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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 exerci
• Другое 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, breat
• Другое 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 materi

Первичные конечные точки

• Changes of Kessler Psychological Distress Scale (K10) [Срок оценки: Change from baseline to 24 weeks after the programme]

Вторичные конечные точки (7)

• Changes of Brief Fatigue Inventory (BFI) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of Numerical Pain Scale (NPS) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of Cognitive Emotion Regulation Questionnaire Short Form (CERQ-short) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of General Self-efficacy Scale (GSS) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of Depression Anxiety Stress Scales (DASS-21) [Срок оценки: Change from baseline to 24 weeks after the programme]
• Changes of Impact of Event Scale - Revised (IES-R) [Срок оценки: Change from baseline to 24 weeks after the programme]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Публикации

• 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. PMID 32570296
• Soklaridis 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. PMID 32858431
• Rauschenberg 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. PMID 33606657
• Cheung 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. PMID 33519545
• Bressington 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. PMID 33192697
• Kwan 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. PMID 32735218
• Choi 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. PMID 32466251
• Lam 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. PMID 32765321

Идентификаторы

NCT: NCT05459896 · HSEARS20220318003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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