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CompletedNCT03432754HEALTHUpdated Feb 14, 2018

Health Education and Lifestyle Training in Older Adults

An interventional study of Mindfulness-Based Attention Training and Lifestyle Education in Older Adults, sponsored by Ohio State University. Completed. Open to participants aged 60 Years to 74 Years. Per ClinicalTrials.gov, last updated 2018-02-14.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Oct 2014, registered Feb 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
60 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

Age-related differences in sustained attention may be related to the prevalence and content of task unrelated thought or mind-wandering. Older adults report less mind-wandering in sustained tasks than younger adults, something that is surprising due to the reduced performance on tasks. It is clear that both cognitive and emotional processes underlie comprehension and sustained attention and relate to prevalence of task unrelated thought and performance. A complex process such as reading comprehension presents a challenge for improvement because of the wide range of changes that occur with age. Pharmacological therapies can target only a limited number of the many changes believed to underlie functional decline. One way that may mitigate these declines in performance in a broad way is mindfulness training. Thus, the investigators conducted a randomized study to assess the effects of mindfulness training relative to an active health education control group on mind wandering and controlled processing abilities in older adults. All individuals that contact the Clinical Neuroscience Laboratory (CNLab) with interest underwent a phone screening assessing inclusion/exclusion criteria.Those participants meeting I/E criteria were invited to participate in the study. During the first assessment session, written informed consent was obtained; additional inclusion/exclusion measures were administered; and self-report questionnaires and assessment measures were completed. Following the first assessment session, four training sessions took place. Participants were randomized into either the a mindfulness training intervention or a health education intervention. Subsequently, all participants were invited back for post-assessment session.

02

Conditions studied

  • Older Adults

Keywords

  • Older adults
  • Mindfulness
  • Mind wandering
  • Health education
  • Working memory
  • Cognitive functioning
  • Emotion regulation
  • Emotional functioning
03

In context

Health Education

483 studies on the registry are indexed under Health Education; 112 are open to participants now.

This study's enrollment of 74 is below the median of 132 across 452 interventional studies indexed under Health Education.

Browse Health Education studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 60 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 (; >23)
  • Depression score on the Geriatric Depression Scale (GDS) below clinical level (\<10)

Exclusion criteria

Exclusion Criteria:

  • 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 (; \<23)
  • Depression score on GDS indicative of clinical depression (>10)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Mindfulness-Based Attention Training

    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

  • Active comparator
    Lifestyle Education Group

    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

  • BehavioralMindfulness-Based Attention Training

    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.

  • BehavioralLifestyle Education

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and after the 4-week intervention

  2. 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.

    Time frame: Baseline and after the 4-week intervention

Secondary outcomes

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

    Self-reported current level of dispositional mindfulness assessed using 15-item Mindful Attention Awareness Scale (MAAS). Each item is scored from 1-6 and then averaged to get a total score between 1-6 with higher scores reflecting higher levels of dispositional mindfulness.

    Time frame: Baseline and after the 4-week intervention

  2. Change on Self-Report Measure of Emotion Dysregulation

    Changes in emotion dysregulation assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). Each items is scored 1-5 with a total score between 36-180 with a higher score reflecting greater emotion dysregulation.

    Time frame: Baseline and after the 4-week intervention

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

    Changes in reaction time and accuracy preceding mind-wandering probes during one of the attentional control tasks, the Go/No-Go Task.

    Time frame: Baseline and after the 4-week intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27541935 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2014 to primary completion in Apr 2015, 6 months.

Of 292 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's 6 months is below that.

Counting every sponsor, half of 293 studies reached it within 11 months; a quarter within 3 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Feb 14, 2018
StartActual
Oct 20, 2014
Primary completionActual
Apr 29, 2015
CompletionActual
Apr 29, 2015
Last update
Feb 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432754
Responsible party
Ruchika Prakash (Associate Professor, Ohio State University) — Principal investigator
First posted
Feb 14, 2018
Start date
Oct 20, 2014
Primary completion
Apr 29, 2015
Completion
Apr 29, 2015
Last update
Feb 14, 2018

Study contacts

Ruchika Prakash, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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