Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Disease Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for FM patients: Aged 18-65 Female Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al. 2011 research criteria for fibromyalgia On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial Right-handed Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days Able to provide written consent Exclusion Criteria for FM: Comorbid acute pain condition Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia Current use of prescription stimulant medications (e.g., modafinil) Routine use of substances of abuse 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 Aged 18-65 Female Right-handed Able to provide written consent Exclusion criteria for Healthy Control Participants: Any acute or chronic pain condition (e.g., FM, arthritis) Current use of stimulant medications Routine use of substances of abuse 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy<br>8 individual weekly visits with a psychologist for pain-related CBT. | Behavioral: Cognitive Behavioral Therapy<br>* Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.<br>|
| Active Comparator: Disease Education<br>8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact). | Behavioral: Disease Education<br>* Providing information about fibromyalgia, including its potential causes and management approaches.<br>|
| No Intervention: Healthy Controls<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: Brief Pain Inventory (BPI) | Pain-related interference and pain severity | Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment | 
| Neurobiological Outcome: Pain Neurocircuitry (fMRI) | Bold responses will be assessed with fMRI (3T) | Post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catastrophizing (PCS) | 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 | 4 weeks (mid-treatment), as well as Post-treatment |