Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Disease Education

• Registration Number: NCT01345344
• Lead Sponsor: 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 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

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.

Study Timeline

• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-05-02
• Study Start: 2014-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy	Cognitive Behavioral Therapy	8 individual weekly visits with a psychologist for pain-related CBT.
Disease Education	Disease Education	8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Catastrophizing (PCS)	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

Trial Locations

Locations (2)

Massaschusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States