Health Promotion in the Prevention of Anxiety and Depression: The Happy Older Latinos are Active (HOLA Study)

预防焦虑和抑郁的健康促进：快乐的拉丁裔老年人很活跃（HOLA 研究）

• 批准号: 10092829
• 负责人: Daniel Enrique Jimenez
• 金额: $ 68.87万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-09 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10092829
• 关键词: Address; Age; Anti-Inflammatory Agents; Anxiety; Behavioral; Biological; Characteristics; Clinical assessments; Communities; Community Health Aides; Data; Development; Education; Educational Materials; Elderly; Event; Generalized Anxiety Disorder; Health; Health Promotion; IL8 gene; Incidence; Inflammatory; Interleukin-12; Interleukin-17; Interleukin-4; Interleukin-6; Intervention; Joints; Latino; Major Depressive Disorder; Measures; Mediating; Mediator of activation protein; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Modeling; Modification; Morbidity - disease rate; Outcome; Participant; Patients; Physical Fitness; Physical activity; Pilot Projects; Prediction of Response to Therapy; Prevalence; Prevention; Prevention Research; Prevention trial; Public Health; Randomized; Recurrence; Research; Research Design; Research Personnel; Resources; Risk; Risk Factors; Role; Schedule; Series; Severities; Social support; Source; Survival Analysis; Symptoms; System; TNF gene; Telephone; Testing; Time; Treatment outcome; Waiting Lists; Walking; Work; acceptability and feasibility; adverse outcome; aged; anakinra; anxiety symptoms; base; compare effectiveness; confirmatory trial; cytokine; depressive symptoms; disability; experience; follow-up; hazard; health care delivery; health related quality of life; healthy lifestyle; improved; innovation; intervention effect; minor depressive disorder; post intervention; prevent; preventive intervention; primary outcome; programs; psychoeducation; psychosocial; secondary outcome; single episode major depressive disorder; social; social cognitive theory; subthreshold depression; systemic inflammatory response; therapy outcome

Abstract Given the prevalence and morbidity of depression in later life, the inadequacies of current treatment approaches for averting years living with disability, the inequities in access to the mental health care delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice. In the proposed study, 240 older Latinos age 60+ with subthreshold depression or anxiety – defined as ≥ 5 on the PHQ-9 OR GAD-7 – will be randomized to either HOLA (n=120) or the healthy lifestyles education program (n=120). Participants will be followed for up to 24 months with repeated assessments of clinical, health-related, and psychosocial outcomes (at baseline, post intervention, 6, 12, 18, and 24 months post intervention). The study has three specific aims: (1a) to compare the effectiveness of HOLA and healthy lifestyles education in reducing risk factors for major depression and generalized anxiety disorder among older Latinos with subthreshold depression or anxiety; (1b) to compare the impact of HOLA and healthy lifestyles education in reducing the 2-year incidence and recurrence of major depression and generalized anxiety disorder among older Latinos with subthreshold depression or anxiety; (2) To compare the effectiveness of HOLA and healthy lifestyles education in improving health-related outcomes among older Latinos with minor or subthreshold depression or anxiety (e.g. pro and anti- inflammatory cytokines, objective measures of physical fitness, and health-related quality of life) among older Latinos with minor or subthreshold depression or anxiety; (3) and to identify biological and psychosocial sources of variability that are predictive of either therapeutic or adverse outcomes to treatment in older Latinos with subthreshold depression or anxiety. For Aims 1a and 2, the primary analytic strategy will be mixed effect modeling for main effects of group, time, and time-by-treatment interaction. For Aim 1b, the primary analytic strategy will be survival analysis of time to major depressive episode or generalized anxiety disorder in HOLA, healthy lifestyles education, and wait list control. For Aim 3, we will use a “joint” model that integrates time-to-event models (i.e. Cox proportional hazards) with models for risk factor trajectories to explore the strongest predictors of treatment response or non-response, which is defined as a 50% decrease in symptom severity. Finally, we will determine whether preventive intervention effects, if detected, are mediated or moderated by changes in perceived social support or systemic inflammation. Health promotion interventions represent a potential solution to the multiple disparities experienced by older Latinos. Such an approach could appeal to older Latinos as a nonstigmatizing and culturally acceptable alternative to traditional mental health services.

摘要 鉴于抑郁症在晚年的流行和发病率， 目前的治疗方法，以避免多年的残疾生活，在获得 精神卫生保健提供系统，以及满足精神卫生需求的劳动力短缺 老年拉丁美洲人的需求，开发和测试创新战略，以防止抑郁症 和焦虑具有重大的公共卫生意义，并有可能改变实践。 在这项拟议中的研究中，240名60岁以上的老年拉丁美洲人患有阈下抑郁或焦虑症， 定义为PHQ-9或GAD-7 ≥ 5-将随机分配至HOLA（n=120）或 健康生活方式教育项目（n=120）。参与者将接受长达24个月的随访 通过临床、健康相关和心理社会结果的重复评估（在基线， 干预后，干预后6、12、18和24个月）。该研究有三个具体的 目的：（1a）比较HOLA和健康生活方式教育在降低 老年拉丁美洲人中重度抑郁症和广泛性焦虑症的危险因素 阈下抑郁或焦虑;（1b）比较HOLA和健康生活方式的影响 教育在减少2年的发病率和复发的重性抑郁症和广义 老年拉丁美洲人中的焦虑症与阈下抑郁或焦虑;（2）比较 HOLA和健康生活方式教育在改善健康相关结果方面的有效性 在患有轻微或阈下抑郁或焦虑的老年拉丁美洲人中（例如，赞成和反对 炎性细胞因子、身体健康的客观指标和健康相关的生活质量） 在患有轻微或阈下抑郁或焦虑的老年拉丁美洲人中;（3）并确定 生物学和心理社会学的变异性来源是预测治疗或 对患有阈下抑郁或焦虑的老年拉丁美洲人治疗的不良结果。为 针对目标1a和2，主要分析策略将是以下主要效应的混合效应建模： 组、时间和时间-治疗相互作用。对于目标1b，主要分析策略将是 HOLA患者至重度抑郁发作或广泛性焦虑症时间生存分析， 健康的生活方式教育和等候名单控制。对于目标3，我们将使用一个“联合”模型， 将事件发生时间模型（即考克斯比例风险）与风险因素模型相结合 轨迹，以探索治疗反应或无反应的最强预测因子， 定义为症状严重程度降低50%。最后，我们将确定是否预防性 干预效果，如果检测到，介导或缓和的变化，感知社会 支持或全身炎症。健康促进干预是一种潜在的解决方案 老年拉美人所经历的多重差异。这种方法可能会吸引老年人 拉丁美洲人作为传统精神健康的非污名化和文化上可接受的替代品 服务