Modernized Collaborative Care to Reduce the Excess CVD Risk of Depressed Patients

现代化协作护理可降低抑郁症患者的过度 CVD 风险

• 批准号: 9250190
• 负责人: Jesse C Stewart
• 金额: $ 60.2万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-21 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9250190
• 关键词: Address; Adult; African American; Aftercare; American; Antidepressive Agents; Autonomic Dysfunction; Cardiotoxicity; Cardiovascular Diseases; Cardiovascular system; Caring; Clinical; Clinical Trials; Cognitive Therapy; Data; Depressed mood; Depressive disorder; Disease Outcome; Early treatment; Economic Burden; Event; Exhibits; Female; Follow-Up Studies; Goals; Health Care Costs; Incidence; Indiana; Inflammation; Intervention; Latino; Mediating; Mediator of activation protein; Mental Depression; Modernization; Moods; Morbidity - disease rate; Myocardial Infarction; Natural History; Onset of illness; Outcome; Pathogenesis; Patient Care; Patient Preferences; Patient risk; Patients; Phase; Phase III Clinical Trials; Platelet Activation; Primary Health Care; Prognostic Factor; Provider; Public Health; Randomized; Randomized Controlled Trials; Research; Risk; Risk Factors; Site; Specific qualifier value; Stroke; Telephone; Testing; Translating; Visit; Woman; cardiovascular disorder prevention; cardiovascular disorder risk; clinical practice; clinically relevant; cohort; collaborative care; computerized; cost; depressed patient; depressive symptoms; design; disorder risk; endothelial dysfunction; evidence base; follow-up; high risk; hypercholesterolemia; improved; men; mortality; multidisciplinary; novel; outcome forecast; prevent; primary outcome; programs; prospective; public health relevance; secondary outcome; tool; treatment as usual; treatment effect; treatment trial; virtual

 DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) is the number one killer of American men and women, and its economic burden is substantial and on the rise. Adults with depression are at elevated risk of CVD events and poor CVD prognosis. Unfortunately, past trials of depression treatments have not observed the anticipated cardiovascular benefits. A novel explanation for these null results is that the interventions in these trials, which all involved patients with preexisting CVD, were delivered too late in the natural history of CVD. To begin to evaluate our hypothesis that treating depression before clinical CVD onset could reduce CVD risk, we conducted an 8-year follow-up study of a positive depression trial, the IMPACT trial. Intervention patients without baseline CVD had a 48% lower risk of fatal/nonfatal myocardial infarction or stroke than did usual care patients. Although these results support our hypothesis, they are post hoc and observational, CVD outcomes were not pre-specified endpoints, and minimal mechanistic data was collected. To address the current need for a well-powered, prospective trial, we propose a Phase 2 randomized controlled trial of 216 primary care patients (=50 years, 60% female, 40% African American, 5% Latino) with a depressive disorder and elevated CVD risk but no clinical CVD. Patients will be randomized to one year of eIMPACT, our modernized version of the IMPACT intervention, or usual care. eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based depression treatments consistent with patient preference. We will modernize our intervention by incorporating computerized cognitive-behavioral therapy and delivering other treatment components via telephone. Our central hypothesis is that eIMPACT will improve endothelial dysfunction, which is considered a barometer of CVD risk, in depressed adults by decreasing autonomic dysfunction, systemic inflammation, and platelet activation. We will test our central hypothesis by carrying out these specific aims: (1) to determine whether eIMPACT reduces the excess CVD risk of depressed patients (primary outcome: endothelial dysfunction; exploratory outcome: incident CVD events) and (2) to examine candidate mechanisms underlying the effect of eIMPACT on CVD risk (secondary outcomes: markers of autonomic dysfunction, systemic inflammation, and platelet activation). A positive trial would generate the mechanistic rationale, efficacy evidence, and effect size estimates that are needed to justify and design a multisite, event-driven Phase 3 trial to confirm eIMPACT's efficacy in reducing CVD risk. Demonstrating that depression treatment reduces CVD risk, the primary expected outcome of this line of research, would have a substantial positive impact. It would identify a novel treatment target (depression) for CVD prevention efforts, and it would equip providers with a new disseminable and scalable tool (eIMPACT) to simultaneously treat depression and manage CVD risk of a large cohort of high-risk patients. Collectively, these changes to clinical practice should translate into reduced CVD morbidity, mortality, and costs.

 描述（由申请人提供）：心血管疾病（CVD）是美国男性和女性的头号杀手，其经济负担巨大且呈上升趋势，患有抑郁症的成年人发生CVD事件的风险较高，且CVD预后较差。过去的抑郁症治疗试验并未观察到预期的心血管益处，对这些无效结果的一个新的解释是，这些试验中的干预措施（所有涉及先前存在心血管疾病的患者）在心血管疾病的自然病程中开始得太晚。为了评估我们的假设，即在临床 CVD 发病前治疗抑郁症可以降低 CVD 风险，我们对一项阳性抑郁症试验进行了为期 8 年的随访研究，即 IMPACT 试验，没有基线 CVD 的干预患者的致命/非致命风险降低了 48%。心肌梗塞或中风的患者比平时护理的患者要多。 结果支持我们的假设，它们是事后和观察性的，CVD结果不是预先指定的终点，并且收集了最少的机械数据，为了满足当前对强有力的前瞻性试验的需求，我们提出了一项 2 期随机对照试验。 216 名患有抑郁症和 CVD 风险升高但没有临床 CVD 的初级保健患者（= 50 岁，60% 女性，40% 非裔美国人，5% 拉丁裔）将被随机分配到一年的治疗中。 eIMPACT 是 IMPACT 干预措施或常规护理的现代化版本，是一种协作性分步护理干预措施，涉及多学科团队提供符合患者偏好的循证抑郁症治疗方法，我们将通过结合计算机化认知行为治疗和实施来实现干预措施的现代化。我们的中心假设是，eIMPACT 将通过减少自主神经功能障碍、全身炎症和血小板活化来改善抑郁成人的内皮功能障碍，这被认为是 CVD 风险的晴雨表。将通过实现以下具体目标来检验我们的中心假设：(1) 确定 eIMPACT 是否降低抑郁症患者的过度 CVD 风险（主要结果：内皮功能障碍；探索性结果：CVD 事件事件）和 (2) 检查潜在的候选机制eIMPACT 对 CVD 风险的影响（次要结果：自主神经功能障碍、全身炎症和血小板激活的标志物）。积极的试验将产生证明和验证所需的机制原理、疗效证据和效应大小估计。设计一项多中心、事件驱动的 3 期试验来确认 eIMPACT 在降低 CVD 风险方面的功效，证明抑郁症治疗可以降低 CVD 风险，这是该研究的主要预期结果，它将产生重大的积极影响。 CVD 预防工作的目标（抑郁症），它将为提供者提供一种新的可传播和可扩展的工具（eIMPACT），以同时治疗抑郁症和管理一大群高风险患者的 CVD 风险。临床实践的改变应转化为心血管疾病发病率、死亡率和费用的降低。