AgingiMBTNCT06410807
Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns
An observational study of Aging and Focus Groups, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this observational study is to develop online, self-paced mindfulness (iMBSR) and lifestyle education (iLifeEd) programs for adults with cognitive concerns. Participants will engage in focus groups to discuss healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aging, Focus Groups
- What is being tested?
- Focus groups
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 2 May 2025
- Phase
- Observational
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Adults aged 50 years and over in the greater Columbus area with subjective cognitive decline
Who may be able to join
- 50 years of age or older
- Report subjective cognitive decline with normatively intact performance on cognitive testing
- Capable of attending the assessment and the majority of focus group sessions
- Fluent English speaker
- Corrected (near and far) visual acuity of 20/40 or better
- Adequate hearing for experimental purposes
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- 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
- 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 mild cognitive impairment (MCI) or dementia: >1 standard deviation (SD) below demographically adjusted normative mean on both measures of one domain OR >1 SD below demographically adjusted normative mean on at least one measure of all three domains OR inadequate self-reported performance of instrumental activities of daily living
- 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 50 years of age or older
- Does not report subjective cognitive decline AND/ OR does not perform in the normatively intact range on cognitive testing
- Any physical limitation or pragmatic limitation that prohibits attendance at assessment and focus group sessions
- No fluency in English
- Corrected (near or far) visual acuity worse than 20/40
- Self-reported hearing impairment that would affect their ability to hear the experimenter
Show all 16Show fewer
- Diagnosis of terminal illness
- Presence of diagnosed neurological disorders
- History of psychotic disorder or substance abuse disorder diagnosed by a psychologist or 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 ongoing
- Medication use that significantly alters brain activity
- History of diagnosed learning disability that would interfere with completion of the cognitive tasks
- Evidence of MCI or dementia: >1 SD below demographically adjusted normative mean on both measures of one domain OR >1 SD below demographically adjusted normative mean on at least one measure of all three domains OR inadequate self-reported performance of instrumental activities of daily living
- 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
Official title: Development of Online Mind-body Training Programs for Adults With Subjective Cognitive Decline
The goal of this observational study is to develop online, self-paced mindfulness (iMBSR) and lifestyle education (iLifeEd) programs for adults with cognitive concerns. Participants will engage in focus groups to discuss healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living. Additionally, participants will provide feedback on the protocol and online platform for either iMBSR or iLifeEd. This feedback will be used to refine the iMBSR and iLifeEd protocols for future use in the randomized controlled trial portion of the parent project.
Read the detailed description
Rising prevalence rates of Alzheimer's Disease (AD) have led to widespread interest in identifying individuals at-risk for AD and for developing interventions that delay or prevent the onset of AD. Growing evidence suggests that subjective cognitive decline (SCD)-characterized by perceived persistent declines in cognitive functioning compared to previously normal cognitive status-may be a preclinical stage of Alzheimer's Disease. Individuals with SCD can be identified by self-reported declines in cognitive functioning based on self-report questionnaires, such as the Everyday Cognition Questionnaire, yet also exhibit normal performance based on age, sex, and education corrected standardized cognitive measures. There is mounting evidence that mindfulness training, traditionally offered as an 8-week in-person MBSR program, improves cognitive functioning including in the investigators' pilot MBSR trial with healthy older adults. Further, recent evidence from adults over the age of 60 has linked trait mindfulness with lower accumulation of AD pathology, lower cognitive decline on measures of global cognition, sustained attention, and immediate and delayed memory. Together, this suggests that mindfulness training could be beneficial as a preventative training program in adults with SCD who have yet to show objective cognitive impairments. However, limited accessibility, time and schedule constraints, and travel logistics are among the greatest barriers for in-person MBSR programs. Internet-based mindfulness programs are a promising and cost-effective approach, but few studies have adapted MBSR for internet-delivery in an asynchronous format. Several internet-based interventions ideographically tailored for the target population, including acquired brain injury, fibromyalgia, and heart disease show promising support. The present study seeks to address the urgent need for the development of alternative training programs that provide theoretical promise for reducing age-related cognitive decline, demonstrate broad transfer effects to domains of cognitive functioning that directly impact everyday functioning, and facilitate the development of a mechanistic model with easily identifiable and separable mechanisms. The aim of the present study is to iteratively develop and refine internet-based MBSR (iMBSR) and internet-based lifestyle education (iLifeEd) protocols with a team of stakeholders (i.e., focus groups). Focus groups of adults with subjective cognitive decline will be recruited to iteratively develop and refine the platforms for the iMBSR and iLifeEd groups. The iMBSR program will be a promising platform to deliver evidence-based mindfulness meditation techniques. Additionally, the iLifeEd program that will match the iMBSR program in terms of format of delivery, duration of training, peer support, and homework assignment will be developed.
- Conditions
- Aging, Focus Groups
- Being tested
- Focus groups
- Keywords
- mindfulness-based stress reduction, cognitive function, mindfulness training, aging, subjective cognitive decline, focus groups, lifestyle education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsOther
The present study consists of 5 focus groups over 3 waves to inform the development and refinement of internet-based mindfulness (iMBSR) and lifestyle education (iLifeEd) protocols for use in future clinical trials. 50% females and 50% minoritized participants will be recruited to ensure representation across sex and race. For all focus groups, adults (over the age of 50 years) who report SCD will be recruited. Specifically, the Everyday Cognition Questionnaire (E-Cog) will be administered to quantify informant-reported deficits in cognitive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Adults with subjective cognitive decline | Five focus groups will be conducted with adults with subjective cognitive decline recruited in the greater Columbus, Ohio area. Receives: Other: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative themes derived from focus group discussions on healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living
Qualitative summary of perceptions and attitudes regarding healthy living, web-based lifestyle interventions, intervention content/format and ideal intervention outcomes
Measured: Baseline
Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on initial intervention protocols
Qualitative summary of perceptions of, attitudes toward, and feedback on initial intervention protocols and how focus group feedback was incorporated into protocol development
Measured: Baseline
Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on fully developed web-based interface of the iMBSR and iLifeEd programs
Qualitative summary of perceptions of, attitudes toward, and feedback on fully developed web-based interface of the iMBSR and iLifeEd programs
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Nov 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruchika Prakash, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410807
- Sponsor's protocol ID
- 2023H0387
- Acronym
- iMBT
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Online Mind-body Training Programs for Adults With Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT06410807
- Acronym / sponsor ID
- iMBT / 2023H0387
- Conditions
- Aging, Focus Groups
- Keywords
- mindfulness-based stress reduction, cognitive function, mindfulness training, aging, subjective cognitive decline, focus groups, lifestyle education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 13 May 2024 (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 observational study is to develop online, self-paced mindfulness (iMBSR) and lifestyle education (iLifeEd) programs for adults with cognitive concerns. Participants will engage in focus groups to discuss healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living. Additionally, participants will provide feedback on the protocol and online platform for either iMBSR or iLifeEd. This feedback will be used to refine the iMBSR and iLifeEd protocols for future use in the randomized controlled trial portion of the parent project.
Detailed description
Rising prevalence rates of Alzheimer's Disease (AD) have led to widespread interest in identifying individuals at-risk for AD and for developing interventions that delay or prevent the onset of AD. Growing evidence suggests that subjective cognitive decline (SCD)-characterized by perceived persistent declines in cognitive functioning compared to previously normal cognitive status-may be a preclinical stage of Alzheimer's Disease. Individuals with SCD can be identified by self-reported declines in cognitive functioning based on self-report questionnaires, such as the Everyday Cognition Questionnaire, yet also exhibit normal performance based on age, sex, and education corrected standardized cognitive measures. There is mounting evidence that mindfulness training, traditionally offered as an 8-week in-person MBSR program, improves cognitive functioning including in the investigators' pilot MBSR trial with healthy older adults. Further, recent evidence from adults over the age of 60 has linked trait mindfulness with lower accumulation of AD pathology, lower cognitive decline on measures of global cognition, sustained attention, and immediate and delayed memory. Together, this suggests that mindfulness training could be beneficial as a preventative training program in adults with SCD who have yet to show objective cognitive impairments. However, limited accessibility, time and schedule constraints, and travel logistics are among the greatest barriers for in-person MBSR programs. Internet-based mindfulness programs are a promising and cost-effective approach, but few studies have adapted MBSR for internet-delivery in an asynchronous format. Several internet-based interventions ideographically tailored for the target population, including acquired brain injury, fibromyalgia, and heart disease show promising support. The present study seeks to address the urgent need for the development of alternative training programs that provide theoretical promise for reducing age-related cognitive decline, demonstrate broad transfer effects to domains of cognitive functioning that directly impact everyday functioning, and facilitate the development of a mechanistic model with easily identifiable and separable mechanisms. The aim of the present study is to iteratively develop and refine internet-based MBSR (iMBSR) and internet-based lifestyle education (iLifeEd) protocols with a team of stakeholders (i.e., focus groups). Focus groups of adults with subjective cognitive decline will be recruited to iteratively develop and refine the platforms for the iMBSR and iLifeEd groups. The iMBSR program will be a promising platform to deliver evidence-based mindfulness meditation techniques. Additionally, the iLifeEd program that will match the iMBSR program in terms of format of delivery, duration of training, peer support, and homework assignment will be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with subjective cognitive decline | – | Other: Focus groupsFive focus groups will be conducted with adults with subjective cognitive decline recruited in the greater Columbus, Ohio area. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 years and over in the greater Columbus area with subjective cognitive decline
Key inclusion criteria (16 listed)
- 50 years of age or older
- Report subjective cognitive decline with normatively intact performance on cognitive testing
- Capable of attending the assessment and the majority of focus group sessions
- Fluent English speaker
- Corrected (near and far) visual acuity of 20/40 or better
Key exclusion criteria (16 listed)
- Not 50 years of age or older
- Does not report subjective cognitive decline AND/ OR does not perform in the normatively intact range on cognitive testing
- Any physical limitation or pragmatic limitation that prohibits attendance at assessment and focus group sessions
- 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 |
|---|---|---|
| Focus groupsThe present study consists of 5 focus groups over 3 waves to inform the development and refinement of internet-based mindfulness (iMBSR) and lifestyle education (iLifeEd) protocols for use in future clinical trials. 50% females and 50% minoritized participants will be recruited to ensure representation across sex and race. For all focus groups, adults (over the age of 50 years) who report SCD will be recruited. Specifically, the Everyday Cognition Questionnaire (E-Cog) will be administered to quantify informant-reported deficits in cognitive functioning. | Other | Adults with subjective cognitive decline |
Primary outcome
Qualitative themes derived from focus group discussions on healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living
Time frame: Baseline
Qualitative summary of perceptions and attitudes regarding healthy living, web-based lifestyle interventions, intervention content/format and ideal intervention outcomes
Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on initial intervention protocols
Time frame: Baseline
Qualitative summary of perceptions of, attitudes toward, and feedback on initial intervention protocols and how focus group feedback was incorporated into protocol development
Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on fully developed web-based interface of the iMBSR and iLifeEd programs
Time frame: Baseline
Qualitative summary of perceptions of, attitudes toward, and feedback on fully developed web-based interface of the iMBSR and iLifeEd programs
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 18 Dec 2025.
- 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, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Focus Groups, 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 16 inclusion and 16 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 18 Dec 2025. 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?
Qualitative themes derived from focus group discussions on healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.