Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001183471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/10/2025
Date registered
Help: Date registered
29/10/2025
Date last updated
Help: Date last updated
9/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating a mental health training refresher module for managers in the ambulance service
Scientific title
A randomised controlled trial evaluating the efficacy of a short mental health refresher training module in maintaining ambulance service managers' responsive and preventative behaviours regarding employee mental health following a mental health training program
Additional trial identifiers [1] 315457 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records
This is an embedded randomised controlled trial conducted within a parent-controlled trial "A Controlled Trial Evaluating MindWise Leadership, a Mental Health Training Program for Managers in the Ambulance Service". ANZCTR registration number: ACTRN12625001102460

Health condition
Health condition(s) studied:
Stigmatising attitudes towards Mental Health 339014 0
Condition category
Condition code
Mental Health 335303 335303 0 0
Anxiety
Mental Health 335304 335304 0 0
Depression
Mental Health 335305 335305 0 0
Other mental health disorders
Mental Health 335306 335306 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The current randomised controlled trial investigates the effectiveness of a short online 15-minute refresher training module at maintaining managers’ confidence, attitude and behavioural changes delivered 6-months following the full manager mental health training program called MindWise Leadership (broader study registered in ANZCTR registration number ACTRN12625001102460). This refresher module has been adapted from the longer program specifically for this study.
MindWise Leadership is a 4-hour, evidence-based mental health training program for people-leaders and managers in the ambulance service, which aims to upskill people-leaders regarding employee mental health. The program was adapted from mental health training programs for workplace managers previously evaluated in randomised controlled trials (Gayed et al., 2019; Gayed et al., 2024; Milligan-Saville et al., 2017).
This training covers 3- modules:
• Module 1: Common Mental Illnesses: Common Mental Illnesses addressed the prevalence of mental illnesses in ambulance staff, how to recognise symptoms of mental illness, the impact of stigma in the workplace, how workplaces can encourage positive mental health, and managerial responsibilities regarding mental health.
• Module 2: Helping Your Employees: Helping your employees taught skills on recognising those at risk, providing support to employees experiencing mental illness, having a conversation about mental illness, facilitating help-seeking, supporting rehabilitation, and facilitating an employee’s return to work after mental health-related absence.
• Module 3: Creating a Mentally Healthy Workplace: Creating a Mentally Healthy Workplace focused on preventing mental ill-health by creating a mentally safe workplace, addressing psychosocial hazards, and promoting wellbeing and a positive culture through respectful managing.

Delivery of the refresher module to be evaluated in the current randomised controlled trial will be embedded into this trial for intervention participants 6-months after attending the full 4-hour in-person training. This refresher module is an online, interactive, self-paced module taking approximately 15-minutes to complete. It will briefly cover the key learning objectives of each of the three modules, using text, video content and quiz questions.
Participating in the parent-controlled trial evaluating the full 4-hour workshop (ANZCTR registration number ACTRN12625001102460) consists of completing a baseline survey, a post-intervention survey, a 6-month follow-up survey and a 12-month follow-up survey. The refresher module in this embedded RCT will be delivered to half of parent-controlled trial intervention participants selected randomly immediately after the 6-month follow-up survey, and accessed via a link at the completion of the survey. This online component will allow us to measure completion of the training module. The other half of the parent-controlled trial intervention participants will not receive the link to the refresher module after completing the 6-month training. Data collected at the 12-month follow-up will be compared to determine any differences between parent-controlled trial intervention participants allocated to the refresher module (embedded RCT intervention group) and those who were not allocated to receive the refresher module (embedded RCT control group).

Gayed A, Bryan BT, LaMontagne AD, Milner A, Deady M, Calvo RA, et al. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. Journal of Occupational and Environmental Medicine. 2019;61(7):545-51.
Gayed A, Strudwick J, Kugenthiran N, LaMontagne AD, Mackinnon A, Christensen H, et al. Mental health training for physicians supervising resident physicians: a cluster randomised controlled trial. Medical Journal of Australia. 2024;221(5):270-6.
Milligan-Saville JS, Tan L, Gayed A, Barnes C, Madan I, Dobson M, et al. Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. The Lancet Psychiatry. 2017;4(11):850-8
Intervention code [1] 332074 0
Prevention
Intervention code [2] 332075 0
Behaviour
Description of the comparator or control
Participants completing the 4-hour MindWise Leadership training workshop will be randomised into the embedded RCT intervention group (receiving the 15-minute refresher module) and the embedded RCT control group (no refresher module). The refresher module will be completed 6-months after the MindWise Leadership workshop.
Outcomes at the 12-month post-training data collection period will be compared between the embedded RCT intervention and control groups.
Control group
Active

Outcomes
Primary outcome [1] 342926 0
Managers' preventative and responsive behaviours regarding employee mental health
Timepoint [1] 342926 0
Baseline (immediately before the refresher module or 6 months after MindWise Leadership workshop), and 6-months follow-up post-refresher module (Primary endpoint)
Secondary outcome [1] 452739 0
Managers' confidence in supporting mental health of staff
Timepoint [1] 452739 0
Baseline (immediately before the refresher module or 6 months after MindWise Leadership workshop), and 6-months follow-up post-refresher module
Secondary outcome [2] 452741 0
Mental Health Stigma
Timepoint [2] 452741 0
Baseline (immediately before the refresher module or 6 months after MindWise Leadership workshop), and 6-months follow-up post-refresher module
Secondary outcome [3] 452742 0
Mental health knowledge
Timepoint [3] 452742 0
Baseline (immediately before the refresher module or 6 months after MindWise Leadership workshop), and 6-months follow-up post-refresher module
Secondary outcome [4] 452743 0
Psychological distress
Timepoint [4] 452743 0
Baseline (immediately before the refresher module or 6 months after MindWise Leadership workshop), and 6-months follow-up post-refresher module

Eligibility
Key inclusion criteria
1. Aged 18 years or above
2. Currently employed with NSW Ambulance
3. Managing/supervising at least one employee at NSW Ambulance
4. Provided consent/participating in the larger controlled trial evaluating MindWise Leadership (ANZCTR registration number ACTRN12625001102460), and allocated to the intervention group of the larger controlled trial evaluating MindWise Leadership
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Not meeting the inclusion criteria above.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
NSW Ambulance will roll out the MindWise Leadership training (ANZCTR registration number ACTRN12625001102460) to all 600 of their leaders across NSW. Those opting to partake in the research evaluation who receive the training in the first 12 months will act as the intervention group. Those opting to partake in the research who will receive the training in the final 9 months will provide control data. 50% of participants in the intervention group of the larger controlled trial will be randomly allocated into the intervention group for the current embedded RCT and will receive the top-up refresher module immediately after the 6-month data collection timepoint. The other 50% will not receive the top-up refresher module but will have completed the MindWise Leadership training - they will act as the control group in this embedded RCT. This will allow us to evaluate the effectiveness of the top-up training module.

Following data collection, data will be cleaned and analysed in SPSS. Mixed model repeated measures (MMRM) will be utilised to determine group-by-time interactions and between group differences. This will allow us to measure changes in behaviour, confidence, stigma and knowledge at the 12-month post-intervention timepoint in those receiving the top-up refresher module (the intervention group) compared to those receiving the MindWise Leadership training without the top-up refresher modules (the control group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
1/10/2027
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 320051 0
Government body
Name [1] 320051 0
Investigator Grant RU00071 (Prof. Harvey) from the National Health and Medical Research Council (NHMRC)
Country [1] 320051 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 322597 0
None
Name [1] 322597 0
Address [1] 322597 0
Country [1] 322597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318593 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 318593 0
Ethics committee country [1] 318593 0
Australia
Date submitted for ethics approval [1] 318593 0
18/08/2025
Approval date [1] 318593 0
20/08/2025
Ethics approval number [1] 318593 0
2025/ETH01640

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

Contacts
Principal investigator
Name 144654 0
Dr Aimee Gayed
Address 144654 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 144654 0
Australia
Phone 144654 0
+61 02906 59043
Fax 144654 0
Email 144654 0
[email protected]
Contact person for public queries
Name 144655 0
Aimee Gayed
Address 144655 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 144655 0
Australia
Phone 144655 0
+61 02906 59043
Fax 144655 0
Email 144655 0
[email protected]
Contact person for scientific queries
Name 144656 0
Aimee Gayed
Address 144656 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 144656 0
Australia
Phone 144656 0
+61 02906 59043
Fax 144656 0
Email 144656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.