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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mina Karami, PhD Student
- 電話番号：18032614523
- メール：karamim@email.sc.edu
研究場所
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South Carolina
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Columbia、South Carolina、アメリカ、29201
- Lourie Center, Senior Resources, Inc.
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コンタクト：
- Mekia A Burgess
- 電話番号：803-252-7734
- メール：mburgess@seniorresourcesinc.org
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Columbia、South Carolina、アメリカ、29201
- University of South Carolina, Aging Gracefully Lab
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コンタクト：
- Mina Karami
- 電話番号：8032614523
- メール：karamim@email.sc.edu
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Kingstree、South Carolina、アメリカ、29556
- Vital Aging of Williamsburg County, Inc
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コンタクト：
- Robert Welch
- 電話番号：843-354-5496
- メール：rwelch@vitalaginginc.org
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West Columbia、South Carolina、アメリカ、29169
- Brookland-Lakeview Empowerment Center
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コンタクト：
- Cindye Richburg Cotton, Ed.D., MBA
- 電話番号：803-744-7943
- メール：crichburgcotton@brookland.cc
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in MoCA Total Score
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Heart Rate Variability
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 4 months
|
Percentage of eligible individuals screened who agree to enroll in the study. |
Up to 4 months
|
|
Retention Rate
時間枠：Day 1
|
Percentage of enrolled participants who complete their assigned study visit. |
Day 1
|
|
Intervention Adherence
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00000925
- CL034115600N230020280007408 (その他の助成金/資金番号：University of South Carolina-Columbia)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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).
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。