CompletedNot Applicable

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

United States26 participantsStarted 2024-04-15

Plain-language 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.

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alcohol abstinence

Timeframe: Up to 3 months

Trial details

NCT IDNCT06333288

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.