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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

Disease Education

About this trial

This is an interventional other trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria for FM patients:

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

Exclusion Criteria for FM:

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

Inclusion Criteria for Healthy Control Participants

Aged 18-65
Female
Right-handed
Able to provide written consent

Exclusion criteria for Healthy Control Participants:

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

Sites / Locations

Massaschusetts General Hospital
Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Cognitive-Behavioral Therapy

Disease Education

Healthy Controls

Arm Description

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

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

No intervention.

Outcomes

Primary Outcome Measures

Clinical outcome: Brief Pain Inventory (BPI)

Pain-related interference and pain severity

Neurobiological Outcome: Pain Neurocircuitry (fMRI)

Bold responses will be assessed with fMRI (3T)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01345344

First Posted

April 27, 2011

Last Updated

February 8, 2023

Sponsor

Brigham and Women's Hospital

Collaborators

Massachusetts General Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT01345344

Brief Title

Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Official Title

Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Massachusetts General Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

Study personnel collecting, entering, and analyzing data are blind to treatment allocation.

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-Behavioral Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Disease Education

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy Controls

Arm Type

No Intervention

Arm Description

No intervention.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.

Intervention Type

Behavioral

Intervention Name(s)

Disease Education

Intervention Description

Providing information about fibromyalgia, including its potential causes and management approaches.

Primary Outcome Measure Information:

Title

Clinical outcome: Brief Pain Inventory (BPI)

Description

Pain-related interference and pain severity

Time Frame

Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment

Title

Neurobiological Outcome: Pain Neurocircuitry (fMRI)

Description

Bold responses will be assessed with fMRI (3T)

Time Frame

Post-treatment

Secondary Outcome Measure Information:

Title

Catastrophizing (PCS)

Description

Time Frame

4 weeks (mid-treatment), as well as Post-treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for FM patients: 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 Exclusion Criteria for FM: 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 Inclusion Criteria for Healthy Control Participants Aged 18-65 Female Right-handed Able to provide written consent Exclusion criteria for Healthy Control Participants: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert R Edwards, PhD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massaschusetts General Hospital

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Facility Name

Brigham and Women's Hospital

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29579370

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.

Results Reference

derived

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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

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