Clinical trial NCT03432754: Health Education and Lifestyle Training in Older Adults
Official title: Health Education and Lifestyle Training in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: Older adults
Mindfulness
Mind wandering
Health education
Working memory
Cognitive functioning
Emotion regulation
Emotional functioning
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Global Performance on Computerized Attentional Control Tasks
timeFrame: Baseline and after the 4-week intervention
measure: Change in Mind-Wandering During Attentional Control Tasks
timeFrame: Baseline and after the 4-week intervention
Secondary outcomes:
measure: Change in Self-report Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline and after the 4-week intervention
measure: Change on Self-Report Measure of Emotion Dysregulation
timeFrame: Baseline and after the 4-week intervention
measure: Change in Local Metrics of Attentional Control During Go/No-Go Task
timeFrame: Baseline and after the 4-week intervention
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Ruchika Prakash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.