Clinical trial NCT06768450: Online Meditation for Mild Cognitive Impairment and Mild Dementia
Official title: Online Mindfulness Meditation for Mild Cognitive Impairment and Mild Dementia: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Dementia
Keywords: Dementia
Mild cognitive impairment
Feasibility
Acceptability
Online
Mindfulness
Meditation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Conversion rate
timeFrame: through study completion, an average of 1 year
measure: Retention rate
timeFrame: through study completion, an average of 1 year
measure: Attrition rate
timeFrame: through study completion, an average of 1 year
measure: Client Satisfaction Questionnaire
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Modified Telephone Interview for Cognitive Status
timeFrame: baseline and immediately after the intervention
measure: Pittsburgh sleep quality index
timeFrame: baseline and immediately after the intervention
measure: Hospital anxiety and depression scale
timeFrame: baseline and immediately after the intervention
Other outcomes:
Locations:
Study officials:
References: