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

NCT ID: NCT05459896

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2026-09-30

Brief Summary

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.

Detailed Description

Studies indicate that during the pandemic, people, particularly those COVID-19 survivors, are more likely to experience distress symptoms, including physical fatigue, decreased sleep quality, and body pain than during normal times. The abovementioned impacts on health can affect everyone during the COVID-19 pandemic. These negative impacts on physical and psychological health also 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. Studies showed that around 10-30% of people who have contracted COVID-19 present with post-COVID-19 conditions, or "Long COVID", and among all the symptoms, physical and psychological complications such as depression, anxiety and reduced quality of life are commonly reported. This indicates an urgent need to identify an evidence-based intervention to address the health issues of people whose health has been affected by COVID-19.

Smart Health is defined as the provision of medical and public healthcare services by using mobile technologies, such as mobile phones, tablet devices, personal digital assistants (PDAs), and other wireless devices. A smart health intervention is a cost-effective and easily operated intervention that can provide various functions, including self-monitoring, data collection, real-time feedback, and notifications. Appropriate use of smart health-based interventions can bring significant changes in people's health behaviour, such as prompting them to adopt a physically active lifestyle. In a systematic review of 12 studies with a total of 3,469 participants, in which the effects of mobile app-based interventions were compared with those of the usual care, significant effects on health outcomes were found from using mobile apps to manage chronic diseases, such as improved physical functioning and increased medication adherence.

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. This research gap gives us the impetus to develop a 24-week intervention guided by an innovative three-level (Prevention, Protection and Progression) Health Apps for Post-Pandemic Years (here-and-after as HAPPY) driven by the Transactional Model of Stress and Coping Theory (TMSCT) to address COVID-related physical and psychosocial distress symptoms of people during the post-pandemic era. The TMSCT emphasizes the use of appraisals to evaluate the harm, threats, and challenges that result in the process of coping with stressful events. The level of stress experienced (in the form of thoughts, emotions, and behaviours) as a result of external stressors depends on appraisals of the situation, which involves a judgement about whether the internal or external demands exceed an individual's resources and ability to cope when the demands exceed the resources. Positive emotions will be elicited when individuals are capable of resolving stressors with the utilisation of both internal (e.g. cognitive appraisals, emotion regulation) and external resources (e.g. social support, access to new knowledge and skills), while negative emotions will be elicited as a result of unresolved distress.

This protocol aims to evaluate the immediate effects (eight weeks after weekly supervised sessions, i.e. on the 8th week) and the mid-term effects (six months when the intervention has been completed; i.e., on the 24th week) of the HAPPY for alleviating people's physiological and psychosocial distress during the post-pandemic era. It is hypothesised that the experimental group will 1) exhibit greater improvement in physiological and psychosocial distress and 2) have a more positive appraisal mindset, greater self-efficacy, and more sustainable self-management ability than participants in the waitlist control group.

Conditions

Physiological Stress; Psychological Distress; COVID-19 Stress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Participants in the experimental group will be triaged to receive different types of interventions at Level 2, namely physical activity training, mindfulness coping strategies and energy conservation techniques, based on participants' screening and outcome assessment results at Level 1. These interventions will be taught in the 8-week regular supervision phase and self-practice during the 16-week self-help phase. The features in the Health Apps for Post-Pandemic Years (HAPPY) will be introduced to the participants in the first two sessions. In the other six sessions participants will be provided guidance in practicing the assigned intervention. Participants will self-practice the assigned intervention at home during 16-week self-help phase. At Level 3 Self-management, participants will be encouraged to work through a total of six thematic modules which aim to enhance participants' favourable appraisals of the current stress factors, to reduce stress levels and improve coping.

Group Type: EXPERIMENTAL

Physical Activity Training

Intervention Type: BEHAVIORAL

Participants who exhibit both physical and psychosocial distress will be recommended to receive physical activity intervention. An approach of adding game mechanics into an interactive environment that combines live action and an award system will be integrated into the intervention. The physical training involves 15-min resistance training and 30-min interactive cardio dancing each with beginner and advanced levels. Participants are recommended to start with the beginner level and do the exercises on regular intervals during the intervention period. The Light Detection and Ranging (LiDAR) motion sensor with tablet-based console and the full-body tracking sensor will be used to capture real-time data on participants' human body movements in order to enhance understanding of performance. Participants will get a commercial wearable sensor. Participants will be asked to wear the sensor at all times and sync the data with the Smart Health Platform to self-monitor daily condition.

Mindfulness-based Intervention

Intervention Type: OTHER

Participants who exhibit psychosocial distress will be recommended to receive mindfulness-based intervention which is designed based on the concept of validated Mindfulness-Based Stress Reduction (MBSR) combined with techniques from Mindfulness-Based Cognitive Therapy (MBCT). The intervention consists of 10 sessions, each session has different main themes and associated activities including body scan, mindful eating, abdominal breathing, chair yoga, awareness of breathing, mindful walking, breathing, body and emotions, yoga stretching, mindful listening and choiceless awreness. The materials will be delivered in the format of animation videos. Participants will be asked to complete one session per week.

Energy Conservation Techniques

Intervention Type: OTHER

Participants who exhibit physiological symptoms will be recommended to receive energy savings intervention which is co-developed by the local Occupational Therapy Association. The intervention consists of six session, each session has different topics and associated energy savings techniques related to particular circumstances, such as the six principle of energy conservation, application of energy conservation in the domains of self-care, household tasks, outdoor activities and work. The materials will be delivered in the format of animation videos. Participants will be asked to complete one session per week. Revision quiz will be given to understand the learning progress of participants.

Waitlist Control Group

Participants in the waitlist control group will receive materials on the promotion of physical and psychological health during the waiting period. Participants will then receive the same 24-week intervention as the experimental group in Week 25 after completing the baseline assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity Training

Participants who exhibit both physical and psychosocial distress will be recommended to receive physical activity intervention. An approach of adding game mechanics into an interactive environment that combines live action and an award system will be integrated into the intervention. The physical training involves 15-min resistance training and 30-min interactive cardio dancing each with beginner and advanced levels. Participants are recommended to start with the beginner level and do the exercises on regular intervals during the intervention period. The Light Detection and Ranging (LiDAR) motion sensor with tablet-based console and the full-body tracking sensor will be used to capture real-time data on participants' human body movements in order to enhance understanding of performance. Participants will get a commercial wearable sensor. Participants will be asked to wear the sensor at all times and sync the data with the Smart Health Platform to self-monitor daily condition.

Intervention Type: BEHAVIORAL

Mindfulness-based Intervention

Participants who exhibit psychosocial distress will be recommended to receive mindfulness-based intervention which is designed based on the concept of validated Mindfulness-Based Stress Reduction (MBSR) combined with techniques from Mindfulness-Based Cognitive Therapy (MBCT). The intervention consists of 10 sessions, each session has different main themes and associated activities including body scan, mindful eating, abdominal breathing, chair yoga, awareness of breathing, mindful walking, breathing, body and emotions, yoga stretching, mindful listening and choiceless awreness. The materials will be delivered in the format of animation videos. Participants will be asked to complete one session per week.

Intervention Type: OTHER

Energy Conservation Techniques

Participants who exhibit physiological symptoms will be recommended to receive energy savings intervention which is co-developed by the local Occupational Therapy Association. The intervention consists of six session, each session has different topics and associated energy savings techniques related to particular circumstances, such as the six principle of energy conservation, application of energy conservation in the domains of self-care, household tasks, outdoor activities and work. The materials will be delivered in the format of animation videos. Participants will be asked to complete one session per week. Revision quiz will be given to understand the learning progress of participants.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Justina Liu Yat Wa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justina Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Justina Liu, PhD

Role: CONTACT

justina.liu@polyu.edu.hk

(852) 2766 4097

Amy Cheung, MA

Role: CONTACT

amy-ka-po.cheung@polyu.edu.hk

(852) 2766 6763

Facility Contacts

Amy Cheung, MA

Role: primary

amy-ka-po.cheung@polyu.edu.hk

+852 27664145 ext. 4145

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HSEARS20220318003

Identifier Type: -

Identifier Source: org_study_id