Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Mass General Brigham

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Disease Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01345344

R01AR064367 (U.S. NIH Grant/Contract)

2009p001021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

148 participants in 3 patient groups

Cognitive-Behavioral Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy

Disease Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Disease Education

Healthy Controls

No Intervention group

Description:

No intervention.