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Clinical Trials/NCT01274715
NCT01274715
Completed
Not Applicable

Behavioral Health Coaching for Rural Veterans With Diabetes and Depression

Michael E. DeBakey VA Medical Center1 site in 1 country12 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Michael E. DeBakey VA Medical Center
Enrollment
12
Locations
1
Primary Endpoint
Change in PHQ-9 (Patient Health Questionnaire-9)Scores
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.

Detailed Description

The co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. Due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. These comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.Rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (CBOCs). Patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. Similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. Using behavioral health coaches (BHCs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. The implementation of such treatments requires the development and testing of therapeutic manuals and BHC training protocols to ensure standardization and effectiveness. The BHC intervention has been labeled Health Outcomes through Patient Empowerment (HOPE) and will be offered to eligible patients receiving care through MEDVAMC and its CBOCs. Preliminary data obtained through this pilot grant is to support a larger VA grant.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
July 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aanand Naik

Assistant Professor of Medicine

Michael E. DeBakey VA Medical Center

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of type 2 diabetes and Primary Care Physician intent to treat
  • Clinically significant symptoms of depression per self-report
  • HA1C average of 7.5 or greater in past 12 months AND no HA1C \< 7.0 in past 12 months.

Exclusion Criteria

  • Factors that render a telephone-based behavioral activation intervention inappropriate
  • Significant cognitive impairment
  • Meet criteria of bipolar, psychotic or substance abuse disorder
  • Serious medical issues; e.g., terminal cancer
  • Reports severe depression or suicidal ideation

Outcomes

Primary Outcomes

Change in PHQ-9 (Patient Health Questionnaire-9)Scores

Time Frame: Baseline, 3 months, and 6 months

The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Change in Hemoglobin A1C

Time Frame: baseline, 3 months, and 6 months

Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Study Sites (1)

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