ChiCTR2000038539尚未招募1 期
The effects of mindfulness-based intervention for loneliness on older adults: a randomised controlled trial
General Research Fund2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年1月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- De Jong Gierveld Loneliness Scale
研究概览
简要总结
- To evaluate the effects of the MBOA programme in reducing loneliness among older adults in Hong Kong;
- To evaluate the effects of MBOA in improving quality of life and decreasing depression, anxiety, and healthcare utilisation among lonely older adults;
- To explore whether self- acceptance, monitoring, and rumination are potential mediators of the intervention and outcomes for loneliness, anxiety, depression, quality of life and healthcare use among older adults in Hong Kong.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 60 至 100（—）
- 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 stable dosage of psychiatric medications of at least three months, because it can interfere with loneliness measurement; and
- •have a validated Chinese six-item De Jong Gierveld Loneliness Scale score of >= 3 suggesting loneliness
排除标准
- •inability to communicate in 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; and
- •previous participation in a mindfulness-based training
研究组 & 干预措施
Experimental group
Mindfulness based intervention for Older Adults (MBOA)
Control group
Group Social Contact Control (SCC)
结局指标
主要结局
De Jong Gierveld Loneliness Scale
时间窗: baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).
次要结局
- Five-level EuroQol-five dimensions (EQ-5D-5L) questionnaire(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- Patient Health Questionnaire-9 (PHQ-9)(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- State-Trait Anxiety Inventory (STAI)(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- Acceptance and Action Questionnaire – II(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- Rumination Response Scale(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- Mindful Attention Awareness Scale (MAAS)(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
- Healthcare utilisation record(baseline (T0), post-intervention (T1), and 6 and 12 months post-randomisation (T2 and T3).)
研究者
研究点 (2)
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