Brief Cognitive Behavioral Therapy for Patients Undergoing Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 主要终点
- Change from Baseline Score on Beck Depression Inventory II (BDI-II)
研究概览
简要总结
Adult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive behavioral therapy for depression/anxiety or treatment as usual.
详细描述
Depression and anxiety are common symptoms in patients undergoing cardiac surgery and associated with increased cardiac morbidity and decreased functional status. Cognitive behavioral therapy (CBT) has been shown to be an effective intervention to treat these symptoms after cardiac surgery, but has not yet been studied in patients undergoing less invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing TAVR.
The CBT protocol was loosely structured on the Managing Depression and Anxiety using Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current intervention was designed to address the needs of individuals who may develop anxiety or depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside treatment sessions with a trained clinician while the participant was hospitalized for TAVR.
Main outcome measures were self-reported symptoms of depression and anxiety as measured by the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary outcomes included health related quality of life and hospital length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age and older
- •Voluntary participation
- •Informed consent obtained
- •Patients with severe aortic stenosis and high surgical risk who are undergoing TAVR
排除标准
- •Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder, active alcoholism or substance abuse)
- •Severe cognitive impairment, i.e. dementia
- •Life threatening co-morbidities
- •Inability to provide consent
研究组 & 干预措施
Brief Bedside CBT
干预措施: Brief Bedside CBT (Behavioral)
Treatment As Usual
结局指标
主要结局
Change from Baseline Score on Beck Depression Inventory II (BDI-II)
时间窗: An average of 3 days post TAVR Procedure, 1-Month Follow Up
21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II.
次要结局
- Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ)(1-Month Follow Up)
- Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)(1-Month Follow Up)
- Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI)(An average of 3 days post TAVR Procedure, 1-Month Follow Up)
研究者
William Fearon
Professor of Medicine
Stanford University