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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Web-based CBT for Insomnia Patients With Fibromyalgia

Clinicaltrials.gov identifier NCT03922867

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted September 17, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Insomnia
  • Intervention/Treatment: Behavioral: CBT
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations

Contact: Shawn Fokken 507-293-2740 GIMresearchstudies@mayo.edu

Contact: Jennifer Soderlind 507-284-4799 GIMresearchstudies@mayo.edu


United States, Minnesota
Mayo Clinic in Rochester

Sponsors and Collaborators

Mayo Clinic


Principal Investigator: Ravindra Ganesh, MBBS, MD Mayo Clinic

Study Chair: Sanjeev Nanda, MD Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03922867 History of Changes
  • Other Study ID Numbers: 18-011637
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: September 17, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Mayo Clinic: insomnia fibromyalgia
  • Additional relevant MeSH terms: Fibromyalgia
    Myofascial Pain Syndromes
    Sleep Initiation and Maintenance Disorders