Mild Cognitive Impairment (MCI)NCT06768450
Online Meditation for Mild Cognitive Impairment and Mild Dementia
A study testing Online mindfulness meditation in people with Mild Cognitive Impairment (MCI) and Dementia, run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia
- What is being tested?
- Online mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Zunera Khan contact
About this study
Official title: 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
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI), Dementia
- Being tested
- Online mindfulness meditation
- Keywords
- Dementia, Mild cognitive impairment, Feasibility, Acceptability, Online, Mindfulness, Meditation
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Conversion Rate= Number of participants enrolled / Number of potential participants contacted × 100%
Measured: 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%
Measured: 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%
Measured: 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.
Measured: immediately after the intervention
Secondary outcomes (3)
Modified Telephone Interview for Cognitive Status
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.
Measured: baseline and immediately after the intervention
Pittsburgh sleep quality index
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.
Measured: baseline and immediately after the intervention
Hospital anxiety and depression scale
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.
Measured: baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startJul 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768450
- Sponsor's protocol ID
- 341708
- Other IDs
- 341708
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41289241
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness Meditation for Mild Cognitive Impairment and Mild Dementia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06768450
- Acronym / sponsor ID
- 341708
- Conditions
- Mild Cognitive Impairment (MCI), Dementia
- Keywords
- Dementia, Mild cognitive impairment, Feasibility, Acceptability, Online, Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online mindfulness meditation arm | Experimental | Behavioral: Online mindfulness meditationParticipants over 60 years old with mild cognitive impairment or mild dementia will be recruited. An 8-week online meditation training program will be provided. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mindfulness meditationThe 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. | Behavioural | Online mindfulness meditation arm |
Primary outcome
Conversion rate
Time frame: through study completion, an average of 1 year
Conversion Rate= Number of participants enrolled / Number of potential participants contacted × 100%
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%
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%
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.
3 secondary outcomes
Modified Telephone Interview for Cognitive Status
Time frame: baseline and immediately after the intervention
Pittsburgh sleep quality index
Time frame: baseline and immediately after the intervention
Hospital anxiety and depression scale
Time frame: baseline and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 41289241You 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunera Khan contact
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness meditation in people with Mild Cognitive Impairment (MCI) and Dementia, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiuhong You (+447562739403, jiuhong.you@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.