Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01345344
First received: April 27, 2011
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

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 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 Intervention
Fibromyalgia
Behavioral: Cognitive Behavioral Therapy
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Clinical outcome: Brief Pain Inventory (BPI) [ Time Frame: 6 Months Post-treatment ] [ Designated as safety issue: No ]
  • Pain Neurocircuitry [ Time Frame: Post-treatment (8 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Catastrophizing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    We hypothesize that early-treatment changes in catastrophizing will produce adaptive brain changes at post-treatment, and clinical improvement at 6 months.


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy
Practicing certain strategies such as relaxation and changing negative thoughts about pain.
Behavioral: Cognitive Behavioral Therapy
Practicing certain strategies such as relaxation and changing negative thoughts about pain.
Active Comparator: Education
Giving information about pain and how to change perceptions of pain.
Behavioral: Education
Giving you information about pain and how to change perceptions of pain.
No Intervention: Healthy Controls
No intervention

Detailed Description:

We 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. We 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 correlates

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for FM patients:

  1. aged 21-65
  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 for 30 days 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 over the previous week and pain report for at least 50% of days over the previous week
  7. fluent in English.

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 opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  4. current or recent use of recreational drugs, assessed by self report and/or urine screening
  5. Certain condition that intervene 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 (e.g unreliable, or inconsistent pain scores).

Inclusion Criteria for Healthy Control Participants

  1. aged 21-65
  2. female
  3. right-handed
  4. fluent in English

Exclusion criteria for Healthy Control Participants:

  1. any acute or chronic pain condition (e.g., FM, arthritis)
  2. current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil) This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
  3. current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  4. current or recent use of recreational drugs, assessed by self report and/or urine screening
  5. Certain condition that intervene with Quantitative Sensory Testing (QST) and fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or any impairment, activity or situation would prevent satisfactory completion of the study protocol (e.g unreliable, or inconsistent pain scores).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345344

Contacts
Contact: Olivia J Franceschelli, B.S. 617-732-9718 ext 29718 ofranceschelli@partners.org

Locations
United States, Massachusetts
Massaschusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Katerina Protsenko, BS BA       eprotsenko@mgh.harvard.edu   
Principal Investigator: Vitaly Napadow, PhD, Lic.Ac         
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Olivia Franceschelli    617-732-9014    ofranceschelli@partners.org   
Principal Investigator: Robert R Edwards, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert Edwards, Robert R. Edwards PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01345344     History of Changes
Other Study ID Numbers: 2009p001021, R01AR064367
Study First Received: April 27, 2011
Last Updated: April 28, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 02, 2015