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

Cognitive Aging Clinical Trial

— MACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714426
• Other study ID #: IRB02-2016-U-0277-N
• Secondary ID: 1F31AG051356-01A
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Aging

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	The Vital Laboratory at the The Village	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements	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)	Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11
Other	Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements	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)	Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Other	Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements	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.	Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Primary	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)	Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary	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)	Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary	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)	Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14