NCT07019402

Internet-based Mind-Body Training for Brain Health

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-06-13
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-06-13
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States