Internet-based Mind-Body Training (iMBT) for Brain Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of intervention: attrition rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blind. Any investigators administering assessments will be blind to participants' group allocation.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Internet-based Mindfulness-Based Stress Reduction (iMBSR) (Behavioral)
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.
干预措施: Internet-based Lifestyle Education (iLifeEd) (Behavioral)
结局指标
主要结局
Feasibility of intervention: attrition rate
时间窗: 8 weeks
High feasibility will be defined as an attrition rate of enrolled participants of no greater than 25%.
Participant attendance
时间窗: 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.
Feasibility of intervention: Recruitment
时间窗: 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
时间窗: 8 weeks
Feasibility will be determined by evaluating retention of participants in the study.
Acceptability of intervention
时间窗: 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
时间窗: 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.
Changes in subjective cognitive decline
时间窗: 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
时间窗: Baseline, 8 weeks
Plasma markers of amyloid and tau pathology will be assayed at pre-intervention and post-intervention.
次要结局
- Behavioral measure of Mind-wandering(Baseline, 8 weeks)
- Default mode network (DMN) strength(Baseline, 8 weeks)
- Self-report measures of Mind-wandering(Baseline, 8 weeks)