Treatment of Functional Impairment in Heart Failure Patients with Depression

描述(申请人提供)：超过500万美国人患有心力衰竭(HF)，这是一种预后不佳、严重影响生活质量的致残性内科疾病。抑郁症在心力衰竭患者中很常见，它会恶化功能障碍和生活质量，并降低存活率。抑郁症的治疗可能会改善这些结果，但很少有治疗研究。对于这些患者来说，安全有效的抗抑郁药选择有限。我们建议对心力衰竭患者进行一项随机、对照、单盲的认知行为干预试验。具体目的是：1)检验认知行为疗法(CBT)在抑郁症、心力衰竭自我护理和心力衰竭相关生活质量方面优于支持性临床治疗(SCM)的假设；2)比较认知行为疗法和SCM在二次结局方面的差异，包括焦虑、一般健康相关生活质量、体力活动和步行测试成绩、心力衰竭相关生物标志物以及心脏住院和死亡；3)确定治疗结果的预测因素、调节因素和中介因素，包括社会人口学特征、非研究性抗抑郁药物、抑郁的严重程度、心力衰竭的严重程度和慢性化、医疗合并症、心力衰竭专科护理的使用以及参与心脏康复。参与者将是240名30岁的成年NYHA心力衰竭患者，他们符合DSM-IV诊断当前重度抑郁症或既往有重度抑郁症病史的轻度抑郁症的标准。基线评估将评估抑郁、心力衰竭自我护理和生活质量，以及病史、通过超声心动图、包括脑钠素和C反应蛋白在内的生物标记物、6分钟步行测试表现、通过运动描记进行的体力活动和焦虑。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别CBT或SCM，并由经验丰富的治疗师进行治疗。CBT将专注于改善自我照顾、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，短暂的维持治疗接触将持续到随机分组后的一年。如果患者不能参加临床会议，会议将通过电话进行。同意的主要照顾者也将被邀请参加每月与治疗师的会议。参与者将被要求回来进行为期6个月的评估，届时将重复除超声心动图外的所有基线测试。他们还将被要求在3个月、9个月和12个月时完成自我报告问卷。在12个月的随访中，住院情况将被跟踪，死亡率将在整个试验过程中被跟踪。如果干预能有效地减少抑郁情绪，提高心力衰竭患者的自理能力，将为心力衰竭合并抑郁症患者的护理提供重要的补充。与公共健康相关：超过500万美国人患有心力衰竭，每年诊断出55万新病例。心力衰竭作为一种进展性疾病，下降速度较快，对功能、生活质量、医疗保健利用和生存都有深刻的负面影响，当伴有抑郁时，所有这些都会恶化。这项临床试验将测试认知行为疗法对抑郁症的疗效，重点是改善自我护理，以改善功能和生活质量。还将调查治疗对其他结果的影响，如体力活动和再次住院。

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.