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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR064367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | 8 individual weekly visits with a psychologist for pain-related CBT. |
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| Disease Education | Active Comparator | 8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact). |
|
| Healthy Controls | No Intervention | No intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain. |
| 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 |
| 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 |
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Inclusion Criteria for FM patients:
Exclusion Criteria for FM:
Inclusion Criteria for Healthy Control Participants
Exclusion criteria for Healthy Control Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Edwards, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massaschusetts General Hospital | Charlestown | Massachusetts | 02129 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925517 | Derived | Lee J, Lazaridou A, Paschali M, Anzolin A, Grahl A, Ellingsen DM, Loggia ML, Wasan AD, Edwards RR, Napadow V. Anterior midcingulate cortex activity during pain catastrophizing predicts and sequentially tracks reduction in pain interference after cognitive behavioral therapy in fibromyalgia. Pain. 2026 Jul 1;167(7):1593-1602. doi: 10.1097/j.pain.0000000000003957. Epub 2026 Apr 1. | |
| 29579370 | Derived | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
| Disease Education | Behavioral | Providing information about fibromyalgia, including its potential causes and management approaches. |
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| Chestnut Hill |
| Massachusetts |
| 02467 |
| United States |
| D009422 |
| Nervous System Diseases |