Back to resultsWeb-based CBT for Insomnia Patients With Fibromyalgia
Primary Purpose
Insomnia, Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
Sponsored by
About this trial
This is an interventional supportive care trial for Insomnia focused on measuring insomnia, fibromyalgia
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Intervention Group
Arm Description
Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program
Outcomes
Primary Outcome Measures
Change in insomnia severity
Surveying the changes in insomnia severity seen during the subjects participation in the study
Change in attitude towards sleep
Surveying the subjects attitude towards sleep over the duration of their participation in the study.
Secondary Outcome Measures
Change in fibromyalgia symptoms
Surveying the change in fibromyalgia symptoms that occur during study participation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922867
Brief Title
Web-based CBT for Insomnia Patients With Fibromyalgia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
March 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Fibromyalgia
Keywords
insomnia, fibromyalgia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
Primary Outcome Measure Information:
Title
Change in insomnia severity
Description
Surveying the changes in insomnia severity seen during the subjects participation in the study
Time Frame
through study completion, an average of 12 weeks
Title
Change in attitude towards sleep
Description
Surveying the subjects attitude towards sleep over the duration of their participation in the study.
Time Frame
through study completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Change in fibromyalgia symptoms
Description
Surveying the change in fibromyalgia symptoms that occur during study participation
Time Frame
through study completion, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravindra Ganesh, MBBS, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjeev Nanda, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Web-based CBT for Insomnia Patients With Fibromyalgia
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