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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

January 24, 2009
July 27, 2011
September 2004
June 2009   (final data collection date for primary outcome measure)
Pain intensity score (NRS) [ Time Frame: post treatment and follow-up (24 and 36 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830011 on ClinicalTrials.gov Archive Site
pain-related disability (MPI) and emotional functioning [ Time Frame: post treatment and followup (24 and 36 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Neuropathy
  • 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.
  • Active Comparator: standard care
    Medical care including medication for neuropathic pain
    Intervention: Other: standard medical care
  • Active Comparator: CBT
    Intervention: Behavioral: cognitive behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2009
June 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00830011
RK0029, DF03-35
No
Robert Kerns, PhD; Chief, Psychology Service (PI), VA Connecticut Healthcare System
VA Connecticut Healthcare System
Donaghue Medical Research Foundation
Principal Investigator: Robert Kerns, PhD VA Connecticut Healthcare System
VA Connecticut Healthcare System
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP