Participants, interventions and outcomes
The study will focus on specific industries with a considerable level of work-related stress, such as the servicing and hospitality industries. Employees in these industries may have a large volume of customer or client interaction, or the job nature may carry heavy personal and/or interpersonal responsibilities. Currently, three large companies in Hong Kong have indicated willingness to involve in the study. These include a company providing travel services, a real estate company, and a property management company. All three companies have signed an agreement to willingly participate in the project.
Sites: Managers of the participating sites are willing to commit to the project and allow the study to be conducted at their branch offices.
Participants: All staff members working at the selected sites are eligible to participate in the study. However, participants have to indicate their willingness to participate in the study and to comply with the requirements of the study by signing the consent form.
Sites: Managers of any sites who are not willing to comply to the requirements of the study and not willing to allow the project team to conduct the Workplace Environment scan in the branch office will be excluded.
Participants: Any staff member at any site who have already received a similar psychoeducation training program or involved in any similar intervention program before will be excluded from the current intervention program.
Intervention to be tested: The intervention program comprises of two main elements: an organisation-directed component and an individual-directed psychoeducation training.
For the organisation-directed component a Workplace Environment scan, using a standard protocol and the Moos Work Environment Scale (WES) , will be conducted by a senior social worker with expertise in workplace issues. The scan will take place at the commencement of intervention program prior to the individual-directed component. Different dimensions of the work environment, including workload (work pressure and task requirements); personal growth (professional growth, support, achievement value and growth); conflict and management relationship, will be assessed to gain a better understanding of the workplace issues at different sites. Information will be gathered via a staff survey and face-to-face interviews. De-identified and aggregated information collected from the assessment will be provided to the management of each participating site with professional interpretation of the findings. Possible strategies to resolve the identified issues will also be offered. Site management is encouraged to make use of this information to improve the work environment during the intervention and the follow-up period. Each site is encouraged to document changes in organisational practices and to, quantitatively and qualitatively, record any changes in the workplace in terms of morale, work performance, productivity, sick leave, and resignations. Information on these changes will be collated at the end of the project through interviews with site managers.
For the individual-directed component, participating sites will adopt the well-studied and evidence-based Workplace Mental Health First Aid (MHFA) training program  with the inclusion of a module on stress reduction and burnout prevention. Based on the e-Health and e-Learning approach, this is a blended training consisting of a series of self-paced online e-Learning modules. Participants will have access to these online modules to complete each at their own convenience. Upon the completion of the online modules, a face-to-face group session lasting for about half a day will be conducted. The aim of the group session is to provide an opportunity for participants to clarify any queries interactively with the program trainer and to gain hands-on experience through communication skills practices.
Pilot testing: a small-scale pilot was conducted by the team on a mental health education and training program in a sample of high school teachers and nurses in China. This project was set up as a joint initiative between the Australian and Chinese governments through the Australia China Council (ACC) of the Department of Foreign Affairs and Trades, Australia Government (http://dfat.gov.au/people-to-people/foundations-councils-institutes/australia-china-council/grants/grantees/Pages/mental-health-education-for-education-and-health-professionals-in-china.aspx). Although the focus of this project was not on workplace mental health, valuable lessons were learned in terms of cooperation between partners as well as the responses of young professionals toward a mental health education program. These will inform the development of the current proposed study.
Pre-randomisation process: An operational agreement between the project and the site management will be established with the manager signing the consent form. Upon recruitment of participants, a briefing session will be conducted by a qualified senior social worker, trained in workplace psychosocial issues, with the manager of the site and the workers separately prior to the randomisation. The aim of the briefing is to provide details on the study and to obtain informed consent before the baseline assessment is conducted on workers. During the session, details and the requirements of the study will be explained, and questions and concerns raised will be answered. This will be followed by the administration of the baseline assessment (T0).
Intervention arm: Consenting participants nested in the sites that are randomised to the intervention arm will receive the intervention immediately (Figure 1). The intervention will commence with a Workplace Environment scan. Results of the scan will be feedback to the manager of the site during a professional consultation session. The psychoeducation training program will be implemented with all willing participants enrolled into the online modules and commence the MHFA program. Upon completion of the online modules by all participants at each site, a face-to-face session will be conducted on site at the workplace. At the end of the intervention program, participants will then be re-assessed on the outcome measures (T1). The sites and participants in the intervention arm will be followed for another 3 months with re-assessment conducted post follow-up (T2).
Control group: Consenting participants randomised to the wait-listed control group will also complete the baseline data collection measures, as those in the intervention group, but will not have access to the training program until participants in the intervention arm have completed the program with the re-assessment of the outcome measures. It is anticipated that the intervention program will be implemented in the control group within 3-4 months after the commencement of the program in the intervention arm. The same procedures will be applied to the controls as in the intervention arm with re-assessment of outcome measures, immediately prior to the intervention (T1), at the end of the intervention (T2), as well as the follow-up re-assessment (T3).
Adherence to intervention: Intervention adherence will be monitored weekly via record checking by the Research Assistant. Upon the completion of one unit of online training, the participant will be informed automatically by the online platform to commence the next unit of the program. For participants who are not progressing through the program as planned, a short reminder message will be sent via common instant messaging applications, such as WhatsApp or WeChat. Should the participants encounter any problems or technical issues with the online program, assistance will be provided by the project team through a hotline.
Primary outcome measure: The primary outcome measure is the MHL of workers. MHL will be assessed using the Australian National Mental Health Literacy and Stigma Survey designed by Jorm and colleagues . The instrument has been validated and widely used in many studies and different countries. As part of the international Mental Health First Aid collaboration, the MHAHK has permission from the Australian headquarters to translate and use the survey freely. The Chinese version of the instrument has been validated by the Mental Health Association Hong Kong (MHAHK). It is hypothesised that the intervention program is efficacious in increasing the level of MHL of workers. A significant increase in the MHL score in the intervention group in comparison to the control group at the end of the intervention period will be able to demonstrate the efficacy of the intervention.
Secondary outcome measures: Secondary outcomes include Burnout, Stress, and Health-related Quality of Life. These will be examined by the following different instruments:
Burnout will be evaluated by the Maslach Burnout Inventory (MBI) which is specifically designed to measure the extent of burnout in adults in the workplace . The instrument consists of three main domains capturing three different aspects of the burnout phenomena in individual. These include emotional exhaustion, depersonalisation, and personal accomplishment. Emotional exhaustion measures the feelings that worker is emotionally exhausted by his/her work. Depersonalization captures the state that the worker is impersonally responding to recipients of one's service, care treatment, or instruction. Personal accomplishment measures the level of competence and successful achievement of the worker in providing services . This instrument has been fully validated and has been widely used around the world for many years. It has been translated into many languages. Recent studies on the psychometric properties of the MBI suggested that the three-factor model fitted well with the data than other alternative models with high internal consistency for all three subscales yielding Cronbach’s alpha values of 0.84, 0.87, and 0.88 respectively .
Stress will be assessed by the Anxiety subscale of the Depression, Anxiety, and Stress scale (DASS) . The DASS is a fully validated and commonly used instrument designed for the assessment of stress, depressive symptoms, and anxiety. This scale has good psychometric properties, which include strong reliability and validity for both the English and the Chinese versions [20, 21].
Health Related Quality of Life (HRQoL) as an indication of general health will be measured by the five-level version of European Quality of Life-5 dimensions (EQ-5D-5L) . The validity of EQ-5D-5L has been well demonstrated and widely published (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/). A Chinese version of the EQ-5D-5L has also been validated and commonly used in many studies .
For the sample size, it has been estimated that about 400 workers are required with an estimated effect size of about 0.5 unit of a standard deviation difference in the MHL scores between the intervention and control arms . The sample size calculation is based on this assumption with a power of 80% required to detect a true intervention effect at a type I error margin of 5% with an intraclass correlation of about 0.01 for the clusters. It is also assumed that 10% of participants will drop out from the project. Since groups of participants are recruited from different sites with an average size of about 20 workers a total of 20 sites would be required.
As aforementioned, three large companies representing different industries and a range of workplace environment have agreed to participate in the study. The study team has connection with the Hunan Resources Department and Senior Management of these companies. The Human Resources Departments will fully support the recruitment process with encouragement for different site offices to be part of the study. Participants will be recruited from different site offices of these companies through internal advertisement of the Human Resources Departments. Participation in the study is totally voluntary and informed consent will be obtained from participants.
Informed consent will be obtained from potential participants during the briefing session conducted by the senior social worker at each site once the site managers have agreed to partake in the study. At the briefing session, information on the study and the intervention program will be provided to all potential participants verbally and as a written information sheet (Appendix A). Willing participation in the study will be solicited from potential participants by signing the Consent form (Appendix B). Upon consenting, participants will be asked to provide their mobile number as the unique identifier of the individual so that data collected at different time points of the study could be linked. Potential participants who are unable to attend the briefing session can contact the research team directly prior to consenting. The same consent process will be applied to all sites.
As a cluster randomised trial, the primary unit of randomisation is the site. For random allocation of sites, a full list of the all participating office sites with some basic staffing information, such as number and the ranks and files of staff in the office, will be obtained from the Human Resources Departments of three companies. In accordance to the preliminary information provided by these companies, the average size of site offices is about 20 staff and the deviation is small, thus the only factor for consideration in randomisation is the distribution of the site offices among these three companies. Hence, the randomisation will be stratified in accordance to the number of participating site offices across three companies. Each participating site office will be allocated to an intervention or wait-listed control arm according to a randomisation schedule generated by a central registry. The randomisation will be conducted by a qualified statistician who is blinded to the process of recruitment and the ongoing outcome assessments. The central registry will be responsible for generating the randomisation tables and will provide the information to the field staff right after the briefing session and baseline data collection via instant messaging. Participants and the site manager will be informed of the allocation at the end of the briefing session. The allocation of the randomisation codes with all information on the site office will be managed by the study coordinator. The allocation ratio between the intervention arm and the controls is 1:1.
Allocation is concealed from the study Principal Investigator and the study team at the time of the participants’ inclusion in the trial, however, field staff and the project coordinator collecting and managing the data will not be blinded to participants’ allocation. In no circumstances that the blinding should be broken to the study team.
Methods: Data collection, management and analysis
Data collection methods
Data on the outcome measures will be collected at four time points during the trial in accordance to the schedule depicted in Figure 1. They are the baseline assessment during enrolment (T0); re-assessment after the completion of the intervention program for the intervention arm and also for the controls (T1); re-assessment of the controls at the end of the intervention program and the follow-up assessment of the intervention arm (T2); follow-up assessment of the controls post-intervention (T3).
Workplace Environment scan: The Workplace Environment scan will be conducted by the senior social worker using the Moos Work Environment Scale (WES) . Data will be collected, during the briefing session through an online survey. Participants of each site will be asked to fill in the survey on site at the end of briefing session. Participants who have consented but miss out on the briefing session can contact the project team. They will be guided to fill in the baseline survey through a telephone call. Incomplete surveys will be identified during the data management process right after baseline data collection. Participants who have not completed the survey will be contacted via instant messaging or emails to encourage a re-attempt of the survey.
Outcome measures: Assessments on the outcome measures will be conducted at different time points in accordance to the time schedule tabulated in Figure 2. Data on these outcome measures will also be collected using an online survey form. For baseline assessment, data will be collected at the same time of the Workplace Environment Scan. Participants will be asked to fill in both surveys at the same time. All participants will be invited to provide their mobile telephone number on the form before commencing the survey. Since the mobile number will be used as the unique identifier for linking data collected at different time points, it would be important to ensure that they are correctly reported. With the permission of the participants, these mobile numbers will be verified with the records retained by their companies.
All hard copies from the study will be kept at the Research Office of the Tung Wah College (TWC) located at the 31 Wylie Road, Homantin, Kowloon, Hong Kong SAR. All electronic files, including documents generated on the study and the electronic version of the signed consent form, the database developed for the study, and other data sets derived from the database will be housed and stored in the secure file server designated for research at TWC. All electronic database and any data sets derived from the database will be password protected. The passwords will only be revealed to the key members of the research team and the statistician who will be handling the data for analyses. For further security, personal information provided by participants during enrolment will be kept in a separate database from the other data collected during the study. The only linkage between these databases is via the unique identifier – the mobile phone number provide by the participant. Hard copies of data will be securely stored in a locked file cabinet inside a secured office accessible only by designated staff member through a security code. All data, both hard and soft copies, will be stored for 7 years.
Information on the participants and their responses to the survey will not be revealed to site managers or the Human Resources Departments of the companies. This will ensure that all identifying data can be managed in a confidential manner. Participants are free to withdraw from the study at any time without any request of a reason. Withdrawal of consent will not affect participants’ employment at their current work site (Appendix B). However, participants will be informed that data that have already been collected may still be used in the analyses, and they will also be advised that it may not be possible to withdraw their data from the study results.
Statistical Analysis Plan: The analysis of the primary and secondary outcome measures will be conducted in accordance to the study design as a wait-listed cluster randomised trial and the nature of the variables. An intention-to-treat analysis will be applied to all primary and secondary outcomes. Any missing data will be imputed using Multiple Imputation by Chined Equations approach. Should there be any differences identified between the intervention arm and the wait-list controls by comparisons on the baseline data collected, these variables will be considered as potential confounders to be adjusted. A significance level of 5% will be adopted for testing all hypotheses.
The primary outcome measure of the study, namely MHL, will be analysed using a repeated measures approach with possible adjustments to participants’ and sites’ characteristics. This will involve the comparison of the mean change in the MHL scores from baseline to the completion of the intervention program between the intervention and control groups (i.e. from T0 to T1). Since the study is a cluster randomised trial, the cluster sampling effect will be adjusted for. In order to cater for the sampling technique as well as the repeated measures of the outcome variable, the Generalise Linear Latent And Mixed Model (GLLAMM) will be applied to test for any group differences.
For secondary outcome measures, they are variables of the same nature of the MHL, namely continuous variables, thus the approach of analyses will be the same. For the follow-up data, since all participants will receive the intervention program, thus there will not be a distinction between intervention and controls groups thus all participants will be considered as a single group. Hence, the analysis will only focus on the changes in outcome measures across time. For the repeated measures of the outcome variables, a Linear Mixed Effect Model will be applied.
Interim analysis: Since the actual trial period will only last for 12 months, and also due to budgetary constraint, the research team has considered not to conduct an interim analysis.
This is a trial of an intervention that involves mainly a psychoeducation training program and does not directly involve treatment or management of any participants thus no adverse events are anticipated. As such a data monitoring committee will not be convened. Should any issues arise, they will be dealt with initially by the research team. If the matter is of a more serious nature it will be referred to an independent Project Management Committee (PMC).
Throughout the study period, regular meetings will be held between the Principal Investigator, key members of the research team, and the field staff for monitoring the progress of the study. During these meetings, the project coordinator will provide regular reports to the research team on recruitment, data collection, and any issues arising during these processes. Any perceived/identified irregularities will be referred to the PMC for further discussions and decision. Any deviation or modification of the study protocol will be reported to the Research Ethics Committee.
Since there is no actual physical intervention applied to the participants, no harms are foreseen for this trial due to the nature of the intervention being a psychoeducation training. However, the research team acknowledges that the contents of the intervention program may evoke some discomfort associated with experience of stress and burnout. The contents of the intervention program will cover ways to handle burnout and stress reduction technique that could possibly alleviate the discomfort. Moreover, supporting professional services from the MHAHK will also be available and the research team can refer any participants requiring counselling and/or psychological intervention to the appropriate support services.