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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

NCT01345344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

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

BEHAVIORAL

Disease Education

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Robert R Edwards, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345344 on ClinicalTrials.gov