MBSR in a Hispanic Immigrant Population in St. Louis

NCT03839589 | Completed

• 1 other identifier: 212832
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Emotional Well-being

Keywords

Hispanics; Mindfulness; Emotional well-being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mindfulness

  6 months

Study Arms (2)

MBSR-A

EXPERIMENTAL

Intervention Mindfulness Condition: MBSR is a structured intervention delivered through an 8-week course. Mindful breathing, awareness, walking, and attention are core activities taught and practiced during and outside of the course.

Behavioral: Mindfulness Based Stress Reduction Adapated (MBSR-A)

Wait-listed MBSR-A

PLACEBO COMPARATOR

The MBSR-A Wait-listed group: This wait-listed group will be followed with the same outcome assessments as the MBSR- A immediate group but will receive no intervention until after outcomes from group 1 are collected at 3 months, when they will also receive the MBSR-A

Behavioral: Mindfulness Based Stress Reduction Adapated (MBSR-A)

Interventions

Mindfulness Based Stress Reduction Adapated (MBSR-A) BEHAVIORAL

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.

MBSR-A; Wait-listed MBSR-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• participants with a history of cognitive or physical disability that would prevent participation.
• participants currently involved in any other type of mind-body intervention.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63105, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: November 26, 2017
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)