Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

Indiana University Indianapolis, Indianapolis IN

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The prevalence of type 2 diabetes (T2DM) has reached epidemic proportions nationally and within underserved rural areas . Economically impoverished populations show increased risk for the development of T2DM and worsened outcomes. Rural residents are disproportionately affected by poverty and barriers to health care that contribute to these outcomes. Depression (MDD) affects 1 in 4 patients with diabetes. Depression is associated with worsened blood glucose levels and diabetes complications. Depression and T2DM also result in significant costs including: financial demands on health care systems, decreases to adherence and quality of life, increased functional disability and early mortality due to a variety of causes. Cognitive behavioral therapy (CBT) and exercise have the capacity to work synergistically as a win-win strategy to improve both T2DM and MDD outcomes while reducing barriers to care endemic to rural regions. Our group conducted a successful pilot study (R34DK071545) entitled, Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise) to test the feasibility of recruitment, retention and change in outcomes using CBT and community-based exercise among rural Appalachian adults with T2DM. We observed improvements in diabetes, MDD, and LDL-C outcomes at post-treatment and 3-month follow-up (3MFU) compared to baseline. A randomized controlled trial (RCT) of Program ACTIVE is proposed to test whether the combination behavioral treatment results in greater improvements in MDD and T2DM outcomes compared to exercise alone, CBT alone and usual care. The study will utilize a 2X2 factorial repeated measures RCT design in which participants will be assessed at baseline, immediately following the intervention (POST), 6- and 12-month follow-up time points. Intervention materials developed in the previous pilot study will be used. Two intervention sites serving rural central Appalachian counties of Ohio and West Virginia will be coordinated by the PI at Indiana University. A total sample of N=216 adults with T2DM and MDD will be recruited. Participants who meet eligibility criteria will be randomized at each site into 1 of 4 groups: usual care, CBT (10 individual sessions), community-based exercise (12 weeks) or CBT+EXER (10 individual sessions and 12 weeks of concurrent exercise). Intention-to-treat analyses will be conducted to assess primary and secondary outcomes. The study makes a significant contribution to the field by testing the effectiveness of separate and combination treatment modalities for T2DM and MDD in comparison to UC and implementing two manualized treatment programs (CBT and exercise) tailored for individuals with T2DM within community settings. The study is innovative in its approach to the design and implementation of the treatment of T2DM and MDD by creating a model for coordinated care for T2DM and MDD treatment across mental health and community exercise facilities and creating a sustainable program that can be adopted by community mental health and exercise facilities in rural regions nationally beyond the period of federal funding.