Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
2019年3月18日 更新者：University of Illinois at Urbana-Champaign
The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor.
The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies.
This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.
研究概览
详细说明
The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition.
The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein.
Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.
研究类型
介入性
注册 (预期的)
126
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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Illinois
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Chicago、Illinois、美国、60608
- 招聘中
- St. Pius V Parish
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接触：
- Jose M Santiago
- 电话号码：312-226-6161
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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 及以上 (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:
- Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
- aged ≥18
- fluent in English or Spanish with ≥8th grade education
- elevated 24-hour ambulatory blood pressure levels (systolic BP> 140 mmHg and >90 mmHg for diastolic BP).
Exclusion Criteria:
- Unavailable for study period; have cognitive impairment denoting dementia
- have severely reduced life expectancy
- are currently enrolled in psychotherapy or take prescribed antidepressants
- history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse
- have severe depression.
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：Positive Psychological Intervention
Our culturally-tailored Positive Psychology (PP) Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
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Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
其他名称：
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无干预：Wait list control
Receipt after the active treatment group has completed the positive psychological intervention.
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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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Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
大体时间：Baseline, 8-, and 12-weeks
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The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode.
Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device.
The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity.
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Baseline, 8-, and 12-weeks
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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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Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks
大体时间：Baseline, 8-, and 12-weeks
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Center for Epidemiological Studies Depression-Scale
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Baseline, 8-, and 12-weeks
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Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks
大体时间：Baseline, 8-, and 12-weeks
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Life Orientation Test-Revised
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Baseline, 8-, and 12-weeks
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General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks
大体时间：Baseline, 8-, and 12-weeks
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General Well-being Schedule
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Baseline, 8-, and 12-weeks
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Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks
大体时间：Baseline, 8-, and 12-weeks
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Life Engagement Test
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Baseline, 8-, and 12-weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical Activity: Change in Hypertension-related Health Behavior(s)
大体时间：Baseline, 8-, and 12-weeks
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Physical Activity using Fitbit One
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Baseline, 8-, and 12-weeks
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Diet: Change in Hypertension-related Health Behavior(s)
大体时间：Baseline, 8-, and 12-weeks
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Diet using Scored Sodium Questionnaire
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Baseline, 8-, and 12-weeks
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Change in Heart Rate Variability
大体时间：Baseline, 8-, and 12-weeks
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Beat-to-beat interval
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Baseline, 8-, and 12-weeks
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Change in High-sensitivity C-Reactive Protein
大体时间：Baseline, 8-, and 12-weeks
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mg/L
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Baseline, 8-, and 12-weeks
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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。
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)
2017年10月1日
初级完成 (预期的)
2020年9月1日
研究完成 (预期的)
2021年7月1日
研究注册日期
首次提交
2017年6月14日
首先提交符合 QC 标准的
2017年7月13日
首次发布 (实际的)
2017年7月18日
研究记录更新
最后更新发布 (实际的)
2019年3月20日
上次提交的符合 QC 标准的更新
2019年3月18日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
We will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed.
If additional outputs result from this research that would be appropriate to share with a wider audience, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Positive Psychological Intervention的临床试验
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Ege Miray Topcu完全的
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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Hospital Universitario GetafeKarolinska Institutet; Medical University of Lodz; Universidad Politecnica de Madrid; KTH Royal... 和其他合作者未知