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Search / Trial NCT06410807

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

Launched by OHIO STATE UNIVERSITY · May 7, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Mindfulness Based Stress Reduction Cognitive Function Mindfulness Training Aging Subjective Cognitive Decline Focus Groups Lifestyle Education

ClinConnect Summary

This clinical trial is looking to create online programs that help adults aged 50 and older who have some concerns about their memory or thinking abilities. The study will involve gathering feedback from participants through focus groups, where they will discuss healthy living and share their thoughts on the content and format of two specific programs: one focused on mindfulness (iMBSR) and the other on lifestyle education (iLifeEd). This feedback will help improve these programs for future studies.

To participate, individuals must be at least 50 years old and report some cognitive concerns while still performing well on cognitive tests. They should be able to attend assessments and focus group sessions, speak English fluently, and have access to the internet. Participants can expect to engage in discussions about healthy living and provide input on the online programs. It's important to note that individuals with certain medical conditions, recent psychiatric diagnoses, or a regular practice of meditation or yoga are not eligible to join.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • 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
  • Exclusion Criteria:
  • 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
  • No access to the internet

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Ruchika Prakash, PhD

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported