Skip to main content
OpenTrials
Completed

NCT Number: NCT05974605

Mindfulness and Attention Training Intervention to Lower Distractibility in Aging

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Vital Longevity

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MM+HighC

Behavioral

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: Combined Mindfulness Meditation and Unpredictable Bird Watch, MM+CT

Primary outcomes

  1. Change in composite score of overall cognition

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    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

  2. Change in task-related functional connectivity of the DMN

    Time frame: 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 outcomes

  1. Change in task-related functional connectivity of the cognitive networks

    Time frame: 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).

  2. Change in the Composite Score of Psychosocial Functioning

    Time frame: 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. Higher scores represent better outcomes.

    • MIDUS 2 (Midlife in the United States 2)
    • GDS (Geriatric Depression Scale)
    • New General Self-Efficacy Scale
  3. Change in white matter structural connectivity

    Time frame: 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 outcomes

  1. Change in composite score of executive control

    Time frame: 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. Higher scores represent better outcomes.

    • Task Switching Response Time (RT; Behavioral data from the fMRI scanner task)
    • Dimensional Change
    • Flanker (RT)
    • Stroop (RT)
    • Visual N-back
    • Random N-back (Behavioral data from the fMRI scanner task)
    • List Sorting Working Memory
  2. Change in composite score of processing speed

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    Change in processing speed composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.

    • random 0-back RT
    • Digit Symbol Substitution Task (DSST)
  3. Change in composite score of reasoning

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    Change in reasoning composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.

    • Visual Puzzles (from Wechsler Adult Intelligence Scale - WAIS-4)
    • Matrix Reasoning (from Wechsler Adult Intelligence Scale - WAIS-4).
  4. Change in composite score of episodic memory

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    Change in episodic memory composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.

    • Mnemonic Similarity Task MST,
    • Picture Sequence Memory (from NIH Toolbox),
    • Story Memory (from Mini-Mental State Examination - MMSE-2)
    • Rey Auditory Verbal Learning Test (RAVLT)
  5. Change in composite score of working memory capacity

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    Change in working memory capacity composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.

    • forward span (from Wechsler Adult Intelligence Scale - WAIS-4),
    • backward span (from Wechsler Adult Intelligence Scale - WAIS-4)
  6. Change in score of everyday cognition

    Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)

    Change in everyday memory score will be calculated using the Rivermead Behavioural Memory Test (RBMT). Higher scores represent better outcomes.

  7. Change in task-related functional connectivity of the motor networks

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Acronym: MATILDA

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 3, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.