Subjective Cognitive DeclineiMBTNCT07019402
Internet-based Mind-Body Training for Brain Health
A study testing Internet-based Mindfulness-Based Stress Reduction (iMBSR) and Internet-based Lifestyle Education (iLifeEd) in people with Subjective Cognitive Decline, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- Internet-based Mindfulness-Based Stress Reduction (iMBSR) and Internet-based Lifestyle Education (iLifeEd)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to 9 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Mind-Body Training (iMBT) for Brain Health
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.
Read the detailed description
A significant limiting factor in the prognosis of AD is the absence of targeted pharmaceutical or behavioral interventions to arrest or reduce the neurodegeneration resulting from the accumulation of two key proteinopathies once cognitive symptoms are observable. In fact, in AD stage sequencing, the aggregation of Aβ in neural plaques followed by tau accumulation in neurofibrillary tangles, predates the onset of known cognitive symptoms-at times one to two decades before observable changes in cognition. Additionally, midline cortical structures of the DMN are the first sites of AD pathophysiology with activity of the DMN heavily linked with internally directed cognitions. Although these internally directed cognitions are adaptive, the ongoing nature of these spontaneous cognitions has a downstream negative impact for overall cognition, psychological well-being, and potentially, is also linked with AD pathophysiology. Mindfulness training, with its cultivation of present moment awareness, has shown promising support for its potential to reduce mind-wandering and strengthen the neural circuitry supporting sustained attention. More recently, there has also been support for mindfulness to be positively associated with lower levels of Aβ and tau pathology. Thus, the primary goal of this study is to evaluate the feasibility, acceptability, and preliminary effects of an internet-based mindfulness training program on mind-wandering, neural connectivity of the DMN, and plasma-based biomarkers of Aβ and tau pathology, which has the potential to make a significant contribution to the prevention of AD-related cognitive decline. The main hypothesis is that the iMBSR program will be feasible and acceptable and improve neural, behavioral, and EMA measures of mind-wandering and slow the accumulation of AD biomarkers. Feasibility will be defined through evaluation of recruitment, retention, and drop-out rates. Acceptability will be defined by assessing prospective acceptability, participant attendance, and program satisfaction. The investigators hypothesize that iMBSR and iLifeEd will be feasible and acceptable for adults with subjective cognitive decline, and that participants in the iMBSR group will also report lower levels of subjective cognitive decline. The investigators additionally hypothesize that iMBSR training will result in a reduction of mind-wandering thoughts and reaction time coefficient of variation (RT_CV) immediately following training. The investigators also hypothesize that network strength in the default mode network (DMN) will increase following training in the iMBSR protocol compared with the iLifeEd training. For plasma markers of amyloid and tau pathology, the investigators hypothesize that there will be a lower rate of accumulation in amyloid and tau pathology in the iMBSR group compared with the iLifeEd group.
- Conditions
- Subjective Cognitive Decline
- Being tested
- Internet-based Mindfulness-Based Stress Reduction (iMBSR), Internet-based Lifestyle Education (iLifeEd)
- Keywords
- mindfulness-based stress reduction, mind-wandering, mind-body training, aging, subjective cognitive decline, lifestyle education, randomized control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Mindfulness-Based Stress Reduction (iMBSR)Behavioural
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 Lifestyle Education (iLifeEd)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Internet-based Lifestyle Education (iLifeEd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Feasibility of intervention: Retention rate
Feasibility will be determined by evaluating retention of participants in the study.
Measured: 8 weeks
Feasibility of intervention: attrition rate
High feasibility will be defined as an attrition rate of enrolled participants of no greater than 25%.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks
Secondary outcomes (3)
Default mode network (DMN) strength
Network strength in the DMN during the Gradual-onset Continuous Performance Task (GradCPT) will be computed from the MRI scans at pre-intervention and post-intervention.
Measured: Baseline, 8 weeks
Behavioral measure of Mind-wandering
The primary measure of mind-wandering will be the reaction time coefficient of variation (RT_CV), which will be obtained by computing the trial to trial fluctuations in participant reaction time during the Go/No-Go task at pre-intervention and post-intervention.
Measured: Baseline, 8 weeks
Self-report measures of Mind-wandering
The primary measure of self-reported mind-wandering will be the self-report endorsement of mind-wandering during daily life collected during ecological momentary assessment (EMA) at pre-intervention and post-intervention.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start13 Jun 2025
- Primary completion29 Jun 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ruchika S Prakash, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019402
- Sponsor's protocol ID
- 2024H0401
- Other IDs
- 1R61AG081982-01A1
- Acronym
- iMBT
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21800937Bondi 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.
PubMed 24844687Jack 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.
PubMed 23332364Sperling 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.
PubMed 21514248Strikwerda-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.
PubMed 36712573Tomaszewski 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.
PubMed 22055976Lawton 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.
PubMed 5349366Sperling 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.
PubMed 25442939Yiannopoulou 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.
PubMed 32165850Weintraub 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.
PubMed 29240561Schultz 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.
PubMed 25150630Martinon 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.
PubMed 30802513Lutz 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.
PubMed 26436313Jak 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.
PubMed 19390294Gauthier 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.
PubMed 26710325
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Mind-Body Training (iMBT) for Brain Health
- ClinicalTrials.gov ID
- NCT07019402
- Acronym / sponsor ID
- iMBT / 2024H0401
- Conditions
- Subjective Cognitive Decline
- Keywords
- mindfulness-based stress reduction, mind-wandering, mind-body training, aging, subjective cognitive decline, lifestyle education, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A significant limiting factor in the prognosis of AD is the absence of targeted pharmaceutical or behavioral interventions to arrest or reduce the neurodegeneration resulting from the accumulation of two key proteinopathies once cognitive symptoms are observable. In fact, in AD stage sequencing, the aggregation of Aβ in neural plaques followed by tau accumulation in neurofibrillary tangles, predates the onset of known cognitive symptoms-at times one to two decades before observable changes in cognition. Additionally, midline cortical structures of the DMN are the first sites of AD pathophysiology with activity of the DMN heavily linked with internally directed cognitions. Although these internally directed cognitions are adaptive, the ongoing nature of these spontaneous cognitions has a downstream negative impact for overall cognition, psychological well-being, and potentially, is also linked with AD pathophysiology. Mindfulness training, with its cultivation of present moment awareness, has shown promising support for its potential to reduce mind-wandering and strengthen the neural circuitry supporting sustained attention. More recently, there has also been support for mindfulness to be positively associated with lower levels of Aβ and tau pathology. Thus, the primary goal of this study is to evaluate the feasibility, acceptability, and preliminary effects of an internet-based mindfulness training program on mind-wandering, neural connectivity of the DMN, and plasma-based biomarkers of Aβ and tau pathology, which has the potential to make a significant contribution to the prevention of AD-related cognitive decline. The main hypothesis is that the iMBSR program will be feasible and acceptable and improve neural, behavioral, and EMA measures of mind-wandering and slow the accumulation of AD biomarkers. Feasibility will be defined through evaluation of recruitment, retention, and drop-out rates. Acceptability will be defined by assessing prospective acceptability, participant attendance, and program satisfaction. The investigators hypothesize that iMBSR and iLifeEd will be feasible and acceptable for adults with subjective cognitive decline, and that participants in the iMBSR group will also report lower levels of subjective cognitive decline. The investigators additionally hypothesize that iMBSR training will result in a reduction of mind-wandering thoughts and reaction time coefficient of variation (RT_CV) immediately following training. The investigators also hypothesize that network strength in the default mode network (DMN) will increase following training in the iMBSR protocol compared with the iLifeEd training. For plasma markers of amyloid and tau pathology, the investigators hypothesize that there will be a lower rate of accumulation in amyloid and tau pathology in the iMBSR group compared with the iLifeEd group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based Mindfulness-Based Stress Reduction (iMBSR) | Experimental | Behavioral: 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. |
| Internet-based Lifestyle Education Group (iLifeEd) | Active comparator | Behavioral: Internet-based Lifestyle Education (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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Mindfulness-Based Stress Reduction (iMBSR)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. | Behavioural | Internet-based Mindfulness-Based Stress Reduction (iMBSR) |
| Internet-based Lifestyle Education (iLifeEd)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. | Behavioural | Internet-based Lifestyle Education Group (iLifeEd) |
Primary outcome
Feasibility of intervention: Recruitment
Time frame: 12 months
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.
Feasibility of intervention: Retention rate
Time frame: 8 weeks
Feasibility will be determined by evaluating retention of participants in the study.
Feasibility of intervention: attrition rate
Time frame: 8 weeks
High feasibility will be defined as an attrition rate of enrolled participants of no greater than 25%.
Acceptability of intervention
Time frame: 8 weeks
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).
Program satisfaction
Time frame: 8 weeks
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.
Participant attendance
Time frame: 8 weeks
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.
Changes in subjective cognitive decline
Time frame: Baseline, 8 weeks
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.
Plasma-based Alzheimer's disease (AD) biomarkers
Time frame: Baseline, 8 weeks
Plasma markers of amyloid and tau pathology will be assayed at pre-intervention and post-intervention.
3 secondary outcomes
Default mode network (DMN) strength
Time frame: Baseline, 8 weeks
Behavioral measure of Mind-wandering
Time frame: Baseline, 8 weeks
Self-report measures of Mind-wandering
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 21800937Warburton 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.
- Background: PubMed 24844687Bondi 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.
- Background: PubMed 23332364Jack 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.
- Background: PubMed 21514248Sperling 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchika S Prakash, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Mindfulness-Based Stress Reduction (iMBSR) and Internet-based Lifestyle Education (iLifeEd) in people with Subjective Cognitive Decline, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention: Recruitment (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019402, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.