Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea
NCT Number: NCT06502756
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High-risk Drinkers|Hazardous Alcohol Use
Interventions: DEVICE: SOBER, mobile Application providing digital CBT
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-05-26
Completion Date: 2023-08-24
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of

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\&#39; 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.

Primary Outcome Measures: 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 Outcome Measures: 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., Administered at baseline (V1), two weeks (V2), and four weeks (V3).|Alcohol Use Disorders Identification Test (AUDIT) Score, 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), 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), 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), 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).