i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.
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
- Single (Participant)
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
- •Being 18 years of age or older
- •Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
- •Acess to the Internet
- •Written informed consent
排除标准
- •Physiological Insomnia
- •Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
- •Epilepsy (seizure disorder)
研究组 & 干预措施
Internet-based sleep restriction
Internet-based sleep restriction
干预措施: Internet-based sleep restriction (Other)
Waiting control group
Access to internet-based intervention after 8-weeks
Multicomponent internet-based self-help
Multicomponent internet-based self-help
干预措施: Multicomponent internet-based self-help (Other)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 6-months
次要结局
- Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)(Baseline, 8-weeks, 6-months)
- Patient satisfaction (ZUF-8)(8-weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 8-weeks, 6-months)
- Diagnosis of Insomnia(Baseline, 8-weeks, 6-months)
- Sleep-diary: Sleep efficiency (SE)(8-weeks)
- EuroQol(Baseline, 8-weeks, 6-months)
- Sleep-Diary-data(8-weeks)
- Empowerment Scale (ES)(Baseline, 8-weeks, 6-months)
- Usability: Satisfaction with the online program (SUS)(8-weeks)