Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea

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

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.

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