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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Department of Psychology
RECRUITING
Columbus
Contact Information
Primary
Niyathi Chakrapani
RA_CNL@OSU.EDU
614-292-9568
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
Experimental: Internet-based Mindfulness-Based Stress Reduction (iMBSR)
Participants will access mindfulness exercises using the ScarletCanvas platform and will complete them at their own pace throughout the intervention. The iMBSR protocol is developed to ensure that participants spend 2.5 hrs/week on each of the eight modules. The protocol will have a mix of didactics, experiential practices, social support, and community building. Experiential practices in iMBSR will include body scans, sitting meditations, and mindful movement.
Active_comparator: Internet-based Lifestyle Education Group (iLifeEd)
Participants will access lifestyle education exercises using the ScarletCanvas platform and will complete them at-their own pace throughout the intervention. The iLifeEd protocol is developed to ensure that participants spend 2.5 hrs/week on each of the eight modules. The protocol will have a mix of didactics, experiential practices, social support, and community building. Experiential practices in iLifeEd will include stretching and toning exercises matched in duration to the practices of iMBSR.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Ohio State University

This content was sourced from clinicaltrials.gov