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Clinical Trials/NCT03626532
NCT03626532
Completed
N/A

Mind-body Interventions for Healthy Aging

Ohio State University1 site in 1 country173 target enrollmentAugust 17, 2018
ConditionsAging

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aging
Sponsor
Ohio State University
Enrollment
173
Locations
1
Primary Endpoint
Change in attentional control on tasks of sustained attention
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2018
End Date
July 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ruchika Prakash

Associate Professor - Clinical

Ohio State University

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

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

Outcomes

Primary Outcomes

Change in attentional control on tasks of sustained attention

Time Frame: Baseline, 2 months, 8 months, 14 months

Participants will complete computerized measures of Continuous Performance Test and Go/No-Go Task to assess sustained attention. Detectability (d') measures will be calculated to assess the effects of mind-body interventions on attentional control. Data collected at 8-months and 14-month will be used to determine maintenance effects.

Secondary Outcomes

  • Change in cognitive performance on the NIH Cognitive Toolbox Battery(Baseline, 2 months, 8 months, 14 months)
  • Change in inflammatory biomarkers(Baseline, 2 months, 8 months, 14 months)
  • Change in neural functioning during measures of attentional control(Baseline, 2 months, 14 months)
  • Change in mind-wandering on tasks of sustained attention(Baseline, 2 months, 8 months, 14 months)
  • Change in self-report measures of emotion dysregulation(Baseline, 2 months, 8 months, 14 months)
  • Change in Measure of Daily Functioning(Baseline, 2 months, 8 months, 14 months)
  • Change in self-report measures of stress(Baseline, 2 months, 8 months, 14 months)
  • Change in emotion regulation strategy sse(Baseline, 2 months, 8months, 14 months)
  • Change in self-report measures of quality of life(Baseline, 2 months, 8 months, 14 months)

Study Sites (1)

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