NCT06768450

Brief Summary

The study will look at whether online mindfulness meditation (OMM) is easy for older adults with mild cognitive impairment (MCI) and mild dementia to use. It will also see how OMM affects their mood, sleep, and quality of life. The investigators will recruit 32 participants, divided into 4 groups of 8 people each. Participants will:

  • Attend an online mindfulness meditation class once a week for 8 weeks
  • Practice at home for 20 minutes each day
  • Keep a simple record of their practice and feelings

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

September 13, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 16, 2025

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 13, 2024

Last Update Submit

January 14, 2025

Conditions

Keywords

DementiaMild cognitive impairmentFeasibilityAcceptabilityOnlineMindfulnessMeditation

Outcome Measures

Primary Outcomes (4)

  • Conversion rate

    Conversion Rate= Number of participants enrolled / Number of potential participants contacted × 100%

    through study completion, an average of 1 year

  • Retention rate

    Retention Rate (%)= Number of participants who completed the study / Number of participants initially enrolled × 100%

    through study completion, an average of 1 year

  • Attrition rate

    Attrition Rate (%)= Number of participants who dropped out / Total number of participants initially enrolled × 100%

    through study completion, an average of 1 year

  • Client Satisfaction Questionnaire

    It is a standardized 8-item tool that has demonstrated good reliability and validity in mental health services. Items are scored from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.

    immediately after the intervention

Secondary Outcomes (3)

  • Modified Telephone Interview for Cognitive Status

    baseline and immediately after the intervention

  • Pittsburgh sleep quality index

    baseline and immediately after the intervention

  • Hospital anxiety and depression scale

    baseline and immediately after the intervention

Study Arms (1)

Online mindfulness meditation arm

EXPERIMENTAL

Participants over 60 years old with mild cognitive impairment or mild dementia will be recruited. An 8-week online meditation training program will be provided.

Behavioral: Online mindfulness meditation

Interventions

The mindfulness meditation program is adapted from the Breathwork Mindfulness for Stress program. However, it uses shorter meditations designed for individuals who cannot sit for 40 minutes. The mindfulness meditation program encourages greater self-acceptance, kindness, and compassion toward oneself. It builds on this concept by helping participants find pleasure in life despite suffering, fostering kindness and compassion toward others, and increasing social connections to counteract the social isolation common among individuals with chronic and long-term illnesses. The program will be led by a well-trained Breathwork mindfulness instructor and conducted remotely via Microsoft Teams once a week for 8 weeks. Each session will last 2 to 2.5 hours and consist of body scans, mindful movements, and various meditations, introducing new ideas every week.

Online mindfulness meditation arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older.
  • MCI: Concern regarding a change in cognition, with impairment in one or more cognitive domains, including memory, executive function, attention, language, and visuospatial skills. Preservation of independence in functional abilities and does not meet the criteria for dementia, as described in the National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic guidelines.
  • Mild dementia: As described in the NIA-AA research framework, mild dementia is defined as substantial progressive cognitive impairment affecting several domains and/or neurobehavioral disturbances. Documented by the individual's report, an observer (e.g., a study partner) report, or by changes observed on longitudinal cognitive testing. Clearly evident functional impact on daily life, mainly affecting instrumental activities. No longer fully independent and requires occasional assistance with daily activities.
  • Access to an electronic device (e.g., smartphone, computer, or tablet) and the internet.
  • Ability and willingness to provide informed consent by signing the Consent Form.

You may not qualify if:

  • Current active or past significant experience with meditation.
  • Clinically significant mental or physical health disorder beyond MCI or dementia that may affect cognition and/or the ability to complete the study (e.g., severe depression, suicidality, psychosis, post-traumatic stress disorder (PTSD), major psychiatric diagnoses, social anxiety (e.g., difficulty participating in a group setting), or severe impairments in eyesight, hearing, or upper limb motor movements).
  • Inability to commit to attending classes (e.g., planning to miss three or more classes).
  • Lack of proficiency in English.
  • Diagnosed with moderate or severe dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • You J, Khan Z, Swaroop R, Sun Y, Velayudhan L, Aarsland D. Online mindfulness meditation for mild cognitive impairment and mild dementia: A feasibility study protocol. PLoS One. 2025 Nov 25;20(11):e0336583. doi: 10.1371/journal.pone.0336583. eCollection 2025.

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

January 10, 2025

Study Start

July 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 16, 2025

Record last verified: 2024-09