NCT04000984

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-06-27
• Last updated: 2020-03-27

Locations

1 site across 1 country: Singapore