? The prevalence of type 2 diabetes (T2DM) continues to expand in epidemic proportions nationally and within the underserved rural Appalachian region. Low-income, at-risk populations, such as Appalachians, show increased risk for the development of type 2 diabetes (T2DM) and worsened outcomes. Depression is two times more likely in patients with T2DM than the general population. Depression rates among Appalachians with T2DM appear to be comparable to national means. Depression and diabetes is associated with worsened glycemic control and complications. Cognitive behavioral therapy (CBT) treatment has been shown to reduce depression and average blood sugars in T2DM patients. Aerobic exercise has been shown to be an efficacious treatment for major depression in patients without diabetes. To date, no studies have combined these treatments for patients with T2DM and depression. Advantages of this combined approach may include: extending depression remission through exercise maintenance; use of exercise as behavioral activation within the CBT framework; improvements in glycemic control; and potential for the reduction of cardiovascular risk factors such as HDL-C. The current study is a pilot and feasibility investigation of a community-based interdisciplinary approach to the treatment of depression in underserved rural Appalachian patients with T2DM, entitled Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise). The study is a single-group repeated measures design. The primary aims of the study are: 1) to assess the feasibility of recruitment, retention and adherence to this combined intervention program; 2) to assess the impact of the intervention on depression outcomes; 3) to assess the impact of the intervention on glycemic control; and 4) to assess the impact of the intervention on cardiovascular risk factors, specifically HDL-C. In Phase I, CBT and community-based exercise intervention protocols used in previous efficacy studies will be culturally-tailored for the Appalachian region. In Phase II, N=51 T2DM and depression participants will be recruited to receive 10 weekly sessions of CBT and 12 weeks of community-based aerobic exercise. Assessments will be conducted at baseline, post-intervention (POST) and 3-month follow-up (3MFU). Intention-to-treat analyses will be conducted to assess the feasibility of study recruitment, retention and the impact of intervention exposure on depressive symptoms, glycemic control, and changes in HDL-C as primary outcomes. Secondary outcomes of diabetes-specific quality of life and social support will also be examined. In addition, the feasibility of collecting cost - effectiveness data for use in the R18 trial will be assessed. Approximately 60% of participants are expected to be non-depressed at POST. Outcomes at POST and 3MFU are anticipated to show improvement over baseline. ? This study will inform the submission of an NIDDK R18 grant proposal for a multi-arm randomized clinical effectiveness trial of the culturally-tailored interdisciplinary depression intervention (usual care, CBT alone, exercise alone, combination therapy). The rationale for the R18 study mirrors the rationale for this R34 proposal. The study is anticipated to evaluate depression, glycemic control, and cardiovascular risk factor outcomes across 4 time points: baseline, POST, 6- and 12-month follow-up periods. Comparative effectiveness of the treatment arms as well as cost-effectiveness of treatment will be assessed. ? ?
