A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Insomnia severity assessed with Insomnia Severity Index
研究概览
简要总结
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.
详细描述
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •- Use of sleep medications on prescription or OTC during the last 6 months
排除标准
- •- Below 18 years of age
研究组 & 干预措施
Self-help book
A self-help book for insomnia (written in Norwegian)
干预措施: self-help book (Other)
Sleep hygiene advice
A sheet of paper with standard sleep hygiene advice
干预措施: sleep hygiene advice (Other)
结局指标
主要结局
Insomnia severity assessed with Insomnia Severity Index
时间窗: 3-6 months
Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep
Use of hypnotics assessed as days per week
时间窗: 3-6 months
Self-reported sleep medication use (days of use per week,0-7)
Insomnia severity assessed with Bergen Insomnia Scale
时间窗: 3-6 months
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
次要结局
未报告次要终点
研究者
Bjorn Bjorvatn
Professor
University of Bergen