A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (The MACS Study: Mindfulness and Attentional Control in Seniors)
Phase: NA
Conditions: Cognitive Aging
Sponsor: University of Florida

Cover Page  Protocol and SAP 
Official Title of the study: A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults 
(The MACS Study: Mindfulness and Attentional Control in Seniors) 
NCT number: NCT02714426 
Date of the document: IRB version: 03-30-2016 

Protocol                                                                                                                               Page 1 of 5 
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1. Background: 
 
The proposed study is an intensive micro-longitudinal 14-week investigation exploring 
week to week changes in attentional and emotional control in older adults who do and 
do not receive 8-weeks of mindfulness education and training. The study focuses 
narrowly on attentional and emotional control. The study compares changes in 
attentional and emotional control between one group of participants who receive 
fourteen weeks of weekly testing plus eight weeks of mindfulness training and 
education, and another that receives that receives the same fourteen weeks of testing  
plus eight weeks of active control ‘brain health’ educational sessions. The 
development of this study was guided by several key concepts: 
 
Mindfulness meditation, with its primary focus on attention to the present moment,1 is 
one possible avenue for attentional improvement in young and middle-aged adults. A 
small but steadily growing body of literature suggests that meditation may have similar 
effects on attentional control in late life, a period of normative decline 2,3  It has been 
shown that mindfulness meditative practice, such as a standardized mindfulness 
based stress reduction program (MBSR; Kabat-Zinn, 2003),1 increases the efficiency 
of attention networks.4,5,6  so applying mindfulness inspired interventions would seem 
to offer one route to cognitive remediation in older adults. 
 
Additionally, 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.7,8,9 More 
recent experimental studies have ventured only to determine that meditation naïve 
individuals can experience attentional improvement with mindfulness 
intervention,10,11,12 (rather than why) using pre-post mindfulness training designs. The 
time course of the association of mindfulness training with attention has yet to be 
studied, leaving a gap in the field’s collective knowledge of when and how these 
improvements manifest.  
 
Finally, although emotion regulation is thought to improve through mindfulness,13 the 
time course of its development and its potential influence on attentional control have 
thus far been unclear. Therefore, emotion-related data is important to collect with 
respect to the time course of attentional change.  
 

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2. Specific Aims: 
 
The proposed micro-longitudinal research study will consider the relationship between 
mindfulness meditation practice and attentional control in older age, with a focus on 
the temporal dynamics of attentional and emotional change produced during 8-weeks 
of mindfulness sessions. This study, by examining the week-to-week trajectory of 
gains in an older adult sample undergoing training in mindfulness, will expand our 
understanding of possible dose-response relationships, as well as possible mediators 
of those gains, areas for which minimal data exist. 
3. Research Plan / Study Description: 
 
Initial Telephone Contact:  
Prior to in-person contact with the study, potential participants will first be contacted 
via telephone.  
Exclusion criteria are:  
• Under 65 years of age 
• 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  
o Have ever had a major stroke or mini-stroke 
o Have ever had a traumatic brain injury (e.g. moderate to severe brain 
injury)Have ever had another significant brain abnormality 
o Have a neurodegenerative disorder (Parkinson’s disease, Huntington’s 
disease, dementia of any type, etc.) 
• Current or past history of major psychiatric disturbance including 
schizophrenia, or active psychosis, current major depressive episode, current 
alcohol or substance abuse or history thereof within the past six months, or 
EVER HOSPITALIZED for any of the above conditions 
• Radiation treatment for cancer above the neck 
• 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  
•  Any prior training in (e.g. multi-day course) in mindfulness meditation, or 
current practice of any form of meditation. 
• History of receiving cognitive or neuropsychological testing within the last 6 
months 
 

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To avoid collecting personal health information, participants will not be asked to report 
on their status regarding these exclusion criteria individually. Instead, they will be 
asked to endorse their eligibility based on all the criteria in the single block. This 
ensures that investigators do not know, and cannot record, which specific exclusion 
criteria, if any, disqualifies the individual.  
 
If individuals are eligible to take part in the study, they will be scheduled for an intake 
consent and baseline assessment session. 
 
Consent, Baseline Assessment/Pretest, and Post-test Assessment: 
Consent procedures are described below. Baseline assessments will include a 
demographics questionnaire, a self-administered health comorbidity scale, a global 
health-related quality of life survey, measures of self-reported everyday function, a 
measure of global cognition, and a measure of reading literacy (Appendix B). 
Participants will also complete emotion, mood, and mindfulness questionnaires, and 
will complete computerized and paper-and-pencil cognitive testing. Following this 
initial visit, participants will be randomly assigned to either the active control brain 
health group or the mindfulness group. 
 
At the Post-test  visit, all participants will complete a subset of the same emotion, 
mood, and mindfulness questionnaires, and cognitive testing measures that were 
completed at the Consent and Baseline/Pre-test  visit. It should be noted that the 
inclusion of the global cognition measure and mood questionnaires is NOT for clinical 
case determination/diagnosis or screening.  Rather, these measures are being used 
as brief, well validated measures of individual differences in mood and global 
cognition, to characterize the sample in manuscripts. 
 
Weeks 1-14 
The total anticipated sample has the goal of enrolling 48 individuals who fully 
complete all study activities. To distribute workload, the study will be conducted in 
three to four replicates, each enrolling twelve (12) to sixteen (16) participants. For all 
participants, their personal study participation is 14-16 weeks long (including pre- and 
post-testing, and includes 1 hour of attentional and emotional control assessment 
challenges each week for 14 weeks. Participants will also spend an additional 2 hours 
each week with the study in weeks 4-11 to participate in 8 weekly group sessions 
(mindfulness or active control ‘brain health’ education). 
 
Mindfulness Procedure 
In the mindfulness program, participants will participate in 8 weekly group sessions, 
each lasting approximately 2 hours in duration, along with a half day Mindfulness 
Retreat at the end of the training period. Specific course material will adhere strictly to 
a manualized protocol by Stahl and Goldstein (2000).14 A detailed schedule of training 
session content is outlined in Appendix E. Each session will include 1) a 
psychoeducational component, 2) formal exercises in the form of guided practice, and 
3) thoughtful exploration of ideas and questions. Formal mindfulness practices will 
follow 21 guided pre-recorded meditative MP3 tracks from the authors for use in class 

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and at home, promoting both fidelity to the protocol and uniformity across replicates. 
Activities in the protocol include mindful breathing, eating, walking, and various other 
practices well documented in the literature to promote mindfulness. Participants will 
also be asked to practice on their own time and to take note of the amount of practice 
they complete outside of class.  
 
Active Control Procedure 
An active control comparison group will be included in this study. This group will take 
the form of a health enhancement ‘brain health’ education program. Topics to be 
presented and discussed in this group will include healthy sleep, healthy eating, 
exercise, aging and mental health, dementia risk factors, cognitively stimulating 
activities, overall safety and health management in older age, and social engagement 
in late life. Like in the mindfulness program, participants randomized to this active 
control group will participate in 8 weekly group sessions, each lasting approximately 2 
hours in duration. Every effort will be made to keep this group equivalent to the 
mindfulness group in terms of length of session, participant interaction with each other 
and with study staff, and other factors like time of day. 
 
Data analysis: 
Jacqueline Maye, with the assistance of Dr. Michael Marsiske, will conduct analyses 
once data have been collected. Multivariate latent change models (e.g. curve of 
factors or factors of curves) and dual change score models will be used to examine 
overall trajectory of global attentional change as well as lead-lag relations between 
affective and cognitive changes across 14 weeks. 
 

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4. Possible Discomforts and Risks: 
 
To the best of our knowledge, the physical, psychological, and social risks associated 
with this study are less than minimal.  However, some participants may experience 
some frustration or worry about their performance during the attention tasks.  
Participants will be encouraged to simply try their best during these tasks.  During the 
testing session, participants will be asked frequently about their level of comfort; if 
they become uncomfortable, they will be offered as many breaks as they want.   
In addition, some participants may feel uncomfortable completing required activities in 
front of others in the group. Participants are reminded that their participation is 
voluntary, that they will be randomly assigned to an experimental group, and selecting 
to opt out of participating will not affect their medical care or residential status at The 
Village (if applicable) in any way.  
There is, as with all research studies, a slight risk that information about participants 
could be revealed inappropriately or accidentally (e.g., if there is a forced break-in into 
our locked offices and locked file cabinets).  Although we consider such risk to be less 
than minimal, depending on the nature of the information, such a release could upset 
or embarrass participants. 
5. Possible Benefits: 
 
There is no guaranteed direct benefit to participants. Repeated re-testing over 14 
weeks has been shown in many studies to result in practice-related improvement. 
Therefore, many participants may be expected to experience improved cognitive 
scores. In addition, given that mindfulness meditation therapies have been effective at 
improving mood and coping, some participants may experience mood benefits that 
would include decreased symptoms of depression, apathy, anxiety, and perceived 
stress. 
6. Conflict of Interest: 
 
No financial or ethical conflicts of interest exist or are anticipated by any investigator.