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Trial registered on ANZCTR


Registration number
ACTRN12624001155583
Ethics application status
Approved
Date submitted
29/08/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A quasi-experimental study of manager mental health training in the university sector
Scientific title
The impact of mental health training on manager confidence, knowledge, stigma and behaviour in supporting employee mental health in the university sector: a quasi-experimental study
Secondary ID [1] 312835 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health stigma 334951 0
Responsive behaviour 334952 0
Psychological distress 334954 0
Condition category
Condition code
Mental Health 331483 331483 0 0
Depression
Mental Health 331484 331484 0 0
Anxiety
Mental Health 331485 331485 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manager training workshops on mental health in the workplace, The training workshops have been adapted from previous manager mental health training research (Milligan-Saville et al., 2017; Gayed et al., 2019). The adaptation of the program was informed by representatives from the participating university and experts in workplace mental health. Each participant attends one of three workshops, each 3-hours in duration, Workshops are interactive and delivered online, facilitated by independent, experienced clinicians. The workshops consist of short videos, interactive activities and discussions across twelve modules covering the following topics:
1 – Introduction and Acknowledgement of Country 10 mins
2 – Prevalence 5 mins
3 – Changes in behaviour 20 mins
4 – Disclosure 30 mins
5 – Approaching a conversation about mental health 10 mins
Break - 5 minutes
6 – Help seeking 5 mins
7 – Practising the conversation 25 mins
8 – What to do if you think someone is suicidal 5 mins
9 – Keeping people at work 25 mins
10 – Getting people back to work after absence 20 mins
11 – How to keep your team healthy 15 mins
12 – Conclusion 5 mins

Attendance across each workshop is monitored and recorded, and participants that do not attend the workshop are excluded from the final analysis.

Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., & Glozier, N. (2019). A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. Journal of occupational and environmental medicine, 61(7), 545-551.
Milligan-Saville, J. S., Tan, L., Gayed, A., Barnes, C., Madan, I., Dobson, M., Bryant, R. A., Christensen, H., Mykletun, A., & Harvey, S. B. (2017). Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. The Lancet Psychiatry, 4(11), 850-858.
Intervention code [1] 329381 0
Behaviour
Comparator / control treatment
A waitlist-control group will be used as a comparator group. Three intervention workshops were held in March 2023, and a further three workshops in August 2023. Participants who opted to attend a workshop in March were allocated into the intervention group, and participants who opted to attend a workshop in August were allocated into the waitlist-control group. Waitlist-control group participants completed the baseline, 1-month follow-up and 3-month follow-up data collection points at the same timepoint as the intervention group, before receiving the intervention.
Control group
Active

Outcomes
Primary outcome [1] 339226 0
Managers' confidence in supporting the mental health of employees.
Timepoint [1] 339226 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
Secondary outcome [1] 439170 0
Managers' stigmatising attitudes towards mental health
Timepoint [1] 439170 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
Secondary outcome [2] 439172 0
Managers' knowledge about mental health
Timepoint [2] 439172 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
Secondary outcome [3] 439173 0
Managers' behavioural responsiveness towards employee mental health
Timepoint [3] 439173 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
Secondary outcome [4] 439174 0
Managers' knowledge of their roles and responsibilities within employee mental health
Timepoint [4] 439174 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
Secondary outcome [5] 439176 0
Managers' psychological distress
Timepoint [5] 439176 0
Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up

Eligibility
Key inclusion criteria
Aged 18 years or above
Supervising at least one other member of staff
Working within the participating faculty at the participating university
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Methods used to generate the sequence in which subjects will be randomised (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
Statistical analyses will be conducted using SPSSv27 statistical software. Baseline participant demographics between the intervention and control groups will be compared using chi squared and t tests. Logistic regression will be used to compare baseline survey results between groups to identify whether underlying differences in mental health knowledge, stigma, knowledge of their role with regards to mental health, confidence or responsiveness influenced the choice of earlier or later workshops and subsequently intervention or control group allocation. Comparisons across outcomes over time between the intervention and control group will be analysed using an intent-to-treat framework utilising mixed-model repeated measure (MMRM) with an alpha of 0.05. Contrast estimates across each outcome for the intervention group compared to the control group will be analysed at post-intervention and 3-month follow-up from baseline .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/05/2023
Date of last participant enrolment
Anticipated
Actual
15/05/2023
Date of last data collection
Anticipated
Actual
15/08/2023
Sample size
Target
150
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317275 0
Government body
Name [1] 317275 0
NHMRC Investigator Grant
Country [1] 317275 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 319553 0
None
Name [1] 319553 0
Address [1] 319553 0
Country [1] 319553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316013 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316013 0
Ethics committee country [1] 316013 0
Australia
Date submitted for ethics approval [1] 316013 0
28/07/2022
Approval date [1] 316013 0
01/08/2022
Ethics approval number [1] 316013 0
HC220374

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

Contacts
Principal investigator
Name 136502 0
Dr Aimee Gayed
Address 136502 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136502 0
Australia
Phone 136502 0
+610290659043
Fax 136502 0
Email 136502 0
a.gayed@unsw.edu.au
Contact person for public queries
Name 136503 0
Aimee Gayed
Address 136503 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136503 0
Australia
Phone 136503 0
+610290659043
Fax 136503 0
Email 136503 0
a.gayed@unsw.edu.au
Contact person for scientific queries
Name 136504 0
Aimee Gayed
Address 136504 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136504 0
Australia
Phone 136504 0
+610290659043
Fax 136504 0
Email 136504 0
a.gayed@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24143Ethical approval    388361-(Uploaded-29-08-2024-14-54-51)-UNSW Ethics Approval_01082022.Pdf



Results publications and other study-related documents

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