Mindfulness and Attention Training Intervention to Lower Distractibility in Aging

Study Overview
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Brief Summary
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The goal of this interventional study is to test the efficacy of combined mindfulness meditation training and cognitive training on brain function and cognition in healthy older adults. Participants will undergo cognitive and neuroimaging (MRI and fNIRS) assessments before and after an 8-week ( 20 hours) training intervention. The intervention will consist of at-home mindfulness meditation followed by playing a cognitive game on a provided tablet. The findings will be compared to an existing data from older adults who trained on the cognitive game only (NCT03988829; Arms 1 and 2).

Detailed Description
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Nearly 14 million people are projected to develop Alzheimer's disease (AD) by 2050 in the USA alone, with those affected by mild cognitive impairment (MCI) being especially at risk. Therefore, interventions aimed at prevention of dementia and promotion of brain and cognitive health in older adults need to be developed. One of the most successful types of non-pharmacological intervention is cognitive training, where participants engage in mental exercises targeting one or multiple cognitive domains. A recent meta-analysis has found that both healthy older adults and older adults affected by MCI, benefit equally in cognitive health from such training. Importantly, both populations showed improvements in cognitive abilities that were beyond the trained skills, such as everyday cognition, suggesting that cognitive training has a broad impact on independence in daily activities and quality of life. The training of attentional control has proven to be the most effective type of single-component training. Attentional control is the ability to focus attention to a task while inhibiting distractors; this core ability is fundamental for many everyday tasks. In addition to directly training attentional control, another promising approach to reducing distractibility is mindfulness meditation. As for the neural effects of attentional control training and meditation training, alterations in resting state brain function are reported, esp. in Default Mode Network (DMN) regions that are related to memory and attentional control. DMN is found to be engaged in older adults, but is disengaged in younger adults; this overactivation is detrimental to cognitive performance. However, the combined benefits of cognitive control training and mindfulness meditation on cognition and DMN are understudied in older adults. In this project, there is a single training arm that will train healthy older adults on a combination training composed of high attentional control and mindfulness meditation using simulation based games. Neural and cognitive changes in near and far transfer tasks will be examined immediately after the intervention. These changes will be compared with that of a previously collected group of older adults who received only cognitive control training (NCT03988829; Arms 1 and 2). Changes in overall cognition (primary cognitive outcome) and changes in DMN connectivity during task (primary neuroimaging outcome) and rest (secondary neuroimaging outcome) in this combination training group will be compared to the respective changes in Arm 1 (low attentional control training) and Arm 2 (High Attentional Control training) of the existing dataset. The protocol of participant recruitment, pre- and post- training assessments (MRI and behavioral), and training platform remain same between this study and the existing database. In this current study, participants also undergo a functional near infra-red spectroscopy (fNIRS) session, after completion of behavioral and MRI session, at pre-training and post-training. This clinical trial will result in the development of more efficient behavioral intervention tools in older adults, based on neuroimaging evidence, that can be readily used from the comfort of home.

Official Title
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Mindfulness and Attention Training Intervention to Lower Distractibility in Aging

Conditions
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Healthy Aging

Intervention / Treatment
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* Behavioral: MM+HighC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: right-handed aged 65 to 85 years old at least high school education learned English before age 5. screening cognitive assessment (MoCA) score above the threshold physical and sensory capacity sufficient to undertake an fMRI study: the ability to stay still for the duration of the scan sufficient finger dexterity to press buttons on the provided button boxes during the scan vision acuity of at least 20/30 after correction no color blindness no claustrophobia no metal implants above the waist if female, cannot be pregnant or likely to be pregnant. cannot have participated in similar training in the past two years. Exclusion Criteria: left-handed or ambidextrous weigh over 300 lb did not attain at least high school education have not learned English before the age of 5 screening cognitive assessment (MoCA) score below the threshold color blind have vision acuity worse than 20/30 after correction experience of excessive hand tremor or other motor impairment related to hand movement history of cardiovascular disease other than treated hypertension diabetes psychiatric disorders illness or trauma affecting the central nervous system, including stroke and head trauma resulting in loss of consciousness over 5 seconds substance/alcohol abuse use of medication with anti-depressant, anti-psychotic effects (use of hypnotic medication is allowed only occasionally at bedtime). certain medical devices or implants non-medical sources of metal, e.g., shrapnel, prior hobby/work with metal MRI image revealing evidence of pathology female participants that are pregnant or likely to become pregnant participated in similar training in the past two years

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: The trail will collect data from a single group. The results will be compared to a previously collected data from two arms of an RCT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined mindfulness meditation and cognitive training<br>Participants train at home for 20 hours over 8 weeks, splitting the time between mindfulness meditation and cognitive training. Participants train for 30 minutes per day, for 5 days a weeks on a provided tablet computer. The participants are to keep a paper log of dates and durations. The mindfulness meditation portion of the training is a commercially available mobile app. Participants listen to guided meditations and follow the instructions. The program includes common mindfulness meditation exercises such as body scan or breath awareness. The cognitive training portion of the intervention uses a highly demanding attentional control training program BirdWatch game (BWGU). BWGU is a gamified n-back paradigm where participants randomly switch the focus of attention to update or maintain an adaptively growing set of bird stimuli in their working memory and are sometimes required to inhibit their response. | Behavioral: MM+HighC<br>* In this intervention, participants will be trained on a available mindfulness meditation app, followed by a working memory updating game, developed by Dr. Chandramallika Basak. This game requires high degree of attentional control (Unpredictable Bird Watch), also known as High-C. The app and the game are delivered through an Android tablet for this home-based training.<br>* Other names: MM+CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite score of overall cognition | Change in composite score of overall cognition from baseline to post-training (after 8 weeks). Overall composite score calculated from standardized scores of tasks of executive control (EC), processing speed (PS), working memory capacity (WMC), reasoning (R), episodic memory (EM), everyday memory. Higher scores represent better outcomes. The composite score for overall cognition will include correct responses (or their response times - RT) from: 7 EC tasks: Task Switching (RT; fMRI task behavioral data) Dimensional Change Flanker (RT) Stroop (RT) Visual N-back Random N-back (fMRI task behavioral data) List Sorting Working Memory 4 EM tasks: Picture Sequence Memory Rey Auditory Verbal Learning Test Story Recall Mnemonic Similarity Task (fMRI task behavioral data) 2 R tasks: Matrix Reasoning Visual Puzzle WMC: Complex span PS tasks: Digit Symbol Substitution Task 0-back RT 1 everyday cognition task: Rivermead Behavioural Memory Test | 9-10 weeks (includes baseline assessment, training, and post-training assessment) | 
| Change in task-related functional connectivity of the DMN | Change in task-related functional connectivity of the default mode network from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition). | 9-10 weeks (includes baseline assessment, training, and post-training assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in task-related functional connectivity of the cognitive networks | Change in task-related functional connectivity of the cognitive networks from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition). | 9-10 weeks (includes baseline assessment, training, and post-training assessment) | 
| Change in the Composite Score of Psychosocial Functioning | Change in composite score of Psychosocial Functioning from baseline to post-training (i.e., after 8 weeks). Overall composite score will be calculated from standardized scores of 3 questionnaires. Higher scores represent better outcomes. MIDUS 2 (Midlife in the United States 2) GDS (Geriatric Depression Scale) New General Self-Efficacy Scale | 9-10 weeks (includes baseline assessment, training, and post-training assessment) | 
| Change in white matter structural connectivity | Change in white matter structural connectivity (number of tracts that pass two ROIs and the fractional anisotropy sampled by the tracks) from baseline to post-training (i.e., after 8 weeks of training). | 9-10 weeks (includes baseline assessment, training, and post-training assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive training, mindfulness meditation training, functional magnetic resonance imaging, improving cognition, improving brain function, simulation games