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

NCT ID: NCT02714426

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-02-28

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.

Conditions

Cognitive Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Brain health

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Mindfulness-inspired treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Mindfulness-based stress reduction; Active comparator

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline E. Maye, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Michael Marsiske, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

The Vital Laboratory at the The Village

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1F31AG051356-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201800586

Identifier Type: OTHER

Identifier Source: secondary_id

IRB02-2016-U-0277-N

Identifier Type: -

Identifier Source: org_study_id