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

Yonsei University17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

High-risk Drinkers Hazardous Alcohol Use

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Study completion rate

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

Time frame: From enrollment to the end of treatment at 4 weeks

Adherence rate

The adherence rate of educational sessions in the application

Time frame: From enrollment to the end of treatment at 4 weeks

Preliminary Effectiveness

days abstinent (%) in the past two weeks

Time frame: 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).

Time frame: In the end of treatment at 4 weeks

Secondary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

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.