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SHUTi Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03922867
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : May 20, 2019
Sponsor:
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: Sleep Healthy Using The Internet Not Applicable

Detailed Description:
We are studying the effect of internet-based cognitive behavioral therapy for insomnia, compared with usual care only in fibromyalgia patients. We will measure insomnia severity, attitudes and beliefs towards sleep, and fibromyalgia symptom severity and track their progression in these two groups.

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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 SHUTi Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 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 Sleep Healthy Using The Internet (SHUTi) program
Behavioral: Sleep Healthy Using The Internet
A web based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
Other Name: SHUTi




Primary Outcome Measures :
  1. Change in insomnia severity [ Time Frame: Baseline, weekly for 12 weeks ]
    Measured using insomnia severity index (ISI) which ranks 7 domains on a scale from 0 to 4, where 0 is none and 4 is very severe. Higher numbers indicate worse insomnia

  2. Change in attitude towards sleep [ Time Frame: Baseline, weekly for 12 weeks ]
    Measured using dysfunctional beliefs about sleep scale (DBAS) from 1 to 10, where 1 is strongly disagree and 10 is strongly agree. Higher scores indicate worse beliefs about sleep quality


Secondary Outcome Measures :
  1. Change in fibromyalgia symptoms [ Time Frame: Baseline, weekly for up to 12 weeks ]
    Measured using Revised Fibromyalgia Impact Questionnaire (FIQR) which ranks 21 domains on a scale of 1 to 10, adjusted to a cumulative scale out of 100, where higher scores are associated with worse disease.



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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 (ISI >15)
  • Have internet access and a device that can access the SHUTi 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 ClinicalTrials.gov identifier (NCT number): NCT03922867


Contacts
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Contact: Juan Yang, M.D., Ph.D. 507-284-2511 yang.juan@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Juan Yang, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ravindra Ganesh, M.B.B.S., M.D. Mayo Clinic

Additional Information:
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Responsible Party: Ravindra Ganesh, Principal Investigator, 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: May 20, 2019
Last Verified: May 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

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Fibromyalgia
Myofascial Pain Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases