ChiCTR2200061862尚未招募Unknown
Pilot study on the effect of mindfulness on the changes in loneliness and psychological outcomes and their association with changes in microbiota and inflammatory markers
The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong1 个研究点 分布在 1 个国家开始时间: 2022年6月17日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 试验地点
- 1
- 主要终点
- Stool microbiota alpha and beta diversity
研究概览
简要总结
To examine whether the changes in loneliness and psychological outcomes are associated with changes in microbiota and inflammatory markers.
研究设计
- 研究类型
- Interventional
- 主要目的
- 病例对照研究
- 盲法
- None
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- All
入选标准
- •Adults aged 60 years and above;
- •Normal cognitive functioning such that they can understand the materials delivered in mindfulness training and can complete home practice each week;
- •Must have been on a stable dosage of psychiatric medications for at least three months because it can interfere with loneliness measurement, and
- •Have a validated Chinese six-item De Jong Gierveld Loneliness Scale >= score 3, suggesting loneliness.
排除标准
- •Inability to communicate and understand Chinese, as the intervention will be conducted in Chinese;
- •Possession of a medical or mental health condition rendering him/her incapable of participating in the study;
- •Previous participation in mindfulness-based training.
研究组 & 干预措施
Mindfulness based intervention for Older Adults (MBOA)
Social contact control (SCC) group
结局指标
主要结局
Stool microbiota alpha and beta diversity
时间窗: baseline, post-intervention, 6 and 12 months after randomization
次要结局
- De Jong Gierveld Loneliness Scale(baseline, post-intervention, 6 and 12 months after randomization)
- Patient Health Questionnaire-9 (PHQ-9)(baseline, post-intervention, 6 and 12 months after randomization)
- State-Trait Anxiety Inventory (STAI)(baseline, post-intervention, 6 and 12 months after randomization)
- Physical Activity Scale for the Elderly (PASE)(baseline, post-intervention, 6 and 12 months after randomization)
- AUDIT questionnaire(baseline, post-intervention, 6 and 12 months after randomization)
- UCLA Health version of the 3-day FR(baseline, post-intervention, 6 and 12 months after randomization)
研究者
研究点 (1)
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