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

NCT04000984 | Completed DMC

• 1 other identifier: 2015/3149
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mindfulness; Cognitive Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Change in Attention

  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.

  10 minutes

• Change in Immediate Memory

  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.

  10 minutes

• Change in Delayed Memory

  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.

  30 minutes

• Change in Processing Speed: Colour Trails 1 and 2

  Speed of cognitive processing and executive functioning is measured by the total time taken to complete each task.

  10 minutes

• Chang in Mindfulness Awareness and Attention Scores

  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.

  An average of 3 months

Secondary Outcomes (5)

• Change in Subjective Quality of Life: Short-Form 36

  An average of 3 months

• Change in Subjective measures of Sleep quality: Insomnia Severity Index

  Two weeks

• Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score

  One month

• Imaging measures (structural): change in orbitofrontal cortex volume

  6 minutes

• Change in functional imaging measures: Resting state

  10 minutes

Study Arms (3)

Mindfulness-Based Intervention

EXPERIMENTAL

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

Cognitive Rehabilitation Training

ACTIVE COMPARATOR

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

Treatment As Usual

NO INTERVENTION

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.

Interventions

Mindfulness Based Training (MBT) Program 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.

Also known as: MBT

Mindfulness-Based Intervention

Cognitive Rehabilitation Training 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.

Also known as: CRT

Cognitive Rehabilitation Training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (18)

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  BACKGROUND

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MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kinjal Doshi, PhD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Julian Lim, PhD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: June 27, 2019
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

SG (1)