Physiological StressNCT05459896
A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress
A study testing Physical Activity Training, Mindfulness-based Intervention and Energy Conservation Techniques in people with Physiological Stress and Psychological Distress, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Physiological Stress, Psychological Distress, COVID-19 Stress Syndrome
- What is being tested?
- Physical Activity Training, Mindfulness-based Intervention and Energy Conservation Techniques
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Feb 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Amy Cheung, MA, +852 27664145 ext. 4145, amy-ka-po.cheung@polyu.edu.hk
About this study
Official title: A Health Apps for Post-Pandemic Years (HAPPY) for People With Physiological and Psychosocial Distress During the Post-Pandemic Era
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.
Read the 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.
- Being tested
- Physical Activity Training, Mindfulness-based Intervention, Energy Conservation Techniques
- Keywords
- Smart Health, COVID-19, Psychosocial distress, Intervention, Physical Activity
- Medical subject headings
- COVID-19 stress syndrome, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity TrainingBehavioural
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 InterventionOther
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 TechniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Behavioral: Physical Activity Training; Other: Mindfulness-based Intervention; Other: Energy Conservation Techniques |
| Waitlist Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 24 weeks after the programme
Secondary outcomes (7)
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
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.
Measured: Change from baseline to 24 weeks after the programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start27 Feb 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded, two-arm randomized controlled trial consisting of experimental and waitlist groups will be adopted to examine the effects of the Health Apps for Post-Pandemic Years (HAPPY) for alleviating people's physiological and psychosocial distress during the post-pandemic era.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 814 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University
- Investigators
- Justina Liu, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459896
- Sponsor's protocol ID
- HSEARS20220318003
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.
Publications
Kontoangelos K, Economou M, Papageorgiou C. Mental Health Effects of COVID-19 Pandemia: A Review of Clinical and Psychological Traits. Psychiatry Investig. 2020 Jun;17(6):491-505. doi: 10.30773/pi.2020.0161. Epub 2020 Jun 15.
PubMed 32570296Soklaridis S, Lin E, Lalani Y, Rodak T, Sockalingam S. Mental health interventions and supports during COVID- 19 and other medical pandemics: A rapid systematic review of the evidence. Gen Hosp Psychiatry. 2020 Sep-Oct;66:133-146. doi: 10.1016/j.genhosppsych.2020.08.007. Epub 2020 Aug 22.
PubMed 32858431Rauschenberg C, Schick A, Hirjak D, Seidler A, Paetzold I, Apfelbacher C, Riedel-Heller SG, Reininghaus U. Evidence Synthesis of Digital Interventions to Mitigate the Negative Impact of the COVID-19 Pandemic on Public Mental Health: Rapid Meta-review. J Med Internet Res. 2021 Mar 10;23(3):e23365. doi: 10.2196/23365.
PubMed 33606657Cheung T, Lam SC, Lee PH, Xiang YT, Yip PSF; International Research Collaboration on COVID-19. Global Imperative of Suicidal Ideation in 10 Countries Amid the COVID-19 Pandemic. Front Psychiatry. 2021 Jan 13;11:588781. doi: 10.3389/fpsyt.2020.588781. eCollection 2020.
PubMed 33519545Bressington DT, Cheung TCC, Lam SC, Suen LKP, Fong TKH, Ho HSW, Xiang YT. Association Between Depression, Health Beliefs, and Face Mask Use During the COVID-19 Pandemic. Front Psychiatry. 2020 Oct 22;11:571179. doi: 10.3389/fpsyt.2020.571179. eCollection 2020.
PubMed 33192697Kwan RY, Lee D, Lee PH, Tse M, Cheung DS, Thiamwong L, Choi KS. Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e16596. doi: 10.2196/16596.
PubMed 32735218Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.
PubMed 32466251Lam SC, Arora T, Grey I, Suen LKP, Huang EY, Li D, Lam KBH. Perceived Risk and Protection From Infection and Depressive Symptoms Among Healthcare Workers in Mainland China and Hong Kong During COVID-19. Front Psychiatry. 2020 Jul 15;11:686. doi: 10.3389/fpsyt.2020.00686. eCollection 2020.
PubMed 32765321Lee JA, Choi M, Lee SA, Jiang N. Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review. BMC Med Inform Decis Mak. 2018 Feb 20;18(1):12. doi: 10.1186/s12911-018-0591-0.
PubMed 29458358Kwan RYC, Lee PH, Cheung DSK, Lam SC. Face Mask Wearing Behaviors, Depressive Symptoms, and Health Beliefs Among Older People During the COVID-19 Pandemic. Front Med (Lausanne). 2021 Feb 5;8:590936. doi: 10.3389/fmed.2021.590936. eCollection 2021.
PubMed 33614680Li W, Zhao N, Yan X, Zou S, Wang H, Li Y, Xu X, Du X, Zhang L, Zhang Q, Cheung T, Ungvari GS, Ng CH, Xiang YT. The prevalence of depressive and anxiety symptoms and their associations with quality of life among clinically stable older patients with psychiatric disorders during the COVID-19 pandemic. Transl Psychiatry. 2021 Jan 26;11(1):75. doi: 10.1038/s41398-021-01196-y.
PubMed 33500389Liu JY, Kor PP, Chan CP, Kwan RY, Cheung DS. The effectiveness of a wearable activity tracker (WAT)-based intervention to improve physical activity levels in sedentary older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Nov/Dec;91:104211. doi: 10.1016/j.archger.2020.104211. Epub 2020 Jul 26.
PubMed 32739713Hung, S. C., Ho, A. Y., Lai, I. H., Lee, C. S., Pong, A. S., & Lai, F. H. (2020). Meta-analysis on the effectiveness of Virtual Reality Cognitive Training (VRCT) and Computer-Based Cognitive Training (CBCT) for individuals with Mild Cognitive Impairment (MCI). Electronics, 9(12), 2185.DOI:10.3390/electronics9122185
Lai FH, Yan EW, Yu KK, Tsui WS, Chan DT, Yee BK. The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic. Am J Geriatr Psychiatry. 2020 Nov;28(11):1175-1184. doi: 10.1016/j.jagp.2020.07.019. Epub 2020 Aug 8.
PubMed 32873496Zhou, C. C. J. W. T., Chu, J., Wang, T., Peng, Q., He, J., Zheng, W., ... & Xu, L. (2008). Reliability and validity of 10-item Kessler scale (K10) Chinese version in evaluation of mental health status of Chinese population. Chinese Journal of Clinical Psychology, 16(6), 627-629. DOI:10.16128/j.cnki.1005-3611.2008.06.026
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Apps for Post-Pandemic Years (HAPPY) for People With Physiological and Psychosocial Distress During the Post-Pandemic Era
- ClinicalTrials.gov ID
- NCT05459896
- Acronym / sponsor ID
- HSEARS20220318003
- Keywords
- Smart Health, COVID-19, Psychosocial distress, Intervention, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 814 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blinded, two-arm randomized controlled trial consisting of experimental and waitlist groups will be adopted to examine the effects of the Health Apps for Post-Pandemic Years (HAPPY) for alleviating people's physiological and psychosocial distress during the post-pandemic era.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Physical Activity Training, Other: Mindfulness-based Intervention, Other: Energy Conservation TechniquesParticipants 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. |
| Waitlist Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity TrainingParticipants 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. | Behavioural | Experimental Group |
| Mindfulness-based InterventionParticipants 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. | Other | Experimental Group |
| Energy Conservation TechniquesParticipants 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. | Other | Experimental Group |
Primary outcome
Changes of Kessler Psychological Distress Scale (K10)
Time frame: Change from baseline to 24 weeks after the programme
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.
7 secondary outcomes
Changes of Brief Fatigue Inventory (BFI)
Time frame: Change from baseline to 24 weeks after the programme
Changes of Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to 24 weeks after the programme
Changes of Numerical Pain Scale (NPS)
Time frame: Change from baseline to 24 weeks after the programme
Changes of Cognitive Emotion Regulation Questionnaire Short Form (CERQ-short)
Time frame: Change from baseline to 24 weeks after the programme
Changes of General Self-efficacy Scale (GSS)
Time frame: Change from baseline to 24 weeks after the programme
Changes of Depression Anxiety Stress Scales (DASS-21)
Time frame: Change from baseline to 24 weeks after the programme
Changes of Impact of Event Scale - Revised (IES-R)
Time frame: Change from baseline to 24 weeks after the programme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 32570296Kontoangelos K, Economou M, Papageorgiou C. Mental Health Effects of COVID-19 Pandemia: A Review of Clinical and Psychological Traits. Psychiatry Investig. 2020 Jun;17(6):491-505. doi: 10.30773/pi.2020.0161. Epub 2020 Jun 15.
- Background: PubMed 32858431Soklaridis S, Lin E, Lalani Y, Rodak T, Sockalingam S. Mental health interventions and supports during COVID- 19 and other medical pandemics: A rapid systematic review of the evidence. Gen Hosp Psychiatry. 2020 Sep-Oct;66:133-146. doi: 10.1016/j.genhosppsych.2020.08.007. Epub 2020 Aug 22.
- Background: PubMed 33606657Rauschenberg C, Schick A, Hirjak D, Seidler A, Paetzold I, Apfelbacher C, Riedel-Heller SG, Reininghaus U. Evidence Synthesis of Digital Interventions to Mitigate the Negative Impact of the COVID-19 Pandemic on Public Mental Health: Rapid Meta-review. J Med Internet Res. 2021 Mar 10;23(3):e23365. doi: 10.2196/23365.
- Background: PubMed 33519545Cheung T, Lam SC, Lee PH, Xiang YT, Yip PSF; International Research Collaboration on COVID-19. Global Imperative of Suicidal Ideation in 10 Countries Amid the COVID-19 Pandemic. Front Psychiatry. 2021 Jan 13;11:588781. doi: 10.3389/fpsyt.2020.588781. eCollection 2020.
- Background: PubMed 33192697Bressington DT, Cheung TCC, Lam SC, Suen LKP, Fong TKH, Ho HSW, Xiang YT. Association Between Depression, Health Beliefs, and Face Mask Use During the COVID-19 Pandemic. Front Psychiatry. 2020 Oct 22;11:571179. doi: 10.3389/fpsyt.2020.571179. eCollection 2020.
- Background: PubMed 32735218Kwan RY, Lee D, Lee PH, Tse M, Cheung DS, Thiamwong L, Choi KS. Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e16596. doi: 10.2196/16596.
- Background: PubMed 32466251Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.
- Background: PubMed 32765321Lam SC, Arora T, Grey I, Suen LKP, Huang EY, Li D, Lam KBH. Perceived Risk and Protection From Infection and Depressive Symptoms Among Healthcare Workers in Mainland China and Hong Kong During COVID-19. Front Psychiatry. 2020 Jul 15;11:686. doi: 10.3389/fpsyt.2020.00686. eCollection 2020.
- Background: PubMed 29458358Lee JA, Choi M, Lee SA, Jiang N. Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review. BMC Med Inform Decis Mak. 2018 Feb 20;18(1):12. doi: 10.1186/s12911-018-0591-0.
- Background: PubMed 33614680Kwan RYC, Lee PH, Cheung DSK, Lam SC. Face Mask Wearing Behaviors, Depressive Symptoms, and Health Beliefs Among Older People During the COVID-19 Pandemic. Front Med (Lausanne). 2021 Feb 5;8:590936. doi: 10.3389/fmed.2021.590936. eCollection 2021.
- Background: PubMed 33500389Li W, Zhao N, Yan X, Zou S, Wang H, Li Y, Xu X, Du X, Zhang L, Zhang Q, Cheung T, Ungvari GS, Ng CH, Xiang YT. The prevalence of depressive and anxiety symptoms and their associations with quality of life among clinically stable older patients with psychiatric disorders during the COVID-19 pandemic. Transl Psychiatry. 2021 Jan 26;11(1):75. doi: 10.1038/s41398-021-01196-y.
- Background: PubMed 32739713Liu JY, Kor PP, Chan CP, Kwan RY, Cheung DS. The effectiveness of a wearable activity tracker (WAT)-based intervention to improve physical activity levels in sedentary older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Nov/Dec;91:104211. doi: 10.1016/j.archger.2020.104211. Epub 2020 Jul 26.
- Individual participant dataSharing planned: No. For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justina Liu, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Training, Mindfulness-based Intervention and Energy Conservation Techniques in people with Physiological Stress and Psychological Distress, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justina Liu, PhD ((852) 2766 4097, justina.liu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Kessler Psychological Distress Scale (K10) (time frame: Change from baseline to 24 weeks after the programme). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459896, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.