NCT03432754

Brief Summary

The investigators conducted a mindfulness training intervention in older adults aimed at examining the effects of brief mindfulness training on mind wandering as well as the cognitive and affective functioning of older adults. Individuals completed pre- and post-assessments of mind wandering and cognitive functioning. Additionally, all participants completed neuropsychological measures and self-report questionnaires.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

February 7, 2018

Last Update Submit

February 12, 2018

Conditions

Keywords

Older adultsMindfulnessMind wanderingHealth educationWorking memoryCognitive functioningEmotion regulationEmotional functioning

Outcome Measures

Primary Outcomes (2)

  • Change in Global Performance on Computerized Attentional Control Tasks

    Signal detection scores on two computerized tasks of attentional control calculated for each task using the formula for logistic distributions: dL = ln{\[H(1-FA)\]/\[(1-H)FA\]}, where H refers to hit rates and FA refers to false alarms.

    Baseline and after the 4-week intervention

  • Change in Mind-Wandering During Attentional Control Tasks

    Frequency with which thoughts categorized as evaluating performance or off-task in response to quasi-random mind-wandering probes collected during two computerized tasks of attentional control.

    Baseline and after the 4-week intervention

Secondary Outcomes (3)

  • Change in Self-report Mindful Attention Awareness Scale (MAAS)

    Baseline and after the 4-week intervention

  • Change on Self-Report Measure of Emotion Dysregulation

    Baseline and after the 4-week intervention

  • Change in Local Metrics of Attentional Control During Go/No-Go Task

    Baseline and after the 4-week intervention

Study Arms (2)

Mindfulness-Based Attention Training

EXPERIMENTAL

Four weekly group mindfulness attention training sessions of a 1.5-hour duration. Participants provided with audio recordings, readings, and homework assignments consisting of various mindfulness practices.

Behavioral: Mindfulness-Based Attention Training

Lifestyle Education Group

ACTIVE COMPARATOR

Four weekly group lifestyle education sessions of a 1.5-hour duration. Homework consisting of reading, diet monitoring, stretching/toning exercises, and brainstorming new healthy living techniques/ideas.

Behavioral: Lifestyle Education

Interventions

The mindfulness-based attention training is closely modeled after the traditional mindfulness-based stress reduction (MBSR) protocol, it incorporates formal MBSR practices such as breath exercises, body scans and long sitting meditations. Specifically, MBAT is an abbreviated version of MBSR with a focus on the cognitive components.

Mindfulness-Based Attention Training

The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning and mind wandering in older adults, will comprise of scientific health and lifestyle information. Lectures will be focused on concepts presented in the book "The Culprit and the Cure: Why lifestyle is the culprit behind America's poor health and how transforming that lifestyle can be the cure." Meetings will cover how to begin and maintain a more nutritious diet, classifying healthy choices across food groups, completing stretching/toning exercises, and reviewing homework.

Lifestyle Education Group

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 74 years of age
  • No prior exposure to mindfulness training
  • No significant meditation experience
  • Have never engaged in regular practices of yoga
  • Capable of attending both assessment and training sessions
  • Corrected (near and far) visual acuity of 20/40 or better
  • Normal color vision
  • No self-reported history of psychiatric, neurological, or chronic inflammatory conditions
  • Absence of psychiatric medication use
  • Native English Speaker
  • Adequate performance on the Mini-Mental Status Examination (MMSE; \>23)
  • Depression score on the Geriatric Depression Scale (GDS) below clinical level (\<10)

You may not qualify if:

  • Below 60 years of age or above 74 years of age
  • Have exposure to or experience with any type of meditation or yoga regularly (one hour a week for at least 12 months)
  • Any physical or pragmatic limitation that prohibits attendance at both sessions
  • Corrected (near or far) visual acuity worse than 20/40
  • All types of color blindness
  • Presence of diagnosed neurological disorders (such as: Alzheimer's disease, Parkinson's disease or multiple sclerosis) or chronic inflammatory conditions
  • Presence of any diagnosed psychiatric disorder such as depression, attention deficit hyperactivity disorder (ADHD), substance abuse
  • Presence of psychiatric medication use such as Xanax, Wellbutrin, or Vivance
  • Non-Native English Speaker or no fluency in English
  • Inadequate performance on the Mini-Mental Status Examination (MMSE; \<23)
  • Depression score on GDS indicative of clinical depression (\>10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fountain-Zaragoza S, Londeree A, Whitmoyer P, Prakash RS. Dispositional mindfulness and the wandering mind: Implications for attentional control in older adults. Conscious Cogn. 2016 Aug;44:193-204. doi: 10.1016/j.concog.2016.08.003. Epub 2016 Aug 16.

  • Duraney EJ, Phansikar M, Prakash RS. Psychosocial Correlates of Adherence to Mind-Body Interventions. Prev Sci. 2025 Jul;26(5):839-848. doi: 10.1007/s11121-025-01810-1. Epub 2025 May 6.

MeSH Terms

Conditions

Health EducationEmotional Regulation

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSelf-ControlSocial Behavior

Study Officials

  • Ruchika Prakash, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomization was conducted by the principle investigator (PI) and study coordinator using a computerized random number generator program (randomization.com). All experimenters (except the PI and study coordinator) were blinded to group assignments until study conclusion. To further reduce demand characteristics, participants were unaware of which group was considered the experimental intervention until debriefed by an experimenter after completing the study. Study binders were created to blind group assignment, and participants in each group were asked not to discuss the sessions with members of the other group or with the experimenter at their post-intervention assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This randomized control trial compared a mindfulness-based attention training (MBAT) group with an active control lifestyle education group. A total of 147 individuals underwent eligibility screening over the phone and in-person at an initial assessment session. Of those eligible, 75 participants volunteered to participate and were randomly assigned to groups. However, one of these participants did not complete the first assessment session and was randomized in error. Thus, 74 participants who completed the first assessment session and met all eligibility criteria were randomly assigned to either the MBAT group or the active control group (lifestyle education). Randomization was conducted by a study author using a computerized random number generator program (randomization.com), applying a varying block size of two and four and stratifying participants by gender. A total of 37 participants were allocated to the each of the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 14, 2018

Study Start

October 20, 2014

Primary Completion

April 29, 2015

Study Completion

April 29, 2015

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share