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

Yonsei University

Status: Completed

Conditions: Hazardous Alcohol Use; High-risk Drinkers

Treatments: Device: SOBER, mobile Application providing digital CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT06502756

WCTP-A-D-1

BT210029 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

mobile application SOBER (digital cognitive behavioral therapy)

Experimental group

Description:

Participants in this group will access to the mobile app SOBER for 4 weeks. Sober is designed to provide digitalized brief-intervention and cognitive CBT-based education for high-risk drinkers. Participants are expected to engage with the app, completing tasks such as self-monitoring (daily log function that instructs participants to record their alcohol consumption, along with changes in mood, appetite and sleep quality). The app will collect data on adherence, including diary completion rates and app login frequency. Participants were also provided with a smart watch to collect biometric data throughout the duration of the study.

Treatment:

Device: SOBER, mobile Application providing digital CBT