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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Web-based CBT for Insomnia Patients With Fibromyalgia

  • Clinicaltrials.gov identifier

    NCT03922867

  • Recruitment Status

    Completed

  • First Posted

    April 22, 2019

  • Last update posted

    March 5, 2021

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:Fibromyalgia
    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
  • Actual Enrollment: 18 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
  • Actual Primary Completion Date: February 2021
  • Actual 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

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

Contacts and Locations

Contacts

Locations

United States, Minnesota
Mayo Clinic in Rochester
Rochester

Sponsors and Collaborators

Mayo Clinic

Investigators

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: March 5, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • 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: fibromyalgia insomnia
  • Additional relevant MeSH terms: Fibromyalgia
    Myofascial Pain Syndromes
    Sleep Initiation and Maintenance Disorders