Cognitive behavioral therapy
BehavioralPracticing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
NCT Number: NCT01345344
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 a group of 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 pain-free controls and a group of education program controls.
Participants will undergo experimental pain assessments as well as brain neuroimaging.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Massaschusetts General Hospital, Charlestown, Massachusetts, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for FM patients:
Exclusion criteria
for FM:
Inclusion criteria
for Healthy Control Participants
Exclusion criteria
for Healthy Control Participants:
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
Providing information about fibromyalgia, including its potential causes and management approaches.
Time frame: Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment
Pain-related interference and pain severity
Time frame: Post-treatment
Bold responses will be assessed with fMRI (3T)
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
Brigham and Women's Hospital
Other
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