Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,170
- 试验地点
- 2
- 主要终点
- Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)
研究概览
简要总结
Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.
详细描述
A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled 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. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three 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
- Double (Participant, 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 at least 3 criteria of alcohol dependence (ICD-10)
排除标准
- •Inadequate Swedish language skills No Internet access
结局指标
主要结局
Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)
时间窗: 3, 6, 12 and 24 months
Change in total in consumption of alcohol last 7 days
次要结局
- Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)(3, 6, 12 and 24 months)
- Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)(3, 6, 12 and 24 months)
- Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)(3, 6, 12 and 24 months)
- Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)(3, 6, 12 and 24 months)
- Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)(3, 6, 12 and 24 months)
- Generalised Anxiety Disorder Assessment (GAD-7)(3, 6, 12 and 24 months)
- Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)(3, 6, 12 and 24 months)
- Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)(3, 6, 12 and 24 months)
- Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)(3, 6, 12 and 24 months)
- The EuroQol generic health index (EQ5D)(3, 6, 12 and 24 months)
- Questions about help-seeking behavior(3, 6, 12 and 24 months)
研究者
Anne H Berman
Associate Professor
Karolinska Institutet