Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in insomnia severity
研究概览
简要总结
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
详细描述
The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Meets diagnostic criteria for fibromyalgia
- •Has insomnia
- •Have internet access and a device that can access the web-based program.
排除标准
- •Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)
- •Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
- •Chronic fatigue syndrome
- •Morbid obesity
研究组 & 干预措施
Control Group
Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Intervention Group
Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program
干预措施: CBT (Behavioral)
结局指标
主要结局
Change in insomnia severity
时间窗: through study completion, an average of 12 weeks
Surveying the changes in insomnia severity seen during the subjects participation in the study
Change in attitude towards sleep
时间窗: through study completion, an average of 12 weeks
Surveying the subjects attitude towards sleep over the duration of their participation in the study.
次要结局
- Change in fibromyalgia symptoms(through study completion, an average of 12 weeks)
研究者
Ravindra Ganesh
Principal Investigator
Mayo Clinic