Treatment of Depression After Coronary Bypass Surgery

描述(改编自研究人员摘要)：抑郁症是一种常见的 冠状动脉旁路移植术(CABG)后持续存在的问题 使康复复杂化，增加心脏事件的风险，并可能加剧 冠脉搭桥术后患者常出现的神经认知缺陷。 尽管冠脉搭桥术是美国最常见的手术之一 在美国，还没有任何关于治疗的随机对照试验 这一人群中的抑郁症。本研究的目的是(1)比较 认知行为疗法(CBT)、压力管理(SM)和常规疗法的疗效 CABG术后重度抑郁症的护理(UC)；(2)确定 CBT对神经认知功能、心理社会适应的影响 功能状况、就业状况和与健康相关的生活质量；以及 (3)收集试点数据，了解治疗与治疗之间的关系 抑郁与12个月心脑血管事件发生率 冠状动脉旁路移植术后。同意的患者将接受4至6岁的抑郁症筛查 手术后几周。那些筛查呈阳性的人将返回接受 大约一周后进行心理诊断评估和额外的测试。 符合所有其他条件的165名重度抑郁症患者的样本 标准将随机到CBT、SM或UC的12周，不受限制 关于非研究的抗抑郁药。将对所有3个分支的参与者进行监控 恶化的抑郁症，并将被转介到额外的护理，如果需要。 抑郁结果将在随机化后12周和6个月进行评估 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在接受治疗的患者中较低 与SM或UC相比，CBT患者具有基线抑郁严重程度和非研究 作为计划协变量的治疗。二次分析将测试 治疗缓解、神经认知和功能恢复、质量 生命，并检查治疗过程和结果之间的关系 变量。

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.