Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000464167
Ethics application status
Approved
Date submitted
14/03/2019
Date registered
20/03/2019
Date last updated
20/03/2019
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Workplace Mental Health Intervention program for the enhancement of Mental Health Literacy and the reduction of stress and burnout among workers: The (WPMHL) Project
Scientific title
Workplace Mental Wellbeing through Enhancing Mental Health Literacy and Improving Workplace Friendliness in Hong Kong: The WPMHL Project
Secondary ID [1] 297690 0
None
Universal Trial Number (UTN)
Trial acronym
WPMHL
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
General Mental Health
 311971 0
Stress 311972 0
Burnout 311973 0
Condition category
Condition code
Public Health 310544 310544 0 0
Health promotion/education
Mental Health 310636 310636 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention program is comprised 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’s Work Environment Scale (WES), will be conducted by a social worker with expertise in workplace issues 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 with a questionnaire specifically design for the project that also includes the WES, and some face-to-face interviews to gain a better insight into the local issues of each site. 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 and possible strategies for resolving the identified issues will be offered. Site management is encouraged to make use of this information to improve the work environment during the intervention and follow-up period. For the individual-directed component, participating sites will adopt the well-studied evidence-based Workplace Mental Health First Aid (MHFA) with the inclusion of a module on stress reduction and burnout prevention. Adopting the e-Health and e-Learning approach, this is a blended training consisting of a series of self-paced online e-Learning modules. Through a series of 18 hours of online sessions, participants will acquire essential knowledge and understanding on the fundamental concepts before having face-to-face sessions. To provide some interaction time with the instructor, participants will attend 6-hour face-to-face sessions (in one day or two sessions) for hands-on practice. Upon completion of the full program and passing a standard quiz, a certificate will be issued to the participant for a qualification of a Mental Health First Aid Officer in accordance to the standard of the Mental Health First Aid, Australia (https://mhfa.com.au/mental-health-first-aid-officers). For the process evaluation of program implementation, in accordance to the structured Process Evaluation guidelines proposed by Sauders et al., four important indicators are to be included. The indicators are listed below, with expected targets and methods of assessment in brackets:
• Fidelity – the extent of each of the program elements is implemented as planned (100% assessed by a checklist for program delivery with all elements listed for each site);
• Dose Delivered – the amount of all intervention components are delivered (100%, assessed by a checklist for all items included in each component of the intervention for each site);
• Dose Received – the extent of each of the program elements is received by all involved in the program, e.g. the organisation and the end-receivers (100%, assessed by the a checklist for program delivery with all elements included for each site);
• Reach – the extent of the total program delivered to the target population is in accordance to a pre-set value (at least 90%, calculated from the information gathered from the above three indicators).

The evaluation will be conducted through data collection by the social worker and/or the psychoeducation instructor. To maintain or to improve the fidelity of the program, the project team will work closely with all participating companies to ensure dropouts are reduced to the minimal. Another layer of assurance in terms of the implementation of the program is that the target companies are committed to the project. Keeping contacts with all participants will be a preventive measure. On the other hand, participants will be informed at the beginning of the program that there will be a closing ceremony for the project at the end when the graduating certificate will be awarded with the naming of Mental Health First Aid officer.
Intervention code [1] 313921 0
Behaviour
Comparator / control treatment
Utilising a wait-list cluster randomised trial design different work sites (clusters), containing different workers, will be allocated randomly into two groups: active intervention, and waiting (control) groups. The comparison/ control treatment will be the normal practices in the workplace. The waitlist control group will be offered the intervention upon the completion of the program in the intervention arm (about 6 months after the commencement of the project).
.
Control group
Active

Outcomes
Primary outcome [1] 319428 0
Proportion of participants with an increased level of mental health literacy, assessed using the Jorm's standard MHL scale (Jorm et al, 1997),
Timepoint [1] 319428 0
Immediate post intervention (6 months after the commencement of the program)
Secondary outcome [1] 368127 0
Change in the stress scores assessed using the Depression, Anxiety, and Stress Scale (DASS, Antony et al., 1988).
Timepoint [1] 368127 0
Immediate post intervention (6 months after the commencement of the program)
Secondary outcome [2] 368129 0
Change in the burnout assessed using the Maslach Burnout Inventory (Maslach & Jackson, 1986).
Timepoint [2] 368129 0
Immediate post intervention (6 months after the commencement of the program)

Eligibility
Key inclusion criteria
The key inclusion criteria are the follows:
Adults aged 18 years or elder;
Working full time currently in any industries;
Receiving a payment in the form of salary or wages.

The ultimate target population of the proposed WPMHL project is the working population in various industries in Hong Kong. However, we will focus on specific industries with a considerable level of work-related stress. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following are the key exclusion criteria:
Individuals younger the age of 18 years;
Not working full time in the position;
Voluntary work without any payment;
Individuals who are employers and/or occupying a senior managerial position of the corporate/organisation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of sites into the intervention and waitlist groups will be conducted using a computerised randomisation mechanism that the person who is in charge of screening for the eligibility of sites will not be aware of the allocation.


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Since this is a wait-list cluster reandomised trial with work sites a s clusters, thus the primary unit for randomisation is the clusters. These clusters will be randomised using permuted block randomisation method with a block size of 6 employing the algorithm designed for the software STATA.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For the primary outcomes, particularly MHL, the focus of the analysis is on the post-intervention percentage changes from baseline between the intervention and control groups. Hence, the association between groups and changes in MHL will be examined using a regression approach taking into consideration of the nature of the variables and possible covariates. However, since the study design is a cluster randomised trial, the cluster sampling effect has to be adjusted for. In order to cater for the sampling technique as well as the categorical nature of the outcome variable, the Generalise Linear Latent And Mixed Model (GLLAMM) will be applied to test for any group differences. The same statistical approach can also be applied to other outcome measures.
In total 20 clusters will be recruited.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2019
Actual
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 21344 0
Hong Kong
State/province [1] 21344 0

Funding & Sponsors
Funding source category [1] 302215 0
Government body
Name [1] 302215 0
Health and Medical Research Fund, Food and Health Bureau, Hong Kong Government
Country [1] 302215 0
Hong Kong
Primary sponsor type
Individual
Name
Lawrence T. Lam
Address
University of Technology Sydney
Faculty of Health,
230 Jones Street, Ultimo, Sydney, NSW 2007
and
Tung Wah College
31 Wylie Road, Homantin, Hong Kong
Country
Australia
Secondary sponsor category [1] 302064 0
None
Name [1] 302064 0
NIL
Address [1] 302064 0
NIl
Country [1] 302064 0
Other collaborator category [1] 280606 0
Charities/Societies/Foundations
Name [1] 280606 0
Mental Health Association Hong Kong
Address [1] 280606 0
2 Kung Lok Road, Kwun Tong.
Country [1] 280606 0
Hong Kong
Other collaborator category [2] 280607 0
Individual
Name [2] 280607 0
Mary K Lam
Address [2] 280607 0
University of Technology Sydney
Faculty of Health
230 Jones Street, Ultimo, Sydney, NSW 2007
Country [2] 280607 0
Australia
Other collaborator category [3] 280608 0
Individual
Name [3] 280608 0
Pransuna Reddy
Address [3] 280608 0
Faculty of Science, Engineering & Technology
Swinburne University of Technology
PO Box 218, Hawthorn VIC 3122
Country [3] 280608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302894 0
Reserch Ethics Committee, Tung Wah College, HK
Ethics committee address [1] 302894 0
Ethics committee country [1] 302894 0
Hong Kong
Date submitted for ethics approval [1] 302894 0
26/01/2019
Approval date [1] 302894 0
14/02/2019
Ethics approval number [1] 302894 0
REC2019020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91762 0
Prof Lawrence T. Lam
Address 91762 0
Faculty of Health
University of Technology Sydney
230 Jones Street, Ultimo, Sydney, NSW 2007
Country 91762 0
Australia
Phone 91762 0
+61 0403500352
Fax 91762 0
Email 91762 0
[email protected]
Contact person for public queries
Name 91763 0
Lawrence T. Lam
Address 91763 0
Faculty of Health
University of Technology Sydney
230 Jones Street, Ultimo, Sydney, NSW 2007
Country 91763 0
Australia
Phone 91763 0
+61 0403500352
Fax 91763 0
Email 91763 0
[email protected]
Contact person for scientific queries
Name 91764 0
Lawrence T. Lam
Address 91764 0
Faculty of Health
University of Technology Sydney
230 Jones Street, Ultimo, Sydney, NSW 2007
Country 91764 0
Australia
Phone 91764 0
+61 0403500352
Fax 91764 0
Email 91764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As part of the funding rules data belong to funding body, namely the Food and Health Bureau of the Hong Kong Government. Without permission from the funding body data could not be made available to the public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a phase III wait-listed cluster randomised controlled trial of an intervention for mental well-being through enhancing mental health literacy and improving work friendliness in Hong Kong.2019https://dx.doi.org/10.1186/s13063-019-3748-y
EmbaseEfficacy of a Workplace Intervention Program With Web-Based Online and Offline Modalities for Improving Workers' Mental Health.2022https://dx.doi.org/10.3389/fpsyt.2022.888157
N.B. These documents automatically identified may not have been verified by the study sponsor.