Internet-based Mind-Body Training for Brain Health

NCT07019402 | Active Not Recruiting

• 2 other identifiers: 2024H04011R61AG081982-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subjective Cognitive Decline

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Feasibility of intervention: Recruitment

  Feasibility will be determined by evaluating the recruitment of study participants. High feasibility will be defined as the successful recruitment of 60 participants over one year.

  12 months

• Feasibility of intervention: Retention rate

  Feasibility will be determined by evaluating retention of participants in the study.

  8 weeks

• Feasibility of intervention: attrition rate

  High feasibility will be defined as an attrition rate of enrolled participants of no greater than 25%.

  8 weeks

• Acceptability of intervention

  Prospective acceptability will be assessed using the Acceptability of Intervention Measure (AIM). High acceptability will be defined as an average score greater than 3 (on a 1-5, completely agree-completely disagree scale).

  8 weeks

• Program satisfaction

  Program satisfaction will be measured by our custom Post-Intervention Acceptability Questionnaire which focuses on program enjoyment and satisfaction and potential barriers. High program satisfaction will be defined as an average score greater than 5 (on a 0-10, not at all-extremely scale) for items focused on satisfaction.

  8 weeks

• Participant attendance

  Participant attendance will be determined by data on module completion on the class platform ScarletCanvas. High participation will be defined as at least 50% of participants successfully completing 6 or more modules.

  8 weeks

• Changes in subjective cognitive decline

  Participants will be administered the self-report Everyday Cognition Questionnaire (ECog) at pre-intervention and post-intervention. Significant changes in subjective reports of cognitive decline will also be considered as evidence for feasibility of the intervention.

  Baseline, 8 weeks

• Plasma-based Alzheimer's disease (AD) biomarkers

  Plasma markers of amyloid and tau pathology will be assayed at pre-intervention and post-intervention.

  Baseline, 8 weeks

Secondary Outcomes (3)

• Default mode network (DMN) strength

  Baseline, 8 weeks

• Behavioral measure of Mind-wandering

  Baseline, 8 weeks

• Self-report measures of Mind-wandering

  Baseline, 8 weeks

Other Outcomes (9)

• Self-report stress

  Baseline, 8 weeks

• Self-report motivation to change life style and health behaviors for dementia risk reduction

  Baseline, 8 weeks

• Self-report quality of life

  Baseline, 8 weeks

Study Arms (2)

Internet-based Mindfulness-Based Stress Reduction (iMBSR)

EXPERIMENTAL

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.

Behavioral: Internet-based Mindfulness-Based Stress Reduction (iMBSR)

Internet-based Lifestyle Education Group (iLifeEd)

ACTIVE COMPARATOR

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.

Behavioral: Internet-based Lifestyle Education (iLifeEd)

Interventions

Internet-based Lifestyle Education (iLifeEd) BEHAVIORAL

iLifeEd is an online and asynchronous lifestyle education program. Participants will be presented with information and activities about healthy aging topics, including physical activity, sedentary behavior, sleep, stress, nutrition and hydration, social support, and cognitively stimulating activities. Stretching and toning exercises will also be included.

Internet-based Lifestyle Education Group (iLifeEd)

Internet-based Mindfulness-Based Stress Reduction (iMBSR) BEHAVIORAL

The iMBSR program is an adaptation of Jon Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) to be delivered in an online and asynchronous manner. MBSR was developed by Kabat-Zinn in the 1970s as a method to help individuals manage stress and pain through mindfulness meditation. Mindfulness practice has been linked to numerous benefits such as boosting cognitive control and emotion regulation. MBSR includes practices such as orienting attention to the present moment, often through an object like the breath, nonjudgmental awareness of thoughts and emotions, mindful listening, mindful eating, and body scan meditation.

Internet-based Mindfulness-Based Stress Reduction (iMBSR)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Department of Psychology

Columbus, Ohio, 43201, United States

Location

Related Publications (17)

• Warburton DE, Jamnik VK, Bredin SS, McKenzie DC, Stone J, Shephard RJ, Gledhill N. Evidence-based risk assessment and recommendations for physical activity clearance: an introduction. Appl Physiol Nutr Metab. 2011 Jul;36 Suppl 1:S1-2. doi: 10.1139/h11-060.

  PMID: 21800937 BACKGROUND

• Bondi MW, Edmonds EC, Jak AJ, Clark LR, Delano-Wood L, McDonald CR, Nation DA, Libon DJ, Au R, Galasko D, Salmon DP. Neuropsychological criteria for mild cognitive impairment improves diagnostic precision, biomarker associations, and progression rates. J Alzheimers Dis. 2014;42(1):275-89. doi: 10.3233/JAD-140276.

  PMID: 24844687 BACKGROUND

• Jack CR Jr, Knopman DS, Jagust WJ, Petersen RC, Weiner MW, Aisen PS, Shaw LM, Vemuri P, Wiste HJ, Weigand SD, Lesnick TG, Pankratz VS, Donohue MC, Trojanowski JQ. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013 Feb;12(2):207-16. doi: 10.1016/S1474-4422(12)70291-0.

  PMID: 23332364 BACKGROUND

• Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.

  PMID: 21514248 BACKGROUND

• Strikwerda-Brown C, Ozlen H, Pichet Binette A, Chapleau M, Marchant NL, Breitner JCS, Villeneuve S. Trait Mindfulness Is Associated With Less Amyloid, Tau, and Cognitive Decline in Individuals at Risk for Alzheimer's Disease. Biol Psychiatry Glob Open Sci. 2022 Jan 17;3(1):130-138. doi: 10.1016/j.bpsgos.2022.01.001. eCollection 2023 Jan.

  PMID: 36712573 BACKGROUND

• Tomaszewski Farias S, Mungas D, Harvey DJ, Simmons A, Reed BR, Decarli C. The measurement of everyday cognition: development and validation of a short form of the Everyday Cognition scales. Alzheimers Dement. 2011 Nov;7(6):593-601. doi: 10.1016/j.jalz.2011.02.007.

  PMID: 22055976 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Sperling R, Mormino E, Johnson K. The evolution of preclinical Alzheimer's disease: implications for prevention trials. Neuron. 2014 Nov 5;84(3):608-22. doi: 10.1016/j.neuron.2014.10.038. Epub 2014 Nov 5.

  PMID: 25442939 BACKGROUND

• Yiannopoulou KG, Papageorgiou SG. Current and Future Treatments in Alzheimer Disease: An Update. J Cent Nerv Syst Dis. 2020 Feb 29;12:1179573520907397. doi: 10.1177/1179573520907397. eCollection 2020.

  PMID: 32165850 BACKGROUND

• Weintraub S, Besser L, Dodge HH, Teylan M, Ferris S, Goldstein FC, Giordani B, Kramer J, Loewenstein D, Marson D, Mungas D, Salmon D, Welsh-Bohmer K, Zhou XH, Shirk SD, Atri A, Kukull WA, Phelps C, Morris JC. Version 3 of the Alzheimer Disease Centers' Neuropsychological Test Battery in the Uniform Data Set (UDS). Alzheimer Dis Assoc Disord. 2018 Jan-Mar;32(1):10-17. doi: 10.1097/WAD.0000000000000223.

  PMID: 29240561 BACKGROUND

• Schultz AP, Chhatwal JP, Huijbers W, Hedden T, van Dijk KR, McLaren DG, Ward AM, Wigman S, Sperling RA. Template based rotation: a method for functional connectivity analysis with a priori templates. Neuroimage. 2014 Nov 15;102 Pt 2(0 2):620-36. doi: 10.1016/j.neuroimage.2014.08.022. Epub 2014 Aug 21.

  PMID: 25150630 BACKGROUND

• Martinon LM, Smallwood J, McGann D, Hamilton C, Riby LM. The disentanglement of the neural and experiential complexity of self-generated thoughts: A users guide to combining experience sampling with neuroimaging data. Neuroimage. 2019 May 15;192:15-25. doi: 10.1016/j.neuroimage.2019.02.034. Epub 2019 Feb 22.

  PMID: 30802513 BACKGROUND

• Lutz A, Jha AP, Dunne JD, Saron CD. Investigating the phenomenological matrix of mindfulness-related practices from a neurocognitive perspective. Am Psychol. 2015 Oct;70(7):632-58. doi: 10.1037/a0039585.

  PMID: 26436313 BACKGROUND

• Jak AJ, Bondi MW, Delano-Wood L, Wierenga C, Corey-Bloom J, Salmon DP, Delis DC. Quantification of five neuropsychological approaches to defining mild cognitive impairment. Am J Geriatr Psychiatry. 2009 May;17(5):368-75. doi: 10.1097/JGP.0b013e31819431d5.

  PMID: 19390294 BACKGROUND

• Gauthier S, Albert M, Fox N, Goedert M, Kivipelto M, Mestre-Ferrandiz J, Middleton LT. Why has therapy development for dementia failed in the last two decades? Alzheimers Dement. 2016 Jan;12(1):60-4. doi: 10.1016/j.jalz.2015.12.003. Epub 2015 Dec 19.

  PMID: 26710325 BACKGROUND

• Farias ST, Mungas D, Reed BR, Cahn-Weiner D, Jagust W, Baynes K, Decarli C. The measurement of everyday cognition (ECog): scale development and psychometric properties. Neuropsychology. 2008 Jul;22(4):531-44. doi: 10.1037/0894-4105.22.4.531.

  PMID: 18590364 BACKGROUND

• Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.

  PMID: 24107443 BACKGROUND

Study Officials

• Ruchika S Prakash, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blind. Any investigators administering assessments will be blind to participants' group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 13, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)