Development, Feasibility, Acceptability, and Preliminary Effectiveness of a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Drinking: A Single-Arm Pilot Study With Predictive Modeling in South Korea
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- High-risk Drinkers
- Sponsor
- Yonsei University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Study completion rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
YOUNG-CHUL JUNG
Professor
Yonsei University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Study completion rate
Time Frame: From enrollment to the end of treatment at 4 weeks
The feasibility of the intervention was assessed based on the completion rates of the study
Preliminary Effectiveness
Time Frame: asked at baseline (V1), two weeks (V2), and four weeks (V3).
days abstinent (%) in the past two weeks
Adherence rate
Time Frame: From enrollment to the end of treatment at 4 weeks
The adherence rate of educational sessions in the application
Acceptability
Time Frame: In the end of treatment at 4 weeks
assessed through participant satisfaction and perceived usefulness of the app, evaluated using a Likert-scale. Participants were asked to rate their satisfaction with the app on a scale from 0 (Not satisfied at all) to 5 (Very satisfied); and usefulness of the app from 0 (Not useful at all) to 5 (Very useful).
Secondary Outcomes
- Patient Health Questionnaire-9 (PHQ-9)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Alcohol Use Disorders Identification Test (AUDIT) Score(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Perceived Stress Scale (PSS)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)