Objective: This article describes design elements of the Multifaceted Depression and Diabetes Program (MDDP) randomized clinical trial. The MDDP trial hypothesizes that a socioculturally adapted collaborative care depression management intervention will reduce depressive symptoms and improve patient adherence to diabetes self-care regimens, glycemic control, and quality-of-life. In addition, baseline data of 387 low-income, 96% Hispanic, enrolled patients with major depression and diabetes are examined to identify study population characteristics consistent with trial design adaptations.
Methods: The PHQ-9 depression scale was used to identify patients meeting criteria for major depressive disorder (1 cardinal depression symptom + a PHQ-9 score of > or = 10) from two community safety net clinics. Design elements included sociocultural adaptations in recruitment and efforts to reduce attrition and collaborative depression care management.
Results: Of 1,803 diabetes patients screened, 30.2% met criteria for major depressive disorder. Of 387 patients enrolled in the clinical trial, 98% had Type 2 diabetes, and 83% had glycated hemoglobin (HbA1c) levels > or = 7%. Study recruitment rates and baseline data analyses identified socioeconomic and clinical factors that support trial design and intervention adaptations. Depression severity was significantly associated with diabetes complications, medical comorbidity, greater anxiety, dysthymia, financial worries, social stress, and poorer quality-of-life.
Conclusion: Low-income Hispanic patients with diabetes experience high prevalence of depressive disorder and depression severity is associated with socioeconomic stressors and clinical severity. Improving depression care management among Hispanic patients in public sector clinics should include intervention components that address self-care of diabetes and socioeconomic stressors.