Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

NCT00830011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-07-28

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy

Interventions

BEHAVIORAL

cognitive behavioral therapy

Ten sessions of manualized CBT delivered by a PhD level psychologist

OTHER

standard medical care

any care recommended by physician for treatment of diabetic neuropathy including medication.

Sponsors & Collaborators

  • Donaghue Medical Research Foundation

    collaborator OTHER
  • VA Connecticut Healthcare System

    lead FED

Principal Investigators

  • Robert Kerns, PhD · VA Connecticut Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2009-06-30
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830011 on ClinicalTrials.gov