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

NCT ID: NCT04000984

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-01

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Based Training (MBT) Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Rehabilitation Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBT; CRT

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kinjal Doshi, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Julian Lim, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke-NUS Graduate Medical School

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

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Other Identifiers

2015/3149

Identifier Type: -

Identifier Source: org_study_id