AzTrials
AzTrials

Older AdultsHEALTHNCT03432754

Health Education and Lifestyle Training in Older Adults

A study testing Mindfulness-Based Attention Training and Lifestyle Education in people with Older Adults, run by Ohio State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 74 years
Conditions the study is for
Older Adults
What is being tested?
Mindfulness-Based Attention Training and Lifestyle Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
No sites listed yet
Study dates
20 Oct 2014to 29 Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

About this study

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.

Conditions
Older Adults
Being tested
Mindfulness-Based Attention Training, Lifestyle Education
Keywords
Older adults, Mindfulness, Mind wandering, Health education, Working memory, Cognitive functioning, Emotion regulation, Emotional functioning
Medical subject headings
Health Education, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Attention TrainingBehavioural

    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.

  • Lifestyle EducationBehavioural

    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.

Study groups in NCT03432754
Study groupRoleWhat they receive
Mindfulness-Based Attention TrainingExperimentalFour 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.
Receives: Behavioral: Mindfulness-Based Attention Training
Lifestyle Education GroupActive comparatorFour 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.
Receives: Behavioral: Lifestyle Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline and after the 4-week intervention

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and after the 4-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start20 Oct 2014
  3. Primary completion29 Apr 2015
  4. Study completion29 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432754
Sponsor's protocol ID
2014B0337
Acronym
HEALTH
Status last verified
Feb 2018
First submitted
7 Feb 2018
Last updated
14 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 40325320

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Attention Training and Lifestyle Education in people with Older Adults, run by Ohio State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Global Performance on Computerized Attentional Control Tasks (time frame: Baseline and after the 4-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432754, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in