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临床试验/NCT02629913
NCT02629913已完成不适用

Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?

University of Zurich1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Insomnia Severity Index

研究概览

简要总结

The Swiss company mementor has recently developed an interactive self-help intervention for the treatment of insomnia entitled mementor somnium. This programme is based on the guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions. An animated personal sleep coach provides relevant audio-information and asks questions to which the patient is invited to respond. The components of the programme flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an instruction for sleep restriction, mementor somnium includes a cognitive restructuring intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based on a complex algorithm in the shape of an decision tree. University of Zurich's Department of Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated randomly to either the active intervention group or the waitlist control group. Participants will have access to the programme mementor somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally, sleep diary data will be collected.

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

  • •Insomnia Disorder (DSM-5)
  • •German language comprehension
  • •Internet-access

排除标准

  • •Other sleep disorder
  • •Suicidality
  • •Current psychotherapy
  • •Drug abuse or recent change in medication

研究组 & 干预措施

Intervention

Experimental

mementor somnium

干预措施: mementor somnium (Device)

Waitlist

Other

干预措施: wait list (Other)

结局指标

主要结局

Insomnia Severity Index

时间窗: Six weeks

次要结局

  • Brief Symptom Inventory 18(Six weeks)
  • SF-12 Health Survey(Six weeks)
  • Beck Depression Inventory(Six weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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