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Completed

NCT Number: NCT01345344

Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massaschusetts General Hospital, Charlestown, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Disease Education

Behavioral

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

Primary outcomes

  1. 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

  2. Neurobiological Outcome: Pain Neurocircuitry (fMRI)

    Time frame: Post-treatment

    Bold responses will be assessed with fMRI (3T)

Secondary outcomes

  1. Catastrophizing (PCS)

    Time frame: 4 weeks (mid-treatment), as well as Post-treatment

    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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
May 2, 2011
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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