A Pilot Randomized Controlled Trial of an At-home Mindfulness Meditation Intervention in Older Adults With Mild Cognitive Impairment and in Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in the Perceived Stress Scale (PSS-10) score
研究概览
简要总结
Individuals diagnosed with mild cognitive impairment (MCI) are at a high risk of developing dementia and are an important target population for interventions that may reduce the risk of cognitive decline. A diagnosis of MCI or dementia also has an important impact on caregivers, who show increased levels of stress, anxiety, and depression. Mindfulness meditation is a promising behavioural intervention that may have important benefits both for older adults with MCI and for caregivers. Previous research suggests that meditation may improve psychological wellbeing, reduce stress, and even improve cognitive function. Technology-based mindfulness meditation platforms may be a much-needed solution for promoting the adoption of mindfulness in these populations.
The current study is a pilot randomized control trial of a mindfulness meditation intervention delivered via the Muse platform in two study populations: a) older adults diagnosed with MCI, and b) family caregivers of persons with MCI or neurodegenerative disorders. Muse is a mobile application for meditation that provides real-time feedback about the user's state of mindfulness during meditation via a headband containing electroencephalographic sensors (EEG) that the user wears while meditating. It is thought that this neurofeedback can promote learning and lead to faster improvements in meditation ability and, consequently, greater benefits from meditation practice.
This aim of this pilot study is to establish the acceptability of the Muse platform as an intervention in the two study populations, to determine the feasibility of the randomized control trial designed to evaluate the effectiveness of a 6 week intervention with the Muse platform, and to evaluate the effect of neurofeedback on meditation. Participants will be randomly allocated to meditation with neurofeedback (NFB) or meditation without neurofeedback (no-NFB) and will complete daily meditation sessions for 6 weeks. An assessment visit before and after the intervention will evaluate participants' psychological well-being using questionnaires; their visual working memory, attention, and visual perception using behavioural tests; and their mindfulness ability using questionnaires and a behavioural measure. EEG will also be recorded using the Muse headband to examine changes in electrophysiological markers during cognitive tests and at rest.
详细描述
The Primary objectives of the main study are:
- To determine if mindfulness meditation with auditory neurofeedback (NFB) leads to greater improvements in mindfulness relative to a mindfulness meditation without neurofeedback (no-NFB).
- To determine if a mindfulness meditation intervention with neurofeedback leads to greater improvements in psychological well-being, with perceived stress levels as the primary outcome measure, in the two study populations, relative to a mindfulness meditation program without neurofeedback .
Secondary objectives of the main study are to determine if the NFB intervention leads to greater improvements in 1) other measures of psychological wellbeing and 2 ) behavioural and EEG markers of perceptual and cognitive function, relative to the no-NFB arm, in the two study populations (individuals with MCI; caregivers)
Feasibility and acceptability objectives of the pilot study
- To evaluate the acceptability of the intervention for older adults with MCI and family caregivers of persons with MCI or neurodegenerative disorders, and to examine whether the acceptability of the intervention is associated with the individual's technological abilities.
- To estimate the recruitment rate of older adults with MCI and family caregivers separately, as well as dyads of older adults with MCI and their caregivers.
- To determine the rate of adherence to the intervention schedule (durations per session and number of sessions), and the rate of completion of assessment visits and weekly questionnaires
- To determine the extent of technical expertise and time resources required of the experimenters to provide technical support to participants in each group
- To determine the feasibility of blinding experimenters to the intervention arm and of blinding Muse-control participants to the neurofeedback group, given that information about the Muse app is easily available online.
- To obtain preliminary estimates of the effects of Muse and Muse-control interventions on the psychological well-being, and perceptual and cognitive measures, and the standard deviations of these measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The outcomes assessor and all individuals involved in analyzing data will be blind to the participant's study arm. Only the research assistant who will be introducing participants to their meditation app will be aware of their study arm assignment. Participants will be told that they are randomized into one of two types of meditation programs, but will not be told about the difference in the two programs and will not be told if they are in the main intervention group or the control group. That said, given the nature of auditory neurofeedback, participants in the NFB group will be aware that they are receiving neurofeedback. Participants in the no-NFB group will not be experiencing any neurofeedback and, a priori, they should not be aware that neurofeedback is missing.
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Older adults with MCI):
- •Diagnosis of mild cognitive impairment, any type, by a physician at the Baycrest Sam & Ida Ross Memory Clinic
- •Confirmation of the absence of progression to dementia within 90 days of study start by a physician or by the study staff
- •Aged 55 years to 90 years
- •Inclusion Criteria (Caregivers):
- •Identify as a caregiver of a family member or friend living with mild cognitive impairment (MCI) or any neurodegenerative disease
- •Not be financially compensated for their caregiving work
- •Aged 20 years to 90 years
- •Passes the Telephone Interview for Cognitive Status and Montreal Cognitive Assessment > 23
排除标准
- •History of neurological disorders (e.g., malignant brain tumour, multiple sclerosis, Down's syndrome or any other developmental disorders, epilepsy, seizures, Parkinson's, any dementia or neurodegenerative disorder except for MCI), and history of MCI for the caregiver group
- •Stroke or history of transient ischemic attack (TIA)
- •History of traumatic brain injury (TBI) with loss of consciousness lasting longer than 30 minutes
- •Active cancer, history of chemotherapy, or history of radiation to the head
- •History of psychiatric conditions including:
- •Diagnosis of major depressive disorder, generalized anxiety disorder, or other psychiatric diagnosis within 90 days of study entry, or
- •Lifetime history of psychosis, bipolar disorder, obsessive compulsive disorder, schizophrenia, or post-traumatic stress disorder
- •History of substance use within the past year
- •Serious medical disease that would/could lead to death over the next 2-3 years (e.g. cardiac/renal/liver disease, or cancer) with poor prognosis
- •Presence of visual impairment (binocular vision worse than Snellen acuity 20/40)
- •Hearing loss that prevents the individual to hear sounds in the Muse app even with a hearing aid (if applicable), or incompatibility of their hearing aid with the Muse headband and inability to hear the Muse app sounds without the hearing aid
- •Started taking psychotropic medication (anti-anxiety, anti-psychotics) or cognitive enhancers (memantine, acetylcholinesterase inhibitors) less than 3 months prior to randomization, or has had a change in dosages of any acetylcholinesterase inhibitors or cognitive enhancers within 6 weeks of randomization, or has had any changes in all types of medications or dosages within 4 weeks of randomization.
- •Already engages in active meditation practice
- •Is enrolled or recently completed (within 30 days) another intervention study or clinical trial
- •Unable to understand, read, and speak English
结局指标
主要结局
Change in the Perceived Stress Scale (PSS-10) score
时间窗: Baseline (Visit 2/Week 1) to Post-Intervention (Visit 3/Week 7).
The 10-item Perceived Stress Scale is a self-administered questionnaire that measures an individual's perception of how uncontrollable, unpredictable and overloading aspects of their life are on a 5-point scale ranging from 0 (never) to 4 (very often). It has been validated in older adults, caregivers of dementia patients, and dementia patients (Deeken et al., 2018; Ezzati et al., 2014). High scores represent high levels of stress. This is the primary outcome measure in the main study.
Total number of meditation sessions
时间窗: Intervention period (6 weeks)
The total number of meditation sessions lasting longer than 3 minutes will be quantified for each participant to evaluate adherence to the intervention schedule. This is a primary acceptability outcome variable for the feasibility study.
Recruitment rate
时间窗: Study recruitment period, approximately 3 months
The recruitment rate will be quantified as the number of participants recruited per month, separately for the two study population groups (MCI and caregivers). This is a primary outcome variable for the feasibility study.
次要结局
- Change in the Beck Depression Inventory (BDI-II) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Warwick Edinburgh Mental Well-being Scale (WEMWBS) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Sleep Disturbance score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Brief Symptom Inventory (BSI) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Multifactorial Memory Questionnaire (MMQ)-Ability scale score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in event-related potentials in the auditory oddball task(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Retention rate(Post-intervention visit (Visit 3/Week 7))
- Change in the Multifactorial Memory Questionnaire (MMQ)-Satisfaction scale score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Conor-Davidson Resilience Scale (CD-RISC) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Average hours of technical support per person(Intervention period (6 weeks))
- Change in the Credibility/Expectancy Questionnaire Score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Mean duration of meditation sessions(Intervention period (6 weeks))
- Change in breath counting accuracy(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the Perceived Stress Scale (PSS-10) score(Baseline (Visit 2/Week 1) to During Intervention (Week 3))
- Change in the Mindfulness Attention and Awareness Scale (MAAS) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in the quality of life (WHO-Quality of Life BREF) score(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- 10-item Burden Scale for Family Caregivers (BSFC-s)(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in visual working memory(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in visual attention(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Change in resting state EEG features with eyes closed(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
- Toronto Mindfulness Scale (TMS)(Intervention period (6 weeks))
- Study acceptability score(Post-intervention visit (Visit 3, Week 7))
- Change in EEG features during meditation(Intervention period (6 weeks))
- Change in resting state EEG features with eyes open(Baseline (Visit 2/Week 1), Post-Intervention (Visit 3/Week 7))
研究者
Dr. Allison B. Sekuler
Sandra A Rotman Chair in Cognitive Neuroscience; Managing Director and Senior Scientist, Rotman Research Institute; Managing Director, Centre for Aging + Brain Health Innovation; Vice-President Research, Baycrest Health Sciences
Baycrest