COVID-19 InfectionNCT06194357
Integrated Mindfulness-based Health Qigong Intervention for COVID-19 Survivors and Caregivers
A study testing Mindfulness-based Health Qigong Intervention in people with COVID-19 Infection, run by TSANG Hector Wing-Hong at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Mindfulness-based Health Qigong Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesHong Kong
- Study dates
- 8 Nov 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Princess Margaret Hospital
Hong Kong
The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness
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, 12 months and 18 months post-intervention, using standardized psychological and physical health assessments.
Read the 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, 12 months, and 18 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.
- Conditions
- COVID-19 Infection
- Being tested
- Mindfulness-based Health Qigong Intervention
- Keywords
- COVID-19 Survivors, caregivers, mindfulness-based health Qigong intervention, physical wellness, psychological wellness
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Health Qigong InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will receive training on Qigong exercise and mindfulness. Receives: Other: Mindfulness-based Health Qigong Intervention |
| Control group | No intervention | Control group will not receive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Symptoms
Depression, Anxiety and Stress Scale (DASS-12)
Measured: From baseline to 18 months post-intervention
Secondary outcomes (1)
Interoception, Quality of Life, Rumination, Hyperarousal, Fear and Stigma Towards COVID-19, Attitude toward rapid testing and vaccine
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).
Measured: From baseline to 18 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start8 Nov 2022
- Primary completion28 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSANG Hector Wing-Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Sponsor-investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
- Investigators
- Wing Hong, Hector TSANG, Prof, Principal investigator, Department of Rehabilitation Science, Faculty of Health and Social Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194357
- Sponsor's protocol ID
- KW/EX-23-001(179-01)
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness
- ClinicalTrials.gov ID
- NCT06194357
- Acronym / sponsor ID
- KW/EX-23-001(179-01)
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19 Survivors, caregivers, mindfulness-based health Qigong intervention, physical wellness, psychological wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- TSANG Hector Wing-HongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 12 months and 18 months post-intervention, using standardized psychological and physical health assessments.
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, 12 months, and 18 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mindfulness-based Health Qigong InterventionIntervention group will receive training on Qigong exercise and mindfulness. |
| Control group | No intervention | –Control group will not receive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Health Qigong InterventionParticipants 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. | Other | Intervention group |
Primary outcome
Psychological Symptoms
Time frame: From baseline to 18 months post-intervention
Depression, Anxiety and Stress Scale (DASS-12)
1 secondary outcome
Interoception, Quality of Life, Rumination, Hyperarousal, Fear and Stigma Towards COVID-19, Attitude toward rapid testing and vaccine
Time frame: From baseline to 18 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Hong, Hector TSANG, Prof principal investigator
Department of Rehabilitation Science, Faculty of Health and Social Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Health Qigong Intervention in people with COVID-19 Infection, run by TSANG Hector Wing-Hong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Symptoms (time frame: From baseline to 18 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.