Clinical trial NCT01274715: HOPE Pilot for Veterans With Complex Diabetes
Official title: Behavioral Health Coaching for Rural Veterans With Diabetes and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Depression
Keywords: Behavioral health coaching
Diabetes
Emotional health
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2011-01-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PHQ-9 (Patient Health Questionnaire-9)Scores
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Hemoglobin A1C
timeFrame: baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MEDVAMC
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Aanand D Naik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael E. DeBakey VA Medical Center
name: Jeffrey A Cully, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naik AD, White CD, Robertson SM, Armento ME, Lawrence B, Stelljes LA, Cully JA. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study. BMC Geriatr. 2012 Jul 24;12:37. doi: 10.1186/1471-2318-12-37.