Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in the WHO-5 Well-Being Index
研究概览
简要总结
Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years of age or older
- •English language fluency
- •Naive to meditation practices (not actively meditating more than one hour per month and/or meditation practice for less than a year in their entire life-time)
- •No MRI contra-indications
- •Cognitively healthy (no diagnosis of dementia, stroke, developmental disorders, or major systemic diseases that may impact cognitive function)
排除标准
- •Below 60 years of age
- •Not fluent in English
- •Active meditator (meditating more than one hour per month and/or meditation practice for more than a year in their entire life-time).
- •Presence of a severe psychiatric (e.g. schizophrenia, bipolar disorder, PTSD), neurological (epilepsy, traumatic brain injury, dementia, multiple sclerosis), or developmental disorder (e.g. autism)
- •Systemic disease (e.g. major recent surgeries, cancer)
- •Claustrophobia
- •Contraindications for MR safety (e.g. metal in body, cochlea implants)
研究组 & 干预措施
intervention
Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.
干预措施: intervention (Behavioral)
waitlist control
Participants will be randomized to a waitlist group for six weeks. The waitlist control group will then be able to use the meditation app for six weeks as the primary intervention group
干预措施: waitlist control (Behavioral)
Baseline physiology
A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants.
干预措施: No Interventions (Other)
结局指标
主要结局
Change in the WHO-5 Well-Being Index
时间窗: Change in well-being from baseline to directly after completing the intervention (6 weeks)
WHO-5 ranges from 0-25, with higher values indicating higher well-being
次要结局
- Change in Psychological Stress Measure (PSM-9)(Change in stress from baseline to directly after completing the intervention (6 weeks))
- Change in Patient Health Questionnaire (PHQ-9)(Change in depression from baseline to directly after completing the intervention (6 weeks))
- Change in the 20-item UCLA loneliness scale(Change in loneliness from baseline to directly after completing the intervention (6 weeks))
- Change in the General Anxiety Disorder-7 (GAD-7)(Change in anxiety from baseline to directly after completing the intervention (6 weeks))