Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

NCT ID: NCT01345344

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-01

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cognitive-Behavioral Therapy

8 individual weekly visits with a psychologist for pain-related CBT.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.

Disease Education

8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).

Group Type: ACTIVE_COMPARATOR

Disease Education

Intervention Type: BEHAVIORAL

Providing information about fibromyalgia, including its potential causes and management approaches.

Healthy Controls

No intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy

Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.

Intervention Type: BEHAVIORAL

Disease Education

Providing information about fibromyalgia, including its potential causes and management approaches.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

1. Aged 18-65

2. Female

3. Right-handed

4. Able to provide written consent

Exclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert Edwards

Robert R. Edwards PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert R Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Massaschusetts General Hospital

Charlestown, Massachusetts, United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29579370 (View on PubMed)

Other Identifiers

R01AR064367

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009p001021

Identifier Type: -

Identifier Source: org_study_id