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Clinical Trials/NCT03922867
NCT03922867
Completed
N/A

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

Mayo Clinic1 site in 1 country18 target enrollmentDecember 3, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Insomnia
Sponsor
Mayo Clinic
Enrollment
18
Locations
1
Primary Endpoint
Change in attitude towards sleep
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 3, 2019
End Date
March 3, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ravindra Ganesh

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in attitude towards sleep

Time Frame: through study completion, an average of 12 weeks

Surveying the subjects attitude towards sleep over the duration of their participation in the study.

Change in insomnia severity

Time Frame: through study completion, an average of 12 weeks

Surveying the changes in insomnia severity seen during the subjects participation in the study

Secondary Outcomes

  • Change in fibromyalgia symptoms(through study completion, an average of 12 weeks)

Study Sites (1)

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