A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress

Recruiting now · Not applicable

Conditions studied: Physiological Stress, Psychological Distress, COVID-19 Stress Syndrome

In brief

The negative impacts on physical and psychological health brought by COVID-19 seem to perpetuate in the post-pandemic era. It is estimated that there will be an impending mental health crisis in the general population in the aftermath of the pandemic due to the delayed negative impacts of COVID-19 and the associated non-pharmaceutical public health interventions such as social distancing, quarantining, and lockdown. Smart Health, defined as the provision of medical and public healthcare services by using mobile technologies, is a cost-effective and easily operated intervention that can provide various functions and can bring significant changes in people's health behaviour, such as prompting them to adopt a physically active lifestyle. Despite the rapid growth of digital health technology, most of them were developed during pandemic with a focus on delivering non-systematic, general virtual healthcare to people. The aim of this study is 1) to develop a Health Apps for Post-Pandemic Years (HAPPY) driven by the Transactional Model of Stress and Coping Theory, and 2) to evaluate its efficacy of alleviating people's physiological and psychosocial distress during post-pandemic era. A total of 814 eligible participants, both COVID-19 victims and non-COVID-19 victims exhibiting physiological and/or psychosocial distress during post-pandemic era, will be recruited and randomized to either the experimental or the waitlist control group. The experimental group will receive a 24-week intervention combined with an 8-week regular supervision phase plus a 16-week self-help phase. Participants will receive different coping strategies, namely physical training, energy conservation techniques and mindfulness-based coping in the intervention hub at Level 2 based on participants' assessments at Level 1, and enhance self-management at Level 3. Participants' physical activity levels will be measured using commercial wearable sensors. The waitlist control group will receive materials on the promotion of physical and psychological health during waiting period and receive the same intervention as the experimental group in week 25. It is hypothesized that the experimental group will exhibit milder symptoms of physiological and psychosocial distress, and have a more positive appraisal mindset, greater self-efficacy, and more sustainable self-management ability than participants in the waitlist control group.

Key facts

Study ID: NCT05459896
Run by: The Hong Kong Polytechnic University
People needed: 814
Starts: 2024-02-27
Expected to finish: 2026-09-30
Last updated by the study team: 2024-02-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged 18 and older;
Exhibiting physiological and/or psychosocial distress:
A cutoff value of ≥ 20 in the Kessler Psychological Distress Scale (K10) will be used to indicate participants with psychological distress.
A cutoff value of ≥ 4 on the Brief Fatigue Inventory (BFI) indicate participants with physical fatigue;
A cutoff value of > 5 on the Pittsburgh Sleep Quality Index (PSQI) indicate participants with decreased sleep quality;
A cutoff value of > 3 on the Numerical Pain Scale (NPS) indicates participants with pain, including headaches, upset stomach, and other forms of pain
Has access to the Internet and a smart phone

You may not qualify if…

Individuals with any health conditions that could hamper participation in the Health Apps for Post-Pandemic Years (HAPPY), such as severe cognitive, visual, or hearing impairments.

Where it is running

The Hong Kong Polytechnic University — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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