Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
|ClinicalTrials.gov Identifier: NCT00796536|
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Group cognitive behavioral therapy Behavioral: Pain education||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||July 2011|
Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Behavioral: Group cognitive behavioral therapy
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.
Active Comparator: 2
Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan.
Behavioral: Pain education
Patients 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.
- Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity [ Time Frame: Measured before and after the 12-week intervention ]
- Acute pain perception and brain activation correlated with improvement in clinical outcomes [ Time Frame: Measured before and after the 12-week intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796536
|United States, Vermont|
|MindBody Medicine Clinic|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Magdalena R. Naylor, MD, PhD||MindBody Medicine Clinic, Department of Psychiatry, University of Vermont|