Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

July 27, 2011 updated by: VA Connecticut Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT
Behavioral: cognitive behavioral therapy
Ten sessions of manualized CBT delivered by a PhD level psychologist
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Collaborators

Donaghue Medical Research Foundation

Investigators

  • Principal Investigator: Robert Kerns, PhD, VA Connecticut Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 24, 2009

First Submitted That Met QC Criteria

January 24, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RK0029
  • DF03-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe