Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)
2012年7月30日 更新者：Uppsala University
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach.
The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL).
Following an active treatment-control period, the control group were re-assigned to CBT.
The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group.
Primary outcome measure was a brief self-report screening form, Insomnia severity index.
研究概览
研究类型
介入性
注册 (实际的)
66
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Uppsala、瑞典、75105
- Uppsala University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Fulfilled research criteria for chronic insomnia
Exclusion Criteria:
- other untreated sleep disturbance
- pregnancy
- shift work
- concurrent medical or psychiatric condition that could be negatively affected by the treatment
- drug abuse
- severe depression
- dementia
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CBT
The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel.
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
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Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
|
|
无干预：Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in the Insomnia severity index (ISI)
大体时间：After 9 weeks
|
A brief self-report screening form
|
After 9 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in sleep-onset latency (SOL)
大体时间：9 weeks
|
Time to fall asleep, measured with sleep diary
|
9 weeks
|
|
Change from baseline in wake time after sleep onset (WASO)
大体时间：After 9 weeks
|
Time awake during the night, measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in number of awakenings during the night (NWAK)
大体时间：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in Sleep efficiency (SE)
大体时间：After 9 weeks
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in time in bed (TIB)
大体时间：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in total sleep time (TST)
大体时间：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in sleep quality (SQ)
大体时间：After 9 weeks
|
Subjective sleep quality (likert scale)
|
After 9 weeks
|
|
Change from baseline in the fatigue severity scale (FSS)
大体时间：After 9 weeks
|
Self-report questionnaire
|
After 9 weeks
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
大体时间：After 9 weeks
|
Questionnaire assessing physical and mental health
|
After 9 weeks
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
大体时间：After 9 weeks
|
Self-report questionnaire measuring depression and anxiety
|
After 9 weeks
|
|
Change from baseline in the Epworth sleepiness scale, ESS
大体时间：After 9 weeks
|
Self-report questionnaire assessing daytime sleepiness
|
After 9 weeks
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
大体时间：After 9 weeks
|
Self-report form assessing sleep quality
|
After 9 weeks
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
大体时间：After 9 weeks
|
Ultra short screening questionnaire for insomnia
|
After 9 weeks
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
大体时间：After 9 weeks
|
A questionnaire intended to assess acceptance of insomnia
|
After 9 weeks
|
|
Change from baseline in Body mass index
大体时间：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sagittal abdominal diameter
大体时间：After 9 weeks
|
Abdominal height (cm)
|
After 9 weeks
|
|
Change from baseline in waist-hip ratio
大体时间：After 9 weeks
|
A ratio of the circumference of the waist to the hips
|
After 9 weeks
|
|
Change from baseline in blood pressure
大体时间：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in heart rate
大体时间：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in ALAT
大体时间：After 9 weeks
|
Liver function
|
After 9 weeks
|
|
Change from baseline in HbA 1c
大体时间：After 9 weeks
|
Glycated hemoglobin
|
After 9 weeks
|
|
Change from baseline in blood glucose
大体时间：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in triglycerides
大体时间：After 9 weeks
|
A type of fat found in the blood
|
After 9 weeks
|
|
Change from baseline in cholesterol (LDL/HDL)
大体时间：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sleep-onset latency (SOL)
大体时间：After 18 months
|
Time to fall asleep, measured with sleep diary
|
After 18 months
|
|
Change from baseline in wake time after sleep onset (WASO)
大体时间：After 18 months
|
Time awake during the night, measured with sleep diary
|
After 18 months
|
|
Change from baseline in number of awakenings during the night (NWAK)
大体时间：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in Sleep efficiency (SE)
大体时间：After 18 months
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 18 months
|
|
Change from baseline in time in bed (TIB)
大体时间：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in total sleep time (TST)
大体时间：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in sleep quality (SQ)
大体时间：After 18 months
|
Subjective sleep quality (likert scale)
|
After 18 months
|
|
Change from baseline in the fatigue severity scale (FSS)
大体时间：After 18 months
|
Self-report questionnaire
|
After 18 months
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
大体时间：After 18 months
|
Questionnaire assessing physical and mental health
|
After 18 months
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
大体时间：After 18 months
|
Self-report questionnaire measuring depression and anxiety
|
After 18 months
|
|
Change from baseline in the Epworth sleepiness scale, ESS
大体时间：After 18 moths
|
Self-report questionnaire assessing daytime sleepiness
|
After 18 moths
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
大体时间：After 18 months
|
Self-report form assessing sleep quality
|
After 18 months
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
大体时间：After 18 months
|
Ultra short screening questionnaire for insomnia
|
After 18 months
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
大体时间：After 18 months
|
A questionnaire intended to assess acceptance of insomnia
|
After 18 months
|
|
Change from baseline in Body mass index
大体时间：After 18 months
|
After 18 months
|
|
|
Change from baseline in sagittal abdominal diameter
大体时间：After 18 months
|
Abdominal height (cm)
|
After 18 months
|
|
Change from baseline in waist-hip ratio
大体时间：After 18 months
|
A ratio of the circumference of the waist to the hips
|
After 18 months
|
|
Change from baseline in blood pressure
大体时间：After 18 months
|
After 18 months
|
|
|
Change from baseline in heart rate
大体时间：After 18 months
|
After 18 months
|
|
|
Change from baseline in ALAT
大体时间：After 18 months
|
Liver function
|
After 18 months
|
|
Change from baseline in HbA 1c
大体时间：After 18 months
|
Glycated hemoglobin
|
After 18 months
|
|
Change from baseline in blood glucose
大体时间：After 18 months
|
After 18 months
|
|
|
Change from baseline in triglycerides
大体时间：After 18 months
|
A type of fat found in the blood
|
After 18 months
|
|
Change from baseline in cholesterol (LDL/HDL)
大体时间：After 18 months
|
After 18 months
|
|
|
Change from baseline in the Insomnia severity index (ISI)
大体时间：After 18 months
|
A brief self-report screening form
|
After 18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jan-Erik Broman, PhD、Uppsala University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.
- Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年5月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2011年9月1日
研究注册日期
首次提交
2012年7月4日
首先提交符合 QC 标准的
2012年7月30日
首次发布 (估计)
2012年8月2日
研究记录更新
最后更新发布 (估计)
2012年8月2日
上次提交的符合 QC 标准的更新
2012年7月30日
最后验证
2012年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.