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

N/ACompletedNCT06194357

TSANG Hector Wing-Hong600 enrolled

Overview

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, and 12 months post-intervention, using standardized psychological and physical health assessments.

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.

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Psychological Symptoms

Depression, Anxiety and Stress Scale (DASS-12)

Time frame: From baseline to 12 months post-intervention

Secondary Outcomes

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).