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

de Groot M, Shubrook JH, Hornsby WG, Pillay Y, Mather KJ, Fitzpatrick K, Yang Z, Saha C. Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes. Diabetes Care. 2019 Jul 1; 42(7):1185-1193.

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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 × 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; = 36), EXER (12 weeks of community-based exercise including six sessions with a personal trainer; = 34), CBT+EXER (concurrent over a 12-week period; = 34), and UC ( = 36). Primary outcomes were depression remission rate (assessed by psychiatric interviewers blind to assignment) and change in glycemic control (HbA). 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 ( < 0.0167). The CBT+EXER group demonstrated improved HbA compared with UC. For participants with a baseline HbA = 7.0%, exploratory post hoc subgroup analysis showed that the CBT+EXER group had a 1.1% improvement in HbA ( < 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.

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