Health Education and Lifestyle Training in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Health Education and Lifestyle Training in Older Adults

Conditions
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Older Adults

Intervention / Treatment
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* Behavioral: Mindfulness-Based Attention Training
* Behavioral: Lifestyle Education


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Attention Training<br>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<br>* 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.<br>|
| Active Comparator: Lifestyle Education Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after the 4-week intervention | 
| 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. | Baseline and after the 4-week intervention | 
| 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. | Baseline and after the 4-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Mindfulness, Mind wandering, Health education, Working memory, Cognitive functioning, Emotion regulation, Emotional functioning