Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Disease Education

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massaschusetts General Hospital
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria for FM patients:

1. Aged 18-65
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 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 and pain report for at least 50% of days
7. Able to provide written consent

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 prescription stimulant medications (e.g., modafinil)
4. Routine use of substances of abuse
5. 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

1. Aged 18-65
2. Female
3. Right-handed
4. Able to provide written consent

Exclusion criteria for Healthy Control Participants:

1. Any acute or chronic pain condition (e.g., FM, arthritis)
2. Current use of stimulant medications
3. Routine use of substances of abuse
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; No intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publications and helpful links

General Publications

• Lee J, Protsenko E, Lazaridou A, Franceschelli O, Ellingsen DM, Mawla I, Isenburg K, Berry MP, Galenkamp L, Loggia ML, Wasan AD, Edwards RR, Napadow V. Encoding of Self-Referential Pain Catastrophizing in the Posterior Cingulate Cortex in Fibromyalgia. Arthritis Rheumatol. 2018 Aug;70(8):1308-1318. doi: 10.1002/art.40507. Epub 2018 Jun 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2014
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (ESTIMATE): May 2, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2009p001021; R01AR064367 (NIH)