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Web-based CBT for Insomnia Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03922867
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : December 10, 2019
Information provided by (Responsible Party):
Ravindra Ganesh, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Insomnia Fibromyalgia Behavioral: CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
No Intervention: Control Group
Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia
Active Comparator: Intervention Group
Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program
Behavioral: CBT
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. Change in fibromyalgia symptoms [ Time Frame: through study completion, an average of 12 weeks ]
    Surveying the change in fibromyalgia symptoms that occur during study participation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03922867

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Contact: Shawn Fokken 507-293-2740
Contact: Jennifer Soderlind 507-284-4799

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shawn Fokken    507-293-2740   
Contact: Jennifer Soderlind    507-284-4799   
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Ravindra Ganesh, MBBS, MD Mayo Clinic
Study Chair: Sanjeev Nanda, MD Mayo Clinic
Additional Information:
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Responsible Party: Ravindra Ganesh, Principal Investigator, Mayo Clinic Identifier: NCT03922867    
Other Study ID Numbers: 18-011637
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ravindra Ganesh, Mayo Clinic:
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases