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Completed NCT07019402

Internet-based Mind-Body Training for Brain Health

Conditions: Subjective Cognitive Decline

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Ohio State University

Location: Department of Psychology Columbus Ohio

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07019402). StuddyBuddy aggregates publicly available trial information.