- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07924904
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mina Karami, PhD Student
- Telefonnummer: 18032614523
- E-Mail: karamim@email.sc.edu
Studienorte
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South Carolina
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Columbia, South Carolina, Vereinigte Staaten, 29201
- Lourie Center, Senior Resources, Inc.
-
Kontakt:
- Mekia A Burgess
- Telefonnummer: 803-252-7734
- E-Mail: mburgess@seniorresourcesinc.org
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Columbia, South Carolina, Vereinigte Staaten, 29201
- University of South Carolina, Aging Gracefully Lab
-
Kontakt:
- Mina Karami
- Telefonnummer: 8032614523
- E-Mail: karamim@email.sc.edu
-
Kingstree, South Carolina, Vereinigte Staaten, 29556
- Vital Aging of Williamsburg County, Inc
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Kontakt:
- Robert Welch
- Telefonnummer: 843-354-5496
- E-Mail: rwelch@vitalaginginc.org
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West Columbia, South Carolina, Vereinigte Staaten, 29169
- Brookland-Lakeview Empowerment Center
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Kontakt:
- Cindye Richburg Cotton, Ed.D., MBA
- Telefonnummer: 803-744-7943
- E-Mail: crichburgcotton@brookland.cc
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in MoCA Total Score
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Heart Rate Variability
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 4 months
|
Percentage of eligible individuals screened who agree to enroll in the study. |
Up to 4 months
|
|
Retention Rate
Zeitfenster: Day 1
|
Percentage of enrolled participants who complete their assigned study visit. |
Day 1
|
|
Intervention Adherence
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00000925
- CL034115600N230020280007408 (Andere Zuschuss-/Finanzierungsnummer: University of South Carolina-Columbia)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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).
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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