Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy
* Other: standard medical care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard care<br>Medical care including medication for neuropathic pain | Other: standard medical care<br>* any care recommended by physician for treatment of diabetic neuropathy including medication.<br>|
| Active Comparator: CBT<br> | Behavioral: cognitive behavioral therapy<br>* Ten sessions of manualized CBT delivered by a PhD level psychologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity score (NRS) |  | post treatment and follow-up (24 and 36 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain-related disability (MPI) and emotional functioning |  | post treatment and followup (24 and 36 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, neuropathy, chronic pain, Cognitive behavioral therapy