Web-based CBT for Insomnia Patients With Fibromyalgia

Not Applicable

Completed

• Conditions: Insomnia; Fibromyalgia
• Interventions: Behavioral: CBT

• Registration Number: NCT03922867
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-22
• Study Start: 2019-12-03
• Primary Completion: 2021-02-28
• Status Verified: 2021-03
• Study Completion: 2021-03-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	CBT	Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program

Primary Outcome Measures

Name	Time	Method
Change in insomnia severity	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	through study completion, an average of 12 weeks	Surveying the subjects attitude towards sleep over the duration of their participation in the study.

Secondary Outcome Measures

Name	Time	Method
Change in fibromyalgia symptoms	through study completion, an average of 12 weeks	Surveying the change in fibromyalgia symptoms that occur during study participation

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States