Internet-based Treatment for Insomnia in Norway.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Insomnia symptoms
研究概览
简要总结
The study will test an internet-based treatment for insomnia.
详细描述
This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 years or older
- •fulfillment of the DMS-IV criteria for insomnia
- •duration of at least 3 months
- •complaints of impaired daytime functioning
排除标准
- •presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
- •working night shifts and unable to discontinue this work pattern
- •having a serious somatic condition preventing further participation.
结局指标
主要结局
Insomnia symptoms
时间窗: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
次要结局
- Daytime functioning (mental health problems and fatigue)(Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU)
- Sleep diary data(Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU)
研究者
Borge Sivertsen
Professor
Norwegian Institute of Public Health