CompRest - a Randomized Comparison Between Sleep Compression and Sleep Restriction for the Treatment of Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This study includes two consecutive sub-trials.
Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but lately, adverse effects related to SR have been reported. A treatment method with similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to have similar effects to SR but without the adverse effects. The first sub-trial thus aims at directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects of CBT-i components given as an add-on treatment to a randomized selection of half participants in each original treatment arm.
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
- •Clinical level of Insomnia (more than 10 on ISI)
- •Meets criteria for Insomnia Disorder according to DSM-V
- •Sufficient language skills
- •Having access to Internet to fill out forms and participating in treatment
- •Not foresee obstacles to participating in treatment during the coming 20 weeks, or participating in measurements during the coming year.
排除标准
- •Sleep disorders requiring other treatment
- •High consumption of alcohol/drugs that affect sleep
- •Somatic or psychiatric conditions counter-indicative of treatments given in the study, requiring acute care, or with symptoms and level of functioning affecting the ability to participate in the treatment programs.
- •Working (night) shifts
- •Ongoing psychological treatment for Insomnia with sleep restriction or sleep compression as a treatment component - also previous such treatment can be excluding
- •Use of sleep medication in such a way that may hinder the implementation of the methods in this treatment
- •Pre-treatment measurements not finished within the given time-frame.
研究组 & 干预措施
Sleep Restriction followed by additional CBT-i components
Sleep Restriction treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Sleep Restriction (Behavioral)
Sleep Restriction followed by additional CBT-i components
Sleep Restriction treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Additional CBT-i components (Behavioral)
Sleep Compression followed by additional CBT-i components
Sleep Compression treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Sleep Compression (Behavioral)
Sleep Compression followed by additional CBT-i components
Sleep Compression treatment during 5+5 weeks. Followed by being offered an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Additional CBT-i components (Behavioral)
Sleep Restriction followed by no intervention
Sleep Restriction treatment during 5+5 weeks. Followed by NOT being offered or informed of an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Sleep Restriction (Behavioral)
Sleep Compression followed by no intervention
Sleep Compression treatment during 5+5 weeks. Followed by NOT being offered or informed of an additional intervention consisting of other ICBT-i components during 10 weeks.
干预措施: Sleep Compression (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks
7-item, self-rated questionnaire measuring change in insomnia severity. Bastien, C. H., Vallières, A., \& Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
次要结局
- Actigraphy(Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10))
- Sleep diary(Continuously from one week before treatment start (-1 week) to the last week of treatment (week 10))
- Adverse Events(Week 2, week 4 and week 5)
- Sleep Problems Acceptance Questionnaire(Change from base-line to 5 weeks, 10 weeks, 20 weeks and 57 weeks)
研究者
Viktor Kaldo
Research Group Leader
Karolinska Institutet