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

July 15, 2024 updated by: YOUNG-CHUL JUNG, Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 4 weeks
Adherence rate
Time Frame: From enrollment to the end of treatment at 4 weeks
The adherence rate of educational sessions in the application
From enrollment to the end of treatment at 4 weeks
Preliminary Effectiveness
Time Frame: asked at baseline (V1), two weeks (V2), and four weeks (V3).
days abstinent (%) in the past two weeks
asked at baseline (V1), two weeks (V2), and four weeks (V3).
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).
In the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
The PHQ-9 is a 9-item self-administered scale for assessing the severity of depression. Score Range: 0-27. : Higher scores indicate more severe depression. Scores of 10 or above suggest the need for treatment of depression.
Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Alcohol Use Disorders Identification Test (AUDIT) Score
Time Frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
The AUDIT is a 10-item questionnaire designed to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Higher scores indicate more severe alcohol-related issues. A score of 8 or above suggests hazardous or harmful alcohol use. Score Range: 0-40
Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
The GAD-7 is a 7-item self-report scale for identifying probable cases of generalized anxiety disorder and assessing its severity. Score Range: 0-21. Higher scores indicate more severe anxiety. Scores of 10 or above suggest the presence of generalized anxiety disorder.
Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Perceived Stress Scale (PSS)
Time Frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
The PSS is a 10-item questionnaire measuring the perception of stress. Score Range: 0-40. Higher scores indicate higher perceived stress levels. There are no specific cut-off scores; rather, scores indicate the relative level of stress perceived by the individual
Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)
Time Frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
The CIWA-Ar is a 10-item scale used to assess the severity of alcohol withdrawal symptoms. Score Range: 0-67. Higher scores indicate more severe withdrawal symptoms. Scores of 10 or above indicate the need for medical intervention.
Administered at baseline (V1), two weeks (V2), and four weeks (V3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Young-Chul Jung, Professor, MD, PhD, Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Actual)

August 22, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCTP-A-D-1
  • BT210029 (Other Grant/Funding Number: Seoul Metropolitan Government, South Korea)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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