Abstract

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. 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. 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.

Highlights

  • One in 10 Americans has diabetes and current projections estimate diabetes will affect one in three Americans born in the year 2000 [1] resulting in annual T2DM-related costs of $256 billion [2]

  • De Groot et al Conclusions—This is the first study to evaluate the comparative effectiveness of combined cognitive behavioral therapy (CBT) and exercise in the treatment of depression using community-based intervention delivery

  • In West Virginia (WV), the statewide age-adjustment prevalence of diagnosed T2DM is 10.4% [4] while the average prevalence rate of T2DM in rural Appalachian Ohio (OH) counties is 11.3% [5] exceeding the national average of 9.3% [1].The Appalachian region bears a disproportionate burden of major depressive disorder (MDD; 8.2%) compared to non-Appalachian areas (7.6%), with higher rates found in central Appalachian states (10.6%) such as WV and OH than northern or southern states [6]

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Summary

Introduction

One in 10 Americans has diabetes and current projections estimate diabetes will affect one in three Americans born in the year 2000 [1] resulting in annual T2DM-related costs of $256 billion [2]. Participants randomized to a stepped-care problem-solving therapy intervention reported higher levels of treatment exposure, satisfaction with care and improved depression outcomes compared to patients in the usual care group. No studies have evaluated the comparative effectiveness of CBT and exercise by implementing these interventions with community fitness and mental health providers using a communityengaged research (CEnR) approach. Program ACTIVE II has been designed to simultaneously achieve two overarching goals: 1) to test the comparative effectiveness of the cognitive behavioral therapy (CBT) and community-based exercise (EXER) to usual care (UC); and 2) to develop a sustainable program that may be used as a scalable model for T2DM and depression treatment for national dissemination. Eligible participants are randomly assigned to one of the four groups: CBT, EXER, CBT+EXER or UC

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