Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Mindfulness Based Training (MBT) ProgramBehavioral: Cognitive Rehabilitation Training
- Registration Number
- NCT04000984
- Lead Sponsor
- Singapore General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Mindfulness-Based Intervention Mindfulness Based Training (MBT) Program Participants in this arm will complete baseline and follow-up visits (approximately 3-months after) and Mid-intervention safety checks. They will attend the in the Mindfulness-Based Training program that will meet weekly for 8 weeks. Each session will last approximately one-and-a-half hours. Cognitive Rehabilitation Training Cognitive Rehabilitation Training Participants in this arm will complete baseline and follow-up visits (approximately 3-months after) and Mid-intervention safety checks. They will attend the Cognitive Rehabilitation program that will meet weekly for 8 weeks. Each session will last one-and-a-half hours.
- Primary Outcome Measures
Name Time Method Change in Immediate Memory 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 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 10 minutes Speed of cognitive processing and executive functioning is measured by the total time taken to complete each task.
Change in Attention 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 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.
- Secondary Outcome Measures
Name Time Method Change in functional imaging measures: Resting state 10 minutes During two rsfMRI scans, subjects are imaged over several minutes while their eyes are open, but without performing any explicit task. The resting state scan will show only a fixation cross on the screen in order to minimize the cognitive processing involved while decreasing head movement and sleepiness in the scanner.
Mindfulness predisposition is measured with the use of traditional connectivity analysis as well as a newer method: graph theory analysis for task ready state in Dynamic Functional Connectivity. These data are extracted by decomposing the time-varying signal during resting periods into independent, intrinsically connected networks.Change in Subjective Quality of Life: Short-Form 36 An average of 3 months Short-Form 36 (SF-36) is a 36-item self-report survey of health, including physical and mental health, with 8 scaled scores, each ranging from a minimum of 0 to max 100. Total score is the mean of all the subscales.
Physical functioning : 10 items; Role functioning/physical : 4 items; Role emotional: 3 items; Energy/fatigue: 4 items; Mental Health: 5 items; Social functioning: 2 items; Body pain: 2 items; General health : 5 items; Reported health transition: 1 item.Imaging measures (structural): change in orbitofrontal cortex volume 6 minutes The change in the volume of orbitofrontal cortex (OFC) is assessed through structural MRI brain scans - Participants will have their baseline fMRI scan before the start of their participation in the intervention and after the end of the intervention.
Change in Subjective measures of Sleep quality: Insomnia Severity Index Two weeks Insomnia Severity Index (ISI) evaluates an individual's level of tendency for insomnia on a 7-item questionnaire, scoring in total from 0 to 28. Scores above 15 indicates moderate severity of clinical insomnia while scores above 22 are indicative of severe clinical insomnia. ISI internal consistency was excellent for population samples both in the community and clinical samples as well, (Cronbach α of 0.90 and 0.91 respectively).
Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score One month Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5.
The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score of 5 and above suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality.
Trial Locations
- Locations (1)
Singapore General Hospital
🇸🇬Singapore, Singapore