change in Alcohol use at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Change in Reasons for drinking at 3 months.
Time Frame: Baseline, 3 months
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Baseline, 3 months
Change in negative affect at 3 months.
Time Frame: Baseline, 3 months
Measured by Positive and Negative Affect Schedule (PANAS).
Baseline, 3 months
Change in AUD severity at 3 months.
Time Frame: 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.
Baseline, 3 months.
Change in AUD frequency status.
Time Frame: 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.
Baseline, 3 months.
Change in positive affect at 3 months.
Time Frame: Baseline, 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Baseline, 3 months.
Change in the quality of life at 3 months.
Time Frame: Baseline, 3 months.
Measured by Quality of Life Scale (QOLS).
Baseline, 3 months.
Percent heavy drinking days at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Percent binge drinking days at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Percent days abstinence at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.
Time Frame: Baseline, 3 months.
Compensatory Measured by Compensatory Cognitive Strategies Scale
Baseline, 3 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: 3 months.
Measured by the Client Counseling Satisfaction Scale(CCSS).
3 months.
Intervention Fidelity
Time Frame: 3 months.
Participant adherence to the PST-APPLE intervention schedule will be assessed by documented session attendance.
3 months.
Participant Retention
Time Frame: 3 months.
Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-month.
3 months.
Protocol Acceptability
Time Frame: 3 months.
PI or a trained research team member will conduct semi-structured interviews 3-month post-intervention with each participant and will adapt the semi-structured interview guide approach from the previous research study (Study named: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor [SPEAC] and DEDICATE study).
3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Hallihan Hagar, PhD, RN, Department of Medicine, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After analyzing.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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