Clinical trial NCT06194357: Integrated Mindfulness-based Health Qigong Intervention for COVID-19 Survivors and Caregivers
Official title: Developing an Integrated Mindfulness-based Health Qigong Intervention (iMBHQ) for COVID-19 Survivors and Caregivers to Improve Their Physical and Psychological Wellness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19 Infection
Keywords: COVID-19 Survivors
caregivers
mindfulness-based health Qigong intervention
physical wellness
psychological wellness
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Psychological wellbeing
timeFrame: 2 years
Secondary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
Study officials:
affiliation: Department of Rehabilitation Science, Faculty of Health and Social Sciences
name: Wing Hong, Hector TSANG, Prof
role: PRINCIPAL_INVESTIGATOR
References: