MindfulnessMLXNCT07040904
Mindfulness to Enhance Cognitive Health in Latino Older Adults
A study testing mindfulness in people with Mindfulness and Alzheimer's Disease Related Dementia, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Alzheimer's Disease Related Dementia
- What is being tested?
- mindfulness
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diana Parra Perez, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63130
Todd Braver, 314-935-5143, tbraver@wustl.edu
Diana Parra-Perez, parrad@wustl.edu
About this study
Official title: Mindfulness to Enhance Cognitive Health in Latinx Older Adults
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.
Read the 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 Latino 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 Latino 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
- Being tested
- mindfulness
- Keywords
- AD Biomarkers, Alzheimer's Disease, Alzheimer's disease and related dementias, cognitive behavioral intervention, Mindfulness, Mindfulness Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulnessBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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:
- General Life Satisfaction
- Meaning and Purpose
- Loneliness
- Sadness
- Positive Affect
- Fear Affect
- Perceived Stress
- Resilience Scale
- Sleep Quality Scale
Measured: baseline (pre-intervention) & immediately post-intervention
Secondary outcomes (1)
EEG metrics of mindfulness practice quality
EEG spectral power (alpha, theta bands) evoked during guided mindfulness state induction
Measured: Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start10 Dec 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Braver, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040904
- Sponsor's protocol ID
- Tbraver
- Acronym
- MLX
- Status last verified
- May 2026
- First submitted
- 4 Nov 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the data collected in will be preserved through deposition in a public access data repository (i.e., Open Science Framework \[OSF\]). Raw self-report, transcription, and EMA data will be recoded, scored, and wrangled to "long" format to enhance accessibility and ease of use prior to sharing. All shared data will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness to Enhance Cognitive Health in Latinx Older Adults
- ClinicalTrials.gov ID
- NCT07040904
- Acronym / sponsor ID
- MLX / Tbraver
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Latino 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 Latino 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Model description
- 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.
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Hispanic/Latino
- Age 65 and older
- Male, female, or non-binary
- Community living
- Medically stable and willing to undergo the study procedures
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulnessMBSR: 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. | Behavioural | – |
Primary outcome
EEG brain markers of cognitive functioning
Time frame: Time-frame: 2 time-points - baseline/pre-intervention, and immediately after the intervention
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.
EEG brain markers of cognitive functioning
Time frame: Time-frame: 2 time-points - baseline/pre-intervention, and immediately after the intervention
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).
AXCPT behavioral performance (reaction time)
Time frame: Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention
Behavioral performance indices during AXCPT task: AX-CPT - reaction time in milliseconds
AXCPT behavioral performance score (accuracy)
Time frame: Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention
Behavioral performance indices during AXCPT task: AX-CPT - % accuracy AX-CPT --% accuracy
Five Facet Mindfulness Questionnaire (FFMQ) score
Time frame: Performed during the intervention (3x /week for 8 weeks)
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.
The Mindful Attention Awareness Scale (MAAS) score
Time frame: Performed during the intervention (3x /week for 8 weeks)
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).
Cognitive and Affective Mindfulness Scale (CAMS-R) score
Time frame: Performed during the intervention (3x /week for 8 weeks)
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)
Patient-Reported Outcomes Measurement Information System (Promis) score
Time frame: Performed during the intervention (3x /week for 8 weeks)
PROMIS (Patient-Reported Outcomes Measurement Information System) are item banks that measure common health outcomes across the domains of physical, mental, and social health.
National Institutes of Health Toolbox Emotion Battery (NIH-TOOLBOX-EB) score
Time frame: baseline (pre-intervention) & immediately post-intervention
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
1 secondary outcome
EEG metrics of mindfulness practice quality
Time frame: Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. All of the data collected in will be preserved through deposition in a public access data repository (i.e., Open Science Framework [OSF]). Raw self-report, transcription, and EMA data will be recoded, scored, and wrangled to "long" format to enhance accessibility and ease of use prior to sharing. All shared data will be deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Parra Perez, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness in people with Mindfulness and Alzheimer's Disease Related Dementia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd S Braver, Ph.D. (800-438-0445, tbraver@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG brain markers of cognitive functioning (time frame: Time-frame: 2 time-points - baseline/pre-intervention, and immediately after the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.