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Search / Trial NCT07019402

Internet-based Mind-Body Training for Brain Health

Launched by OHIO STATE UNIVERSITY · Jun 12, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Mindfulness Based Stress Reduction Mind Wandering Mind Body Training Aging Subjective Cognitive Decline Lifestyle Education Randomized Control Trial

ClinConnect Summary

This clinical trial is exploring a new online program designed to help improve brain health for adults who may be at risk of developing Alzheimer's disease. It compares two different approaches: one that focuses on mindfulness and stress reduction (called iMBSR) and another that provides general lifestyle education (iLifeEd). The study will involve 60 participants aged 50 and older who report having some decline in their thinking abilities, but who do not have any serious cognitive disorders like dementia.

To participate, individuals must be fluent in English, have good vision and hearing, and be able to engage in light movement activities. They should not have any serious medical conditions or previous experience with structured mindfulness programs. Over the course of eight weeks, participants will take part in online sessions and will undergo assessments to measure any changes in their cognitive abilities and brain health. This trial is not yet recruiting, but it aims to provide valuable insights into how mindfulness practices can help those at risk for cognitive decline.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 50 years or greater
  • Capable of attending screening and assessment sessions and the internet-based intervention modules
  • 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 diagnosed by a psychologist or psychiatrist
  • Absence of medication use that significantly alters brain activity
  • No history of diagnosed learning disability that would interfere with the completion of the cognitive tasks
  • Report elevated scores on the self-report Everyday Cognition (E-Cog)-39 subjective cognitive decline with normatively intact performance on cognitive testing (as determined by the neuropsychological battery)
  • No evidence of mild cognitive impairment or dementia as assessed by the neuropsychological measures from the National Alzheimer's Coordinating Center (NACC) Uniform Data Set OR inadequate self-reported performance of instrumental activities of daily living
  • Ability to engage in light stretching/movement-based activities with or without assistive devices
  • Absence of any MRI contraindications
  • Not pregnant and not attempting to become pregnant
  • Absence of self-reported claustrophobia
  • No regular practice of meditation or yoga (defined as once or more per week) AND No previous participation in a structured mindfulness class (e.g., Mindfulness-Based Stress Reduction, intensive meditation retreat)
  • Access to internet and at-home computer with a working microphone and video
  • Not enrolled in other RCTs examining the efficacy of exercise training, cognitive rehabilitation, stress management, progressive muscle relaxation or other health-based rehabilitation
  • Exclusion Criteria:
  • Aged less than 50 years
  • Any physical or pragmatic limitation that prohibits attendance of screening or assessment sessions, or intervention engagement
  • No fluency in English
  • Corrected (near or far) visual acuity worse than 20/40
  • Self-reported hearing impairment that would affect ability to hear the experimenter
  • Diagnosis of terminal illness
  • Presence of diagnosed neurological disorders such as: Alzheimer's disease, Vascular Dementia, Parkinson's disease, Multiple Sclerosis, Traumatic Brain Injury, Fronto-Temporal Lobar Degeneration, Lewy Body Disease
  • History of psychotic disorder or substance abuse disorder diagnosed by a psychologist or psychiatrist
  • Medication use that significantly alters brain activity
  • History of diagnosed learning disability that would interfere with the completion of the cognitive tasks
  • Does not report subjective cognitive decline AND/ OR does not perform in the normatively intact range on neuropsychological testing
  • Evidence of mild cognitive impairment (MCI) or dementia OR inadequate self-reported performance of instrumental activities of daily living
  • Any physical limitation or pragmatic limitation that prohibits attendance at assessment sessions and intervention modules with or without assistive devices
  • Presence of MRI contraindications as assessed through the MRI screening form.
  • Pregnant or attempting to become pregnant
  • Self-reported claustrophobia
  • Any regular practice of meditation or yoga (defined as once or more per week) OR Previous participation in a structured mindfulness class (e.g., Mindfulness-Based Stress Reduction, intensive meditation retreat)
  • No access to internet or at-home computer with a working microphone and video
  • Current enrollment in other RCTs examining the efficacy of exercise training, cognitive rehabilitation, stress management, progressive muscle relaxation or other health-based rehabilitation

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 S Prakash, PhD

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported