Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFebruary 20, 2013
February 1, 2013
4.9 years
February 15, 2013
February 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Seven Months
Study Arms (4)
Group Cognitive Behavioral Therapy
EXPERIMENTALParticipants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Pain Education
ACTIVE COMPARATORParticipants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
Therapeutic Interactive Voice Response
EXPERIMENTALFour months of therapeutic interactive voice response (TIVR).
No TIVR
ACTIVE COMPARATORControl - no intervention
Interventions
Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
Subjects 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.
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.
Eligibility Criteria
You may qualify if:
- At least 12 months of muscular-skeletal, non-neuropathic pain
You may not qualify if:
- Malignancy causing or influencing chronic pain
- Radiation or chemotherapy, or metastatic cancer of any type
- Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
- Neurological disorders such as epilepsy or stroke, or other medical conditions
- Psychiatric disorders
- Opioid medication use for pain management
- Past year history of illicit drug use that can result in altered cognition
- Pregnancy
- Exceeding weight limit of the MRI scanner
- Incompatible implants due to MRI safety
- Awaiting pain related surgical procedure
- Involved in pain-related litigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont College of Medicine, MindBody Medicine Clinic
Burlington, Vermont, 05401, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Naylor, MD, PhD
Faculty, University of Vermont College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Magdalena R. Naylor, MD, PhD
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 20, 2013
Study Start
July 1, 2010
Primary Completion
June 1, 2015
Last Updated
February 20, 2013
Record last verified: 2013-02