Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Neuropathy |
Behavioral: cognitive behavioral therapy Other: standard medical care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) ] [ Designated as safety issue: No ]
- pain-related disability (MPI) and emotional functioning [ Time Frame: post treatment and followup (24 and 36 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Robert Kerns, PhD; Chief, Psychology Service (PI), VA Connecticut Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00830011 History of Changes |
| Other Study ID Numbers: | RK0029, DF03-35 |
| Study First Received: | January 24, 2009 |
| Last Updated: | July 27, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Connecticut Healthcare System:
|
diabetes neuropathy chronic pain Cognitive behavioral therapy |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013