ChiCTR2200062460尚未招募Unknown
Online integrated mindfulness-meaning programme for depression and anxiety during COVID-19: A pilot randomized controlled trial
Health and Medical Research Fund, Food and Health Bureau, HKSAR1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月26日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The primary objective is to:
- Evaluate the feasibility and acceptability of the online IMMP by measuring recruitment feasibility, intervention adherence, dropout, participants self-rated satisfaction/engagement/ perceived difficulty/helpfulness of the IMMP intervention, and adverse events. The secondary objectives are to provide:
- Preliminary efficacy of IMMP on depression and anxiety, negative and positive affect, meaning in life, and mindfulness, to provide useful sample size calculation reference for future full RCTs.
- Qualitative feedbacks on the IMMP for improvement.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Due to the nature of the intervention, it is impossible to blind participants, but the investigators and persons who conduct the statistical analyses will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Adults aged 18 or above in Hong Kong;
- •With PHQ-9 and/or GAD-7 scores at 5-14 which suggested mild to moderate depression and/or anxiety levels;
- •No regular practice of mindfulness meditation; and
- •Willing to complete the 8 weekly online interventions.
排除标准
- •Suicidal ideation, plans or behaviours, as they may need more intensive clinical care;
- •Cannot understand Chinese as the programmes will be conducted in Chinese;
- •No WhatsApp account as the intervention will be sent through WhatsApp - a popular instant messenger in Hong Kong; and
- •Other conditions rendering them incapable of following in the 8-week online interventions (e.g., vision and hearing problems).
研究组 & 干预措施
Intervention
The Integrated Mindfulness-Meaning Programme (IMMP)
Control
Health Education
结局指标
主要结局
Feasibility
时间窗: During the whole study period (Recruitment, intervention period, follow-up period)
次要结局
- Depression and Anxiety(Baseline, 2 months (post intervention) and 5 months (3 months post intervention))
- Positive and negative affect: The validated Positive Affect and Negative Affect Schedule (PANAS) scale(Baseline, 2 months (post intervention) and 5 months (3 months post intervention))
- Purpose in life(Baseline, 2 months (post intervention) and 5 months (3 months post intervention))
- Mindfulness(Baseline, 2 months (post intervention) and 5 months (3 months post intervention))
研究者
研究点 (1)
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