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Mindfulness Meditation to Reduce Cognitive Load

2026年11月2日 更新者：Jean Neils-Strunjas、University of South Carolina

Mindful Meditation to Reduce Stress and Cognitive Load for Older Adults

Older adults from disadvantaged backgrounds may score lower on memory and thinking tests because of test anxiety and stress, not because of true memory problems. This can lead to being wrongly diagnosed with dementia. This study will test whether a short, 15-minute guided meditation before taking a memory and thinking test helps older adults do better on the test and feel less stressed. About 60 adults age 50 and older, with lower education and income levels, will take part. Participants will be randomly assigned to either listen to a guided meditation or listen to a neutral story for 15 minutes before taking the test. The study will measure stress using heart rate, blood pressure, saliva samples, and a stress questionnaire.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This pilot study examines whether a brief mindfulness meditation intervention, administered immediately before cognitive testing, can reduce measurement bias caused by test-related anxiety in older adults from low-income, low-education backgrounds. Participants are randomized to a 15-minute guided mindfulness meditation session or a 15-minute neutral story-listening control session, both administered immediately before the Montreal Cognitive Assessment (MoCA). Physiological stress markers (heart rate variability, blood pressure, salivary pH) and self-reported anxiety (State-Trait Anxiety Inventory) are assessed to evaluate the intervention's effect on stress. Assessments and physiological data collection are administered via a custom application developed by the study team, which standardizes test administration and scoring.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • South Carolina
      • Columbia、South Carolina、美国、29201
      • Columbia、South Carolina、美国、29201
        • University of South Carolina, Aging Gracefully Lab
        • 接触：
      • Kingstree、South Carolina、美国、29556
        • Vital Aging of Williamsburg County, Inc
        • 接触：
      • West Columbia、South Carolina、美国、29169
        • Brookland-Lakeview Empowerment Center
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 50 years or older
  • Self-identified low educational attainment (high school diploma or less)
  • Low socioeconomic status per local criteria
  • Able to provide informed consent

Exclusion Criteria:

  • Diagnosis of dementia
  • Uncorrected hearing impairment preventing completion of the audio-guided intervention
  • Uncorrected vision impairment preventing completion of the Montreal Cognitive Assessment (MoCA)
  • Current regular mindfulness meditation practice
  • Diagnosis of atrial fibrillation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Mindfulness Meditation

Participants complete a 15-minute guided mindfulness meditation session immediately before completing the Montreal Cognitive Assessment (MoCA).
行为的：Guided Mindfulness Meditation

A 15-minute audio-guided mindfulness meditation session delivered via the study application, administered immediately before cognitive testing.
有源比较器：Story-Listening Control

Participants listen to a 15-minute neutral, non-mindfulness story immediately before completing the Montreal Cognitive Assessment (MoCA).
行为的：Neutral Story Listening

A 15-minute audio recording of a neutral, non-mindfulness-based story delivered via the study application, administered once immediately before cognitive testing.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in MoCA Total Score
大体时间：Immediately following the 15-minute intervention session (single study visit)

Cognitive performance measured using the Montreal Cognitive Assessment (MoCA), ranging from 0 to 30, with higher scores indicating better cognitive performance, administered by an examiner immediately after the assigned 15-minute intervention session.
Immediately following the 15-minute intervention session (single study visit)

次要结果测量

结果测量
措施说明
大体时间
Change in Heart Rate Variability
大体时间：Baseline to immediately post-session

Change in heart rate variability measured continuously via the study application before and during the assigned intervention session.
Baseline to immediately post-session
Change in Systolic Blood Pressure
大体时间：Baseline to immediately post-session

Change in systolic blood pressure measured via automated cuff before and immediately after the assigned intervention session.
Baseline to immediately post-session
Change in Salivary pH
大体时间：Baseline to immediately post-session

Change in salivary pH measured via test strips before and immediately after the assigned intervention session.
Baseline to immediately post-session
Change in State-Trait Anxiety Inventory Score
大体时间：Baseline to immediately post-assessment

Change in self-reported state anxiety measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI), a 20-item scale ranging from 20 to 80, with higher scores indicating greater state anxiety, administered at baseline and immediately after the assigned intervention session.
Baseline to immediately post-assessment
Change in Perceived Stress Scale (PSS-10) Score
大体时间：Baseline to immediately post-assessment

Change in self-reported perceived stress measured using the 10-item Perceived Stress Scale (PSS-10), ranging from 0 to 40, with higher scores indicating greater perceived stress, administered at baseline and immediately after the assigned intervention session.
Baseline to immediately post-assessment
Recruitment Rate
大体时间：Up to 4 months

Percentage of eligible individuals screened who agree to enroll in the study.
Up to 4 months
Retention Rate
大体时间：Day 1

Percentage of enrolled participants who complete their assigned study visit.
Day 1
Intervention Adherence
大体时间：Day 1

Percentage of participants who complete the full 15-minute assigned intervention session (mindfulness meditation or story-listening control), as recorded by the study application
Day 1
Participant Acceptability
大体时间：Day 1

Acceptability assessed via a 3-item investigator-developed measure: (1) enjoyment of the session, (2) comfort during the session, (3) perceived health benefit. Each item is rated on a 3-point scale (No / Neutral / Yes) and reported individually.
Day 1
Task Feasibility (Participant-Reported)
大体时间：Day 1

Feasibility assessed via a 2-item investigator-developed measure: (1) physical ease of the seated/lying position, (2) clarity of the recorded audio instructions. Each item is rated on a 3-point scale and reported individually.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of South Carolina

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月14日

初级完成 (估计的)

2027年3月15日

研究完成 (估计的)

2027年3月15日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00000925
  • CL034115600N230020280007408 (其他赠款/资助编号：University of South Carolina-Columbia)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Data sharing plans have not yet been finalized. As a pilot study with a small sample size (n=60), the investigators will determine after study completion whether de-identified individual participant data will be made available, and if so, under what conditions (e.g., data use agreement, timeframe, and mechanism of access).

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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