Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Behavioral Insomnia Therapy With Fibromyalgia
研究概览
地位
详细说明
FM is a debilitating condition that can lead to impaired occupational and social functioning, disability, and increased health care utilization. FM symptoms vary among individuals, but they typically include chronic widespread pain, persistent daytime fatigue, sleep disturbances, low mood, and loss of stamina. The cause of FM remains unknown, and current treatment involves symptom-focused interventions such as antidepressants, behavioral stress management, coping skills training, and exercise programs. However, there are no interventions specifically designed to reduce sleep disturbances in people with FM.
Past research has shown that individuals with FM experience the same behavioral and psychological factors that individuals suffering from insomnia experience. Cognitive behavioral insomnia therapy, a form of psychotherapy that aims to eliminate factors that disrupt sleep, may prove useful for people with FM. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving FM-related pain, fatigue, mood, and quality of life among individuals with FM. The study will also examine the use of sleep electroencephalogram (EEG) as a means to measure improvements in FM symptoms.
This study will last about 9 months and will include approximately 16 study visits. An initial 2-week screening period will include a physical examination, blood collection, a mental status exam, a tender-point exam, a sleep history questionnaire, and structured sleep and psychiatric interviews. Participants will complete a 1-week sleep log and one overnight polysomnogram test, in which several body functions (e.g., brain activity, eye movement, heart rate, etc.) are recorded. If an FM diagnosis is confirmed, an additional 2-week assessment period will take place, followed by an 8-week treatment period. During treatment, participants will be randomly assigned to one of the following three treatment groups: 1) usual FM care (medical advice and medication prescription), 2) usual FM care plus psychological treatment to decrease insomnia, and 3) usual FM care plus placebo psychological treatment to decrease insomnia. Groups 2 and 3 will attend four bi-weekly individual therapy sessions with a sleep psychologist. Participants will meet with a rheumatologist at least once. Throughout treatment, nightly sleep logs and medication questionnaires will be completed, and participants will wear a wrist-watch sized device that will record their day- and night-time activity. A therapy evaluation questionnaire will be completed during the first and last weeks of treatment and an outcome questionnaire packet will be completed after 4 weeks of treatment. All participants will be evaluated following the end of treatment and again 6 months later.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Reside in or around Durham, NC
- History of insomnia complaints for more than 1 month
- Diagnosis of primary FM
- Diagnosis of insomnia
Exclusion Criteria:
- Terminal illness or acute serious medical illness
- Secondary FM or condition other than FM that seriously compromises sleep
- Current psychiatric illness or currently suicidal
- Substance abuse or dependence
- Other primary sleep disorder (e.g., sleep apnea or restless legs syndrome)
学习计划
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:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1个
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4 biweekly outpatient sessions with sleep psychologist
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假比较器:2个
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4 biweekly outpatient visits with sleep psychologist
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有源比较器:3个
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3 outpatient visits with study physician
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Total wake time
大体时间:Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
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Total sleep time
大体时间:Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
|
Sleep efficiency
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Sleep onset latency
大体时间:Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
|
Wake time after sleep onset
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on an insomnia rating scale
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a fatigue rating scale
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a mood rating scale
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Subjective pain ratings
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a health-related quality of life scale
大体时间:Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
合作者和调查者
调查人员
- 首席研究员:Jack D. Edinger, PhD、Duke University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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