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

Psychological Distress Clinical Trial

Official title:

A Health Apps for Post-Pandemic Years (HAPPY) for People With Physiological and Psychosocial Distress During the Post-Pandemic Era

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459896
• Other study ID #: HSEARS20220318003
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: Justina Liu, PhD
• Phone: (852) 2766 4097
• Email: justina.liu[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 814
• Est. completion date: September 30, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Physiological Stress
• Psychological Distress

Intervention

Behavioral:
• 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.

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Kessler Psychological Distress Scale (K10)	The Kessler Psychological Distress Scale (K10) is a simple measure of psychological distress which involves 10 questions about emotional states each with a five-level response scale. The scores on this scale range from 10 to 50 points, with lower scores reflecting better psychological health status. A cutoff value of = 20 on the K10 scale indicates psychological distress.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Brief Fatigue Inventory (BFI)	The Brief Fatigue Inventory (BFI) measures nine items on 10-point numeric scales for fatigue level and interference with daily life. A global fatigue score can be obtained by averaging all the items on the BFI. The total scores range from 0-10 points, with higher scores indicate greater fatigue. A cutoff value = 4 on the BFI scale indicates intervention for fatigue.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. The scores range from 0 to 21 points, with higher scores indicate poor sleep quality. A cutoff value > 5 indicates poor sleep quality.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Numerical Pain Scale (NPS)	The Numerical Pain Scale (NPS) is a self-reported questionnaire consists of 1 question measuring pain intensity. The scores range from 0 to 10, with higher scores indicate greater pain. A cutoff value > 3 indicates greater pain.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Cognitive Emotion Regulation Questionnaire Short Form (CERQ-short)	The Cognitive Emotion Regulation Questionnaire Short Form (CERQ-short) is a validated, multidimensional questionnaire to identify the cognitive emotion regulation strategies (or cognitive coping strategies) someone uses after having experienced negative events or situations. It measures 18 items on 5-point numeric scales. There are a total of nine subscales measuring the domains of self-blame, acceptance, rumination, positive refocusing, planning, positive reappraisal, putting into perspective, catastrophizing and other-blame. The total scores of the scale range from 0 to 90 points, with higher scores indicate higher cognitive emotional regulation ability.	Change from baseline to 24 weeks after the programme
Secondary	Changes of General Self-efficacy Scale (GSS)	The General Self-Efficacy Scale (GSS) is a self-reported questionnaire designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. It measures 10 items on 4-point numeric scales. The scores range from 10 to 40 points, with higher scores indicate higher self-efficacy.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Depression Anxiety Stress Scales (DASS-21)	The Depression Anxiety Stress Scales (DASS-21) is a self-reported questionnaire designed to measure the emotional states of depression, anxiety and stress. It consists of three subscales of depression, anxiety and stress, each contains 7 items on 4-point numeric scales. The score of each subscale has to be multiplied by 2 to obtain the total subscale scores. The total scores of each subscale range from 0 to 42 points, with higher scores indicate more severe depression/anxiety/stress symptoms.	Change from baseline to 24 weeks after the programme
Secondary	Changes of Impact of Event Scale - Revised (IES-R)	The Impact of Event Scale - Revised (IES-R) is self-reported measure that assesses subjective distress caused by traumatic events. It measures 22-items on 5-point numeric scales. The scores range from 0 to 88 points, with higher scores indicate more severe Post-Traumatic Stress Disorder symptoms.	Change from baseline to 24 weeks after the programme