Clinical Trials Directory

Trials / Completed

CompletedNCT00796536

Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain

Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Vermont · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Chronic pain is a condition in which pain continues for 1 month or more beyond the usual recovery period for an injury or illness or persists for months or years due to a chronic condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT) has been found to be effective in treating people with chronic pain. The purpose of this study is to determine whether and how CBT geared specifically for treating chronic pain can change the way the brain responds to painful emotional and physical stimuli.

Detailed description

Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry. To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain. Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup cognitive behavioral therapyEach CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
BEHAVIORALPain educationPatients will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.

Timeline

Start date
2009-06-01
Primary completion
2010-06-01
Completion
2011-07-01
First posted
2008-11-24
Last updated
2013-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00796536. Inclusion in this directory is not an endorsement.