Web-based Psychological Intervention to Coronary Artery Heart Disease Patients
2014年8月11日 更新者:National Taiwan University Hospital
Development and Evaluation of a Web-based Group Cognitive-behavioral Therapy Program for Coronary Artery Heart Disease Patients
The purpose of this study is to evaluate medical cost-effectiveness, reduce the psychological risk factors( including hostility, anxiety, depression, and perceived stress) in coronary artery disease (CAD) patients and enhance the regulation of the autonomic nervous system (including respiration rate, heart rate, distal blood vessel pulse, and finger temperament) through web-based cognitive -behavioral group therapy.
研究概览
详细说明
Cognitive-behavioral therapy (CBT) is effective in reducing the level of anger, hostility and depression present in coronary artery disease (CAD) patients.In Taiwan, Weng et al. also confirmed the eight-week group CBT program not only diminished the emotion disturbances including anger, hostility and depression of CAD, but also significantly prolonged the coagulation time, thus reducing the rate of thrombosis formation.
Even though the therapeutic effect of the CBT program was valid, this program is still not accessible for some patients in need because they are not aware of it, or they are restricted by time and transportation.
Internet-based therapeutic intervention can overcome the obstacles to access this program at any time and in any place.
Presently, structured CBT intervention is provided through the Internet and used widely by patients with physical or psychological problems such as smoking, obesity, or headaches, but not by CAD patients.
Therefore, the purpose of this research is to evaluate the effects to reduce the psychological risk factors of a web-based group CBT program in CAD patients.
Follow-up assessments will be performed after 3 and 6-month durations.
The investigators expect that, after an eight-week group intervention, there will be significant decrease of the psychological risk factors.
Moreover, the therapeutic effects can be maintained during the three- and six-month follow-up.evaluate
In addition, web-based cognitive -behavioral group therapy will significantly reduce indirect medical costs (travel time and money).
研究类型
介入性
注册 (预期的)
30
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
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Taipei、台湾、100
- National Taiwan University Hospital
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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
30年 至 70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:
- coronary artery disease
- regular medication
exclusion:
1.Psychiatric diseases
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:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:CAD-CBT group therapy
CAD receive web-based CBT group therapy
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其他:CAD-CBT group therapy waiting list
CAD waiting list will receive web-based CBT group therapy later
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Significant decrease of the psychological risk factors in web-based group CBT intervention group after an eight-week group intervention
大体时间:Time point(s) at post-group intervention, 3 months, and 6 months follow up
|
Evaluate the effects to reduce the psychological risk factors and enhance the regulation of automatic nerve system: Time point:Post-intervention, 3 months, and 6 months follow up Subjective (self report inventories), including hostility, anxiety,and perceived stress. Objective (Biofeedback devices):including blood vessel pulse, EKG, skin conductance, ect. |
Time point(s) at post-group intervention, 3 months, and 6 months follow up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Significantly reduce health care costs
大体时间:intervention
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Evaluate indirect medical cost-effectiveness (travel time and money) during web-based Psychological Interventions
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intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Psychosocial risk factor and characteristic cardiovascular responses present present in CAD patients on pre-group intervention
大体时间:Pre- group intervention
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Time point:Pre-group intervention Subjective (self report inventories), including hostility, anxiety,and perceived stress. Objective (Biofeedback devices):including blood vessel pulse, EKG, skin conductance, ect. |
Pre- group intervention
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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:Bee-Horng Lue、National Taiwna University Hospital
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
2013年12月1日
初级完成 (预期的)
2014年12月1日
研究完成 (预期的)
2014年12月1日
研究注册日期
首次提交
2013年10月18日
首先提交符合 QC 标准的
2013年11月24日
首次发布 (估计)
2013年12月2日
研究记录更新
最后更新发布 (估计)
2014年8月13日
上次提交的符合 QC 标准的更新
2014年8月11日
最后验证
2014年8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.
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