STEPPED CARE FOR DEPRESSION IN HEART FAILURE

心力衰竭抑郁症的分级护理

• 批准号: 9922786
• 负责人: KENNETH E FREEDLAND
• 金额: $ 69.47万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-03 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922786
• 关键词: Affect; Aftercare; Aging; American; Antidepressive Agents; Anxiety; Beck depression inventory; Behavioral; Bupropion; Caring; Cessation of life; Citalopram; Clinical; Clinical Treatment; Cognitive; Cognitive Therapy; Controlled Clinical Trials; Diagnosis; Disease; Disease remission; Escitalopram; Fatigue; Goals; Heart failure; Hospitalization; Hospitals; Individual; Intervention; Life; Maintenance; Major Depressive Disorder; Measures; Medical; Medical Records; Mental Depression; Mirtazapine; Multicenter Trials; Nurses; Outcome; Outpatients; Participant; Patient Care; Patients; Pharmaceutical Preparations; Phase; Population; Prevalence; Problem behavior; Quality of life; Randomized; Randomized Controlled Trials; Regimen; Research; Residual state; Risk; Schedule; Selective Serotonin Reuptake Inhibitor; Self Care; Self Care outcome; Sertraline; Severities; Single-Blind Study; Sleep; Sleeplessness; Social Functioning; Testing; Therapy trial; arm; clinically significant; comorbidity; cost; depressed patient; design; disorder later incidence prevention; efficacy testing; evidence base; experience; follow up assessment; follow-up; functional disability; health related quality of life; hospital readmission; improved; mortality; news; outcome forecast; programs; psychosocial; public health relevance; research clinical testing; response; secondary outcome; sleep quality; treatment as usual; treatment guidelines; treatment planning; usual care arm

 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.

 描述（由申请人提供）：心力衰竭 (HF) 是一种使人衰弱的疾病，预后不良，影响着近 600 万美国人。重度抑郁和自我护理不足是心衰患者常见且相互关联的行为问题，会降低生活质量并增加住院和死亡的风险。之前的随机对照试验（RCT）表明，这两个问题都很难治疗。重度抑郁症的阶梯式护理是一种很有前景的方法，但尚未在心力衰竭患者中进行过测试，并且之前的心力衰竭自我护理试验并未解决抑郁症问题，尽管事实证明抑郁症是自我护理的重大障碍。这项随机、单盲、平行组对照临床试验的目的是测试对心力衰竭患者重度抑郁症的阶梯式护理干预措施，并确定在干预自我护理之前是否可以通过治疗抑郁症来改善心力衰竭自我护理结果。患有心力衰竭并伴有重度抑郁症的门诊患者 (n=180) 将被随机分配接受为期 18 周的阶梯式护理干预 (SC) 或抑郁症常规护理 (UC)。 SC 干预的第一步是个体认知行为治疗 (CBT)。如果 CBT 的早期反应不充分（抑郁症改善 <10%），则在第 6 周时将使用抗抑郁药物加强治疗；如果届时改善情况 <50%，则将在第 12 周修改抗抑郁药物治疗方案。抗抑郁药物的选择将包括舍曲林、艾司西酞普兰、安非他酮和米氮平，并且选择将以临床评估为指导。 CBT 治疗计划也将根据需要在第 6 周和第 12 周进行修改，并将包括一个用于治疗残余失眠的模块（如有需要）。如果在 18 周之前达到缓解和复发预防标准，CBT 疗程的安排将逐渐减少。双臂的所有参与者都将在第 18 周至第 24 周期间接受单独定制的、由护士指导的心力衰竭自我护理干预措施。后续评估将持续到第 52 周，以评估收益的维持情况，并在整个后续期间获取医疗记录以记录住院和死亡情况。结果将包括抑郁症的缓解、心力衰竭自我护理的改善以及全因住院治疗。其他结果将包括抑郁和焦虑的严重程度、心力衰竭相关的生活质量、疲劳、睡眠质量和社会功能的变化。如果这项随机对照试验证明阶梯式护理对心力衰竭患者的重度抑郁症有效，并且在干预自我护理之前治疗抑郁症可以改善自我护理结果，那么将有助于将该方法确立为针对心力衰竭门诊患者的循证临床干预措施。它还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。