Mindfulness Meditation to Reduce Cognitive Load
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Mina Karami, PhD Student
- Номер телефона: 18032614523
- Электронная почта: karamim@email.sc.edu
Места учебы
-
-
South Carolina
-
Columbia, South Carolina, Соединенные Штаты, 29201
- Lourie Center, Senior Resources, Inc.
-
Контакт:
- Mekia A Burgess
- Номер телефона: 803-252-7734
- Электронная почта: mburgess@seniorresourcesinc.org
-
Columbia, South Carolina, Соединенные Штаты, 29201
- University of South Carolina, Aging Gracefully Lab
-
Контакт:
- Mina Karami
- Номер телефона: 8032614523
- Электронная почта: karamim@email.sc.edu
-
Kingstree, South Carolina, Соединенные Штаты, 29556
- Vital Aging of Williamsburg County, Inc
-
Контакт:
- Robert Welch
- Номер телефона: 843-354-5496
- Электронная почта: rwelch@vitalaginginc.org
-
West Columbia, South Carolina, Соединенные Штаты, 29169
- Brookland-Lakeview Empowerment Center
-
Контакт:
- Cindye Richburg Cotton, Ed.D., MBA
- Номер телефона: 803-744-7943
- Электронная почта: crichburgcotton@brookland.cc
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Mindfulness Meditation
Participants complete a 15-minute guided mindfulness meditation session immediately before completing the Montreal Cognitive Assessment (MoCA). |
A 15-minute audio-guided mindfulness meditation session delivered via the study application, administered immediately before cognitive testing. |
|
Активный компаратор: Story-Listening Control
Participants listen to a 15-minute neutral, non-mindfulness story immediately before completing the Montreal Cognitive Assessment (MoCA). |
A 15-minute audio recording of a neutral, non-mindfulness-based story delivered via the study application, administered once immediately before cognitive testing. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in MoCA Total Score
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Heart Rate Variability
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Up to 4 months
|
Percentage of eligible individuals screened who agree to enroll in the study. |
Up to 4 months
|
|
Retention Rate
Временное ограничение: Day 1
|
Percentage of enrolled participants who complete their assigned study visit. |
Day 1
|
|
Intervention Adherence
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00000925
- CL034115600N230020280007408 (Другой номер гранта/финансирования: University of South Carolina-Columbia)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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).
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .