MBSR in a Hispanic Immigrant Population in St. Louis

Mindfulness Clinical Trial

Official title:

Adaptation and Implementation of a Mindfulness Intervention Among a Hispanic Immigrant Population in St. Louis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839589
• Other study ID #: 212832
• Status: Completed
• Phase: N/A
• Start date: November 26, 2017
• Est. completion date: December 26, 2018

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 26, 2018
• Est. primary completion date: December 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• participants with a history of cognitive or physical disability that would prevent participation.

• participants currently involved in any other type of mind-body intervention.

Related Conditions & MeSH terms

• Emotional Well-being
• Mindfulness

Intervention

Behavioral:
• Mindfulness Based Stress Reduction Adapated (MBSR-A)
Mindfulness-based stress reduction (MBSR) is a group-based intervention developed in 1979 by Dr. Jon Kabat-Zinn to provide mindfulness training in order to decrease stress and improve overall well-being. MBSR has been shown to be effective for a series of patient outcomes including depression, anxiety disorders, sleep disorders, and chronic pain management. MBSR is a structured intervention delivered through an 8-week course of up to 30 participants who meet for 2.5 hours per week.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional well-being	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.	6 months
Secondary	Mindfulness	The Mindfulness Attention Awareness Scale (MAAS) will be used to evaluate quality of consciousness and well-being associated with increased self-awareness.61 The 15-item measure uses a 6-point scale to ask participants how often they experience mindful thinking and awareness, with response options ranging from "1-Almost always" to "6-Almost never." An average is taken of the 15 responses for a total possible score range from 1 - 6 with higher scores indicating greater mindful awareness. A translated version of this scale has been previously used in Spanish-speaking community settings and tested for psychometric properties showing high levels of reliability and validity.	6 months