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Behavioural Intervention
Mindfulness + Cognitive Training for Healthy Aging (MATILDA Trial)
N/A
Waitlist Available
Led By Paulina Skolasinska, MS
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Awards & highlights
Summary
This trial will test if meditation & cognitive game can improve brain function & cognition in older adults. Participants will be assessed before & after 8-week (~20 hr) training of at-home meditation & cognitive game.
Who is the study for?
This trial is for right-handed individuals aged 65-85 who learned English before age 5, have at least a high school education, and can undergo MRI scans without issues like claustrophobia or metal implants. They should not be pregnant, have significant health problems like heart disease or CNS trauma, substance abuse issues, or severe vision impairments.
What is being tested?
The study tests if mindfulness meditation combined with cognitive games (MM+HighC) improves brain function in healthy older adults. Participants will practice meditation and play games on a tablet for about 20 hours over eight weeks and get cognitive and neuroimaging assessments before and after the intervention.
What are the potential side effects?
Since this trial involves non-invasive practices such as mindfulness meditation and cognitive training games, side effects are minimal to none. However, discomfort from staying still during MRI scans may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9-10 weeks (includes baseline assessment, training, and post-training assessment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-10 weeks (includes baseline assessment, training, and post-training assessment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in composite score of overall cognition
Change in task-related functional connectivity of the DMN
Secondary study objectives
Change in task-related functional connectivity of the cognitive networks
Change in the Composite Score of Psychosocial Functioning
Change in white matter structural connectivity
Other study objectives
Change in composite score of episodic memory
Change in composite score of executive control
Change in composite score of processing speed
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Combined mindfulness meditation and cognitive trainingExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
The University of Texas at DallasLead Sponsor
62 Previous Clinical Trials
106,628 Total Patients Enrolled
Chandramallika Basak, PhDStudy DirectorThe University of Texas at Dallas
1 Previous Clinical Trials
75 Total Patients Enrolled
Paulina Skolasinska, MSPrincipal InvestigatorThe University of Texas at Dallas
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My corrected vision is at least 20/30.I have diabetes.I have a history of heart disease, but not including high blood pressure that's under control.I am between 65 and 85 years old.I weigh more than 300 pounds.I have had a brain injury or stroke that made me lose consciousness for more than 5 seconds.I learned English before I was 5 years old.I am currently pregnant or might become pregnant soon.I can physically and mentally handle an fMRI scan.I can stay still for a long scan.I only use sleep medication occasionally at night and do not take anti-depressants or anti-psychotics.I am not pregnant nor planning to become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Combined mindfulness meditation and cognitive training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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