COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US.

Background: Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes.

Design: This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities.

Baseline Results: 139 patients (Mean age = 52.6 ± 9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <$10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ± 2.0; Mean BMI = 37.0 ± 9.1; Mean duration = 11.2 ± 8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ± 1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ± 6.1).

Conclusion: Patients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population.

Clinical Trial Registration: NCT02863523.