[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474591":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":63,"collaborators":20,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":20,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Behavioral: Physical Activity Training","Other: Mindfulness-based Intervention","Other: Energy Conservation Techniques",{"label":17,"type":18,"description":19,"interventionNames":20},"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.",null,[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"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.",[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":20},"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.",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":20},"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.",[9],[36],{"name":37,"affiliation":5,"role":38},"Justina Liu, PhD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":20,"email":43},"CONTACT","(852) 2766 4097","justina.liu@polyu.edu.hk",{"name":45,"role":41,"phone":46,"phoneExt":20,"email":47},"Amy Cheung, MA","(852) 2766 6763","amy-ka-po.cheung@polyu.edu.hk",[49],{"facility":5,"status":50,"city":51,"state":20,"zip":20,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Hong Kong","HK",{"type":54,"coordinates":55},"Point",[56,57],114.17469,22.27832,{"lat":57,"lon":56},[60],{"name":45,"role":41,"phone":61,"phoneExt":62,"email":47},"+852 27664145","4145",{"type":38,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Dr. Justina Liu Yat Wa","Principal Investigator","100474591","a-health-apps-for-post-pandemic-years-for-people-with-physiological-and-psychosocial-distress-100474591",false,"NCT05459896","A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress","A Health Apps for Post-Pandemic Years (HAPPY) for People With Physiological and Psychosocial Distress During the Post-Pandemic Era","Inclusion Criteria:\n\n* Aged 18 and older;\n* Exhibiting physiological and\u002For psychosocial distress:\n* A cutoff value of ≥ 20 in the Kessler Psychological Distress Scale (K10) will be used to indicate participants with psychological distress.\n* A cutoff value of ≥ 4 on the Brief Fatigue Inventory (BFI) indicate participants with physical fatigue;\n* A cutoff value of \\> 5 on the Pittsburgh Sleep Quality Index (PSQI) indicate participants with decreased sleep quality;\n* A cutoff value of \\> 3 on the Numerical Pain Scale (NPS) indicates participants with pain, including headaches, upset stomach, and other forms of pain\n* Has access to the Internet and a smart phone\n\nExclusion Criteria:\n\n* 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.","ALL","18 Years","70 Years",{"count":77,"type":78},814,"ESTIMATED","INTERVENTIONAL",[81],"NA","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\u002For 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.",[84,85,86],"Physiological Stress","Psychological Distress","COVID-19 Stress Syndrome",[88,89,90,91,92],"Smart Health","COVID-19","Psychosocial distress","Intervention","Physical Activity","2024-02-26",{"date":95,"type":96},"2024-02-28","ACTUAL",{"date":98,"type":96},"2024-02-27",{"date":100,"type":78},"2026-09-30",{"name":5,"class":6},1]