TREATMENT OF FUNCTIONAL IMPAIRMENT IN PATIENTS WITH HEART FAILURE AND COMORBID DE

描述（由申请人提供）：超过500万美国人患有心力衰竭（HF），这是一种预后不良并对生活质量产生深远影响的致残性医学疾病。抑郁症在HF患者中很常见，它损害功能损害和生活质量，并降低生存率。抑郁症的治疗可能会改善这些结果，但很少有治疗研究。这些患者安全有效的抗抑郁药选择有限。我们建议进行一项随机、对照、单盲试验，对患有心力衰竭的抑郁症门诊患者进行认知行为干预。具体目标是：1）检验认知行为疗法（CBT）在抑郁、心力衰竭自我护理和HF相关生活质量结局方面上级支持性临床管理（SCM）的假设; 2）比较CBT与SCM在次要结局方面的差异，包括焦虑、一般健康相关生活质量、体力活动和步行测试表现、HF相关生物标志物以及心脏病住院和死亡;和3）确定治疗结果的预测因子、调节因子和介导因子，包括社会人口学特征、非研究抗抑郁药、抑郁的严重程度、心力衰竭的严重程度和慢性程度、医学合并症、HF专科护理的使用和心脏康复的参与。参与者将是240名年龄>30岁的NYHA I级、II级或III级心力衰竭的成年人，他们符合DSM-IV标准，用于当前的重度抑郁症或当前的轻度抑郁症，具有重度抑郁症的既往病史。基线评价将评估抑郁、HF自我护理和生活质量，以及病史、通过超声心动图的左心室功能、生物标志物（包括BNP和CRP）、6分钟步行试验表现、通过活动记录仪的体力活动和焦虑。所有参与者都将收到心脏护士提供的HF教育材料和HF教育联系人。参与者将被随机分配到个人CBT或SCM与经验丰富的治疗师。CBT将专注于改善自我护理，功能和情绪的认知和行为策略。SCM将为抑郁症和应对疾病提供支持性关注。干预将持续6个月，短暂的维持治疗联系将持续到随机化后1年。如果患者无法参加临床会议，将通过电话进行会议。还将邀请初级照顾者参加与治疗师的每月会议。将要求受试者返回进行6个月评价，届时将重复除超声心动图外的所有基线检查。他们还将被要求在3、9和12个月时完成自我报告问卷。将在12个月随访期间跟踪住院情况，并在整个试验期间跟踪死亡率。如果干预在减少抑郁和改善HF自我护理方面有效，则它将为HF和共病抑郁患者的护理提供重要的补充。公共卫生相关性：超过500万美国人患有心力衰竭，每年诊断出550，000例新病例。作为一种相对快速下降的进行性疾病，心力衰竭对功能、生活质量、卫生保健利用和生存具有深刻的负面影响，当伴有抑郁症时，所有这些都会恶化。这项临床试验将测试抑郁症的认知行为治疗的疗效，重点是改善自我护理，以改善功能和生活质量。还将研究治疗对其他结局的影响，如体力活动和再住院。

DESCRIPTION (provided by applicant): Over 5 million Americans have heart failure (HF), a disabling medical illness with a poor prognosis and profound effects on quality of life. Depression is common in patients with HF, and it worsens functional impairment and quality of life, and decreases survival. Treatment of depression might improve these outcomes, yet there have been very few treatment studies. Safe and effective antidepressant options are limited for these patients. We propose to conduct a randomized, controlled, single-blind trial of a cognitive behavioral intervention for depressed outpatients with HF. The specific aims are: 1) To test the hypothesis that cognitive behavior therapy (CBT) is superior to supportive clinical management (SCM) with respect to depression, heart failure self-care, and HF-related quality of life outcomes; 2) to compare CBT to SCM on secondary outcomes including anxiety, general health-related quality of life, physical activity and walk test performance, HF-related biomarkers, and cardiac hospitalizations and deaths; and 3) To identify predictors, moderators, and mediators of treatment outcomes, including sociodemographic characteristics, non-study antidepressants, severity of depression, severity and chronicity of heart failure, medical comorbidity, use of HF specialty care, and participation in cardiac rehabilitation. The participants will be 240 adults age >30 years in NYHA Class I, II, or III heart failure who meet the DSM-IV criteria for current major depression or for current minor depression with a past history of major depression. The baseline evaluation will assess depression, HF self-care, and quality of life, as well as medical history, left ventricular function via echocardiography, biomarkers including BNP and CRP, 6-minute walk test performance, physical activity via actigraphy, and anxiety. All participants will receive HF education materials and HF education contacts by a cardiac nurse. Participants will be randomly assigned to individual CBT or SCM with an experienced therapist. CBT will focus on cognitive and behavioral strategies for improving self-care, functioning, and mood. SCM will provide supportive attention to depression and coping with illness. The intervention will last up to 6 months, and brief maintenance therapy contacts will continue until one year after randomization. Sessions will be conducted by telephone if the patient is unable to participate in clinic sessions. Consenting primary caregivers will also be invited to participate in monthly sessions with the therapist. Participants will be asked to return for a 6-month evaluation at which time all of the baseline tests except for echocardiography will be repeated. They will also be asked to complete the self-report questionnaire battery at 3, 9, and 12 months. Hospitalizations will be tracked during the 12-month follow-up, and mortality will be tracked throughout the trial. If the intervention is efficacious in reducing depression and improving HF self- care, it will offer an important addition to the care of patients with HF and comorbid depression. PUBLIC HEALTH RELEVANCE: Over 5 million Americans suffer from heart failure and 550,000 new cases are diagnosed annually. As a progressive disease with a relatively rapid downward course, heart failure has profoundly negative effects on functioning, quality of life, health care utilization, and survival, all of which are worsened when it is accompanied by depression. This clinical trial will test the efficacy of cognitive-behavioral treatment of depression with an emphasis on improving self-care, in order to improve functioning and quality of life. The effects of treatment on other outcomes such as physical activity and rehospitalizations will also be investigated.