Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (MACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714426
Recruitment Status : Completed
First Posted : March 21, 2016
Results First Posted : February 21, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief 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 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.


Condition or disease Intervention/treatment Phase
Cognitive Aging Behavioral: Mindfulness-inspired treatment Other: Brain health Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (The MACS Study: Mindfulness and Attentional Control in Seniors)
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
Active Comparator: Brain Health
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.
Other: Brain health
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.
Other Name: Active comparator

Experimental: Mindfulness-inspired Treatment/Testing
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
Behavioral: Mindfulness-inspired treatment
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.
Other Name: Mindfulness-based stress reduction




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
    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)

  2. 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 ]
    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)


Other Outcome Measures:
  1. Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements [ Time Frame: Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11 ]
    Participants in both arms are asked, at the end of each of their eight intervention sessions, to focus on breathing. They are interrupted five times during this breathing exercise and asked what proportion of their attention (0-100) was wandering off the breathing task. Score is the average proportion of self-rated mind-wandering over five probes. 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. Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements [ Time Frame: Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 ]
    Participants will answer computer 7 administered questions about anxiety in the past week. Score is a Likert-type scale response from the following scale: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)

  3. Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements [ Time Frame: Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 ]
    Cognitive and Affective Mindfulness Scale (CAMSr) will be computer administered. It is a psychological measurement to explore mindfulness. Each week ten items are rated on a 4-point Likert-type scale (1=rarely/never, 2=sometimes, 3=often, 4=almost always). Higher scores indicate greater cognitive and emotional focus. Scores are the average of the ten items, normalized and converted to T-score (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = better) metric.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714426


Locations
Layout table for location information
United States, Florida
The Vital Laboratory at the The Village
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Jacqueline E. Maye, MS University of Florida
Principal Investigator: Michael Marsiske, PhD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02714426    
Other Study ID Numbers: IRB02-2016-U-0277-N
1F31AG051356-01A1 ( U.S. NIH Grant/Contract )
IRB201800586 ( Other Identifier: UF IRB )
First Posted: March 21, 2016    Key Record Dates
Results First Posted: February 21, 2019
Last Update Posted: March 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Data will become available twelve months after the date of publication or e-publication in final form
Access Criteria: All investigators may request data if the request is supported by a research protocol that has been certified as "exempt" by their local Institutional Review Board.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Cognitive Aging
Attention
Mindfulness