Norra MacReady

June 28, 2017

SAN DIEGO — Exercise and cognitive behavioral therapy (CBT), individually or in combination, can significantly relieve depression in people with type 2 diabetes, according to new findings presented at the recent American Diabetes Association (ADA) 2017 Scientific Sessions.

The results also demonstrate the feasibility of involving local community practitioners to help patients in rural areas who might not otherwise have access to comprehensive self-care programs, said Mary de Groot, PhD, associate professor of medicine and acting director of the Diabetes Translational Research Center, Indiana University School of Medicine, Indianapolis.

Psychosocial support is important for these patients, because depression is twice as prevalent among people with diabetes as in the general population, explained Dr de Groot.

One in four diabetic patients will be diagnosed with depression at some time in their lives. In addition to the depressive symptoms themselves, depression in people with diabetes has been associated with worse glycemic control, more severe diabetes complications, and poorer adherence to medical and dietary guidelines, compared with diabetic patients who are not depressed, she noted.

The end result is increased functional disability and premature mortality.

Program ACTIVE

Dr de Groot presented data from the Adults Coming Together to Increase Vital Exercise (Program ACTIVE II) trial, which examined the effectiveness of counseling and exercise in managing depression and glycemic control in people with type 2 diabetes and major depressive disorder, compared with the usual care patients receive from their primary-care clinicians.

The abstract was among just eight selected for presentation in the ADA President's Oral Session on the last day of the conference.

The study is a continuation of the Appalachians Coming Together to Increase Vital Exercise (Program ACTIVE) trial, a pilot that tested recruitment and retention as well as change of outcomes with CBT and exercise among adults living in rural Appalachia, which "represents an epicenter of the type 2 diabetes epidemic," Dr de Groot noted.

Program ACTIVE II was conducted at three sites: in Indianapolis, southeastern Ohio, and West Virginia. Eligible patients were at least 21 years of age, ambulatory, had type 2 diabetes for at least 1 year, and met diagnostic criteria for major depressive disorder as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.

Exclusion criteria included a diagnosis of type 1 diabetes, uncontrolled hypertension, and complications that would contraindicate participation in an exercise program. Patients who were already seeing a therapist or taking antidepressants were permitted to continue those treatments.

A total of 140 participants were randomly assigned to one of four interventions. The exercise intervention (n = 34) consisted of 12 weeks of community-based exercise plus six classes lead by personal trainers trained in specific Program ACTIVE interventions. Participants also received memberships to local exercise clubs. Patients in the CBT intervention (n = 36) received 10 individual sessions with a licensed community therapist who used a manualized treatment approach and was also trained in Program ACTIVE interventions. Patients in the third group underwent both interventions (n = 34), and the fourth group was a control group, who received usual care from their primary-care practitioners (n = 36).

All of the patients also participated in a nutrition education program originally developed in West Virginia and now available in 22 states, said Dr de Groot.

In this analysis, the patients were assessed at baseline and immediately postintervention. Future studies will include follow-up assessments at 6 and 12 months after recruitment.

The participants included 104 women (74%), had an average age of 56 years, and had had diabetes for a mean of 11 years. All income and educational levels were represented, with no significant demographic differences between groups.

All Interventions Effective Compared With Usual Care

After adjustment for change in antidepressant medications, the odds of partial or full remission from major depressive disorder for the CBT-only and exercise-only groups were 12.6 and 5.8 times the odds associated with usual care, respectively (< .03), Dr de Groot said.

And in an analysis limited to patients in full remission, "all three intervention groups were five to six times more likely than those in usual care to be depression-free at the end of the intervention."

The changes in depression were reflected in measures such as the Beck Depression Inventory, in which scores improved significantly after CBT alone (= .011), CBT and exercise (P < .001), and exercise alone (P = .021), compared with usual care.

Patients also experienced significant improvements in diabetes-related distress and quality of life across the three intervention groups. Exercise self-efficacy, which Dr De Groot defined as "a measure of confidence in one's ability to engage in exercise," improved significantly with CBT plus exercise (P < .001) and exercise alone (P = .002), although not with CBT alone (P = .329).

CBT plus exercise also had a salutary effect on glycemic control: among patients with a baseline HbA1c of at least 7%, the combination was associated with a "clinically meaningful" improvement of 0.7% (P < .04), compared with those receiving CBT alone or usual care.

This study is the first to show an improvement in HbA1c associated with psychotherapy and exercise, Dr De Groot stressed.

"We believe these findings demonstrate the capacity to extend access to depression care in both rural and urban areas," she concluded, noting that the interventions were carried out in partnership with community organizations and providers, "so we've already started to increase the sustainability of this model by training people who are in the communities where patients need it the most."

Dr de Groot is on the faculty of the Johnson & Johnson Diabetes Institute. Disclosures for the coauthors are listed in the abstract.

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American Diabetes Association 2017 Scientific Sessions. June 13, 2017; San Diego, California. Abstract 376-OR

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