Clinical trial NCT05974605: Mindfulness and Attention Training Intervention to Lower Distractibility in Aging
Official title: Mindfulness and Attention Training Intervention to Lower Distractibility in Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: cognitive training
mindfulness meditation training
functional magnetic resonance imaging
improving cognition
improving brain function
simulation games
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in composite score of overall cognition
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in task-related functional connectivity of the DMN
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Secondary outcomes:
measure: Change in task-related functional connectivity of the cognitive networks
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in the Composite Score of Psychosocial Functioning
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in white matter structural connectivity
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Other outcomes:
measure: Change in composite score of executive control
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in composite score of processing speed
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in composite score of reasoning
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in composite score of episodic memory
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in composite score of working memory capacity
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in score of everyday cognition
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Change in task-related functional connectivity of the motor networks
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Locations:
city: Dallas
country: United States
facility: Center for Vital Longevity
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Paulina Skolasinska, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Dallas
name: Chandramallika Basak, PhD
role: STUDY_DIRECTOR
References:
citation: Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.
citation: 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.