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OpenTrials
Completed

NCT Number: NCT03922867

Web-based CBT for Insomnia Patients With Fibromyalgia

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

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Key information

Conditions

Insomnia Dyssomnias Fibromyalgia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2019
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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