NCT03626532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

August 4, 2018

Last Update Submit

August 29, 2023

Conditions

Aging

Keywords

Mindfulness-based stress reductionCognitive functionEmotion regulationLifestyle educationAttentional controlMindfulness trainingAgingOlder adultsMind-wanderingFunctional connectivityRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in attentional control on tasks of sustained attention

    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.

    Baseline, 2 months, 8 months, 14 months

Secondary Outcomes (9)

  • 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 emotion regulation strategy sse

    Baseline, 2 months, 8months, 14 months

  • Change in cognitive performance on the NIH Cognitive Toolbox Battery

    Baseline, 2 months, 8 months, 14 months

  • Change in Measure of Daily Functioning

    Baseline, 2 months, 8 months, 14 months

  • +4 more secondary outcomes

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

Participants will meet once a week for 8 weeks (2.5 hours per session), plus a 4-hour retreat day, to engage in mindfulness meditation exercises. Didactic components will include oral presentations, informational videos, and group discussion. Additionally, daily homework assignments will require participants to engage in guided practices for 30 minutes a day for 5 days a week.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Lifestyle Education

ACTIVE COMPARATOR

Participants will meet once a week for 2.5 hours for 8 weeks, plus a 4-hour retreat day, to engage in light stretching exercises and interactive discussions on health topics, such as physical activity, nutrition, sleep, stress, etc. Didactic components will include oral presentations, informational videos, and group discussion. Additionally, daily homework assignments will ask participants to engage in stretching, read or watch informational content, and answer reflection questions for 30 minutes a day for 5 days a week.

Behavioral: Lifestyle Education (LifeEd)

Interventions

Mindfulness-Based Stress Reduction (MBSR)BEHAVIORAL

The MBSR program is a mind-body approach developed by Kabat-Zinn to reduce pain and stress through mindfulness meditation. MBSR is a form of mental training characterized by the self-regulation of attention and focal orientation to present moment experiences. Mindfulness practice is thought to effectively promote emotional and cognitive control. Mindfulness includes directing awareness away from thoughts, emotions and sensations towards some specific "anchor" to the present, such as the breath. Participants will engage in various practices including breath awareness, body scans, mindful listening, etc.

Also known as: MBSR
Mindfulness-Based Stress Reduction
Lifestyle Education (LifeEd)BEHAVIORAL

This group will engage in light stretching exercises at each session. They will also be provided with information drawn from the scientific literature on topics related to healthy aging, including physical activity, sedentary behavior, nutrition, hydration, stress, sleep, and cognitively stimulating activities. Group discussion will be incorporated throughout.

Also known as: LifeEd
Lifestyle Education

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 35964000DERIVED

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ruchika Prakash, Ph.D.

    The Ohio State Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind. Any investigators administering assessments will be blind to participants' group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Clinical

Study Record Dates

First Submitted

August 4, 2018

First Posted

August 13, 2018

Study Start

August 17, 2018

Primary Completion

August 22, 2022

Study Completion

July 24, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)