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出境医 / 临床实验 / Web-based CBT for Insomnia Patients With Fibromyalgia

Web-based CBT for Insomnia Patients With Fibromyalgia

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 Intervention/treatment Phase
Insomnia Fibromyalgia Behavioral: CBT Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 3, 2019
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : March 3, 2021
Arms and Interventions
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
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
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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
  • 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

Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ravindra Ganesh, MBBS, MD Mayo Clinic
Study Chair: Sanjeev Nanda, MD Mayo Clinic
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE December 3, 2019
Actual Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Change is sleep quality [ Time Frame: Baseline, weekly for up to 12 weeks ]
    Measured using insomnia severity index (ISI) on a scale from 0 to 4, where 0 is none and 4 is very severe
  • Change is sleep quality [ Time Frame: Baseline, weekly for up to 12 weeks ]
    Measured using dysfunctional beliefs about sleep scale (DBAS) from 1 to 10, where 1 is strongly disagree and 10 is strongly agree
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019) 		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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019) 		Change in fibromyalgia symptoms [ Time Frame: Baseline, weekly for up to 12 weeks ]
Measured using fibromyalgia impact Questionnaire (FIQR)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based CBT for Insomnia Patients With Fibromyalgia
Official Title  ICMJE Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
Brief Summary Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Insomnia
  • Fibromyalgia
Intervention  ICMJE Behavioral: CBT
A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: CBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2021) 		18
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		60
Actual Study Completion Date  ICMJE March 3, 2021
Actual Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922867
Other Study ID Numbers  ICMJE 18-011637
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ravindra Ganesh, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ravindra Ganesh, MBBS, MD Mayo Clinic
Study Chair: Sanjeev Nanda, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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