A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 570
- 试验地点
- 20
- 主要终点
- Changes from baseline to 18 months in depressive symptoms (HADS-D)
研究概览
简要总结
In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease
- •German speaking men and women
- •Recent coronary angiogram (<= 3 months old)
- •Depression score (HADS-D) >= 8
- •Written informed consent
排除标准
- •Severe heart failure
- •Other acutely life- threatening conditions
- •Severe chronic inflammatory disease
- •Current suicidal tendency
- •Severe depressive episode
- •Other severe mental illness.
结局指标
主要结局
Changes from baseline to 18 months in depressive symptoms (HADS-D)
时间窗: 18 months
次要结局
- coagulation(18 months)
- heart rate variability(18 months)
- cardiac events(18 months)
- Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)(18 months)
- Health-related quality of life (SF36, EuroQuol-5D)(18 months)
- cardiovascular risk profile(18 months)
- neuroendocrine and immunological activation(18 months)
- health care utilisation and costs(18 months)
研究者
Christoph Herrmann-Lingen
Professor Dr.
University of Göttingen
