Mindfulness to Enhance Cognitive Health in Latinx Older Adults

NCT ID: NCT07040904

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2026-07-31

Brief Summary

The primary objective of the proposed research is to investigate the promise and underlying mechanisms of mindfulness training as a preventative lifestyle intervention to enhance cognitive health in Latinx older adults, thereby mitigating risk of Alzheimer's Disease (AD) in a population that may be particularly vulnerable.

Detailed Description

This proposal rigorously examines the feasibility and mechanisms of action of a novel, culturally-sensitive mindfulness training program developed by the PIs, utilizing EEG methods and theoretically-optimized cognitive control tasks to assess neurocognitive effects. Additionally, blood-based assessment of AD biomarkers will be utilized to test whether biomarker status will moderate the effect of training, such that the neurocognitive benefits will be larger Latinx older adults with greater evidence of AD-related pathology. Furthermore, the study will also seek to elucidate the subjective effects of mindfulness training on daily-life experiences using ecological momentary assessment (EMA) methods. The study will utilize a mixed between and within-subject design involving longitudinal (pre vs. post-training) assessment and a wait-list control group. 60 Latinx older adults will first complete a baseline assessment protocol, followed by randomized assignment to either the mindfulness or wait-list group (N=30 in each group). The mindfulness group will receive 8 weeks of mindfulness training. During this 8-week period participants from both groups will also complete an EMA protocol, consisting of prompts occurring 4x/day on 3 random days per week, assessing subjective mindfulness states, practice experiences, mood, cognition, setting, and activity. Both groups will then return to repeat performance of the same assessment protocol. The assessment protocol involves two testing sessions performed on separate days, each involving completion of the Stroop and AX-CPT task while continuous EEG is recorded. The mindfulness training curriculum utilizes a novel adaptation of the well-validated mindfulness-based stress reduction (MBSR) course, that has been previously validated in focus groups. Participants will meet weekly with an instructor (either in-person or on-line) in classes to receive instructions and practice mindfulness skills. The curriculum embeds core MBSR principles and practices within a culturally-sensitive didactic framework, that includes four key modifications: (1) delivering all instruction in participants native Spanish language; (2) emphasizing/encouraging the connection between mindfulness practices and participants' personal religious beliefs (e.g., "connecting the breath/body to God"), (3) incorporating culturally unique experiences into group activities/exercises (e.g., sharing immigration stories and examining how alterations in perspective can influence meaning and affect), and (4) adding more familial focus to course content (e.g., highlighting how certain skills or practices can benefit the family). In addition to weekly class meetings, participants will also have access to instructional videos and guided audio practices available on their mobile device; on these devices, they will also be periodically prompted to partake in a short mindfulness behavioral task, a 2-minute breath-counting exercise. Finally, all participants will complete a blood draw at the end of the study to determine AD biomarker status. Outcomes will be assessed using EMA measures of daily mindfulness and mood/cognition as well as other qualitative self-report measures assessing the accessibility, utility and feasibility of the mindfulness training curriculum (Aim 1); EEG/ERP measures of state mindfulness and neurocognitive functioning (Aim 2); behavioral metrics of cognitive performance (Aim 2); and moderating role of AD biomarker status (Aim 3).

Conditions

Mindfulness; Alzheimer's Disease Related Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

mindfulness

MBSR: Mindfulness Program A novel and culturally-adapted version of the well-validated mindfulness-based stress reduction (MBSR) course will be used for the intervention. The adapted program curriculum embeds core MBSR principles and practices within a culturally responsive didactic framework developed directly from community focus-group feedback. The course will be delivered via a group meeting across 8 weeks, with weekly classes held at a local community center. All classes will be held in hybrid format, with most participants attending in person, but with a live-stream option offered via Zoom.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Hispanic/Latinx
• Age 65 and older
• Male, female, or non-binary
• Community living
• Medically stable and willing to undergo the study procedures
• No extensive mindfulness training experience

Exclusion Criteria

• Clinically unstable psychiatric disorder that requires immediate treatment (e.g., ECT)
• Medical conditions suggesting significantly shortened lifespan (e.g., metastatic cancer) or prohibiting safe participation in the interventions/assessments (e.g., Parkinson's disease, musculoskeletal conditions)
• Sensory impairment (hearing, vision) preventing participation
• Current alcohol or substance abuse
• Current/concurrent cognitive training known to affect neuroplasticity (e.g., brain-training programs), or other interventions expected to affect neuroplasticity significantly (e.g., psychedelics, cholinesterase inhibitors, high-dose sedatives).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Todd Braver

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Washington University

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Todd S Braver, Ph.D.

Role: CONTACT

tbraver@wustl.edu

800-438-0445

Diana Parra Perez, Ph.D.

Role: CONTACT

parrad@wustl.edu

Facility Contacts

Todd Braver

Role: primary

tbraver@wustl.edu

314-935-5143

Diana Parra-Perez

Role: backup

parrad@wustl.edu

Other Identifiers

Tbraver

Identifier Type: -

Identifier Source: org_study_id