Web-based CBT for Insomnia Patients With Fibromyalgia
Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
1 other identifier
interventional
18
1 country
1
Brief Summary
Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedStudy Start
First participant enrolled
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2021
CompletedMarch 5, 2021
March 1, 2021
1.2 years
April 18, 2019
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in fibromyalgia symptoms
through study completion, an average of 12 weeks
Study Arms (2)
Control Group
NO INTERVENTIONSubjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Intervention Group
ACTIVE COMPARATORSubjects will receive standard of care and additionally complete the online cognitive behavior therapy program
Interventions
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
Eligibility Criteria
You may qualify if:
- Meets diagnostic criteria for fibromyalgia
- Has insomnia
- Have internet access and a device that can access the web-based program.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ravindra Ganesh, MBBS, MD
Mayo Clinic
- STUDY CHAIR
Sanjeev Nanda, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 18, 2019
First Posted
April 22, 2019
Study Start
December 3, 2019
Primary Completion
February 28, 2021
Study Completion
March 3, 2021
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share