Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
NCT00830011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2011-07-28
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 of two treatment conditions: CBT plus standard medical care or standard medical care alone. CBT will be offered in ten, ninety-minute group sessions and will be provided by a psychologist with experience in the management of both diabetes and chronic pain. CBT will involve teaching and encouraging practice of adaptive pain coping skills such as relaxation skills, activity pacing, and positive self-statements, among others. This study will allow us to determine which treatment is superior in terms of improvements in pain management, functioning and overall quality of life.
Conditions
- Diabetic Neuropathy
Interventions
- BEHAVIORAL
-
cognitive behavioral therapy
Ten sessions of manualized CBT delivered by a PhD level psychologist
- OTHER
-
standard medical care
any care recommended by physician for treatment of diabetic neuropathy including medication.
Sponsors & Collaborators
-
Donaghue Medical Research Foundation
collaborator OTHER -
VA Connecticut Healthcare System
lead FED
Principal Investigators
-
Robert Kerns, PhD · VA Connecticut Healthcare System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2009-06-30
- Completion
- 2009-12-31
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