Cognitive Behavioral Therapy as Guided Self-help for Insomnia - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Sleep diary
研究概览
简要总结
The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.
详细描述
CBT has previously been identified as an effective treatment for insomnia. However, there is a lack of trained CBT-therapists, and self-help is beginning to prove useful for many areas of psychological distress. Earlier studies of different kinds of self-help (e.g. computer based and bibliotherapeutic) suggest that many patients do indeed benefit from self-help treatments for insomnia, but there is a need for independent replications. Also, most previous studies have had very strict inclusion criteria, such that for instance only individuals with primary insomnia and no co-morbid problems have been included. A general question in self-help is whether patients need therapist support to benefit from treatment, or if a book is enough to alleviate symptoms.
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
- •Age 18 and above
- •Diagnosis of Insomnia (Research Diagnostic Criteria)
- •Access to computer
- •Ability to read and write Swedish
排除标准
- •Severe psychopathology (e.g. bipolar disorder, suicidality)
- •Shift work
研究组 & 干预措施
Bibliotherapy
A group receiving a self-help book to work on for six weeks with no therapist support.
干预措施: Self-help CBT-I (Behavioral)
Bibliotherapy with support
A group receiving a self-help book to work on for six weeks, together with brief weekly telephone calls (<15 minutes) from a therapist.
干预措施: Self-help CBT-I (Behavioral)
Wait-list control group
This group receives no intervention until about five months after the two treatment groups, when participants in this group receive the self-help book without therapist support.
结局指标
主要结局
Sleep diary
时间窗: 15 months after the end of treatment
Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.
Sleep diary
时间窗: Six weeks after beginning of treatment
Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.
Sleep diary
时间窗: 5 months after beginning of treatment (i.e. about three months after the end of treatment)
Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.
次要结局
- Insomnia Severity Index(15 months after the end of treatment)
- Insomnia Severity Index(Six weeks after beginning of treatment)
- Insomnia Severity Index(5 months after beginning of treatment (i.e. about three months after the end of treatment))