Psychodynamic Motivation and Training Program (PMT)
2016年2月25日 更新者:Matthias Michal、Johannes Gutenberg University Mainz
Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease
The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.
研究概览
地位
完全的
详细说明
Nonpharmacological secondary prevention of coronary heart disease is considered to be a safe and effective measure for reducing mortality substantially.
Major targets are the improvement of physical activity and dietary habits, smoking cessation and stress reduction.
Despite the effectiveness of life style changes, the compliance rate of patients is very low.
To improve compliance with life style change programs psychotherapeutic interventions appear to have significant potential.
Against this background our study aims to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) in addition to one session of advice in exercise training based on the results of spiroergometry (+EX) and usual cardiological care (TAU).
PMT will be compared with +Ex and TAU.
N = 90 patients with stable coronary artery disease class, low physical activity, class I to III angina pectoris will be randomly assigned to the three treatment conditions.
The Primary efficacy endpoint is change in the anaerobic threshold from baseline to 6 month follow-up.
The results of the study will 1) help to determine the effectiveness of a psychodynamic life style change programs for the secondary prevention of cardiovascular disease and 2) will help to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Mainz、德国、55131
- University Medical Center Mainz
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stable coronary heart disease with CCS functional classification of angina class I-III
- Low self rated physical activity
- Condition after percutaneous coronary intervention > 4 weeks until < 26 weeks or > 52 weeks after index percutaneous coronary intervention
- Residence < 50 km radius of Mainz
- If treatment with betablockers or ivabradine then stable > 4 weeks
Exclusion Criteria:
- Acute coronary sydnrome or myocardial infarction < 8 weeks
- Coronary stenosis of the dominant vessel > 25% or high grade stenosis of the left coronary artery
- Heart failure with left ventricular ejection fraction < 40%
- NYHA III-IV
- Severe heart valve disorder
- Insulin dependent diabetes
- Orthopedic disorders or other disorders, which preclude regular physical activity
- Coronary artery bypass surgery < 6 months before index PCI
- Severe obesity (BMI ≥ 40)
- Need for systemic immunosuppression with cortisone or methotrexate
- Kidney failure with need for dialysis
- Intake of nitrates < 12 hours
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Psychodynamic Motivation and Training Program (PMT)
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The Psychodynamic Motivation and Training Program (PMT) is a psychodynamic stepped care approach.
Depending on the individual needs PMT consists of 3 to 8 sessions of individual psychodynamic psychotherapy.
If appropriate session 4 - 8 may be conducted by a nurse.
PMT targets the mental and external barriers to improve physical activity by focusing on affects, interpersonal relations and maladaptive self- and other representations.
PMT will be offered in addition to +Ex.
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有源比较器:Advice in Exercise Training
One session of advice in exercise training based on the results of spiroergometry
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Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.
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其他:Treatment as usual (TAU)
Usual care by family doctor and cardiologist
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Usual care by family doctor, cardiologist
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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 |
|---|---|
|
Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
大体时间:6 months
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in quality of life according to the EQ-5D
大体时间:6 months
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6 months
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Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire
大体时间:6 Months
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6 Months
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Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire
大体时间:6 months
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6 months
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Change in endothelial function according to the flow mediated dilatation
大体时间:6 months
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6 months
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Change in high density lipoprotein levels
大体时间:6 months
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6 months
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Change in biomarkers of inflammation and oxidative burst
大体时间:6 months
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6 months
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Change in fatigue according to the Maastricht Questionnaire
大体时间:6 months
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6 months
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Change in illness perception
大体时间:6 months
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(Illness perception as measured with the Brief Illness Perception Questionnaire)
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6 months
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Change in maximal aerobic capacity (VO2 max)
大体时间:6 months
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6 months
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Change in body mass index
大体时间:6 months
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(BMI kg/m²)
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Matthias Michal, PD Dr. med.、University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2015年2月1日
研究注册日期
首次提交
2011年9月30日
首先提交符合 QC 标准的
2011年9月30日
首次发布 (估计)
2011年10月4日
研究记录更新
最后更新发布 (估计)
2016年2月26日
上次提交的符合 QC 标准的更新
2016年2月25日
最后验证
2016年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.