Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
2 other identifiers
interventional
80
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 24, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 28, 2011
July 1, 2011
4.8 years
January 24, 2009
July 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity score (NRS)
post treatment and follow-up (24 and 36 weeks)
Secondary Outcomes (1)
pain-related disability (MPI) and emotional functioning
post treatment and followup (24 and 36 weeks)
Study Arms (2)
standard care
ACTIVE COMPARATORMedical care including medication for neuropathic pain
CBT
ACTIVE COMPARATORInterventions
Ten sessions of manualized CBT delivered by a PhD level psychologist
any care recommended by physician for treatment of diabetic neuropathy including medication.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- acute medical condition, substance abuse, or psychiatric condition that would impair ability to participate
- dementia (MMSE score of 23 or lower)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Higgins DM, Heapy AA, Buta E, LaChappelle KM, Serowik KL, Czlapinski R, Kerns RD. A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain. J Health Psychol. 2022 Mar;27(3):649-662. doi: 10.1177/1359105320962262. Epub 2020 Oct 19.
PMID: 33070667DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Kerns, PhD
VA Connecticut Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
January 24, 2009
First Posted
January 27, 2009
Study Start
September 1, 2004
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
July 28, 2011
Record last verified: 2011-07