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

NCT ID: NCT06502756

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2023-08-24

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.

Conditions

High-risk Drinkers; Hazardous Alcohol Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

mobile application SOBER (digital cognitive behavioral therapy)

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.

Group Type: EXPERIMENTAL

SOBER, mobile Application providing digital CBT

Intervention Type: DEVICE

SOBER is a software application (Android) that delivers cognitive behavioral therapy (CBT) in a structured and interactive manner. It analyzes patterns in participants\' lifestyles to identify problematic behaviors related to their alcohol consumption. By providing tailored guidance and support, the app aims to help individuals make sustainable changes, ultimately reducing hazardous drinking. This approach combines the principles of CBT with the convenience and accessibility of digital technology, offering a personalized experience to support the reduction of alcohol consumption.

Interventions

SOBER, mobile Application providing digital CBT

SOBER is a software application (Android) that delivers cognitive behavioral therapy (CBT) in a structured and interactive manner. It analyzes patterns in participants\' lifestyles to identify problematic behaviors related to their alcohol consumption. By providing tailored guidance and support, the app aims to help individuals make sustainable changes, ultimately reducing hazardous drinking. This approach combines the principles of CBT with the convenience and accessibility of digital technology, offering a personalized experience to support the reduction of alcohol consumption.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

YOUNG-CHUL JUNG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-Chul Jung, Professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BT210029

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

WCTP-A-D-1

Identifier Type: -

Identifier Source: org_study_id