Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Positive Psychological Intervention (Behavioral)
Wait list control
Receipt after the active treatment group has completed the positive psychological intervention.
结局指标
主要结局
Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
时间窗: Baseline, 8-, and 12-weeks
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.
次要结局
- Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks(Baseline, 8-, and 12-weeks)
- Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks(Baseline, 8-, and 12-weeks)
- Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks(Baseline, 8-, and 12-weeks)
- General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks(Baseline, 8-, and 12-weeks)