Cognitive Behavioral Therapy for Diabetic Neuropathic Pain

NCT00829387 | Completed Results

• 2 other identifiers: B6044RRK0035
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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 neuropathic pain.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetes; Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale (NRS) Pain Intensity

  Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported.

  baseline to 12 weeks post-baseline [post-treatment]

• Numeric Rating Scale (NRS) Pain Intensity

  Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity.

  baseline to 36 weeks post-baseline [follow-up]

Secondary Outcomes (4)

• The Interference Subscale of the Multidimensional Pain Inventory (MPI)

  baseline to 12 weeks post-baseline [post-treatment]

• Beck Depression Inventory (BDI)

  baseline to 12 weeks post-baseline [post-treatment]

• The Interference Subscale of the Multidimensional Pain Inventory (MPI)

  baseline to 36 weeks post-baseline [follow-up]

• Beck Depression Inventory (BDI)

  baseline to 36 weeks post-baseline [follow-up]

Study Arms (2)

Behavioral

EXPERIMENTAL

Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.

Behavioral: CBT plus standard pharmaceutical care (CBT/SC)

Educational

ACTIVE COMPARATOR

Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator

Behavioral: Diabetic Education plus standard pharmaceutical care (ED/SC)

Interventions

CBT plus standard pharmaceutical care (CBT/SC) BEHAVIORAL

Ten sessions of individual treatment delivered by a doctoral level psychologist.

Also known as: cognitive behavioral therapy

Behavioral

Diabetic Education plus standard pharmaceutical care (ED/SC) BEHAVIORAL

Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.

Also known as: patient education

Educational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (2)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

VA Connecticute Health Care System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Pain; Neuralgia

Interventions

Cognitive Behavioral Therapy; Patient Education as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Rebecca Czlapinski
• Organization: VA Connecticut Healthcare System

rebecca.czlapinski@va.gov

203-932-5711

Study Officials

• Robert D Kerns, PhD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2009
• First Posted: January 27, 2009
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 18, 2015
• Results First Posted: June 18, 2015

Record last verified: 2015-06

Locations

US (2)