Clinical trial NCT03839589: MBSR in a Hispanic Immigrant Population in St. Louis
Official title: Adaptation and Implementation of a Mindfulness Intervention Among a Hispanic Immigrant Population in St. Louis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Emotional Well-being
Keywords: Hispanics
Mindfulness
Emotional well-being
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We will use a wait-listed design versus a standard parallel group RCT because the wait-listed design allows all participants to (eventually) receive the intervention, and maximizes the overall amount of information obtained. A wait-listed design has been previously used by the primary mentor of this award, Dr. Lenze; successfully increasing recruitment, retention and adherence of the intervention and control groups. This design also allows us to get participant feedback in the whole sample and get preliminary estimates of outcomes, which will be crucial to inform the proposed R01 to be submitted by year 4 of the current award.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotional well-being
timeFrame: 6 months
Secondary outcomes:
measure: Mindfulness
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References: