Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

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.

Inclusion criteria

• 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 criteria

• acute medical condition, substance abuse, or psychiatric condition that would impair ability to participate
• dementia (MMSE score of 23 or lower)