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| ID | Type | Description | Link |
|---|---|---|---|
| BT210029 | Other Grant/Funding Number | Seoul Metropolitan Government, South Korea |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Chul Jung, Professor, MD, PhD | Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea |
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uncontrolled, single-arm, pilot study
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| 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). |