Treatment of Depression After Coronary Bypass Surgery

冠状动脉搭桥手术后抑郁症的治疗

• 批准号: 6539029
• 负责人: KENNETH E FREEDLAND
• 金额: $ 61.43万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-29 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6539029
• 关键词: clinical trials; cognitive behavior therapy; coronary bypass; human subject; human therapy evaluation; major depression; outcomes research; patient oriented research; postoperative state; quality of life; stress management

DESCRIPTION (Adapted from investigator's abstract): Depression is a common and persistent problem after coronary artery bypass graft (CABG) surgery that complicates recovery, increases the risk of cardiac events, and may exacerbate the neurocognitive deficits that are often observed in post-CABG patients. Although CABG is one of the most frequently performed operations in the United States, there have not been any randomized, controlled trials of treatments for depression in this population. The aims of this study are (1) to compare the efficacy of cognitive behavior therapy (CBT), stress management (SM), and usual care (UC) for major depression following CABG surgery; (2) to determine the effects of CBT on neurocognitive performance, psychosocial adjustment, functional status, employment status, and health-related quality of life; and (3) to collect pilot data on the relationship between the treatment of depression and the 12-month incidence of cardiac and cerebrovascular events following CABG. Consenting patients will be screened for depression 4 to 6 weeks after surgery. Those who screen positive will return for a psycho-diagnostic evaluation and additional testing approximately 1 week later. A sample of 165 patients with major depression who meet all other eligibility criteria will be randomized to 12 weeks of CBT, SM, or UC with no restriction on non-study antidepressants. Participants in all 3 arms will be monitored for worsening depression and will be referred for additional care if needed. Depression outcomes will be assessed 12 weeks post-randomization and 6 months after surgery (2 months after termination of CBT or SM.) The primary hypothesis is that the post-treatment severity of depression is lower in patients treated with CBT than with SM or UC, with baseline depression severity and non-study treatment as planned covariates. Secondary analyses will test the effects of treatment on remission, neurocognitive and functional recovery, quality of life, and examine the relationships between treatment process and outcome variables.

描述（改编自研究者摘要）：抑郁症是一种常见且 冠状动脉旁路移植术（CABG）后的持续问题， 使恢复复杂化，增加心脏事件的风险，并可能加剧 在CABG术后患者中经常观察到的神经认知缺陷。 尽管冠状动脉旁路移植术是美国最常见的手术之一， 在美国，还没有任何随机对照试验的治疗， 抑郁症在这个人群中。本研究的目的是（1）比较 认知行为疗法（CBT）、压力管理（SM）和常规治疗的疗效 CABG术后抑郁症的护理（UC）;（2）确定 CBT对神经认知表现，心理社会适应， 功能状况、就业状况和健康相关的生活质量;以及 (3)收集试验数据， 抑郁症与12个月心脑血管事件发生率 CABG后。接受治疗的患者将接受抑郁症筛查4至6 手术后几周。那些筛查呈阳性的人将返回 大约1周后进行心理诊断评估和额外测试。 165例符合所有其他条件的重性抑郁症患者的样本 将根据标准随机分配至12周CBT、SM或UC，无限制 服用非研究用抗抑郁药将对所有3组的受试者进行监测， 抑郁症恶化，如果需要，将被转诊接受额外护理。 将在随机化后12周和6个月评估抑郁结局 手术后（CBT或SM终止后2个月）主要假设 治疗后抑郁症的严重程度较低， 与SM或UC相比，CBT组的基线抑郁严重程度和非研究 治疗作为计划协变量。次要分析将检验以下因素的影响： 缓解期治疗，神经认知和功能恢复， 生活，并检查治疗过程和结果之间的关系 变量