Cognitive AgingMACSNCT02714426
A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults
A study testing Mindfulness-inspired treatment and Brain health in people with Cognitive Aging, run by University of Florida at 1 site in United States.
Trial summary
Attentional control, or individuals' ability to choose which stimuli in the environment they attend to and which they ignore, declines with older age. Studies from the past two decades suggest that mindfulness meditative practice, such as a standardized mindfulness based stress reduction programs, may increase the… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging
- What is being tested?
- Mindfulness-inspired treatment and Brain health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to provide informed consent and perform cognitive and behavioral (mindfulness) interventions;
- Time and willingness to commit to the completion of this study;
- Ability to read at an 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) and reading text at 14 point font
Who cannot join
- Lack of time and willingness to commit to the completion of this 14-week study
- Less than an 8th grade education
- Having been told by a healthcare provider that they (1) have had a stroke or mini-stroke in the past 12 months, (2) have ever had a traumatic brain injury, (3) have had schizophrenia or psychosis, (4) have problem with alcohol or substance abuse
- extreme difficulty reading ordinary print in a newspaper, or have stopped reading due to poor eyesight.
- extreme difficulty hearing, or being completely unable to hear, ordinary speech in low-noise conditions, even with hearing aid.
- Currently participating in cognitive training or brain training
- Having participated in any cognitive or brain training study within the last 6 months
- Currently participating in yoga or meditation based practices
Trial locations and contacts
1 site in 1 country.
United States1 site
The Vital Laboratory at the The Village
Gainesville, Florida, 32606
About this study
Official title: A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (The MACS Study: Mindfulness and Attentional Control in Seniors)
Attentional control, or individuals' ability to choose which stimuli in the environment they attend to and which they ignore, declines with older age. Studies from the past two decades suggest that mindfulness meditative practice, such as a standardized mindfulness based stress reduction programs, may increase the efficiency of attention networks.To date, the majority of studies that have related mindfulness meditation practice to attentional control have been based on retrospective self-reported mindfulness or cross-sectional measurement in experienced meditators. More recent experimental studies using pre-post training designs have shown that meditation-naïve individuals can experience attentional improvement with mindfulness intervention. This study seeks to elucidate the time course and process by which such attentional improvements might be achieved.
This research study investigates change in attentional control as participants progress through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific aims: 1) to determine the time course of change in attentional components such as cognitive control and sustained attention as a consequence of MIT; attention will be measured weekly for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent to which change in attentional performance is coupled/correlated with markers of emotion regulation, perceived mindfulness, and perceived mind wandering.
Read the detailed description
This will be a 14-week research study exploring week to week changes in attentional control and selected time-varying covariates. The study will involve comparison of two groups of adults aged 65 and older. Half the participants (n=20) will be randomized to received eight weeks of mindfulness-inspired training, while the other half (n=20) are not.
Groups will be compared in the amount of change experienced in measures of attentional control. In addition, the association between changes in emotion regulation, perceived mindfulness, and perceived mind wandering with changes in attentional control will be examined, as well as whether this association differs between persons who did and did not receive mindfulness-inspired training. Measurement will include both paper-and-pencil and computer-administered tests.
- Conditions
- Cognitive Aging
- Being tested
- Mindfulness-inspired treatment, Brain health
- Keywords
- Cognitive Aging, Attention, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-inspired treatmentBehavioural
Also called Mindfulness-based stress reduction
Eight weekly group MIT sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal MIT training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. MIT activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice MIT on their own time, and to log this.
Brain healthOther
Also called Active comparator
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
| Study group | Role | What they receive |
|---|---|---|
| Brain Health | Active comparator | In weeks 1 and 14, participants receive: Montreal Cognitive Assessment (MoCA), Wechsler Test of Adult Reading (WTAR), Functional Activities Questionnaire (FAQ), Older Americans Resources and Services (OARS) Complete Activities of Daily Living Scale, The Short Form (36) Health Survey (SF-36), Attention measures (Attention Network Test (ANT); Continuous Performance Test (CPT); Auditory Dual Task (ADT); Mind wandering; Cued Stroop), Positive and Negative Affect Scale (PANAS), Geriatric Depression Scale (GDS), Mindfulness Attention Awareness Scale (MAAS), Five Facet Mindfulness Questionnaire (FFMQ), Emotion Regulation Questionnaire (ERQ), State-Trait Anxiety Inventory (STAI), and Starkstein Apathy Scale (AS). In weeks 4-11, participants receive the Brain Health control instruction. Receives: Other: Brain health |
| Mindfulness-inspired Treatment/Testing | Experimental | Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment Receives: Behavioral: Mindfulness-inspired treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
The Attention Network Task is a computerized test that measures three different components of attention (alerting, orienting, and conflict monitoring). Score is the computed as the difference between reaction time on correct trials in cued and uncued conditions. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Measured: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary outcomes (2)
Performance in Useful Field of View Over 14 Weekly Measurements
The useful field of view task is a computer-administered selective visual attention test that determines the minimum presentation time needed (between 16-500 msec) to correctly make two visual judgments: (a) is a centrally presented line drawing of a car or truck? and (b) where on the screen is a peripheral car located? Score is the fastest presentation time at which participants achieve at least 75% accuracy. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Measured: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Performance in Stroop Interference Over 14 Weekly Measurements
This task set is computerized presents participants with a word (red or green or blue) that may be presented in (a) congruent (same) color as the word itself (e.g., red word is printed in red), or (b) incongruent (word red printed in green or blue). Participants are cued to either select the word or the color, this varies from trial to trial. Score is the reaction time difference between correct responses to congruent and incongruent stimuli. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Measured: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startNov 2016
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jacqueline E. Maye, MS, Principal investigator, University of FloridaMichael Marsiske, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714426
- Sponsor's protocol ID
- IRB02-2016-U-0277-N
- Other IDs
- 1F31AG051356-01A1, IRB201800586
- Acronym
- MACS
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2016
- Last updated
- 7 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon request by the study principal investigator. Data to be released will include the variables and participants included in any specific published manuscript, and will be eligible for release twelve months after the date of publication or e-publication in final form.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (The MACS Study: Mindfulness and Attentional Control in Seniors)
- ClinicalTrials.gov ID
- NCT02714426
- Acronym / sponsor ID
- MACS / IRB02-2016-U-0277-N
- Conditions
- Cognitive Aging
- Keywords
- Cognitive Aging, Attention, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 21 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attentional control, or individuals' ability to choose which stimuli in the environment they attend to and which they ignore, declines with older age. Studies from the past two decades suggest that mindfulness meditative practice, such as a standardized mindfulness based stress reduction programs, may increase the efficiency of attention networks.To date, the majority of studies that have related mindfulness meditation practice to attentional control have been based on retrospective self-reported mindfulness or cross-sectional measurement in experienced meditators. More recent experimental studies using pre-post training designs have shown that meditation-naïve individuals can experience attentional improvement with mindfulness intervention. This study seeks to elucidate the time course and process by which such attentional improvements might be achieved.
This research study investigates change in attentional control as participants progress through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific aims: 1) to determine the time course of change in attentional components such as cognitive control and sustained attention as a consequence of MIT; attention will be measured weekly for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent to which change in attentional performance is coupled/correlated with markers of emotion regulation, perceived mindfulness, and perceived mind wandering.
Detailed description
This will be a 14-week research study exploring week to week changes in attentional control and selected time-varying covariates. The study will involve comparison of two groups of adults aged 65 and older. Half the participants (n=20) will be randomized to received eight weeks of mindfulness-inspired training, while the other half (n=20) are not.
Groups will be compared in the amount of change experienced in measures of attentional control. In addition, the association between changes in emotion regulation, perceived mindfulness, and perceived mind wandering with changes in attentional control will be examined, as well as whether this association differs between persons who did and did not receive mindfulness-inspired training. Measurement will include both paper-and-pencil and computer-administered tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Health | Active comparator | Other: Brain healthIn weeks 1 and 14, participants receive: Montreal Cognitive Assessment (MoCA), Wechsler Test of Adult Reading (WTAR), Functional Activities Questionnaire (FAQ), Older Americans Resources and Services (OARS) Complete Activities of Daily Living Scale, The Short Form (36) Health Survey (SF-36), Attention measures (Attention Network Test (ANT); Continuous Performance Test (CPT); Auditory Dual Task (ADT); Mind wandering; Cued Stroop), Positive and Negative Affect Scale (PANAS), Geriatric Depression Scale (GDS), Mindfulness Attention Awareness Scale (MAAS), Five Facet Mindfulness Questionnaire (FFMQ), Emotion Regulation Questionnaire (ERQ), State-Trait Anxiety Inventory (STAI), and Starkstein Apathy Scale (AS). In weeks 4-11, participants receive the Brain Health control instruction. |
| Mindfulness-inspired Treatment/Testing | Experimental | Behavioral: Mindfulness-inspired treatmentParticipants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Able to provide informed consent and perform cognitive and behavioral (mindfulness) interventions;
- Time and willingness to commit to the completion of this study;
- Ability to read at an 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) and reading text at 14 point font
Key exclusion criteria (8 listed)
- Lack of time and willingness to commit to the completion of this 14-week study
- Less than an 8th grade education
- Having been told by a healthcare provider that they (1) have had a stroke or mini-stroke in the past 12 months, (2) have ever had a traumatic brain injury, (3) have had schizophrenia or psychosis, (4) have problem with alcohol or substance abuse
- extreme difficulty reading ordinary print in a newspaper, or have stopped reading due to poor eyesight.
- extreme difficulty hearing, or being completely unable to hear, ordinary speech in low-noise conditions, even with hearing aid.
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 |
|---|---|---|
| Mindfulness-inspired treatmentAlso: Mindfulness-based stress reductionEight weekly group MIT sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal MIT training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. MIT activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice MIT on their own time, and to log this. | Behavioural | Mindfulness-inspired Treatment/Testing |
| Brain healthAlso: Active comparatorEight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health. | Other | Brain Health |
Primary outcome
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
The Attention Network Task is a computerized test that measures three different components of attention (alerting, orienting, and conflict monitoring). Score is the computed as the difference between reaction time on correct trials in cued and uncued conditions. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
2 secondary outcomes
Performance in Useful Field of View Over 14 Weekly Measurements
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Performance in Stroop Interference Over 14 Weekly Measurements
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request by the study principal investigator. Data to be released will include the variables and participants included in any specific published manuscript, and will be eligible for release twelve months after the date of publication or e-publication in final form.
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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.
Jacqueline E. Maye, MS principal investigator
University of Florida
Michael Marsiske, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-inspired treatment and Brain health in people with Cognitive Aging, run by University of Florida 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 3 inclusion and 8 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 7 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements (time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.