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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01345344
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital

Brief Summary:

This study design has two components: 1) a cross sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.

The investigators will evaluate 90 fibromyalgia patients who will receive CBT treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from 30 pain-free controls and 60 education program controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.


Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Cognitive Behavioral Therapy Behavioral: Disease Education Not Applicable

Detailed Description:
Investigators propose to use fMRI (functional Magnetic Resonance Imaging) to study CNS pain processing during the anticipation and experience of acute pain in individuals with FM and healthy controls. Investigators will recruit patients who are diagnosed with FM as well as healthy controls. After the baseline visit, FM participants will be randomly assigned into the CBT or control condition (Education). Overall, FM Participants will attend 8 treatment visits, and 6 assessment visits (two at baseline, one at mid-treatment, two at the end of treatment, and one at 6 months post-treatment). These assessment visits include a total of 3 fMRI sessions (at baseline, mid-treatment, and end of treatment). Healthy Controls will undergo the same baseline procedures as the FM subjects but will not attend any of the treatment or follow up assessment visits. Findings from this research will provide important information about catastrophizing's CNS (Central Nervous System) correlates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
Primary Purpose: Other
Official Title: Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy
8 individual weekly visits with a psychologist for pain-related CBT.
Behavioral: Cognitive Behavioral Therapy
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.

Active Comparator: Disease Education
8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).
Behavioral: Disease Education
Providing information about fibromyalgia, including its potential causes and management approaches.

No Intervention: Healthy Controls
No intervention.



Primary Outcome Measures :
  1. Clinical outcome: Brief Pain Inventory (BPI) [ Time Frame: Post-treatment, with long-term outcomes at 6 Months Post-treatment ]
    Pain-related interference and pain severity

  2. Neurobiological Outcome: Pain Neurocircuitry (fMRI) [ Time Frame: Post-treatment ]
    Bold responses will be assessed with fMRI (3T)


Secondary Outcome Measures :
  1. Catastrophizing (PCS) [ Time Frame: 4 weeks (mid-treatment), as well as Post-treatment ]
    Catatrophizing will be assessed with the Pain Catastrophizing Scale (PCS).Investigators hypothesize that early-treatment changes in catastrophizing will produce adaptive brain changes at post-treatment, and clinical improvement at 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for FM patients:

  1. Aged 18-65
  2. Female
  3. Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al. 2011 research criteria for fibromyalgia
  4. On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
  5. Right-handed
  6. Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
  7. Able to provide written consent

Exclusion Criteria for FM:

  1. Comorbid acute pain condition
  2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
  3. Current use of prescription stimulant medications (e.g., modafinil)
  4. Routine use of substances of abuse
  5. Certain condition that interfere with Quantitative Sensory Testing (QST) and/or fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or/and any impairment, activity or situation that could prevent satisfactory completion of the study protocol

Inclusion Criteria for Healthy Control Participants

  1. Aged 18-65
  2. Female
  3. Right-handed
  4. Able to provide written consent

Exclusion criteria for Healthy Control Participants:

  1. Any acute or chronic pain condition (e.g., FM, arthritis)
  2. Current use of stimulant medications
  3. Routine use of substances of abuse
  4. Certain condition that interfere with Quantitative Sensory Testing (QST) and/or fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or/and any impairment, activity or situation that could prevent satisfactory completion of the study protocol

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): NCT01345344


Locations
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United States, Massachusetts
Massaschusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Edwards, Robert R. Edwards PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01345344    
Other Study ID Numbers: 2009p001021
R01AR064367 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases