Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Psychological wellbeing
研究概览
简要总结
This study examines the effectiveness of a 16-week Integrated Mindfulness-based Health Qigong (iMBHQ) program, delivered via a mobile application, in improving the mental and physical well-being of COVID-19 survivors, their caregivers, and the general public. We hypothesize that participants in the iMBHQ group will demonstrate significant reductions in stress, depression, and anxiety compared to a control group receiving treatment-as-usual. This parallel-group randomized controlled trial aims to recruit 600 participants (200 COVID-19 survivors, 200 caregivers, and 200 individuals from the general public). Effectiveness is evaluated at baseline, 8 weeks, 16 weeks, 6 months, and 12 months post-intervention, using standardized psychological and physical health assessments.
详细描述
Background & Objective The COVID-19 pandemic has precipitated significant psychological challenges, including stress, anxiety, and depression, among COVID-19 survivors, their caregivers, and the general public. The primary objective of this study is to examine whether an Integrated Mindfulness-based Health Qigong (iMBHQ) program can improve the physical and psychological wellness of these three distinct populations within the community.
Study Design & Participants This study employs a 3 × 2 factorial parallel-group randomized controlled trial design. The trial aims to recruit a total of 600 participants (200 COVID-19 survivors, 200 caregivers, and 200 individuals from the general public). Participants will be randomized into either the treatment group (receiving the 16-week iMBHQ program) or the control group (receiving treatment-as-usual).
Intervention Procedures Delivered via a tailor-made mobile application, the iMBHQ program combines Health Qigong (Baduanjin) and Mindfulness-Based Interventions (MBIs) to target both physical health and psychological distress. During Weeks 1-8, participants complete mindfulness-based sessions lasting 2 hours per week. During Weeks 9-16, they transition to practicing Qigong for 30 minutes per day, five days a week. To evaluate efficacy, outcome data will be collected at baseline, 8 weeks (inter-intervention), 16 weeks (post-intervention), 6 months, and 12 months post-intervention.
Outcome Measures & Analysis Primary and secondary outcome measures include the Depression, Anxiety and Stress Scale (DASS-21), Multidimensional Assessment of Interoceptive Awareness (MAIA), 12-item Short Form Health Survey (SF-12), Rumination Reflection Questionnaire (RRQ), Hyperarousal Scale, and specific scales measuring COVID-19-related fear, stigma, and attitudes toward vaccination. Data will be analyzed using the Intention-to-Treat (ITT) principle, and linear mixed models will be utilized to examine treatment × group interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-19 survivors: people aged 18 years or above who were infected by COVID-19 (both symptomatic and asymptomatic) and clinically recovered
- •Caregivers of COVID-19 patients, including family members or medical professionals who have contacts with patients diagnosed COVID-19 aged 18 years or above
- •General healthy public aged 18 years or above
排除标准
- •people diagnosed severe and/or chronic conditions that prevent the practice of Qigong (e.g., acute exacerbation of dyspnoea, severe cardiopulmonary disease) or mindfulness intervention,
- •people with severe psychiatric disorder
- •people who have regular psychiatric follow-ups
研究组 & 干预措施
Intervention group
Intervention group will receive training on Qigong exercise and mindfulness.
干预措施: Mindfulness-based Health Qigong Intervention (Other)
Control group
Control group will not receive intervention.
结局指标
主要结局
Psychological wellbeing
时间窗: 2 years
Depression, Anxiety and Stress Scale (DASS-12)
Psychological Symptoms
时间窗: From baseline to 12 months post-intervention
Depression, Anxiety and Stress Scale (DASS-12)
次要结局
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(2 years)
- Interoception, Quality of Life, Rumination, Hyperarousal, Fear and Stigma Towards COVID-19, Attitude toward rapid testing and vaccine(From baseline to 12 months post-intervention)
研究者
TSANG Hector Wing-Hong
Professor
The Hong Kong Polytechnic University