Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Time Line Follow Back (TLFB)
研究概览
简要总结
A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.
详细描述
A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)
排除标准
- •Risk of severe withdrawal symptoms.
- •Risk of suicide.
- •Other psychiatric diagnosis that requires current treatment.
- •Need for medication for alcohol dependence.
- •Inadequate Swedish language skills.
- •No Internet access
结局指标
主要结局
Time Line Follow Back (TLFB)
时间窗: 3, 6, 12 and 24 months
Change in number of standard drinks per day during last 7 days
次要结局
- Time Line Follow Back (TLFB) Change in number of consumption days(3, 6, 12 and 24 months)
- Alcohol Use Disorders Identification Test Consumption (AUDIT-C)(3, 6, 12 and 24 months)
- Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)(3, 6, 12 and 24 months)
- Questions about help-seeking behavior from professionals(3, 6, 12 and 24 months)
- Questions about help-seeking behavior from family and friends(3, 6, 12 and 24 months)
- Generalised Anxiety Disorder Assessment (GAD-7)(3, 6, 12 and 24 months)
- Time Line Follow Back (TLFB) Change in number of days binge-drinking days(3, 6, 12 and 24 months)
- Alcohol Use Disorders Identification Test (AUDIT)(3, 6, 12 and 24 months)
研究者
Anne H Berman
Associate Professor
Karolinska Institutet