Online Mindfulness Meditation for Mild Cognitive Impairment and Mild Dementia: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Conversion rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Conversion rate
时间窗: through study completion, an average of 1 year
Conversion Rate= Number of participants enrolled / Number of potential participants contacted × 100%
Retention rate
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)