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

Singapore Health Services (SingHealth)

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Cognitive Rehabilitation Training; Behavioral: Mindfulness Based Training (MBT) Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04000984

2015/3149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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81 participants in 3 patient groups

Mindfulness-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Training (MBT) Program

Cognitive Rehabilitation Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Rehabilitation Training

Treatment As Usual

No Intervention group

Description:

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.