Mindfulness to Enhance Cognitive Health in Latino Older Adults

NCT07040904 | Recruiting

• 1 other identifier: Tbraver
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 Latino older adults, thereby mitigating risk of Alzheimer's Disease (AD) in a population that may be particularly vulnerable.

Conditions

Mindfulness; Alzheimer's Disease Related Dementia

Keywords

AD Biomarkers; Alzheimer's Disease; Alzheimer's disease and related dementias; cognitive behavioral intervention; Mindfulness; Mindfulness Training

Outcome Measures

Primary Outcomes (9)

• EEG brain markers of cognitive functioning

  EEG indices of cognitive performances evoked by task stimuli and participant responses. ERP components of attention and cognitive control during task performance, focused on target-related P3 amplitude.

  Time-frame: 2 time-points - baseline/pre-intervention, and immediately after the intervention

• EEG brain markers of cognitive functioning

  EEG indices of cognitive performances evoked by task stimuli and participant responses. ERP components of attention and cognitive control during task performance, focused on cue-related Contingent Negative Variation (CNV).

  Time-frame: 2 time-points - baseline/pre-intervention, and immediately after the intervention

• AXCPT behavioral performance (reaction time)

  Behavioral performance indices during AXCPT task: AX-CPT - reaction time in milliseconds

  Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention

• AXCPT behavioral performance score (accuracy)

  Behavioral performance indices during AXCPT task: AX-CPT - % accuracy AX-CPT --% accuracy

  Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention

• Five Facet Mindfulness Questionnaire (FFMQ) score

  Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report inventory used to measure five distinct facets of mindfulness. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience, each rated on a 5-point Likert scale.

  Performed during the intervention (3x /week for 8 weeks)

• The Mindful Attention Awareness Scale (MAAS) score

  The Mindful Attention Awareness Scale (MAAS) is a 15-item measure of mindfulness that prioritizes assessment of the general tendency to be attentive and aware of experiences in the present moment. It is is rated on a 6-point Likert scale (almost always, very frequently, somewhat frequently, somewhat infrequently, very infrequently, almost never).

  Performed during the intervention (3x /week for 8 weeks)

• Cognitive and Affective Mindfulness Scale (CAMS-R) score

  Cognitive and Affective Mindfulness Scale (CAMS-R) is used to evaluate symptoms of mindfulness as EMA (ecological momentary assessment) questions. It will be measured in a Likert scale (Not at all, Somewhat, Quite a bit, Almost completely)

  Performed during the intervention (3x /week for 8 weeks)

• Patient-Reported Outcomes Measurement Information System (Promis) score

  PROMIS (Patient-Reported Outcomes Measurement Information System) are item banks that measure common health outcomes across the domains of physical, mental, and social health.

  Performed during the intervention (3x /week for 8 weeks)

• National Institutes of Health Toolbox Emotion Battery (NIH-TOOLBOX-EB) score

  National Institutes of Health Toolbox Emotion Battery for English- and Spanish-speaking adults (NIH-TOOLBOX-EB): National Institutes of Health Toolbox Emotion Battery for English- and Spanish-speaking adults (NIH-TOOLBOX-EB) A series of scales that will be rated on a 5-point Likert scale which include: 1. General Life Satisfaction 2. Meaning and Purpose 3. Loneliness 4. Sadness 5. Positive Affect 6. Fear Affect 7. Perceived Stress 8. Resilience Scale 9. Sleep Quality Scale

  baseline (pre-intervention) & immediately post-intervention

Secondary Outcomes (1)

• EEG metrics of mindfulness practice quality

  Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention

Interventions

mindfulness BEHAVIORAL

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.

Eligibility Criteria

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

You may qualify if:

• Hispanic/Latino
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Todd S Braver, Ph.D.

CONTACT

800-438-0445; tbraver@wustl.edu

Diana Parra Perez, Ph.D.

CONTACT

parrad@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization Description: After the pre-training assessment phase, participants will be randomized to either the Mindfulness Based Program or wait-list groups. The only difference between the two groups is that the wait-list group will not receive the mindfulness intervention until after they complete both pre- and post-assessments during the 4-month study period. Intervention Description: 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.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: June 27, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data will be made available one year after data collection begins and updated annually until the award period ends. All data, data wrangling procedures, registrations, and analysis scripts associated with published manuscripts will be organized into an easily accessible subfolder and made available no later than the time of publication acceptance. The data will be available for public access indefinitely, or until new guidelines are released regarding data archival duration.
• Access Criteria: All data that is uploaded to OSF will be publicly available with no controlled access.

Locations

US (1)