Alcohol Use Disorder
Conditions
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).
Interventions
BEHAVIORALPST-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.
BEHAVIORALEducation-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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol abstinence | Up to 3 months | Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reasons for drinking at 3 months. | Baseline, 3 months | Measured by Drinking Motives Questionnaire Revised (DMQ-R). |
| Change in the quality of life at 3 months. | Baseline, 3 months. | Measured by Quality of Life Scale (QOLS). |
| Percent heavy drinking days at 3 months. | Baseline, 3 months. | Measured by 90-day Timeline Followback (TLFB). |
| Percent binge drinking days at 3 months. | Baseline, 3 months. | Measured by 90-day Timeline Followback (TLFB). |
| Percent days abstinence at 3 months. | Baseline, 3 months. | Measured by 90-day Timeline Followback (TLFB). |
| Change in AUD severity at 3 months. | 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. |
| Change in AUD frequency status. | 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. |
| Change in Alcohol-related negative consequences at 3 months. | Baseline, 3 months. | Measured by Rutgers Alcohol Problem Index (RAPI). |
| Change in Alcohol use at 3 months. | Baseline, 3 months. | Measured by 90-day Timeline Followback (TLFB). |
| Change in negative affect at 3 months. | Baseline, 3 months | Measured by Positive and Negative Affect Schedule (PANAS). |
| Change in positive affect at 3 months. | Baseline, 3 months. | Measured by Positive and Negative Affect Schedule (PANAS). |
| Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. | Baseline, 3 months. | Compensatory Measured by Compensatory Cognitive Strategies Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention | 3 months. | Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-month. |
| Protocol Acceptability | 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). |
| Intervention Acceptability | 3 months. | Measured by the Client Counseling Satisfaction Scale(CCSS). |
| Intervention Fidelity | 3 months. | Participant adherence to the PST-APPLE intervention schedule will be assessed by documented session attendance. |
Countries
United States
Outcome results
None listed