Clinical trial NCT01345344: Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
Official title: Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2011-05-02
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Clinical outcome: Brief Pain Inventory (BPI)
timeFrame: Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment
measure: Neurobiological Outcome: Pain Neurocircuitry (fMRI)
timeFrame: Post-treatment
Secondary outcomes:
measure: Catastrophizing (PCS)
timeFrame: 4 weeks (mid-treatment), as well as Post-treatment
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massaschusetts General Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert R Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.