FibromyalgiaNCT01345344
Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
A study testing Cognitive Behavioral Therapy and Disease Education in people with Fibromyalgia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cognitive Behavioral Therapy and Disease Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Able to provide written consent
- Aged 18-65
- Female
- Right-handed
- Able to provide written consent
Who cannot join
- 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
- Any acute or chronic pain condition (e.g., FM, arthritis)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massaschusetts General Hospital
Charlestown, Massachusetts, 02129
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
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.
Read the 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
- Being tested
- Cognitive Behavioral Therapy, Disease Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
Disease EducationBehavioural
Providing information about fibromyalgia, including its potential causes and management approaches.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | 8 individual weekly visits with a psychologist for pain-related CBT. Receives: Behavioral: Cognitive Behavioral Therapy |
| Disease Education | Active comparator | 8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact). Receives: Behavioral: Disease Education |
| Healthy Controls | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome: Brief Pain Inventory (BPI)
Pain-related interference and pain severity
Measured: 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)
Measured: Post-treatment
Secondary outcomes (1)
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
Measured: 4 weeks (mid-treatment), as well as Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startDec 2014
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
- Investigators
- Robert R Edwards, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345344
- Sponsor's protocol ID
- 2009p001021
- Other IDs
- R01AR064367
- Status last verified
- Feb 2023
- First submitted
- 27 Apr 2011
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41925517Lee 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.
PubMed 29579370
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
- ClinicalTrials.gov ID
- NCT01345344
- Acronym / sponsor ID
- 2009p001021
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2014 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy8 individual weekly visits with a psychologist for pain-related CBT. |
| Disease Education | Active comparator | Behavioral: Disease Education8 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyPracticing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain. | Behavioural | Cognitive-Behavioral Therapy |
| Disease EducationProviding information about fibromyalgia, including its potential causes and management approaches. | Behavioural | Disease Education |
Primary outcome
Clinical outcome: Brief Pain Inventory (BPI)
Time frame: Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment
Pain-related interference and pain severity
Neurobiological Outcome: Pain Neurocircuitry (fMRI)
Time frame: Post-treatment
Bold responses will be assessed with fMRI (3T)
1 secondary outcome
Catastrophizing (PCS)
Time frame: 4 weeks (mid-treatment), as well as Post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 41925517Lee 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.
- Derived from this study: PubMed 29579370Lee 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert R Edwards, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Disease Education in people with Fibromyalgia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome: Brief Pain Inventory (BPI) (time frame: Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01345344, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.