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Objective: Program ACTIVE II was a randomized controlled trial to assess the comparative effectiveness of cognitive behavioral therapy (CBT) and/or community-based exercise (EXER) individually and in combination (EXER+CBT) compared to usual care (UC) in adults with type 2 diabetes and major depression. We sought to estimate the cost-effectiveness of the three interventions relative to each other and to UC. Research Design and Methods: Empirical trial data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year time horizon from the healthcare sector and societal perspectives, discounting both costs and benefits at 3% annually. The primary outcome was costs per quality-adjusted life-year (QALY) gained. Results: From the healthcare sector perspective, compared to UC, the EXER intervention saved $313 per patient and produced 0.38 more QALY (cost-saving), the CBT intervention cost $596 more and gained 0.29 more QALY ($2,054/QALY), and the EXER+CBT intervention cost $403 more and gained 0.69 more QALY ($585/QALY). Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared to EXER, the EXER+CBT intervention cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared to UC, the EXER intervention still saved $126, the CBT intervention cost $2,833/QALY, and the EXER+CBT intervention cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. Compared to EXER, the EXER+CBT intervention cost $3,021/QALY. Results were robust in sensitivity analyses. Conclusions: All three Program ACTIVE II interventions represented a good value for money compared to UC. The EXER+CBT intervention was highly cost-effective or cost-saving compared to the EXER or CBT intervention. Disclosure S. Kuo: None. W. Ye: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc. M. de Groot: Consultant; Self; Kenner Family Foundation, Inc., LifeScan Diabetes Institute. J.H. Shubrook: Advisory Panel; Self; Bayer U.S., Eli Lilly and Company, Novo Nordisk Inc., Sanofi US. W. Hornsby: None. Y. Pillay: None. K.J. Mather: Research Support; Self; Abbott, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. W.H. Herman: Consultant; Spouse/Partner; Nestlé. Other Relationship; Self; Merck Sharp & Dohme Corp. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK092765, R34DK071545)

Few studies have evaluated the long-term comparative effects of behavioral treatments for major depressive disorder (MDD) on glycemic and psychological outcomes. Program ACTIVE II was a multi-state randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), community-based exercise (EXER), combination treatment (CBT+EXER) or usual care (UC) for adults with MDD and type 2 diabetes (T2DM). CBT+EXER had a lasting A1c benefit at 6-months (-1.27%; SE: 0.6; p=0.04) and 12 months (-1.42%; SE: 0.6; p=0.03) compared to UC in those with baseline A1c ≥ 7.0%, after controlling for baseline covariates. At 6-month (N=74) and 12-month (N=64) follow-up assessments, all groups had high rates of MDD full remission (range: 63-93%; NS) and minimal depressive symptoms (BDI total score range: 10.7-15.6; NS). At 6 months, CBT+EXER had significant improvements in diabetes-related distress regimen burden (p=0.05); and personal support for health (p=0.05) compared to UC. EXER had improvements in negative thoughts (p=0.005), community social support (p=0.005), diabetes-specific quality of life (DQoL; p=0.04) and satisfaction with T2DM (p=0.01) compared to UC. CBT had improvements over UC in personal support for health (p=0.04) and DQoL (p=0.047). At 12 months, all 3 treatment groups reported improved support from health care providers (p=0.03 CBT, EXER and CBT+EXER) compared to UC. CBT+EXER had improved SF-12 Physical Component Scores (p=0.04) compared to UC. The Program ACTIVE II CBT+EXER intervention had a sustained benefit for A1c beyond the effect of MDD full remission. All 3 behavioral interventions sustained improvements in psychological well-being over 1 year. These findings highlight durable benefits of community-based depression interventions delivered by behavioral health and exercise professionals, which could allow expanded access to depression treatment for T2DM patients in rural and urban areas. Disclosure M. de Groot: Consultant; Self; Johnson &Johnson Diabetes Institute, LLC., Eli Lilly and Company.W. Hornsby: None.C.K. Saha: None.Z. Yang: None.Y. Pillay: None.K.M. Fitzpatrick: None. K.J. Mather: Research Support; Self; Merck &Co., Inc., Sanofi-Aventis, Novo Nordisk A/S, Abbott. Advisory Panel; Self; Merck & Co., Inc.J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..