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Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment (MEDIC)

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ClinicalTrials.gov Identifier: NCT04000984
Recruitment Status : Completed
First Posted : June 27, 2019
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Mindfulness Based Training (MBT) Program Behavioral: Cognitive Rehabilitation Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Participants will be randomly assigned to receive either the treatment intervention, Mindfulness-Based Intervention, compared against an active control, the Cognitive Rehabilitation Training in parallel and both groups will also be compared against a passive control group, the Treatment as Usual, where no intervention takes place.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Investigating the Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Mindfulness-Based Intervention
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.
Behavioral: Mindfulness Based Training (MBT) Program
Participants in the MBT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. Mindfulness, defined as caring moment-to-moment awareness, will be cultivated through the teaching and formal practice of sitting and walking meditation, body scan, and mindful movement (e.g. yoga). Participants will also be taught how to practice mindfulness informally when eating, engaging in pleasurable activities and through interactions with others. Participants will be encouraged to practice approximately 30 minutes a day, and will be provided handouts as well as guided audio recordings of formal practices taught in session to aid their practice at home.
Other Name: MBT

Active Comparator: 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.
Behavioral: Cognitive Rehabilitation Training
Participants in the CRT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. The 8 week-program will consist of the following components: (i) identifying and working on at least one personal rehabilitation goal related to everyday life that is associated with cognitive difficulties; (ii) reviewing and building on the use of practical memory strategies, and or introducing and teaching the use of a new strategy or memory aid; (iii) introducing techniques for learning new information and associations, identifying the preferred strategy, and encouraging the application of this strategy in daily life; (iv) providing practice in maintaining attention and concentration; and (v) exploring current ways of coping with stress and anxiety as well as providing relaxation techniques to help aid with coping (Clare, 2007). Participants will be provided with instructional hand-outs as well as logs to record, monitor and evaluate their progress.
Other Name: CRT

No Intervention: Treatment As Usual
Participants in the Treatment As Usual group were only required to attend baseline and follow-up visits (approximately 3-months after) and Mid-intervention safety checks. Participants in this group will not receive an intervention for the duration of the study. They received treatment as usual which is 6 months to 1-year follow up visits with their attending neurologist of psychologist.



Primary Outcome Measures :
  1. Change in Attention [ Time Frame: 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.

  2. Change in Immediate Memory [ Time Frame: 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.

  3. Change in Delayed Memory [ Time Frame: 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.

  4. Change in Processing Speed: Colour Trails 1 and 2 [ Time Frame: 10 minutes ]
    Speed of cognitive processing and executive functioning is measured by the total time taken to complete each task.

  5. Chang in Mindfulness Awareness and Attention Scores [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Subjective Quality of Life: Short-Form 36 [ Time Frame: 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.


  2. Change in Subjective measures of Sleep quality: Insomnia Severity Index [ Time Frame: 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).

  3. Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score [ Time Frame: 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.


  4. Imaging measures (structural): change in orbitofrontal cortex volume [ Time Frame: 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.

  5. Change in functional imaging measures: Resting state [ Time Frame: 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.




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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fluent in English
  2. Mild Cognitive Impairment: Fulfill Diagnostic and Statistical Manual of Mental Disorders version five (DSM-V) diagnostic criteria for Minor Neurocognitive Disorder
  3. MMSE score = 20-30
  4. Clinical Dementia Rating Score (CDR) = 0.5
  5. Age: ≤75 years

Exclusion Criteria:

  1. Presence of major neurological conditions such as epilepsy, stroke, Parkinson's Disease and or brain injury
  2. Presence of major psychiatric conditions such as major depression or schizophrenia
  3. Unsuitability for fMRI scanning (e.g. pacemakers, metallic implants, claustrophobia)
  4. Unable to give or no consent available
  5. Left-handed participants may take part in the study but will not undergo fMRI scanning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000984


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
Investigators
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Principal Investigator: Kinjal Doshi, PhD Singapore General Hospital
Principal Investigator: Julian Lim, PhD Duke-NUS Graduate Medical School
Publications:
Mcbee, L. (2008) Mindfulness-based elder care. New York: Springer.

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04000984    
Other Study ID Numbers: 2015/3149
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Mindfulness
Cognitive Rehabilitation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders