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临床试验/NCT03075683
NCT03075683已完成不适用

Internet-based Cognitive Behavioural Therapy for Insomnia in Chronic Pain: a Randomised Controlled Trial

Uppsala University2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
2
主要终点
Insomnia Severity Index

研究概览

简要总结

The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

详细描述

Both chronic pain and sleep disorders are prevalent and potentially very debilitating problem. The prevalence of insomnia in people with chronic pain seems to be about 50%, but figures up to 88% have been reported. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment for both primary insomnia and co-morbid insomnia. CBT-I is a psychotherapeutic multicomponent treatment that seeks to influence the behaviors and cognitions which perpetuates the problem. Usually, the treatment is 6-8 weeks long with one session a week, individually or in a small group setting.

Internet Mediated CBT-I has been shown to be an effective alternative to more traditional CBT. How well internet mediated CBT-I work for individuals with insomnia and co-morbid chronic pain has however not previously been investigated. The aim of the project is to study the effects of internet mediated cognitive behavioral therapy for individuals with insomnia and co chronic benign pain. The aim is to compare the effect of Internet-mediated cognitive behavioral therapy with a group that offered internet-based relaxation training. CBT-I comprises eight modules with evidence-based treatment components for insomnia (e.g. sleep restriction, stimulus control and cognitive techniques). The relaxation training comprises eight modules of applied muscular relaxation.

Hypothesis

Patients suffering from both insomnia and chronic benign pain gets significantly better treatment outcome with respect to insomnia symptoms if they receive internet-based cognitive behavioral therapy compared to those receiving internet mediated relaxation training.

Primary outcome measure: the Insomnia Severity Index (ISI), a well-used, valid and reliable self-report scale, which has been shown possible to administer via internet.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic insomnia Chronic benign pain No or stable pharmacological treatment for insomnia and or pain

排除标准

  • Participation in pain management programme Pregnancy Shift work Untreated medical or psychiatric disease or disorder that could be negatively affected by insomnia treatment

结局指标

主要结局

Insomnia Severity Index

时间窗: 8 weeks

A well-used, valid and reliable self-report questionnaire with seven items concerning subjective symptoms and consequences of insomnia ranging from 0 to 28 points.

次要结局

  • Wake time after sleep onset(8 weeks)
  • Sleep latency(8 weeks)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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