Psychotherapy and Cardiovascular Risk Factors in Depression
The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Marburg、德国、35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Exclusion Criteria:
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
- infections during the last 2 weeks
- injuries during the last 2 weeks
- neurological disorders
- diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
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无干预：Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in depressive symptoms (BDI-II)
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in heart rate variability
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in blood pressure
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in baroreceptor sensitivity (ms/mmHg)
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in peripheral vascular resistance (dyne*s/cm5)
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in C-reactive protein
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in proinflammatory cytokines
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in anti-inflammatory interleukin-10
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in Subjective social status (MacArthur scale)
大体时间：Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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合作者和调查者
调查人员
- 首席研究员：Frank Euteneuer, PhD、Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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