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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333288
• Other study ID #: 2024-0268
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: University of Illinois at Chicago
• Contact: Hallihan Hagar, PhD, RN
• Phone: 312-413-5361
• Email: hhalli2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: March 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Acceptability	Measured by the Client Counseling Satisfaction Scale(CCSS).	3 months.
Other	Intervention Fidelity	Participant adherence to the PST-APPLE intervention schedule will be assessed by documented session attendance.	3 months.
Other	Participant Retention	Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-month.	3 months.
Other	Protocol Acceptability	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.
Primary	Alcohol abstinence	Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.	Up to 3 months
Secondary	Change in AUD severity at 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.
Secondary	Change in AUD frequency status.	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.
Secondary	Change in Alcohol-related negative consequences at 3 months.	Measured by Rutgers Alcohol Problem Index (RAPI).	Baseline, 3 months.
Secondary	Change in Alcohol use at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.
Secondary	Change in Reasons for drinking at 3 months.	Measured by Drinking Motives Questionnaire Revised (DMQ-R).	Baseline, 3 months
Secondary	Change in negative affect at 3 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 3 months
Secondary	Change in positive affect at 3 months.	Measured by Positive and Negative Affect Schedule (PANAS).	Baseline, 3 months.
Secondary	Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.	Measured by the CANTAB test developed by Cambridge cognition. Two tests will be conducted, including Cognition Kit Digital Symbol Substitution (DSST) and Cognition Kit N-Back (NBX).	Baseline, 3 months.
Secondary	Change in the quality of life at 3 months.	Measured by Quality of Life Scale (QOLS).	Baseline, 3 months.
Secondary	Percent heavy drinking days at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.
Secondary	Percent binge drinking days at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.
Secondary	Percent days abstinence at 3 months.	Measured by 90-day Timeline Followback (TLFB).	Baseline, 3 months.