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Program ACTIVE II: A comparative effectiveness trial to treat major depression in T2DM

American Diabetes Association Press Releases Jun 27, 2017

Depression in patients with diabetes is associated with higher rates of difficulty in managing diabetes and has an impact on long–term health outcomes. This 12–week study, “Program ACTIVE II: A Comparative Effectiveness Trial to Treat Major Depression in T2DM” (376–OR), evaluated the effectiveness of talk therapy and physical exercise on depression and A1C levels among adults with type 2 diabetes diagnosed with clinical depression. The study included 140 adults, with an average age of 57, from three different states in the U.S., and from all levels of income and educational background.

The participants were randomly assigned to one of four groups to receive either: 12 weeks of exercise with a personal trainer (EXER); 10 individual talk therapy/cognitive behavioral therapy sessions (CBT); concurrent interventions of exercise combined with talk therapy over 12 weeks (CBT+EXER); or usual care (UC).

At the end of the 12–week intervention period, the EXER participants, CBT participants and CBT+EXER participants all showed significant improvements in depressive symptoms, diabetes–related distress and quality of life compared to those receiving UC. Participants in the EXER, CBT, and CBT+EXER groups reported fewer depressive symptoms (all p<.05); reduction in negative automatic thoughts (all p<.03), improved physical quality of life (all except CBT only p<.03); and decreased diabetes distress (p<.01), compared to the participants in the UC group.

After controlling for change in antidepressant medications, people assigned to the talk therapy (CBT group) were significantly more likely to be free of major clinical depression symptoms than people assigned to the UC group. Participants assigned to the exercise group were also significantly more likely to be free of major clinical depression symptoms compared to the participants who received usual care. And, participants assigned to the exercise group with a starting A1C level of 7.0 percent or greater showed a clinically meaningful reduction in their A1C of 0.7 percent at the end of the exercise intervention, compared to those receiving CBT or UC, after controlling for baseline education levels and changes in diabetes medications (p <.04).

“Depression occurs at higher rates in people with diabetes than in the general population and has significant implications for physical and mental health,” said lead study author Mary de Groot, PhD, associate professor of medicine and acting director of the Diabetes Translational Research Center at Indiana University. “Our study is the first to demonstrate that exercise guided by a personal trainer and performed by participants in their communities is effective in treating both depression and diabetes, even after accounting for changes in diabetes medications. Exercise is also effective in managing blood sugar control in people who have depression and type 2 diabetes.”

The study researchers plan to evaluate the long–term effects of both talk therapy and exercise on depression and A1C to determine if the improvements that were observed in this trial can be sustained over an additional 12–months beyond treatment. Research is also being conducted to evaluate the cost–effectiveness of each intervention to further understand the extent to which these treatments can reduce health care costs.
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