Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition.
The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted.
The expectations are that:
- Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
- Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)
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
- 是
入选标准
- •Insomnia Severity Index Score ≥ 10
- •18 years or older
- •Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
- •Daytime problems related to sleep complaints
- •Sleep efficiency < 85%
- •Dutch speaking
排除标准
- •(1) No acces to internet
- •(2) Pregnant or breastfeeding
- •(3) working in night shifts
- •(4) currently in psychological treatment (started < 6 months) or on wait-list for treatment
- •(5) cognitive behavioral treatment for insomnia in last 12 months
- •(6) concrete suicidal ideation
- •(7) schizophrenic or psychotic disorder
- •(8) high level of depressive complaints (BDI-II > 28)
- •(9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed
结局指标
主要结局
Insomnia Severity Index
时间窗: Change from baseline to six weeks post-randomization
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
次要结局
- Cognitive arousal(Change from baseline to six weeks post randomization)
- Sleep diary: sleep onset latency(Change from baseline to six-month follow-up (intervention only))
- Sleep diary: time in bed(Change from baseline to six-month follow-up (intervention only))
- Current sleepiness(Change from baseline to six weeks post randomization)
- Depression(Change from baseline to six-month follow-up (intervention only))
- Acceptance(Change from baseline to six-month follow-up (intervention only))
- Sleep diary: wake after sleep onset(Change from baseline to six-month follow-up (intervention only))
- Pre-sleep arousal(Change from baseline to six-month follow-up (intervention only))
- Dysfunctional beliefs(Change from baseline to six-month follow-up (intervention only))
- Rating coach(Six-weeks post-randomization)
- Sleep diary: terminal wakefulness(Change from baseline to six-month follow-up (intervention only))
- Sleep diary: sleep efficiency(Change from baseline to six-month follow-up (intervention only))
- Insomnia Severity(Change from baseline to six-month follow-up (intervention only))
- Epworth Sleepiness Scale(Change from baseline to six-month follow-up (intervention only))
- Anxiety(Change from baseline to six-month follow-up (intervention only))
- Sleep diary: total sleep time(Change from baseline to six-month follow-up (intervention only))
- Somatic arousal(Change from baseline to six weeks post randomization)
- Sleep-bed association(Change from baseline to six-month follow-up (intervention only))
- Sleep safety(Change from baseline to six-month follow-up (intervention only))
- Adverse events(Six-weeks post-randomization)
- Treatment quality(Six-weeks post-randomization)
研究者
Jaap Lancee
Assistant Professor
University of Amsterdam