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），这是一种预后不良且严重影响生活质量的致残性医学疾病。心衰患者常见抑郁，它会加重功能损害和生活质量，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。对这些患者来说，安全有效的抗抑郁药物选择有限。我们建议进行一项随机、对照、单盲试验，对患有心衰的抑郁症门诊患者进行认知行为干预。具体目的是：1)验证认知行为疗法（CBT）在抑郁、心力衰竭自我护理和hf相关生活质量结局方面优于支持性临床管理（SCM）的假设；2)比较CBT与SCM在次要结局方面的差异，包括焦虑、总体健康相关生活质量、身体活动和步行测试表现、hf相关生物标志物、心脏住院和死亡；3)确定治疗结果的预测因子、调节因子和中介因子，包括社会人口学特征、非研究抗抑郁药物、抑郁严重程度、心力衰竭的严重程度和慢性性、医疗合并症、心衰专科护理的使用和心脏康复的参与。参与者将是240名年龄在30岁至30岁之间的NYHA I、II或III级心力衰竭患者，他们符合DSM-IV当前重度抑郁症或当前轻度抑郁症的标准，并有既往重度抑郁症病史。基线评估将评估抑郁、心衰自我护理和生活质量，以及病史、超声心动图显示的左心室功能、包括BNP和CRP在内的生物标志物、6分钟步行测试表现、活动记录仪显示的身体活动和焦虑。所有参与者将获得心衰教育材料和心衰教育联系人。参与者将被随机分配到有经验的治疗师的个人CBT或SCM。CBT将侧重于改善自我保健、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。干预将持续长达6个月，短暂的维持治疗接触将持续到随机分组后一年。如果病人不能参加门诊会议，会议将通过电话进行。同意的主要照顾者也将被邀请参加治疗师每月的会议。参与者将被要求返回进行为期6个月的评估，在此期间，除超声心动图外，所有基线测试都将重复进行。他们还将被要求在3、9和12个月时完成自我报告问卷。在12个月的随访期间，将跟踪住院情况，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心衰自我护理方面是有效的，它将为心衰合并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55万新病例。心衰是一种进行性疾病，病程下行相对较快，对机体功能、生活质量、医疗保健利用、生存等方面都有深刻的负面影响，伴抑郁加重。这项临床试验将测试认知行为治疗抑郁症的疗效，重点是提高自我保健，以改善功能和生活质量。治疗对身体活动和再住院等其他结果的影响也将被调查。

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.