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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mina Karami, PhD Student
- Telefonnummer: 18032614523
- E-post: karamim@email.sc.edu
Studieorter
-
-
South Carolina
-
Columbia, South Carolina, Förenta staterna, 29201
- Lourie Center, Senior Resources, Inc.
-
Kontakt:
- Mekia A Burgess
- Telefonnummer: 803-252-7734
- E-post: mburgess@seniorresourcesinc.org
-
Columbia, South Carolina, Förenta staterna, 29201
- University of South Carolina, Aging Gracefully Lab
-
Kontakt:
- Mina Karami
- Telefonnummer: 8032614523
- E-post: karamim@email.sc.edu
-
Kingstree, South Carolina, Förenta staterna, 29556
- Vital Aging of Williamsburg County, Inc
-
Kontakt:
- Robert Welch
- Telefonnummer: 843-354-5496
- E-post: rwelch@vitalaginginc.org
-
West Columbia, South Carolina, Förenta staterna, 29169
- Brookland-Lakeview Empowerment Center
-
Kontakt:
- Cindye Richburg Cotton, Ed.D., MBA
- Telefonnummer: 803-744-7943
- E-post: crichburgcotton@brookland.cc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in MoCA Total Score
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Heart Rate Variability
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 4 months
|
Percentage of eligible individuals screened who agree to enroll in the study. |
Up to 4 months
|
|
Retention Rate
Tidsram: Day 1
|
Percentage of enrolled participants who complete their assigned study visit. |
Day 1
|
|
Intervention Adherence
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00000925
- CL034115600N230020280007408 (Annat bidrag/finansieringsnummer: University of South Carolina-Columbia)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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).
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .