Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia | |
| Intervention Group | Active Comparator | Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ravindra Ganesh, MBBS, MD | Mayo Clinic | Principal Investigator |
| Sanjeev Nanda, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |