RECRUITING

Internet-based Mind-Body Training for Brain Health

Conditions

Subjective Cognitive Decline mindfulness-based stress reduction mind-wandering mind-body training aging lifestyle education randomized control trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to conduct a Stage I pilot study examining the feasibility, acceptability, and preliminary effects of an internet-based, asynchronous mindfulness-based stress reduction program (iMBSR) compared to an internet-based, asynchronous lifestyle education program (iLifeEd), for adults at-risk for Alzheimer's disease (AD). Sixty middle-aged and older adults (aged 50 years or older) with subjective cognitive decline will be randomized to either an 8-week iMBSR program or an 8-week iLifeEd program control group, designed to provide adequate control for placebo effects. Behavioral, neuroimaging, and ecological momentary assessment (EMA) measures of mind-wandering will be administered to determine preliminary effects as a function of engagement in the iMBSR program. AD biomarkers will be examined at pre-training and post-training assessments.

Official Title

Internet-based Mind-Body Training (iMBT) for Brain Health

Quick Facts

Study Start:2025-06-13

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07019402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Niyathi Chakrapani

CONTACT

614-292-9568

RA_CNL@OSU.EDU

Principal Investigator

Ruchika S Prakash, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

Department of Psychology

Columbus, Ohio, 43201

United States

Collaborators and Investigators

Sponsor: Ohio State University

Ruchika S Prakash, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-13

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-06-13

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

mindfulness-based stress reduction
mind-wandering
mind-body training
aging
subjective cognitive decline
lifestyle education
randomized control trial

Additional Relevant MeSH Terms

Subjective Cognitive Decline