Status:
COMPLETED
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
Lead Sponsor:
VA Connecticut Healthcare System
Collaborating Sponsors:
Donaghue Medical Research Foundation
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the usefulness of cognitive behavioral therapy (CBT) for the management of painful diabetic neuropathy. Participants will be randomly assigned to one...
Detailed Description
Research Design: A randomized mixed factorial controlled design will be employed in which CBT plus standard pharmaceutical care (CBT/SC) is compared to a standard pharmaceutical care (SC) treatment co...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus
- daily lower extremity pain or discomfort (burning, tingling or other parasthesias) for at least 3 months
- documented trial of at least one medication for neuropathic pain
- pain of at least 4 on a 0-10 numeric rating scale
Exclusion
- acute medical condition, substance abuse, or psychiatric condition that would impair ability to participate
- dementia (MMSE score of 23 or lower)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00830011
Start Date
September 1 2004
End Date
December 1 2009
Last Update
July 28 2011
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