Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by:
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00830011
First received: January 24, 2009
Last updated: July 27, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Pain intensity score (NRS) [ Time Frame: post treatment and follow-up (24 and 36 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830011

Sponsors and Collaborators
VA Connecticut Healthcare System
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Robert Kerns, PhD VA Connecticut Healthcare System
  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:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014