Adaptation and Implementation of a Mindfulness Intervention Among a Hispanic Immigrant Population in St. Louis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Emotional well-being
研究概览
简要总结
Hispanics are the largest ethnic group in the US as well as the fastest growing. Yet, despite being such a large population group, Hispanics are under-studied and under-represented in most studies of health, psychological well-being, and mind-body interventions. For many Hispanic immigrants, life in the U.S. carries multiple socio-economic stressors, which places them at higher risk for depression and other poor health-related quality of life outcomes. Mindfulness-based stress reduction (MBSR) is a group-based training shown to reduce stress and improve overall well-being. There is a quality gap about adaptation and implementation of MBSR programs in community settings and among Hispanic immigrants. This K23 seeks to adapt and test the implementation of an MBSR intervention among under-resourced Hispanic immigrants in St. Louis guided by methods and frameworks from the field of dissemination and implementation (D&I) science as applied to community settings. Implementation research of mindfulness-based interventions among Hispanic immigrant populations is justifiable under several conditions, including ineffective clinical engagement with this population, risk or resilience factors that are unique to the Hispanic community, and lack of cultural relevance of many evidence-based MBIs.
详细描述
This career development award will establish Dr. Parra as a clinical translational investigator focused on mind-body interventions for Hispanic immigrant populations. This K23 award will provide her the support needed to develop expertise in 3 areas: (1) Training to conduct well designed randomized clinical trials; (2) Dissemination and Implementation (D&I) science; and (3) Mindfulness research. To achieve these goals, Dr. Parra has assembled an expert multidisciplinary team in clinical research, D&I, and mindfulness. Her primary mentor, Dr. Eric Lenze, has extensive experience in conducting randomized clinical trials and mentoring junior faculty to become independent investigators. Her secondary mentor, Dr. Ross Brownson, is an internationally recognized and leading expert in D&I science. Her scientific collaborators and advisors include Dr. Douglas Ziedonis, a leading expert in mindfulness clinical research and Dr. Tod Braver, a mindfulness research expert. Dr. Parra will also benefit from the expertise of two renowned researchers in D&I science in the areas of intervention adaptation (Dr. Ana Baumann) and measuring implementation and feasibility outcomes (Dr. Rachel Tabak), as well as the experience from a senior MBSR expert (Dr. Jeannie Kloeckner), and an expert on mental health interventions for Hispanic populations (Dr. Patricia Cavazos-Rehg). Hispanics are the largest and fastest-growing ethnic group in the US, currently representing 14 percent of the population. Despite this, Hispanics are seldom represented in research studies and health promoting programs, in part due to a lack of cultural appropriateness by researchers and low levels of trust of the research community by many Hispanics. Using D&I frameworks and methods, Dr. Parra will adapt a Mindfulness Based Stress Reduction intervention (MBSR-A) among under-resourced Hispanic immigrants in St. Louis (Aim 1). Dr. Parra will also conduct a pilot feasibility RCT trial among 60 Hispanic immigrants (Aim 2) to test and measure implementation outcomes including acceptability, appropriateness and feasibility. This research plan leverages existing institutional resources at Washington University in St. Louis (WU), including the Healthy Mind Lab from Dr. Lenze, Dr. Brownson's D&I center, as well as Dr. Lenze's and Dr. Braver's NIH-funded mindfulness research groups. Finally, this training and research will form the basis for an R01 application to further study the adoption, implementation and effectiveness of a Mindfulness intervention in under-resourced Hispanic immigrant populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to the intervention assignment. Within the resources available to this study, intervention staff will not be engaged in evaluating participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-institutionalized adult Hispanic men and women attending community centers in St. Louis that serve the immigrant population, under resourced (those earning less than twice the federal poverty line)42, less than five years of having immigrated to the United States, low to normal English literacy, and no history of cognitive or physical disability that would prevent participation. Participants must not be currently involved in any other type of mind-body intervention.
排除标准
- •participants with a history of cognitive or physical disability that would prevent participation.
- •participants currently involved in any other type of mind-body intervention.
结局指标
主要结局
Emotional well-being
时间窗: 6 months
We will use the NIH Toolbox Emotion Battery (NIHTB-EB) for adults. The NIHTB-EB is a computerized assessment of emotions with 17 scales and four theoretically driven subdomains (negative affect, psychological well-being, stress and self-efficacy, and social relationships) with established psychometric properties. The battery takes 20 to 30 minutes to complete, and is self-administered. Each item is assessed on a 5 to 7 point Likert scale (ranging from "not at all" to "very much") and scored using item response theory (IRT) that generates a theta score. Spanish versions of the questionnaire are available and have been tested for psychometric properties in Hispanic populations, showing strong reliability and validity.
次要结局
- Mindfulness(6 months)
研究者
Diana Parra Perez
Assistant Profesor
Washington University School of Medicine