AgingHealthyAgersNCT03626532
Mind-body Interventions for Healthy Aging
A study testing Mindfulness-Based Stress Reduction (MBSR) and Lifestyle Education (LifeEd) in people with Aging, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) and Lifestyle Education (LifeEd)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2018to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Mindfulness-Based Stress Reduction (MBSR), Lifestyle Education (LifeEd)
- 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
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Also called MBSR
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.
Lifestyle Education (LifeEd)Behavioural
Also called LifeEd
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Education (LifeEd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 months, 8 months, 14 months
Secondary outcomes (9)
Change in neural functioning during measures of attentional control
Participants will complete an functional magnetic resonance imaging (fMRI) assessment before and after the intervention. Functional connectivity changes will be examined during tasks of attentional control to determine neural correlates of mind-body interventions.
Measured: Baseline, 2 months, 14 months
Change in mind-wandering on tasks of sustained attention
To measure mind-wandering, participants will also be prompted with quasi-random probes asking them to categorize the thoughts they were having immediately preceding the probe.
Measured: Baseline, 2 months, 8 months, 14 months
Change in emotion regulation strategy sse
Participants will complete lab-based and ecological momentary assessment (EMA)-based emotion regulation strategy use tasks to determine change in ER strategy use following mind-body interventions.
Measured: Baseline, 2 months, 8months, 14 months
Change in cognitive performance on the NIH Cognitive Toolbox Battery
Participants will perform the NIH Cognitive Toolbox Battery comprised of seven different tasks aimed at measuring episodic memory, executive function, attention, working memory, language, and processing speed. Change on this measure will be assessed to determine the impact of the mind-body interventions on various domains of cognitive functioning.
Measured: Baseline, 2 months, 8 months, 14 months
Change in Measure of Daily Functioning
Participants will complete the Driving Scenes subtest of the Neuropsychological Assessment Battery (NAB) as a measure of everyday cognition. This subtest measures attention and working memory to changing driving scenes.
Measured: Baseline, 2 months, 8 months, 14 months
Change in inflammatory biomarkers
Data on inflammatory markers - C-reactive protein (CRP), interleukin 6 (IL-6), and interleukin 10 (IL-10) - will be collected to determine the impact of mind-body interventions on systemic markers of inflammation.
Measured: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of stress
Participants will be administered the Perceived Stress Scale (PSS) to measure changes in self-reported perceived stress following mind-body interventions. This measure has 10 items, each measured on a 5-point rating scale. One total score will be calculated by summing the individual item responses. Higher scores represent greater feelings of stress, unpredictability, and uncontrollability.
Measured: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of emotion dysregulation
Participants will be administered the Difficulties in Emotion Regulation Scale (DERS) to examine changes in degree of self-reported emotion dysregulation following mind-body interventions. This measure has 36 items, each measured on a 5-point rating scale. One total score will be calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.
Measured: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of quality of life
Participants will be administered the The World Health Organization Quality of Life abbreviated scale (WHOQOL-BREF) to examine changes in self-reported quality of life following mind-body interventions. This measure has 26 items, each measured on a 5-point rating scale. Four domains are measured by taking the average of representative items: psychological (six items), environmental (eight items), physical health (seven items), and social relationships (three items), as well as overall QoL (two items). Higher scores represent better perceived quality of life.
Measured: Baseline, 2 months, 8 months, 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start17 Aug 2018
- Primary completion22 Aug 2022
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ruchika Prakash, Ohio State University
- Investigators
- Ruchika Prakash, Ph.D., Principal investigator, The Ohio State Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626532
- Sponsor's protocol ID
- 2017H0223
- Other IDs
- R01AG054427
- Acronym
- HealthyAgers
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35964000
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-body Interventions for Healthy Aging
- ClinicalTrials.gov ID
- NCT03626532
- Acronym / sponsor ID
- HealthyAgers / 2017H0223
- Conditions
- Aging
- Keywords
- Mindfulness-based stress reduction, Cognitive function, Emotion regulation, Lifestyle education, Attentional control, Mindfulness training, Aging, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)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. |
| Lifestyle Education | Active comparator | Behavioral: Lifestyle Education (LifeEd)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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)Also: MBSRThe 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. | Behavioural | Mindfulness-Based Stress Reduction |
| Lifestyle Education (LifeEd)Also: LifeEdThis 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. | Behavioural | Lifestyle Education |
Primary outcome
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.
9 secondary outcomes
Change in neural functioning during measures of attentional control
Time frame: Baseline, 2 months, 14 months
Change in mind-wandering on tasks of sustained attention
Time frame: Baseline, 2 months, 8 months, 14 months
Change in emotion regulation strategy sse
Time frame: Baseline, 2 months, 8months, 14 months
Change in cognitive performance on the NIH Cognitive Toolbox Battery
Time frame: Baseline, 2 months, 8 months, 14 months
Change in Measure of Daily Functioning
Time frame: Baseline, 2 months, 8 months, 14 months
Change in inflammatory biomarkers
Time frame: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of stress
Time frame: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of emotion dysregulation
Time frame: Baseline, 2 months, 8 months, 14 months
Change in self-report measures of quality of life
Time frame: Baseline, 2 months, 8 months, 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 35964000Prakash 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchika Prakash, Ph.D. principal investigator
The Ohio State Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) and Lifestyle Education (LifeEd) in people with Aging, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in attentional control on tasks of sustained attention (time frame: Baseline, 2 months, 8 months, 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03626532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.