Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001102460p
Ethics application status
Submitted, not yet approved
Date submitted
19/08/2025
Date registered
9/10/2025
Date last updated
9/10/2025
Date data sharing statement initially provided
9/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Controlled Trial Evaluating MindWise Leadership, a Mental Health Training Program for Managers in the Ambulance Service
Scientific title
A controlled trial evaluating the efficacy of MindWise Leadership, a mental health training program, in improving ambulance service managers' responsive and preventative behaviours regarding employee mental health
Secondary ID [1] 315174 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stigmatising attitudes towards Mental Health 338613 0
Condition category
Condition code
Mental Health 334910 334910 0 0
Anxiety
Mental Health 334911 334911 0 0
Depression
Mental Health 334912 334912 0 0
Other mental health disorders
Mental Health 334913 334913 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MindWise Leadership is an 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). The adaptation of this program was informed by available literature on the mental health of first responders and two-step consultation process. Initially, the program was adapted based on feedback from our industry partners at NSW Ambulance, followed by a two-hour semi-structured consultation workshop with six leaders and managers working in the NSW Ambulance service.

The workshop will be delivered in-person by two experienced facilitators at NSW Ambulance. The first facilitator is a psychologist with 14 years of experience in mental health, supporting organisations to create healthy workforces through expert and professional support, wellbeing advice and education. The second facilitator is a program manager, frontline leader specialist with a Graduate Certificate in Adult Education, CERT IV in TAE, Masters in Educational Leadership, Professional Certificate in Wellbeing Science and currently completing a Masters in Applied Positive Psychology.

To monitor adherence, an attendance list will be taken at the workshop by facilitators. If participants do not attend, or have to leave or join part-way through the training, this will be noted. Participants will also be asked to confirm whether they attended the workshop at the beginning of their post-intervention survey.

The primary training will be approximately 4-hours in duration and consists of 3- modules:
• Module 1: Common Mental Illnesses
• Module 2: Helping Your Employees
• Module 3: Creating a Mentally Healthy Workplace

Module 1: 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 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 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.

The training workshop is designed to be interactive to increase engagement and consisted of informative slides, video content, individual self-reflection activities, group discussions and quizzes.

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] 331789 0
Behaviour
Intervention code [2] 331790 0
Prevention
Comparator / control treatment
25 cohorts of training will take place over 21 months - 17 in the first 12 months and 8 in the final 9 months. The first 17 cohorts will be considered the intervention group and the final 8 cohorts, the waitlist-control group. A controlled trial design will allow us to investigate changes in the intervention group compared to the waitlist-control group. Managers trained in the first 12 months who opt into the research form the intervention group with baseline, post-intervention, 6-month and 12-month data collected. Similarly, managers completing the training in the final 9 months who opt into the research will complete a baseline questionnaire (12-months prior to their training), a 6-month follow-up questionnaire (6-months prior to their training) and a 12-month follow-up questionnaire (immediately prior to training) to form the control group. Managers in the control group will not receive a survey at the same time as the intervention group at the post-intervention timepoint, because this would be too soon after baseline without having received any intervention. However, we will also collect post-intervention survey data from the control group after they have received their training, which for this group is following the collection of 12-month data, to measure any cross-over effects on this group and to collect feedback on the training.

The allocation into training cohorts, and therefore intervention or control group, will not be randomised due to logistical issues of ensuring employees are available at the times of the live workshop.
Control group
Active

Outcomes
Primary outcome [1] 342535 0
Managers' preventative and responsive behaviours regarding employee mental health
Timepoint [1] 342535 0
Baseline, post-intervention, 6-months follow-up (Primary endpoint) and 12-months follow-up
Secondary outcome [1] 451219 0
Managers' confidence in supporting mental health of staff
Timepoint [1] 451219 0
Baseline, post-intervention, 6-month and 12-month follow-up
Secondary outcome [2] 451220 0
Mental health stigma
Timepoint [2] 451220 0
Baseline, post-intervention, 6-month and 12-month follow-up
Secondary outcome [3] 451221 0
Mental health knowledge
Timepoint [3] 451221 0
Baseline, post-intervention, 6-month and 12-month follow-up
Secondary outcome [4] 451222 0
Psychological distress
Timepoint [4] 451222 0
Baseline, post-intervention, 6-month and 12-month follow-up

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. Attending the MindWise Leadership training workshops
5. Willing to voluntarily participate and complete the Participant Information Statement and Consent Form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not meeting the inclusion criteria above.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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 training to all 600 of their leaders across NSW. However, participating in the research (evaluation of the training) is entirely voluntary and we anticipate recruitment of approx 60% of the total group attending training with a 30% dropout rate (n=252) which is adequate to detect a small but meaningful effect size of 0.35 (a=.05). The 4-hour intervention will be delivered once every 3 weeks over a period of 21 months, from approximately September/October 2025 until around May/June 2027, making the collection of control data possible over the first 12 months. All 600 leaders in NSWA will be assigned to one of approximately 25 training cohorts and all will be invited to participate in the research evaluation, however as detailed above we anticipate 60% will provide consent and participate. Each training cohort will have 20-25 managers.

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 6-month and 12-month post-intervention in the intervention group compared to the control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2026
Actual
Date of last participant enrolment
Anticipated
1/04/2027
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319748 0
Government body
Name [1] 319748 0
Investigator Grant RU00071 (Prof. Harvey) from the National Health and Medical Research Council (NHMRC).
Country [1] 319748 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 322253 0
None
Name [1] 322253 0
Address [1] 322253 0
Country [1] 322253 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318300 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 318300 0
Ethics committee country [1] 318300 0
Australia
Date submitted for ethics approval [1] 318300 0
18/08/2025
Approval date [1] 318300 0
Ethics approval number [1] 318300 0

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

Contacts
Principal investigator
Name 143750 0
Dr Aimee Gayed
Address 143750 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 143750 0
Australia
Phone 143750 0
+61 02906 59043
Fax 143750 0
Email 143750 0
[email protected]
Contact person for public queries
Name 143751 0
Aimee Gayed
Address 143751 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 143751 0
Australia
Phone 143751 0
+61 02906 59043
Fax 143751 0
Email 143751 0
[email protected]
Contact person for scientific queries
Name 143752 0
Aimee Gayed
Address 143752 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 143752 0
Australia
Phone 143752 0
+61 02906 59043
Fax 143752 0
Email 143752 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?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Appendix 1 - Study protocol - NSWA Trial V5 CLEAN - 18.08.25.docx


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.