Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
2 other identifiers
interventional
148
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 10, 2023
February 1, 2023
7 years
April 27, 2011
February 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Catastrophizing (PCS)
4 weeks (mid-treatment), as well as Post-treatment
Study Arms (3)
Cognitive-Behavioral Therapy
EXPERIMENTAL8 individual weekly visits with a psychologist for pain-related CBT.
Disease Education
ACTIVE COMPARATOR8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).
Healthy Controls
NO INTERVENTIONNo intervention.
Interventions
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
Providing information about fibromyalgia, including its potential causes and management approaches.
Eligibility Criteria
You may qualify if:
- Aged 18-65
- Female
- Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al. 2011 research criteria for fibromyalgia
- On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
- Right-handed
- Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
- Able to provide written consent
You may not qualify if:
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Current use of prescription stimulant medications (e.g., modafinil)
- Routine use of substances of abuse
- 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
- Aged 18-65
- Female
- Right-handed
- Able to provide written consent
- Any acute or chronic pain condition (e.g., FM, arthritis)
- Current use of stimulant medications
- Routine use of substances of abuse
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massaschusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Related Publications (1)
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.
PMID: 29579370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert R Edwards, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Robert R. Edwards PhD
Study Record Dates
First Submitted
April 27, 2011
First Posted
May 2, 2011
Study Start
December 1, 2014
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
February 10, 2023
Record last verified: 2023-02