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NCT03922867 Clinical Trial

Web-based CBT for Insomnia Patients With Fibromyalgia

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03922867
Other study ID # 18-011637
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2019
Est. completion date March 3, 2021

Study information
Verified date March 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date March 3, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• CBT
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in fibromyalgia symptoms Surveying the change in fibromyalgia symptoms that occur during study participation through study completion, an average of 12 weeks
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