MATILDA: Mindfulness and Attention Training Intervention to Lower Distractibility in Aging
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Nearly 14 million people are projected to develop Alzheimer's disease (AD) by 2050 in the USA alone (Geda, 2012), 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 (Basak, Qin & O'Connell, 2020) 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 (Basak, Qin & O'Connell, 2020). Attentional control is the ability to focus our 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 (Qin & Basak, 2020); 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, we have 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. We will compare these changes 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combined mindfulness meditation and cognitive training 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
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in composite score of overall cognition [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Change in composite score of overall cognition from baseline to post-training (i.e., after 8 weeks). Overall composite score will be calculated from standardized scores of all cognitive tasks including tasks of executive control (EC), processing speed (PS), working memory capacity (WMC), reasoning (R), episodic memory (EM), and a task of everyday cognition. The composite score for overall cognition will include correct responses (or RTs of correct responses) from: 6 EC tasks: Task Switching Response Time (RT; Behavioral data from the fMRI scanner task) Dimensional Change Flanker (RT) Stroop (RT) Visual N-back List Sorting Working Memory 4 EM tasks: Picture Sequence Memory RAVLT Story Recall (MMSE) Mnemonic Similarity Task (Behavioral data from the fMRI scanner task) 2 R tasks: Matrix Reasoning Visual Puzzle 1 WMC: 1. Complex span 2 PS tasks: DSST (MSMSE) 0-back RT 1 everyday cognition task: 1. RBMT
- Change in task-related functional connectivity of the DMN [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
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).
Secondary Outcome Measures
- Change in task-related functional connectivity of the cognitive networks [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
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).
- Change in the Composite Score of Psychosocial Functioning [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
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: MIDUS-II GDS (Geriatric Depression Scale) New General Self-Efficacy Scale
- Change in white matter structural connectivity [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
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).
Other Outcome Measures
- Change in composite score of executive control [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Change in executive control composite score will be calculated using the standardized measures from the following tasks: Task Switching Response Time (RT; Behavioral data from the fMRI scanner task) Dimensional Change Flanker (RT) Stroop (RT) Visual N-back List Sorting Working Memory
- Change in composite score of processing speed [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Processing speed scores will be calculated as a composite of the measures from the following tasks: random 0-back, Digit Symbol Substitution Task DSST (MMSE-2). The change in the processing speed score from baseline to post-training will be evaluated.
- Change in composite score of reasoning [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Reasoning scores will be calculated as a composite of the measures from tasks: Visual Puzzles (WAIS-4), Matrix Reasoning (WAIS-4). The change in the reasoning score from baseline to post-training will be evaluated.
- Change in composite score of episodic memory [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Attentional control scores will be calculated as a composite of the measures from the following tasks: Mnemonic Similarity Task MST, Picture Sequence Memory (NIH Toolbox), Story Memory (MMSE-2), Rey Auditory Verbal Learning Test RAVLT. The change in the episodic memory score from baseline to post-training will be evaluated.
- Change in composite score of working memory capacity [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Working memory capacity scores will be calculated as a composite of the measures from the following tasks: List Sorting Working Memory LSWM (NIH Toolbox), forward span (MMSE-2), backward span (MMSE-2). The change in the working memory capacity score from baseline to post-training will be evaluated.
- Change in score of everyday cognition [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Everyday memory scores will be calculated from the Rivermead-Behavioral Memory Test RBMT. The change in the everyday memory score from baseline to post-training will be evaluated.
- Change in task-related functional connectivity of the motor networks [9-10 weeks (includes baseline assessment, training, and post-training assessment)]
Change in task-related functional connectivity of the motor 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
Individuals will be included in the study only if they are right-handed, aged 65 to 85, have at least high school education and learned English before age 5. No claustrophobia or metal implants above the waist. If female, cannot be pregnant or likely to be pregnant. To be included in the study, one needs to meet a score threshold on the screening cognitive assessment (MoCA). Moreover, one needs physical and sensory capacity sufficient to undertake an fMRI study, which we will determine during the pre-screening session. Physical capacity includes the ability to stay still for the duration of the scan and sufficient finger dexterity to press buttons on the provided button boxes during the scan. Sensory capacity includes vision acuity of at least 20/30 after correction and no color blindness. Participant cannot have participated in similar training in the past two years.
Exclusion Criteria:
Participants will be excluded from the study if they are left-handed or ambidextrous weigh over 300 lb, did not attain at least high school education, and have not learned English before the age of 5. They will also be excluded if they are color blind, have vision acuity worse than 20/30 after correction, or experience excessive hand tremor or other motor impairment related to hand movement. Additionally, there are multiple medical conditions which could preclude one from participation in this study, including, history of cardiovascular disease other than treated hypertension, diabetes, psychiatric disorder, illness or trauma affecting the central nervous system, including stroke and head trauma resulting in loss of consciousness over 5 seconds, substance/alcohol abuse, and use of medication with anti-depressant, anti-psychotic effects. Use of hypnotic medication is allowed only occasionally at bedtime. Hypnotics are prescribed to induce sleep or improve its length and/or quality, and include such prescription drugs as Xanax, Ambien, Valium, etc.
An MRI screening questionnaire will be administered prior to entering the scanner. This screening questionnaire assesses current and prior medical conditions that could potentially exclude participation in the study. The screening questionnaire also addresses medical devices or implants that you may have, as well as non-medical sources of metal, e.g., shrapnel, prior hobby/work with metal. One will be excluded if the MRI image reveals evidence of pathology. Female participants that are pregnant or likely to become pregnant are not eligible for this study. Participants will be excluded if they participated in similar training in the past two years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Vital Longevity | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- The University of Texas at Dallas
Investigators
- Principal Investigator: Paulina Skolasinska, MS, The University of Texas at Dallas
- Study Director: Chandramallika Basak, PhD, The University of Texas at Dallas
Study Documents (Full-Text)
More Information
Publications
- Basak C, Qin S, O'Connell MA. Differential effects of cognitive training modules in healthy aging and mild cognitive impairment: A comprehensive meta-analysis of randomized controlled trials. Psychol Aging. 2020 Mar;35(2):220-249. doi: 10.1037/pag0000442. Epub 2020 Feb 3.
- Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.
- IRB-22-189