title: Program ACTIVE II: Design and Methods for a Multi-Center Community-Based Depression Treatment for Rural and Urban Adults with Type 2 Diabetes.
abstract: 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.
  
  
  METHODS
  The study is a 2-by-2 factorial randomized controlled trial consisting of 4 treatment groups: CBT alone, EXER alone, combination of CBT and EXER, and UC. Adults with T2DM for > 1 year and who meet DSM-IVTR criteria for Major Depressive Disorder (MDD) are eligible to participate at two rural Appalachian sites (southeastern Ohio and West Virginia) and one urban site (Indianapolis). This type II behavioral translation study uses a community-engaged research (CEnR) approach by incorporating community fitness centers and mental health practices as interventionists.
  
  
  CONCLUSIONS
  This is the first study to evaluate the comparative effectiveness of combined CBT and exercise in the treatment of depression using community-based intervention delivery. This approach may serve as a national model for expanding depression treatment for patients with T2DM.
authors: Indiana University School of Medicine, USA.
authors: Mary
authors: M
authors: de Groot
authors: Touro University School of Medicine, USA.
authors: Jay
authors: J
authors: Shubrook
authors: Ohio University Heritage College of Osteopathic Medicine, USA.
authors: Frank
authors: F
authors: Schwartz
authors: West Virginia University School of Medicine, USA.
authors: W Guyton
authors: WG
authors: Hornsby
authors: Ohio University, USA.
authors: Yegan
authors: Y
authors: Pillay
authors: Indiana University School of Medicine, USA.
authors: Chandan
authors: C
authors: Saha