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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Study personnel collecting, entering, and analyzing data are blind to treatment allocation.|
|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|
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
- 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
- Neurobiological Outcome: Pain Neurocircuitry (fMRI) [ Time Frame: Post-treatment ]Bold responses will be assessed with fMRI (3T)
- 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.
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
|United States, Massachusetts|
|Massaschusetts General Hospital|
|Charlestown, Massachusetts, United States, 02129|
|Brigham and Women's Hospital|
|Chestnut Hill, Massachusetts, United States, 02467|
|Principal Investigator:||Robert R Edwards, PhD||Brigham and Women's Hospital|