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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Study completion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Study completion rate
时间窗: 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
Preliminary Effectiveness
时间窗: asked at baseline (V1), two weeks (V2), and four weeks (V3).
days abstinent (%) in the past two weeks
Adherence rate
时间窗: From enrollment to the end of treatment at 4 weeks
The adherence rate of educational sessions in the application
Acceptability
时间窗: 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).
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Alcohol Use Disorders Identification Test (AUDIT) Score(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
- Perceived Stress Scale (PSS)(Administered at baseline (V1), two weeks (V2), and four weeks (V3).)
研究者
YOUNG-CHUL JUNG
Professor
Yonsei University