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OBJECTIVE We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.

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; 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 (HbA1c). 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 HbA1c compared with UC. For participants with a baseline HbA1c ≥7.0%, exploratory post hoc subgroup analysis showed that the CBT+EXER group had a 1.1% improvement in HbA1c (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.

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)

OBJECTIVE: The 6 Minute Walk Test (6MWT) is a measure that is routinely used to assess a response to treatment for cardiopulmonary diseases such as pulmonary fibrosis and congestive heart failure. The measure has never been verified as a valid measure of exercise capacity in the highly prevalent patient population of type 2 diabetes (T2DM). This study investigated the correlation between the 6MWT and graded exercise testing (GXT) in an effort to validate the 6MWT as a quality tool for assessing exercise capacity in adults with T2DM. RESEARCH DESIGN AND METHOD: This is a secondary data analysis of Program ACTIVE II, a randomized controlled trial designed to assess the effectiveness of two behavioral interventions on depression and glycemic outcomes in adults with T2DM. The correlation of 6MWT and predicted VO2 max (PVO2M) using GXT was examined in a subsample of participants at the time of study enrollment and at post-intervention. RESULTS: PVO2M showed a significant correlation with 6MWT distance both at baseline (r=0.57, p=0.014) and post-intervention (r = 0.66, p = 0.037). The regression analysis of baseline data revealed that 6MWT distance alone explained 45% (F = 13.03, p = .0024) of the variability in PVO2M. When combined with the SF-12 physical health component score (PCS), 6MWT explained 66% (F = 13.62, p < .001) of the variance in PVO2M. After adjusting for PCS, 6MWT distance explained an additional 30% variability in PVO2M. CONCLUSIONS: Findings from this study indicate that the 6MWT and predicted exercise capacity are significantly correlated. The 6MWT can be used to estimate exercise capacity in adults with T2DM.

Background Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. Methods Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff. Results Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment. Conclusions Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas. Trial registration ClinicalTrials.gov, NCT03371940. Registered on 13 December 2017.

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..

Objective Depression affects one in four adults with type 2 diabetes (T2DM) and is associated with worsened diabetes complications, increased health care costs and early mortality. Rural and low-income urban areas, including the Appalachian region, represent an epicenter of the T2DM epidemic. Program ACTIVE II is a comparative effectiveness treatment trial designed to test whether a combination of cognitive behavioral therapy (CBT) and community-based exercise (EXER) will offer greater improvements in diabetes and depression outcomes compared to individual treatment approaches and usual care (UC). The secondary aims are to assess changes in cardiovascular risk factors across groups and to conduct a cost-effectiveness analysis of predicted incidence of cardiovascular complications across groups.