Web-based CBT for Insomnia Patients With Fibromyalgia

March 3, 2021 updated by: Ravindra Ganesh, Mayo Clinic

Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 12 weeks
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.
through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ravindra Ganesh, MBBS, MD, Mayo Clinic
  • Study Chair: Sanjeev Nanda, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-011637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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