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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AG081982-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 weeks |
| Behavioral measure of Mind-wandering |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report stress | The Perceived Stress Scale (PSS) will be administered pre-intervention and post-intervention to measure self-report perceptions of stress. The measure has 10 items measured on a 5-point scale. Total score is obtained by summing individual item scores, with a higher score indicating greater stress. | Baseline, 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruchika S Prakash, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology | Columbus | Ohio | 43201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21800937 | Background | 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. | |
| 24844687 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2026 | Jun 25, 2026 | ICF_000.pdf |
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Single-blind. Any investigators administering assessments will be blind to participants' group allocation.
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| 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. |
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| 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 |
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. |
| 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. | Baseline, 8 weeks |
| Self-report motivation to change life style and health behaviors for dementia risk reduction |
The Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) will be administered pre-intervention and post-intervention to assess self-report motivation to change life style and health behaviors for dementia risk reduction. The measure has 27 items measured on a 5-point scale. Total score is obtained by summing individual item scores, with a higher score indicating greater motivation. |
| Baseline, 8 weeks |
| Self-report quality of life | The World Health Organization Quality of Life abbreviated scale (WHOQOL-BREF) will be administered pre-intervention and post-intervention to assess self-reported quality of life. The measure has 26 items scored on a 5-point scale. Total score is obtained by summing individual item scores, with a higher score indicating greater quality of life. | Baseline, 8 weeks |
| Self-report anxiety | The Beck Anxiety Inventory (BAI) will be administered pre-intervention and post-intervention to assess self-report anxiety. The measure has 21 items measured on a 4-point scale. Total score is obtained by summing individual item scores, with a higher score indicating greater anxiety. | Baseline, 8 weeks |
| Self-report worry | The Penn State Worry Questionnaire (PSWQ) will be administered pre-intervention and post-intervention to assess self-report worry. The measure has 16 items measured on a 5-point scale. Total score is obtained by summing individual item scores (with 5 items reverse-scored), with a higher score indicating greater worry. | Baseline, 8 weeks |
| Self-report discrimination | The Everyday Discrimination Scale (EDS) will be administered pre-intervention and post-intervention to assess self-report accounts of everyday discrimination. The measure has 9 required items scored on a 6-point scale. Total score is obtained by summing individual item scores, with a higher score indicating greater discrimination. | Baseline, 8 weeks |
| Self-report depression | The Center for Epidemiological Studies-Depression Scale (CES-D) will be administered pre-intervention and post-intervention to assess self-report depression. The measure has 20 items scored on a 4-point scale. Total score is obtained by summing individual item scores (with 4 items reverse-scored), with a higher score indicating greater depression. | Baseline, 8 weeks |
| Intra-individual variability in EMA-based cognitive functioning | Participants will complete ecological momentary assessment of cognitive functioning before and immediately after the intervention. We will compute intraindividual variability in cognitive performance to examine the effect of the intervention. | Baseline, 8 weeks |
| Hippocampal Volume | Hippocampal volume will be computed using a high-resolution MRI scan. Multi-spectral analyses, employing the Automatic Segmentation of Hippocampal Subfields, will be conducted to quantify volumetric changes in the hippocampal subfields. | Baseline, 8 weeks |
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