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

NCT ID: NCT06194357

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2026-09-30

Brief Summary

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.

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

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention group will receive training on Qigong exercise and mindfulness.

Group Type: EXPERIMENTAL

Mindfulness-based Health Qigong Intervention

Intervention Type: OTHER

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.

Control group

Control group will not receive intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

TSANG Hector Wing-Hong

Chair Professor and Head of Department of Rehabilitation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wing Hong, Hector TSANG, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Science, Faculty of Health and Social Sciences

Locations

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Travis,Tsz-kwun Law, Mr

Role: CONTACT

tk120@ha.org.hk

29901017

Facility Contacts

Travis,Tsz-kwun Law, Mr

Role: primary

tk120@ha.org.hk

(852)29901017

Other Identifiers

KW/EX-23-001(179-01)

Identifier Type: -

Identifier Source: org_study_id