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

NCT02714426 | Completed Results

• 3 other identifiers: IRB02-2016-U-0277-N1F31AG051356-01A1IRB201800586
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Aging

Keywords

Cognitive Aging; Attention; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Performance in Useful Field of View Over 14 Weekly Measurements

  Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

• Performance in Stroop Interference Over 14 Weekly Measurements

  Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

Other Outcomes (3)

• Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements

  Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11

• Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements

  Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

• Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements

  Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

Study Arms (2)

Brain Health

ACTIVE COMPARATOR

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

Mindfulness-inspired Treatment/Testing

EXPERIMENTAL

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

Interventions

Mindfulness-inspired treatment 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.

Also known as: Mindfulness-based stress reduction

Mindfulness-inspired Treatment/Testing

Brain health 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.

Also known as: Active comparator

Brain Health

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Vital Laboratory at the The Village

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Michael Marsiske, Ph.D.
• Organization: University of Florida

marsiske@phhp.ufl.edu

352.273.5097

Study Officials

• Jacqueline E. Maye, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

• Michael Marsiske, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 21, 2016
• Study Start: November 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: March 7, 2019
• Results First Posted: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)