BRIGHTEN Heart: Design and baseline characteristics of a randomized controlled trial for minority older adults with depression and cardiometabolic syndrome

Abstract

ObjectivesAfrican American and Hispanic elderly are at elevated risk of both depression and cardiovascular disease, relative to non-Hispanic whites. Effective interventions are therefore needed to address depressive symptoms and to reduce these disparities. BRIGHTEN Heart was a behavioral randomized controlled trial to test the efficacy of a virtual team intervention in reducing depressive symptoms in minority elderly as measured by the 9-item Patient Health Questionnaire (PHQ9). Study design250 African American and Hispanic adults, age ≥60 years, with comorbid depression and overweight/obesity were randomized. Participants randomized to the Intervention condition received a social work evaluation, team-based electronic consultation, case management, and psychotherapy over a 12 month period. Control participants were enrolled in a membership program that provided health classes and other services to support chronic disease self-management. Blinded research assistants completed assessments at baseline, and 6 and 12 months postrandomization. ResultsThe study population was characterized by low socioeconomic status, with 81.4% having a household income of less than $20,000. Although median depression scores were in the mild range, 25% of participants had scores showing moderate to severe depression at baseline. 75% of participants had four or more chronic conditions. Significant demographic and clinical differences were observed between the African American and Hispanic populations. ConclusionsBRIGHTEN Heart was designed to rigorously test the efficacy of a multi-level intervention to reduce comorbid depressive symptoms and cardiovascular risk in minority elderly. Investigators successfully recruited a cohort well suited to testing the study hypothesis.