Mindfulness and Attention Training Intervention to Lower Distractibility in Aging

NCT05974605 | Completed

• 1 other identifier: IRB-22-189
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Aging

Keywords

cognitive training; mindfulness meditation training; functional magnetic resonance imaging; improving cognition; improving brain function; simulation games

Outcome Measures

Primary Outcomes (2)

• 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 1. WMC: Complex span 2. 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 Outcomes (3)

• Change in task-related functional connectivity of the cognitive networks

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

• Change in the Composite Score of Psychosocial Functioning

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

• Change in white matter structural connectivity

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

Other Outcomes (7)

• Change in composite score of executive control

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

• Change in composite score of processing speed

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

• Change in composite score of reasoning

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

Study Arms (1)

Combined mindfulness meditation and cognitive training

EXPERIMENTAL

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

Interventions

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.

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

Combined mindfulness meditation and cognitive training

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

Center for Vital Longevity

Dallas, Texas, 75235, United States

Location

Related Publications (2)

• Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.

  PMID: 22773365 BACKGROUND

• 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.

  PMID: 32011155 BACKGROUND

Study Officials

• Paulina Skolasinska, MS

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Chandramallika Basak, PhD

  The University of Texas at Dallas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: March 17, 2022
• Primary Completion: November 1, 2023
• Study Completion: June 27, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)