- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768450
Online Meditation for Mild Cognitive Impairment and Mild Dementia
Online Mindfulness Meditation for Mild Cognitive Impairment and Mild Dementia: a Feasibility Study
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research aims to investigate the feasibility and acceptability of online meditation for older adults with mild cognitive impairment (MCI) and mild dementia in the UK and to explore its impact on cognitive function, mood, mindfulness, and quality of life. This study will recruit 32 participants with MCI and mild dementia. Participants will receive mindfulness meditation training in an online group-based format, with 8 participants per group in 4 waves. A qualified meditation teacher will lead the sessions via Microsoft Teams once a week for 8 weeks (lasting 2 to 2.5 hours per session).
The study outcomes will include feasibility of the intervention, acceptability to participants, cognitive function, mindfulness, and quality of life. Data will be collected at baseline and after the intervention. A paired t-test will compare pre- and post-intervention changes if the data meet assumptions of normal distribution and homogeneity of variance. Otherwise, non-parametric statistical analyses will be applied.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiuhong You
- Phone Number: +447562739403
- Email: jiuhong.you@kcl.ac.uk
Study Contact Backup
- Name: Zunera Khan
- Email: zunera.2.khan@kcl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online mindfulness meditation arm
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire
Time Frame: immediately after the intervention
|
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
|
|
Conversion rate
Time Frame: through study completion, an average of 1 year
|
Conversion Rate= Number of participants enrolled / Number of potential participants contacted × 100%
|
through study completion, an average of 1 year
|
|
Retention rate
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
Attrition Rate (%)= Number of participants who dropped out / Total number of participants initially enrolled × 100%
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Telephone Interview for Cognitive Status
Time Frame: baseline and immediately after the intervention
|
The Modified Telephone Interview for Cognitive Status is a brief, 13-item test of cognitive functioning with total scores ranging from 0 to 50.
Questions of orientation, repetition, naming, and calculations are some of the items covered.
Additionally, a 10-item non-semantically related word list is recalled both immediately and after a delay of about 5 minutes filled with distractor questions.
Higher scores mean a better outcome.
|
baseline and immediately after the intervention
|
|
Pittsburgh sleep quality index
Time Frame: baseline and immediately after the intervention
|
It is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The total scores range from 0 to 21.
Higher scores mean a worse outcome.
|
baseline and immediately after the intervention
|
|
Hospital anxiety and depression scale
Time Frame: baseline and immediately after the intervention
|
It is used in the setting of a general medical hospital outpatient clinic to assess the mental health of patients.
It has two subscales (anxiety and depression), each with seven items and a score of 0-3 for each item, the total score is 21 respectively.
Higher scores indicate a worse condition.
|
baseline and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 341708 (Registry Identifier: The Integrated Research Application System (IRAS) in UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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