Status:
COMPLETED
Cognitive Behavioral Therapy for Diabetic Neuropathic Pain
Lead Sponsor:
VA Connecticut Healthcare System
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with diabetic peripheral neuro...
Detailed Description
Research Design: A randomized controlled design will be employed in which CBT plus standard pharmaceutical care (CBT/SC) is compared to an educational intervention plus standard pharmaceutical care (E...
Eligibility Criteria
Inclusion
- Established diagnosis of type 2 diabetes mellitus according to American Diabetes Association criteria
- History of daily lower extremity pain or discomfort (burning, tingling or other paresthesias) for a period of at least 3 months immediately prior to enrollment,
- Presence of neuropathy, as determined by evaluation at the VACHS Neuromuscular Disease and Neuropathy Clinic at the time of the baseline examination
- Judgment of the study endocrinologist (EH) that the patient is not experiencing a paradoxical precipitation of neuropathy following institution of good control which can be expected to resolve spontaneously
- Confirmation of the study neurologists that pain is not attributable to other medical conditions that could mimic DPNP (e.g., HIV, Hepatitis C, cryoglobulinemia, pernicious anemia, untreated hypothyroidism)
- Documentation of treatment of neuropathic pain with the maximum dose of one of the medications identified as a first line or second line treatment in either VA guidelines28 or other published consensus recommendations27 with maximum dose defined as either the maximum allowable dose or the maximum tolerated dose for the recommended duration of an adequate trial, unless otherwise contraindicated or patient refusal)
- Continued use of a guideline endorsed medication for neuropathic pain (unless otherwise contraindicated or patient refusal)
- Continued refractory pain despite pharmacological intervention as described above (as determined by a pain intensity score at least 4 on a 0-10 numeric rating scale)
- No medical condition that could impair the subject's ability to participate (e.g., unstable angina, severe COPD, limb amputation, intermittent claudication)
- No psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair subjects' ability to participate as defined by their responses to the SCID and BDI (e.g., presence of major Depressive Disorder and BDI score 30 or greater or presence of suicidal intent; presence of these conditions will require immediate medical/psychiatric attention to assure safety and institution of appropriate treatment)
- Absence of dementia defined by a score of 24 or greater on the Folstein Mini-Mental Status Exam (MMSE)
- Urine toxicology screen confirming the absence of illegal substances or non-prescribed opioids
- Provision of participant consent to consult their primary care physician and review their medical records to ensure that eligibility criteria are met,
- Availability of a touch-tone telephone in the participant's residence to facilitate the provision of IVR data
- English fluency sufficient to participate meaningfully in treatment. Prospective participants' medical and pharmacy records will be reviewed to determine whether they meet the 4th and 5th criteria listed above.
Exclusion
- No history of Type 2 diabetes mellitus
- Any life threatening illnesses or acute physical disease
- Any current psychiatric condition (psychosis, substance abuse/dependence)
- Any current suicidal thoughts or ideations
- The presence of profound cognitive impairment rendering successful participation in CBT or ED impossible
- prior or current psychological treatment for chronic pain
- The presence of physical disabilities resulting in an inability to attend treatment sessions and/or inability to participate in telephone interventions (e.g., severe dysarthria)
- No access to touch tone telephone
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00829387
Start Date
March 1 2010
End Date
December 1 2013
Last Update
June 18 2015
Active Locations (2)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
2
VA Connecticute Health Care System
West Haven, Connecticut, United States, 06516