An interventional study of SOBER, mobile Application providing digital CBT in High-risk Drinkers and Hazardous Alcohol Use, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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:
Participants will:
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 17 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Yonsei University