Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00830011|
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : July 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Behavioral: cognitive behavioral therapy Other: standard medical care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioral Therapy for Painful Diabetic Neuropathy|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
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
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830011
|Principal Investigator:||Robert Kerns, PhD||VA Connecticut Healthcare System|