Health Enhancement And Resilience Training (HEART)
2021年1月22日 更新者：University of California, San Francisco
The Effect of a Stress Reduction Program Using Mindfulness Techniques on Markers of Cellular Stress and Aging
The purpose of this research study is to examine whether a stress reduction intervention can improve health, mood and biological markers of cellular stress and aging in a group of chronically-stressed maternal caregivers and healthy maternal controls.
研究概览
详细说明
This stress-reduction intervention was added into an ongoing observational study in May of 2013. The parent study is a prospective cohort study of the effects of chronic stress in a group of maternal caregivers with children on the autism spectrum and healthy controls whose children have no diagnosis. Study participants are being invited to enroll in a 12-week stress reduction course based on the principles of mindfulness. They will attend four six-hour workshops and participate in 12 weekly hour-long web video conferencing calls to reinforce what is taught in the workshops.
At the beginning and the end of the intervention, they complete self-report measures of psychological well-being and give saliva samples. Since the women are also participating in the longitudinal study, we have other before and after data for them. These include psycho-social measures, body measurements, psycho-physiology measurements, cognitive tests, actigraphy (for sleep), as well as saliva (for hormones), hair (for hormones) and blood (for telomeres, telomerase, gene expression, circulating hormones, inflammation and oxidative stress).
研究类型
介入性
注册 (实际的)
70
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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California
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San Francisco、California、美国、94118
- University of California, San Francisco
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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
20年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Must have at least one child between 2 and 16 at time of enrollment
- Caregivers must have a child diagnosed in that age range diagnosed with an autism spectrum disorder.
- Controls must have a healthy child in that age range. All women must be
Exclusion Criteria:
- Chronic disease, including recent history of cancer
- History of psychiatric disorder, such as bipolar disorder or post-traumatic stress disorder
- Medications, including statins, anti-anxiety drugs, and for controls only anti-depressants.
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：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Stress-reduction class
Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness.
They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops.
We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment.
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Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness.
They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops.
We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment.
Both groups received similar instruction.
其他名称：
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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 |
|---|---|---|
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Salivary telomere length
大体时间：Change from beginning to end of 12-week intervention
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Participants will give saliva samples at the beginning and the end of the intervention.
Salivary telomere length will be analyzed at both time points.
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Change from beginning to end of 12-week intervention
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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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Psychological Well-Being
大体时间：Change from beginning to end of 12-week intervention
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We will collect perceived stress, acceptance and awareness of emotions and rumination at the beginning and at the end of the intervention.
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Change from beginning to end of 12-week intervention
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Telomere length from blood cells
大体时间：Change over six months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will measure telomere length pre- and post-intervention in a variety of blood cell types.
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Change over six months pre- and post-intervention
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Telomerase
大体时间：Change over 6 months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will measure telomerase pre- and post-intervention in a variety of blood cell types.
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Change over 6 months pre- and post-intervention
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Cognitive functioning
大体时间：Change over six months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will complete a battery of cognitive tasks at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will be able to assess performance pre- and post-intervention, to see if it improves after the stress-reduction training.
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Change over six months pre- and post-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：Elissa S Epel, PhD、University of California, San Francisco
- 首席研究员：Elizabeth Blackburn, PhD、University of California, San Francisco
- 首席研究员：Jue Lin, PhD、University of California, San Francisco
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 (实际的)
2013年5月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2015年11月1日
研究注册日期
首次提交
2013年7月10日
首先提交符合 QC 标准的
2013年10月7日
首次发布 (估计)
2013年10月9日
研究记录更新
最后更新发布 (实际的)
2021年1月26日
上次提交的符合 QC 标准的更新
2021年1月22日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 10-02063
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.
Stress-reduction class的临床试验
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Brain & Behavior Research... 和其他合作者招聘中
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World BankAddis Ababa University; Ethiopian Medical Association; Policy Studies Institute招聘中
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University Hospital, Clermont-Ferrand完全的
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University of California, San FranciscoUnited States Department of Defense; San Francisco Veterans Affairs Medical Center完全的