Clinical trial NCT03626532: Mind-body Interventions for Healthy Aging
Official title: Mind-body Interventions for Healthy Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Mindfulness-based stress reduction
Cognitive function
Emotion regulation
Lifestyle education
Attentional control
Mindfulness training
Aging
Older adults
Mind-wandering
Functional connectivity
Randomized controlled trial
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-08-13
Enrollment: 173
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the impact of mind-body interventions in enhancing behavioral and neural correlates of attentional control in older adults. Participants will be randomized to either a 8-week mindfulness meditation group or a 8-week lifestyle education group. Additional booster sessions, spanning the course of a year, will be offered to participants in both groups. Participants will complete pre- and post-assessments of neurocognitive and emotional functioning, and will be assessed for maintained benefits 12-months post-intervention.

Detailed description: Mind-body interventions are increasingly being examined for their potential to improve cognitive function, enhance emotion regulation, reduce stress and related inflammatory markers, and alter the neural circuitry supporting cognitive and emotional functioning. The primary goal of this study is to examine changes in attentional control resulting from engaging in mind-body interventions with additional booster sessions over the course of a year. Within this goal, the behavioral and neural mechanisms of change in attentional control will be investigated and the transfer of benefits to performance on measures of everyday cognition and emotion regulation will be assessed. Our main hypothesis is that eight weeks of mindfulness training will increase attentional control performance in the elderly, partially through mindfulness-induced reductions in mind-wandering and changes in the functional architecture of the brain. Up to 200 older adults (ages 65-85) will be enrolled for the study. Of these, 151 older adults meeting eligibility criteria will be randomized to either an eight-week MBSR (mindfulness based stress reduction) program or a lifestyle education group. Participants will attend weekly mindfulness training or lifestyle education sessions and will be asked to complete homework assignments administered via a mobile/web-based application designed by the laboratory. All participants will also be invited to participate in four booster sessions over the course of 12 months following the intervention with continued access to the mobile application content. Behavioral metrics of cognitive function and inflammatory markers will be collected before and after the eight-week intervention as well as at 6-months and 12-month follow-up assessments. Neural metrics of cognitive functioning will be collected before and after the eight-week intervention as well as at 12-month follow-up assessments.

Eligibility criteria: Inclusion Criteria:

* Between ages 65-85 years
* Capable of attending the assessment and the majority of intervention sessions
* Right-handed
* Fluent English speaker
* Corrected (near and far) visual acuity of 20/40 or better
* Normal color vision
* Adequate hearing for experimental purposes
* Absence of diagnosed terminal illness
* Absence of diagnosed neurological disorders
* No history of psychotic disorder or substance abuse disorder
* Absence of any psychiatric disorder that was 1) diagnosed by a psychologist or psychiatrist and 2) diagnosed within the past 2 years OR symptoms and/or treatment is ongoing
* Score less than 20 on the Center for Epidemiologic Studies Depression Scale (CES-D)
* Absence of medication use that significantly alters brain activity
* No history of diagnosed learning disability that would interfere with the completion of cognitive tasks
* No evidence of dementia: No scores below 2 standard deviations from the mean on neuropsychological battery AND adequate self-reported performance of instrumental activities of daily living
* To be included in the MRI portion of the study (not exclusionary for study participation): Absence of any non-MRI safe objects that cannot be removed, not pregnant and not attempting to become pregnant, and absence of self-reported claustrophobia
* Able to engage in light stretching exercises with or without assistive devices
* No regular practice of meditation or yoga (defined as once or more per week) AND no previous participation in a structured mindfulness class such as MBSR
* Access to the internet

Exclusion Criteria:

* Not between the ages of 65-85
* Any physical limitation or pragmatic limitation that prohibits attendance at assessment sessions and intervention sessions
* Left-handed or ambidextrous
* No fluency in English
* Corrected (near or far) visual acuity worse than 20/40
* All types of color blindness
* Self-reported hearing impairment that would affect their ability to hear the experimenter
* Diagnosis of terminal illness
* Presence of diagnosed neurological disorders
* History of psychotic disorder or substance abuse disorder diagnosed by a psychologist or psychiatrist
* History of psychotic disorder or substance abuse disorder diagnosed by a psychologist of psychiatrist
* Presence of any psychiatric disorder that was 1) diagnosed by a psychologist or psychiatrist and 2) diagnosed within the past 2 years OR symptoms/treatment is on going
* Score greater than or equal to 20 on the CES-D
* Medication use that significantly alters brain activity
* History of diagnosed learning disability that would interfere with completion of the cognitive tasks
* Evidence of dementia: one or more memory scores below 2 standard deviations from the mean AND one or more non-memory scores below 2 standard deviations from the mean on neuropsychological battery OR total score below 2 standard deviations from the mean on neuropsychological battery OR inadequate self-reported performance of instrumental activities of daily living
* Presence of non-MRI safe objects that cannot be removed, pregnant or attempting to become pregnant, or self-reported claustrophobia (exclusionary for MRI portion of the study only)
* Actual or perceived limitation that prohibits engaging in light stretching exercises with or without assistive devices
* Any regular practice of meditation or yoga (defined as once or more per week) OR previous participation in a structured mindfulness class such as MBSR
* No access to the internet

Primary outcomes:
measure: Change in attentional control on tasks of sustained attention
timeFrame: Baseline, 2 months, 8 months, 14 months
Secondary outcomes:
measure: Change in neural functioning during measures of attentional control
timeFrame: Baseline, 2 months, 14 months
measure: Change in mind-wandering on tasks of sustained attention
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in emotion regulation strategy sse
timeFrame: Baseline, 2 months, 8months, 14 months
measure: Change in cognitive performance on the NIH Cognitive Toolbox Battery
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in Measure of Daily Functioning
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in inflammatory biomarkers
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in self-report measures of stress
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in self-report measures of emotion dysregulation
timeFrame: Baseline, 2 months, 8 months, 14 months
measure: Change in self-report measures of quality of life
timeFrame: Baseline, 2 months, 8 months, 14 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Department of Psychology, The Ohio State University
state: Ohio
Study officials:
affiliation: The Ohio State Universty
name: Ruchika Prakash, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prakash RS, Fountain-Zaragoza S, Fisher M, Gbadeyan O, Andridge R, Kiecolt-Glaser J, Manglani HR, Duraney EJ, Shankar A, McKenna MR, Teng J, Phansikar M, Canter R. Protocol for a randomized controlled trial of mindfulness-based stress reduction to improve attentional control in older adults (HealthyAgers trial). BMC Geriatr. 2022 Aug 13;22(1):666. doi: 10.1186/s12877-022-03334-7.