STEPPED CARE FOR DEPRESSION IN HEART FAILURE

 描述（由申请人提供）：心力衰竭（HF）是一种预后不良的衰弱性疾病，影响近600万美国人。重度抑郁症和自我护理不足是HF中常见的相关行为问题，可降低生活质量并增加住院和死亡风险。先前的随机对照试验（RCT）表明，这两个问题都是难以治疗的。重度抑郁症的阶梯式护理是一种有前途的方法，但尚未在HF患者中进行过测试，而先前的HF自我护理试验尚未解决抑郁症，尽管它已被发现是自我护理的一个重要障碍。这项随机、单盲、平行组、对照临床试验的目的是测试HF患者中重度抑郁症的阶梯式护理干预，并确定在干预自我护理之前治疗抑郁症是否可以改善HF自我护理结局。患有HF和共病的重度抑郁症的门诊患者（n=180）将被随机分配到18周的阶梯式护理干预（SC）或常规护理（UC）治疗抑郁症。SC干预的第一步将是个体认知行为治疗（CBT）。如果对CBT的早期反应不充分（抑郁症改善<10%），则在第6周时使用抗抑郁药物加强治疗，如果到第12周时改善<50%，则在第12周时修改抗抑郁药物方案。抗抑郁药的选择将包括舍曲林、艾司西酞普兰、安非他酮和米氮平，选择将由临床评估指导。CBT治疗计划也将根据需要在第6周和第12周进行修改，并将包括一个治疗残余失眠的模块。如果在18周前达到缓解和复发预防标准，CBT会议的时间表将逐渐减少。两组中的所有受试者将在第18周至第24周之间接受个性化定制的、护士指导的HF自我护理干预。将进行随访评估直至第52周，以评价增益的维持情况，并在整个随访期间获得医疗记录，以记录住院和死亡情况。结局将包括抑郁缓解、HF自我护理改善和全因住院。其他结果将包括抑郁和焦虑的严重程度、HF相关生活质量、疲劳、睡眠质量和社会功能的变化。如果该RCT证明分级护理对HF患者的重度抑郁有效，并且在干预自我护理之前治疗抑郁可改善自我护理结果，这将有助于建立这种方法作为门诊心力衰竭患者的循证临床干预。这也将有助于为以住院或死亡为主要复合终点的III期多中心试验铺平道路。

 DESCRIPTION (provided by applicant): Heart failure (HF) is a debilitating disorder with a poor prognosis that affects nearly 6 million Americans. Major depression and inadequate self-care are common and interrelated behavioral problems in HF that diminish quality of life and increase the risks of hospitalization and death. Previous randomized controlled trials (RCTs) have shown that both of these problems are difficult to treat. Stepped care for major depression is a promising approach that has not been tested in patients with HF, and previous HF self-care trials have not addressed depression despite the fact that it has been found to be a significant barrier to self-care. The purpose of this randomized, single-blind, parallel groups, controlled clinical trial is to test a stepped care intervention for major depression in patients with HF and o determine whether HF self-care outcomes can be improved by treating depression before intervening in self-care. Outpatients with HF and comorbid major depression (n=180) will be randomly assigned to an 18-week stepped care intervention (SC) or to usual care (UC) for depression. The initial step in the SC intervention will be individual cognitive behavior therapy (CBT). The therapy will be augmented with an antidepressant medication at Week 6 if the early response to CBT is inadequate (<10% improvement in depression), and the antidepressant regimen will be modified at Week 12 if there has been <50% improvement by then. The antidepressant options will include sertraline, escitalopram, bupropion, and mirtazapine, and the choice will be guided by clinical evaluation. The CBT treatment plan will also be modified at Weeks 6 and 12 as needed, and will include a module for treatment of residual insomnia when indicated. The schedule of CBT sessions will be tapered if remission and relapse prevention criteria are met before 18 weeks. All participants in both arms will receive an individually tailored, nurse-directed HF self-care intervention between Weeks 18 and 24. Follow-up assessments will be conducted through Week 52 to evaluate maintenance of gains, and medical records will be obtained throughout the follow-up period to document hospitalizations and deaths. The outcomes will include remission of depression, improvement in HF self-care, and all-cause hospitalizations. Additional outcomes will include change in the severity of depression and anxiety, HF-related quality of life, fatigue, sleep quality, and social functioning.If this RCT demonstrates that stepped care is efficacious for major depression in patients with HF, and that treating depression before intervening in self-care improves self-care outcomes, it will help to establish this approach as an evidence- based clinical intervention for outpatients with heart failure. It will also help to pave the way for Phase III multicenter trial with a primary composite end point of hospitalization or death.