Healthy AgingMATILDANCT05974605
Mindfulness and Attention Training Intervention to Lower Distractibility in Aging
A study testing MM+HighC in people with Healthy Aging, run by The University of Texas at Dallas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- MM+HighC
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- MM+HighC
- Keywords
- cognitive training, mindfulness meditation training, functional magnetic resonance imaging, improving cognition, improving brain function, simulation games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM+HighCBehavioural
Also called Combined Mindfulness Meditation and Unpredictable Bird Watch, MM+CT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MM+HighC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Secondary outcomes (3)
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).
Measured: 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
Measured: 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).
Measured: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start17 Mar 2022
- Primary completion1 Nov 2023
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandramallika Basak, The University of Texas at Dallas
- Investigators
- Paulina Skolasinska, MS, Principal investigator, The University of Texas at DallasChandramallika Basak, PhD, Study director, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974605
- Sponsor's protocol ID
- IRB-22-189
- Acronym
- MATILDA
- Status last verified
- Nov 2024
- First submitted
- 25 Jul 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.
PubMed 22773365Basak 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.
PubMed 32011155
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Attention Training Intervention to Lower Distractibility in Aging
- ClinicalTrials.gov ID
- NCT05974605
- Acronym / sponsor ID
- MATILDA / IRB-22-189
- Conditions
- Healthy Aging
- Keywords
- cognitive training, mindfulness meditation training, functional magnetic resonance imaging, improving cognition, improving brain function, simulation games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined mindfulness meditation and cognitive training | Experimental | Behavioral: MM+HighCParticipants 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM+HighCAlso: Combined Mindfulness Meditation and Unpredictable Bird Watch, MM+CTIn 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. | Behavioural | Combined mindfulness meditation and cognitive training |
Primary outcome
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 1. WMC: Complex span 2. PS tasks: Digit Symbol Substitution Task 0-back RT 1 everyday cognition task: Rivermead Behavioural Memory Test
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).
3 secondary outcomes
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 the Composite Score of Psychosocial Functioning
Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Change in white matter structural connectivity
Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 22773365Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.
- Background: PubMed 32011155Basak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulina Skolasinska, MS principal investigator
The University of Texas at Dallas
Chandramallika Basak, PhD study director
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MM+HighC in people with Healthy Aging, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite score of overall cognition (time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.