Treatment of Depression After Coronary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D-17)
研究概览
简要总结
This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.
详细描述
Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.
Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months
- •Meets DSM-IV criteria for major or minor depressive episode
排除标准
- •Severe cognitive impairment
- •Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia)
- •Severely debilitating or life-threatening illness other than coronary disease
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D-17)
时间窗: 12 weeks post-randomization
The HAM-D-17 is an observer-rated measure of the severity of depression.
次要结局
- Beck Depression Inventory(12 weeks post-randomization)
- Beck Anxiety Inventory(12 weeks post-randomization)
- Beck Hopelessness Scale(12 weeks post-randomization)
- Perceived Stress Scale(12 weeks post-randomization)
- SF-36(12 weeks post-randomization)
研究者
Kenneth Freedland
Professor of Psychiatry
Washington University School of Medicine