跳至主要内容
临床试验/NCT07040904
NCT07040904招募中不适用

Mindfulness to Enhance Cognitive Health in Latinx Older Adults

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
EEG brain markers of cognitive functioning

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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).

结局指标

主要结局

EEG brain markers of cognitive functioning

时间窗: 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.

AXCPT behavioral performance (reaction time)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • EEG metrics of mindfulness practice quality(Assessed at 2 timepoints: baseline/pre-intervention immediately post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Braver

Professor

Washington University School of Medicine

研究点 (1)

Loading locations...

相似试验