Clinical trial NCT02714426: A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults
Official title: A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (The MACS Study: Mindfulness and Attentional Control in Seniors)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Keywords: Cognitive Aging
Attention
Mindfulness
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
timeFrame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary outcomes:
measure: Performance in Useful Field of View Over 14 Weekly Measurements
timeFrame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
measure: Performance in Stroop Interference Over 14 Weekly Measurements
timeFrame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Other outcomes:
measure: Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
timeFrame: Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11
measure: Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
timeFrame: Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
measure: Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
timeFrame: Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Locations:
city: Gainesville
country: United States
facility: The Vital Laboratory at the The Village
state: Florida
Study officials:
affiliation: University of Florida
name: Jacqueline E. Maye, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Michael Marsiske, PhD
role: PRINCIPAL_INVESTIGATOR
References: