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

NCT06502756 | Completed

• 2 other identifiers: WCTP-A-D-1BT210029
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

digital intervention; mobile app; high-risk drinkers; hazardous alcohol use; secondary prevention; digital cognitive behavioral therapy; digital health

Outcome Measures

Primary Outcomes (4)

• Study completion rate

  The feasibility of the intervention was assessed based on the completion rates of the study

  From enrollment to the end of treatment at 4 weeks

• Adherence rate

  The adherence rate of educational sessions in the application

  From enrollment to the end of treatment at 4 weeks

• Preliminary Effectiveness

  days abstinent (%) in the past two weeks

  asked at baseline (V1), two weeks (V2), and four weeks (V3).

• Acceptability

  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).

  In the end of treatment at 4 weeks

Secondary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  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).

• Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)

  Administered at baseline (V1), two weeks (V2), and four weeks (V3).

Study Arms (1)

mobile application SOBER (digital cognitive behavioral therapy)

EXPERIMENTAL

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.

Device: SOBER, mobile Application providing digital CBT

Interventions

SOBER, mobile Application providing digital CBT 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.

mobile application SOBER (digital cognitive behavioral therapy)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

Study Officials

• Young-Chul Jung, Professor, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: uncontrolled, single-arm, pilot study

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: May 26, 2023
• Primary Completion: August 22, 2023
• Study Completion: August 24, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)