Health Education and Lifestyle Training in Older Adults (HEALTH)
February 12, 2018 updated by: Ruchika Prakash, Ohio State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 (MMSE; >23)
- Depression score on the Geriatric Depression Scale (GDS) below clinical level (<10)
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 (MMSE; <23)
- Depression score on GDS indicative of clinical depression (>10)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Global Performance on Computerized Attentional Control Tasks
Time Frame: Baseline and after the 4-week intervention
|
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
Time Frame: Baseline and after the 4-week intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-report Mindful Attention Awareness Scale (MAAS)
Time Frame: Baseline and after the 4-week intervention
|
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.
|
Baseline and after the 4-week intervention
|
|
Change on Self-Report Measure of Emotion Dysregulation
Time Frame: Baseline and after the 4-week intervention
|
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.
|
Baseline and after the 4-week intervention
|
|
Change in Local Metrics of Attentional Control During Go/No-Go Task
Time Frame: Baseline and after the 4-week intervention
|
Changes in reaction time and accuracy preceding mind-wandering probes during one of the attentional control tasks, the Go/No-Go Task.
|
Baseline and after the 4-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ruchika Prakash, PhD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2014
Primary Completion (Actual)
April 29, 2015
Study Completion (Actual)
April 29, 2015
Study Registration Dates
First Submitted
February 7, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (Actual)
February 14, 2018
Study Record Updates
Last Update Posted (Actual)
February 14, 2018
Last Update Submitted That Met QC Criteria
February 12, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014B0337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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