Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in Sou… (NCT06502756) | Clinical Trial Compass
CompletedNot Applicable
Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea
South Korea17 participantsStarted 2023-05-26
Plain-language summary
The goal of this single arm pilot study is to investigate the feasibility, acceptability and preliminary effectiveness of the mobile app SOBER; for reducing and preventing hazardous alcohol drinking.
The main questions it aims to answer are:
* Feasibility: How well participants adhere to the app's lessons?
* Acceptability: Participants\' satisfaction with and perceived usefulness of the app.
* Preliminary Effectiveness: The number of days participants remain abstinent.
Participants will:
* Use the mobile application SOBER, which delivers digital cognitive behavioral therapy, for four weeks.
* Wear a smartwatch to collect biometric data throughout the study.
* Visit the clinic three times: at baseline (V1), two weeks after the initial visit (V2), and four weeks after the initial visit (V3).
* Be evaluated using various questionnaires about their alcohol consumption, mood, and stress levels at each visit.
* Receive psychiatric consultation with a board-certified psychiatrist regarding their alcohol consumption, based on the data entered into the mobile app.
Who can participate
Age range
19 Years – 65 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:
* Individuals aged between 19 and 65 years.
* Individuals classified as high-risk drinkers (hazardous drinking): Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
* Individuals who have been admitted for treatment of alcohol use disorder no more than once.
* Individuals who are assessed to have completed detoxification treatment for alcohol.
* Individuals who own a smartphone and can independently use apps on the smartphone.
* Individuals who voluntarily agree to participate in this clinical study and have signed the consent form (or whose representative has signed the consent form).
Exclusion Criteria:
* individuals with active and progressive physical illnesses or a life expectancy of less than 6 months
* individuals with major psychiatric comorbidities such as schizophrenia, bipolar disorder, or major depressive disorder
* pregnant women or those planning to become pregnant during the study
* individuals who had participated in another clinical study within four weeks prior to the screening for this study
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
1
Study completion rate
Timeframe: From enrollment to the end of treatment at 4 weeks
2
Adherence rate
Timeframe: From enrollment to the end of treatment at 4 weeks
3
Preliminary Effectiveness
Timeframe: asked at baseline (V1), two weeks (V2), and four weeks (V3).