Internet-Based Relapse Prevention With Therapist Support vs Face to Face Therapy at an Employee Assistance Program: A Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Alcohol Use Identification Test (AUDIT)
研究概览
简要总结
Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life.
Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.
Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).
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
- None
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
- •Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.
排除标准
- •Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability
研究组 & 干预措施
eChange web-based relapse prevention
A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.
干预措施: eChange (Behavioral)
Face-to-face therapy
Face-to-face psychotherapy, consisting of 20 sessions. The content will be vary for different therapists, but all have an evidence-based approach to therapy
干预措施: Face-to-face therapy (Behavioral)
结局指标
主要结局
Alcohol Use Identification Test (AUDIT)
时间窗: Post, 3, 6 and 12 months
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
次要结局
- Time Line Follow Back (TLFB)(Post, 3, 6 and 12 months)
- Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)(Post, 3, 6 and 12 months)
- World Health Quality of Life Scale (WHOQOL-BREF)(Post, 3, 6 and 12 months)
研究者
Anne H Berman
Associate Professor
Karolinska Institutet