Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes

OBJECTIVE Depression (major depressive disorder [MDD]) in adults with type 2 diabetes mellitus (T2DM) is associated with worsened diabetes complications, increased health care costs, and early mortality. Program ACTIVE II was a randomized, controlled, multicenter treatment trial designed to test the comparative effectiveness of cognitive behavioral therapy (CBT) and/or community-based exercise (EXER) on diabetes and depression outcomes compared with usual care (UC). RESEARCH DESIGN AND METHODS Using a 2 x 2 factorial randomized controlled trial design, adults with T2DM for >= 1 year who met DSM-IV-TR criteria for MDD were randomized to CBT (10 sessions occurring over 12 weeks; N = 36), EXER (12 weeks of community-based exercise including six sessions with a personal trainer; N = 34), CBT+EXER (concurrent over a 12-week period; N = 34), and UC (N = 36). Primary outcomes were depression remission rate (assessed by psychiatric interviewers blind to assignment) and change in glycemic control (HbA(1c)). RESULTS The mean age was 56.0 years (SD 10.7). Participants were female (77%), white (71%), and married (52%). After controlling for education and antidepressant use, odds of achieving full MDD remission in the intervention groups were 5.0-6.8 times greater than UC (P < 0.0167). The CBT+EXER group demonstrated improved HbA(1c) compared with UC. For participants with a baseline HbA(1c) >= 7.0%, exploratory post hoc subgroup analysis showed that the CBT+EXER group had a 1.1% improvement in HbA(1c) (P < 0.0001) after controlling for covariates. CONCLUSIONS The Program ACTIVE behavioral treatment interventions demonstrated clinically meaningful improvements in depression outcomes in adults with T2DM and MDD. These community-based interventions are complementary to medical care and extend access to those in rural and urban areas.