Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
|Diabetic Neuropathy||Behavioral: cognitive behavioral therapy Other: standard medical care|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Cognitive Behavioral Therapy for Painful Diabetic Neuropathy|
- Pain intensity score (NRS) [ Time Frame: post treatment and follow-up (24 and 36 weeks) ]
- pain-related disability (MPI) and emotional functioning [ Time Frame: post treatment and followup (24 and 36 weeks) ]
|Study Start Date:||September 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: standard care
Medical care including medication for neuropathic pain
Other: standard medical care
any care recommended by physician for treatment of diabetic neuropathy including medication.
|Active Comparator: CBT||
Behavioral: cognitive behavioral therapy
Ten sessions of manualized CBT delivered by a PhD level psychologist
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 condition. Participants will be randomized in equal numbers to the two conditions. Repeated assessments of key outcome domains will occur at pretreatment/baseline and at 12, 24 and 36 weeks following baseline.
Methodology: Study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment) and at 24 and 36 weeks post-baseline (follow-up). Baseline assessment will include a neurological examination with a nerve conduction study to confirm the diagnosis of diabetic neuropathy. The primary outcome measure will be pain intensity. Secondary outcome measures will be pain quality, pain-related disability, physical and emotional functioning. Measures of treatment feasibility will also be examined. Participants receiving CBT will attend 10 weekly, group treatment sessions of 90 minutes. A target sample size of approximately 120 participants will be recruited.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830011
|Principal Investigator:||Robert Kerns, PhD||VA Connecticut Healthcare System|