Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Other: standard medical care; Behavioral: cognitive behavioral therapy

• Registration Number: NCT00830011
• Lead Sponsor: VA Connecticut Healthcare System

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 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.

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 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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2009-01-24
• Study First Submitted QC: 2009-01-24
• Study First Posted: 2009-01-27
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-27
• Last Update Posted: 2011-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard medical care	Medical care including medication for neuropathic pain
CBT	cognitive behavioral therapy	-

Primary Outcome Measures

Name	Time	Method
Pain intensity score (NRS)	post treatment and follow-up (24 and 36 weeks)

Secondary Outcome Measures

Name	Time	Method
pain-related disability (MPI) and emotional functioning	post treatment and followup (24 and 36 weeks)