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

项目总结/摘要 除了失去配偶的情绪紧张外，丧亲者的日常生活也发生了深刻的变化。 常规;成年人突然觉得没有理由起床，上床睡觉，吃饭或在特定时间从事活动 的一天。这些关键的社会计时器，或“时间表”的破坏，破坏了昼夜节律的稳定性， 将这些人置于情绪障碍的高风险中，如重度抑郁症（MDD）和其他不良反应。 与自我保健不良有关的健康后果。预防MDD具有公共卫生重要性，因为它 患病率和相关的身体残疾、发病率和超额死亡率。PI的初步数据 K 01奖（MH 103467）表明，使用技术和激励健康的行为干预 针对个人时间表（睡眠、饮食、活动）的稳定性进行指导是可行的，也是可以接受的， 由于抑郁症的阈下症状而具有MDD高风险的丧偶老年人。 可行性分析证明了初步的疗效信号（关于减少抑郁症），并显示 这种干预稳定了昼夜节律（“目标”或假设的作用机制）。结果 这项试点研究支持推进全面的疗效试验。此R 01应用程序的主要目的是 为了测试基于技术的行为干预的有效性，该行为干预针对睡眠的时间和规律， 饮食和体育活动，以稳定昼夜节律，以减少老年人的抑郁症状 失去配偶的成年人使用指示性预防方法，我们建议招募150名配偶- 在配偶死亡后的前6个月内，60岁及60岁以上的丧偶成年人处于MDD的高风险中 因为抑郁症的阈下症状。将进行确证性疗效试验，其中 参与者将被随机分配到（a）自我监测睡眠，饮食和身体活动12周， 数字监测加激励性健康指导（WELL; n=75）;或（B）增强常规护理（EUC，常规护理 加上研究评估，n=75）。昼夜24小时模式的客观腕动计测量 活动-被称为休息-活动节律-将被测量，以评估昼夜节律作为介导者， 治疗结果。将在基线、干预后以及干预后3个月、6个月和12个月对参与者进行评估。 干预这项试验的结果，无论是积极的还是消极的，都将为未来的研究提供明确的决定。 干预发展（即，干预措施的有效性测试或传播）。拟定试验 与战略目标3（努力预防）相一致，并通过“发展”来响应研究优先事项3.2 针对核心机制的背景依赖性干预措施，包括那些在心理健康领域常见的干预措施。 与精神疾病的前驱期、新近发作期和慢性期有关的疾病，包括干预措施 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.”