Web-based CBT for Insomnia Patients With Fibromyalgia

Study Overview
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Brief Summary
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Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.

Detailed Description
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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.

Official Title
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Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia

Conditions
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Insomnia, Fibromyalgia

Intervention / Treatment
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* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets diagnostic criteria for fibromyalgia Has insomnia Have internet access and a device that can access the web-based program. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia | |
| Active Comparator: Intervention Group<br>Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program | Behavioral: CBT<br>* A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia severity | Surveying the changes in insomnia severity seen during the subjects participation in the study | through study completion, an average of 12 weeks | 
| Change in attitude towards sleep | Surveying the subjects attitude towards sleep over the duration of their participation in the study. | through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fibromyalgia symptoms | Surveying the change in fibromyalgia symptoms that occur during study participation | through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, fibromyalgia