Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns

NCT06410807 | Completed

• 1 other identifier: 2023H0387
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Aging; Focus Groups

Keywords

mindfulness-based stress reduction; cognitive function; mindfulness training; aging; subjective cognitive decline; focus groups; lifestyle education

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Baseline

Study Arms (1)

Adults with subjective cognitive decline

Five focus groups will be conducted with adults with subjective cognitive decline recruited in the greater Columbus, Ohio area.

Other: Focus groups

Interventions

Focus groups OTHER

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.

Adults with subjective cognitive decline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 50 years and over in the greater Columbus area with subjective cognitive decline

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Department of Psychology, The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ruchika Prakash, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: May 13, 2024
• Study Start: November 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)