Integrated Mindfulness-based Health Qigong Intervention for COVID-19 Survivors and Caregivers

January 4, 2024 updated by: TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness

COVID-19-related depression, anxiety, and stigma are expected to have short-term and long-term adverse impacts on mental health, help seeking and preventive behaviours in affected individuals, including care providers and the general population. Health qigong (HQ), a form of traditional Chinese martial arts with emphasis placed on the body movement and status of mind, has been demonstrated to enhance both physical and mental health. Mindfulness-based interventions (MBIs), another mind-body treatment, have become increasingly popular for treating a number of health problems. This study proposes an integrated intervention that combines the effects of HQ and MBIs (iMBHQ) to improve the mental wellbeing of COVID-19 survivors, caregivers including healthcare providers and family members as well as the general public in the community.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective:

The study aims to examine whether iMBHQ can improve the physical and psychological wellness of COVID-19 survivors, caregivers and the general public in the community.

Procedures:

Participants will be randomized into either the treatment group (16-week iMBHQ program) or the control group. For the treatment group, a face-to-face initial session will be arranged for each participant to introduce the practice of the most essential skills, particularly mindfulness, the basic movements of Qigong and the use of the resources package. Following the initial session, participants will kick off 8 bi-weekly online sessions of MBIs approximately two hours each via the Mobile App. Afterwards, participants will be asked to practice Qigong for 30 minutes per day with five days weekly for another 8 weeks. Follow-up sessions will be conducted by an experienced coach via the Mobile App. After the first 16-week intervention, booster sessions will be provided every 3 months to revise the interventions and follow-up assessments will be completed every 6 months for 2 years.

Participants:

will be asked to practice Qigong for 30 minutes per day with five days weekly for another 8 weeks. Follow-up sessions will be conducted by an experienced coach via the Mobile App. After the first 16-week intervention, booster sessions will be provided every 3 months to revise the interventions and follow-up assessments will be completed every 6 months for 2 years.

Results:

The investigators predict that the integrated intervention developed will significantly reduce fear, anxiety and stigma in COVID-19 survivors, their caregivers and the general public by improving stress, cognitive, and mood coping strategies.

Conclusions:

The findings will be able to explain the effects and outcomes of integrated intervention derived from the hypothetical model which the investigators will propose. The outcomes will also help transform the hypothetical model into a psychosocial and rehabilitation theory, which can explain many of the psychosocial and behavioral consequences that may hinder the recovery of those affected by COVID-19 and hinder their caregivers and the general public to seek help and take preventive measures against the disease. The findings will also demonstrate that the integrated intervention developed by the research group will be the long-term and cost-effective rehabilitation management approaches for COVID-19 survivors, caregivers, and the general public to promote their physical and psychological wellbeing in the community

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Travis,Tsz-kwun Law, Mr
  • Phone Number: 29901017
  • Email: tk120@ha.org.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
          • Travis,Tsz-kwun Law, Mr
          • Phone Number: (852)29901017
          • Email: tk120@ha.org.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Intervention group
Intervention group will receive training on Qigong exercise and mindfulness.
Other: Mindfulness-based Health Qigong Intervention
Participants are introduced the practice of the most essential skills, particularly mindfulness, the basic movements of Qigong and the use of the resources package. Following the initial session, participants will kick off 8 bi-weekly online sessions of Mindfulness-based interventions approximately two hours each via the Mobile App. Afterwards, participants will be asked to practice Qigong for 30 minutes per day with five days weekly for another 8 weeks. Follow-up sessions will be conducted by an experienced coach via the Mobile App. After the first 16-week intervention, booster sessions will be provided every 3 months to revise the interventions and follow-up assessments will be completed every 6 months for 2 years.
No Intervention: Control group
Control group will not receive intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological wellbeing
Time Frame: 2 years
Depression, Anxiety and Stress Scale (DASS-12)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame: 2 years
12-item Short Form healthy survey (SF-12); Rumination Reflection Questionnaire (RRQ); Hyperarousal Scale COVID-19 Fear Scale; Stigma: Perceived stigma and Self-stigma Scale; Attitudes toward rapid testing and vaccine scale
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Wing Hong, Hector TSANG, Prof, Department of Rehabilitation Science, Faculty of Health and Social Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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