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

NCT05459896 | Recruiting DMC

• 1 other identifier: HSEARS20220318003
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Stress; Psychological Distress; COVID-19 Stress Syndrome

Keywords

Smart Health; COVID-19; Psychosocial distress; Intervention; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes of Brief Fatigue Inventory (BFI)

  Change from baseline to 24 weeks after the programme

• Changes of Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to 24 weeks after the programme

• Changes of Numerical Pain Scale (NPS)

  Change from baseline to 24 weeks after the programme

• Changes of Cognitive Emotion Regulation Questionnaire Short Form (CERQ-short)

  Change from baseline to 24 weeks after the programme

• Changes of General Self-efficacy Scale (GSS)

  Change from baseline to 24 weeks after the programme

Study Arms (2)

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.

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.

Interventions

Physical Activity Training 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.

Experimental Group

Mindfulness-based Intervention 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.

Experimental Group

Energy Conservation Techniques 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

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MeSH Terms

Conditions

COVID-19 stress syndrome; COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Justina Liu, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina Liu, PhD

CONTACT

(852) 2766 4097; justina.liu@polyu.edu.hk

Amy Cheung, MA

CONTACT

(852) 2766 6763; amy-ka-po.cheung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who perform the outcome assessment and analysis will be blinded to the group allocations of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 15, 2022
• Study Start: February 27, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)