Efficacy of a Healthy Lifestyle Intervention to Prevent Depression in Older Spousally-bereaved Adults

项目摘要/摘要 除了失去配偶的情感压力外，失去配偶的人的日常生活也发生了深刻的变化 例行公事；成年人突然觉得没有理由在特定的时间起床、睡觉、吃饭或从事活动 今天的事。扰乱这些关键的社会计时器或“时代变更者”，会扰乱昼夜节律的稳定性， 将这些人置于严重抑郁障碍(MDD)等情绪障碍的高危状态 与自理能力差有关的健康后果。预防MDD具有公共卫生重要性，因为它 患病率及相关的肢体残疾、发病率和超额死亡率。来自PI的初步数据 K01奖(MH103467)表明，一种使用技术和动机健康的行为干预 以个人时间因素(睡眠、饮食、活动)稳定性为目标的指导是可行的，也是可以接受的 失去配偶的老年成年人，由于抑郁的临界值以下症状，他们患MDD的风险很高。 可行性分析显示了初步的疗效信号(与减轻抑郁有关)，并显示 这种干预可以稳定昼夜节律(“靶点”或假想的作用机制)。结果： 这项试点研究支持推进一项全面的疗效试验。此R01应用程序的主要目标是 为了测试以睡眠时间和规律为目标的基于技术的行为干预的有效性， 饮食和体力活动以稳定昼夜节律，以减少老年人的抑郁症状 丧偶的成年人。采用有针对性的预防方法，我们建议招募150名配偶- 配偶死亡后前6个月内60岁及以上丧偶的成年人，患有MDD的风险很高 因为抑郁症的临界值以下症状。将进行验证性疗效试验，其中 参与者将被随机分配到(A)自我监测睡眠、饮食和体力活动12周，使用 数字监测加激励性健康指导(Well；n=75)；或(B)加强日常护理(EUC，普通护理 加上研究评估，n=75)。昼夜24小时动态模式的客观测量 活动--被称为休息-活动节律--将被测量来评估昼夜节律作为 治疗结果。参与者将在基线、干预后以及3个月、6个月和12个月后- 干预。这项试验的结果，无论是积极的还是消极的，都将为未来提供最终的决定 干预措施的制定(即，干预措施的有效性测试或传播)。拟议中的审判 与战略目标3(努力预防)保持一致，并响应研究优先事项3.2 以核心机制为目标的上下文相关干预，包括那些在心理上普遍存在的机制 与精神疾病的前驱症状、近期发病和慢性阶段有关的疾病，包括干预措施 这针对可改变的风险因素，以预防下游发病率和相关残疾。

PROJECT SUMMARY/ABSTRACT Apart from the emotional strain of losing a spouse, there are profound changes to bereaved individuals' daily routine; adults suddenly feel no reason to get up, go to bed, eat meals, or engage in activity at particular times of the day. Disruption of these key social timekeepers, or “zeitgebers”, disrupt the stability of circadian rhythms, placing these individuals at high risk for mood disorders like major depressive disorder (MDD) and other adverse health consequences related to poor self-care. Preventing MDD has public health importance due to its prevalence and associated physical disability, morbidity, and excess mortality. Preliminary data from the PI's K01 award (MH103467) show that a behavioral intervention that uses technology and motivational health coaching to target the stability of individuals' zeitgebers (sleep, meals, activity) is feasible and acceptable to older spousally-bereaved adults who are high risk for MDD because of subthreshold symptoms of depression. Feasibility analyses demonstrate a preliminary efficacy signal (with respect to reducing depression) and show that this intervention stabilizes circadian rhythms (the “target” or hypothesized mechanism of action). Results of this pilot study support moving forward with a full-scale efficacy trial. The primary aim of this R01 application is to test the efficacy of a technology-based behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity for stabilizing circadian rhythms, to reduce symptoms of depression among older spousally-bereaved adults. Using an indicated prevention approach, we propose to enroll 150 spousally- bereaved adults aged 60 years and older in the first 6 months after spousal death who are at high risk for MDD because of subthreshold symptoms of depression. A confirmatory efficacy trial will be conducted in which participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (WELL; n=75); or (b) enhanced usual care (EUC, usual care plus study assessments, n=75). Objective actigraphic measures of the 24-hour pattern of day and nighttime activity – known as the rest-activity rhythm – will be measured to evaluate circadian rhythms as a mediator of treatment outcomes. Participants will be assessed at baseline, post-intervention, and 3-, 6-, and 12-months post- intervention. Results from this trial, whether positive or negative, will provide definitive decisions about future intervention development (i.e., effectiveness testing or dissemination of the intervention). The proposed trial aligns with Strategic Objective 3 (Strive for Prevention) and is responsive to research priority 3.2 by “developing context dependent interventions that target core mechanisms, including those that are common across mental illnesses, related to the prodromal, recent onset, and chronic stages of mental illness, including interventions that target modifiable risk factors in the service of preventing downstream morbidity and associated disability.”