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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mina Karami, PhD Student
- Numéro de téléphone: 18032614523
- E-mail: karamim@email.sc.edu
Lieux d'étude
-
-
South Carolina
-
Columbia, South Carolina, États-Unis, 29201
- Lourie Center, Senior Resources, Inc.
-
Contact:
- Mekia A Burgess
- Numéro de téléphone: 803-252-7734
- E-mail: mburgess@seniorresourcesinc.org
-
Columbia, South Carolina, États-Unis, 29201
- University of South Carolina, Aging Gracefully Lab
-
Contact:
- Mina Karami
- Numéro de téléphone: 8032614523
- E-mail: karamim@email.sc.edu
-
Kingstree, South Carolina, États-Unis, 29556
- Vital Aging of Williamsburg County, Inc
-
Contact:
- Robert Welch
- Numéro de téléphone: 843-354-5496
- E-mail: rwelch@vitalaginginc.org
-
West Columbia, South Carolina, États-Unis, 29169
- Brookland-Lakeview Empowerment Center
-
Contact:
- Cindye Richburg Cotton, Ed.D., MBA
- Numéro de téléphone: 803-744-7943
- E-mail: crichburgcotton@brookland.cc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in MoCA Total Score
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Heart Rate Variability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 4 months
|
Percentage of eligible individuals screened who agree to enroll in the study. |
Up to 4 months
|
|
Retention Rate
Délai: Day 1
|
Percentage of enrolled participants who complete their assigned study visit. |
Day 1
|
|
Intervention Adherence
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00000925
- CL034115600N230020280007408 (Autre subvention/numéro de financement: University of South Carolina-Columbia)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .