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临床试验/NCT03110263
NCT03110263
终止
不适用

i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial

University of Bern1 个研究点 分布在 1 个国家目标入组 104 人2016年6月10日
适应症Insomnia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Insomnia
发起方
University of Bern
入组人数
104
试验地点
1
主要终点
Insomnia Severity Index (ISI)
状态
终止
最后更新
7年前

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.

注册库
clinicaltrials.gov
开始日期
2016年6月10日
结束日期
2018年1月7日
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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)

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)

研究点 (1)

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