Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title:

Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830011
• Other study ID #: RK0029
• Secondary ID: DF03-35
• Status: Completed
• Phase: N/A
• First received: January 24, 2009
• Last updated: July 27, 2011
• Start date: September 2004
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	Donaghue Medical Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity score (NRS)		post treatment and follow-up (24 and 36 weeks)	No
Secondary	pain-related disability (MPI) and emotional functioning		post treatment and followup (24 and 36 weeks)	No

External Links

•   American Diabetes Association