- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06194357
Integrated Mindfulness-based Health Qigong Intervention for COVID-19 Survivors and Caregivers
Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
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Hong Kong, Hong Kong
- Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Intervention group will receive training on Qigong exercise and mindfulness.
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Participants are introduced the practice of the most essential skills, particularly mindfulness and the basic movements of Qigong. The intervention lasts 16 weeks and is divided into two sequential 8-week phases: Phase 1 (Weeks 1-8): Participants complete mindfulness-based sessions lasting 2 to 2.5 hours per week. They are also instructed to complete three self-practice sessions (5 to 10 minutes per session), scheduled flexibly at their convenience. Phase 2 (Weeks 9-16): Participants complete 40 sessions of Health Qigong (5 sessions per week, 30 minutes each). To verify compliance, participants must upload a 1-minute self-practice video to the mobile application each week. |
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No Intervention: Control group
Control group will not receive intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological Symptoms
Time Frame: From baseline to 12 months post-intervention
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Depression, Anxiety and Stress Scale (DASS-12)
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From baseline to 12 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Interoception, Quality of Life, Rumination, Hyperarousal, Fear and Stigma Towards COVID-19, Attitude toward rapid testing and vaccine
Time Frame: From baseline to 12 months post-intervention
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Multidimensional Assessment of Interoceptive Awareness (MAIA); 12-item Short Form healthy survey (SF-12); Rumination Reflection Questionnaire (RRQ); Pre-sleep Arousal Scale (PSAS); COVID-19 Public Stigma Scale (PSS); Fear of COVID-19 Scale (FCV); Thought on Covid-19 vaccination (TCV).
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From baseline to 12 months post-intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wing Hong, Hector TSANG, Prof, Department of Rehabilitation Science, Faculty of Health and Social Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KW/EX-23-001(179-01)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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