Investigating the Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in Immediate Memory
研究概览
简要总结
This study evaluates the effects of Mindfulness-based Interventions (MBI) on the neuropsychological profile of individuals with mild cognitive impairment (MCI). It will also investigate changes in fMRI activity, such as resting-state functional connectivity networks and changes in activity in attention networks in task-related fMRI using graph theory analysis after Mindfulness-based Interventions. Participants will be randomly assigned to receive either the Mindfulness-Based Intervention, Cognitive Rehabilitation Training or Treatment as Usual as the passive control group comparison.
详细描述
As the population of Singapore ages rapidly, cognitive decline associated with both normal aging and disease is becoming a frequently encountered health challenge. In our proposed study, we will investigate the effects of mindfulness-based interventions (MBI), which have shown significant promise in halting and even reversing age-related cognitive impairment. MBI enhances the quality and frequency of mindfulness, defined as a mental state achieved by focusing one's attention and awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. In this study, we will administer a standardized MBI program or Cognitive Rehabilitation Therapy to a group of 60 patients diagnosed with mild cognitive impairment (MCI), a condition marked by deficits in language, memory and attention that often leads to dementia; an additional 30 patients will be assigned to the control group. There will be 3 runs with 30 persons per run; each group will have 10 randomly assigned participants. By comparing the 3 groups across the 3 runs, we seek to test the following hypotheses: 1) MBI will result in significantly greater improvements in neuropsychological testing outcomes across multiple cognitive domains, including attention, memory, language and processing speed, 2) MBI will strengthen cortical connectivity as measured by functional magnetic resonance imaging (fMRI), and 3) MBI will lead to changes in fMRI activation on a test of facets of attention. Neuropsychological testing will take place in SGH, while fMRI and EEG scanning will take place in the Center for Cognitive Neuroscience at Duke-NUS. Both the MBI and CRT will be facilitated by trained personnel. Our proposed experiment comprises one of the most comprehensive interrogations of the effects of MBT on patients to date, and if successful, could rapidly translate into a program with both clinical and economic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research Assistants who perform the pre- and post-assessments will not be privy to the group assignment of the participants and will not be involved in the data collection process during the duration of the intervention weeks.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •Mild Cognitive Impairment: Fulfill Diagnostic and Statistical Manual of Mental Disorders version five (DSM-V) diagnostic criteria for Minor Neurocognitive Disorder
- •MMSE score = 20-30
- •Clinical Dementia Rating Score (CDR) = 0.5
- •Age: ≤75 years
排除标准
- •Presence of major neurological conditions such as epilepsy, stroke, Parkinson's Disease and or brain injury
- •Presence of major psychiatric conditions such as major depression or schizophrenia
- •Unsuitability for fMRI scanning (e.g. pacemakers, metallic implants, claustrophobia)
- •Unable to give or no consent available
- •Left-handed participants may take part in the study but will not undergo fMRI scanning
结局指标
主要结局
Change in Immediate Memory
时间窗: 10 minutes
The RBANS Immediate Memory Index is composite of the learning (immediate) trials of the Story Memory and List Learning subtests. This index is a measure of initial encoding and learning complex and simple verbal information. Low scores on this index indicate difficulties with verbal learning.
Chang in Mindfulness Awareness and Attention Scores
时间窗: An average of 3 months
Dispositional Mindfulness and present-centered attention-awareness in everyday experience is measured with this scale. This instrument focused on the absence of attention to and awareness of present experience, and operationalized mindfulness as a single construct.
Change in Processing Speed: Colour Trails 1 and 2
时间窗: 10 minutes
Speed of cognitive processing and executive functioning is measured by the total time taken to complete each task.
Change in Attention
时间窗: 10 minutes
The RBANS Attention Index is a composite of the Digit Span and Coding subtests. This index is a measure of simple auditory registration and visual scanning and processing speed. Low scores on this index indicate difficulties with basic attention processes and speed of information processing.
Change in Delayed Memory
时间窗: 30 minutes
The RBANS Delayed Memory Index is a composite of the Story Memory Recall, List Learning Recall, List Learning Recognition, and Figure Recall subtests. This index is a measure of delayed recall and recognition for verbal and visual information. Low scores on this index indicate difficulties with recognition and retrieval of information from long-term memory stores.
次要结局
- Change in functional imaging measures: Resting state(10 minutes)
- Change in Subjective Quality of Life: Short-Form 36(An average of 3 months)
- Imaging measures (structural): change in orbitofrontal cortex volume(6 minutes)
- Change in Subjective measures of Sleep quality: Insomnia Severity Index(Two weeks)
- Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score(One month)