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BRIGHTEN Heart:针对患有抑郁症和心脏代谢综合征的老年少数族裔成年人的一项随机对照试验的设计与基线特征

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

作者信息

Rothschild S K, Emery-Tiburcio E E, Mack L J, Wang Y, Avery E F, Li H, Golden R L, Powell L H

机构信息

Departments of Preventive Medicine and Family Medicine, Rush Medical College, USA.

Department of Behavioral Sciences, Rush Medical College, USA.

出版信息

Contemp Clin Trials. 2016 May;48:99-109. doi: 10.1016/j.cct.2016.04.008. Epub 2016 Apr 16.

Abstract

OBJECTIVES

African 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 DESIGN

250 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.

RESULTS

The 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.

CONCLUSIONS

BRIGHTEN 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.

摘要

目的

与非西班牙裔白人相比,非裔美国人和西班牙裔老年人患抑郁症和心血管疾病的风险更高。因此,需要有效的干预措施来解决抑郁症状并减少这些差异。“照亮心灵”(BRIGHTEN Heart)是一项行为随机对照试验,旨在测试虚拟团队干预在减少少数族裔老年人抑郁症状方面的疗效,抑郁症状通过9项患者健康问卷(PHQ9)进行测量。

研究设计

将250名年龄≥60岁、患有合并症抑郁症且超重/肥胖的非裔美国人和西班牙裔成年人随机分组。被随机分配到干预组的参与者在12个月内接受了社会工作评估、基于团队的电子咨询、病例管理和心理治疗。对照组参与者参加了一个会员计划,该计划提供健康课程和其他服务以支持慢性病自我管理。不知情的研究助理在基线以及随机分组后的6个月和12个月完成评估。

结果

研究人群的特点是社会经济地位较低,81.4%的家庭收入低于20,000美元。尽管抑郁评分中位数处于轻度范围,但25%的参与者在基线时的评分显示为中度至重度抑郁。75%的参与者患有四种或更多慢性病。在非裔美国人和西班牙裔人群之间观察到显著的人口统计学和临床差异。

结论

“照亮心灵”(BRIGHTEN Heart)旨在严格测试一种多层次干预措施在减少少数族裔老年人合并症抑郁症状和心血管风险方面的疗效。研究人员成功招募了一个非常适合检验研究假设的队列。

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