Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001157561
Ethics application status
Approved
Date submitted
4/09/2024
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
The impact of workplace mental health training on knowledge, stigma and mental health management skills for university staff
Scientific title
The impact of workplace mental health training on knowledge, stigma and mental health management skills for university staff: a quasi-experimental study
Secondary ID [1] 312896 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health knowledge 335048 0
Mental health stigma 335049 0
Mental health management skills 335050 0
Condition category
Condition code
Mental Health 331558 331558 0 0
Anxiety
Mental Health 331559 331559 0 0
Depression
Mental Health 331560 331560 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is skills-based mental health training workshops with the aim of upskilling participants to look after their own and their colleagues' mental health. Training programs are 2-hours in duration and delivered online through interactive workshops, including group conversation and workbooks to fill out, Each participant attends one workshop. The workshops are facilitated by independent clinicians and were adapted from evidence-based manager mental health training (Milligan-Saville et al., 2017) in partnership with representatives from the university to reflect the needs of the faculty. They consisted of 10 modules covering the following content:

1. Acknowledgement of Country & Introductions 9 mins
2. Prevalence of mental illness 6 mins
3. Recognising changes in behaviour 11 mins
4. Disclosure of mental ill-health 14 mins
5. Approaching a conversation about mental health 10 mins
6. Help Seeking 4 mins
Break 5 mins
7. Practising the conversation 25 mins
8. What to do if you think someone is suicidal 5 mins
9. Remaining at work or being absent? 10 mins
10. How to keep your team healthy 18 mins
Conclusion 3 mins
TOTAL 120 mins

Attendance at the workshop is recorded to monitor adherence, including if participants attend only part of the workshop.

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] 329431 0
Behaviour
Comparator / control treatment
A waitlist-control group was used for comparison. Three training workshops were held in April 2023 and three training workshops in July 2023. Participants could choose one training workshop to attend and those who opted to attend one of the earlier workshops were assigned into the intervention group and participants who opted to attend the later workshops were assigned to the waitlist-control group. All data was collected before participants in the waitlist-control group could attend the training workshop.
Control group
Active

Outcomes
Primary outcome [1] 339293 0
Mental health knowledge
Timepoint [1] 339293 0
Baseline, 1-month post-intervention, and 3-months post-intervention (primary timepoint)
Primary outcome [2] 339294 0
Mental health stigma
Timepoint [2] 339294 0
Baseline, 1-month post-intervention, and 3-months post-intervention (primary timepoint)
Primary outcome [3] 339295 0
Mental health management skills
Timepoint [3] 339295 0
Baseline, 1-month post-intervention, and 3-months post-intervention (primary timepoint)
Secondary outcome [1] 439382 0
Psychological distress
Timepoint [1] 439382 0
Baseline, 1-month post-intervention, and 3-months post-intervention

Eligibility
Key inclusion criteria
- Aged 18 years or above
- 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
Participating in another parallel workplace mental health study ongoing at the Black Dog Institute

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 scale total scores between groups to identify whether underlying differences in mental health knowledge, stigma or management skills 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 1-month post-intervention and 3-month follow-up from baseline.

Based on previous research into mental health training programs (Gayed, Bryan, et al., 2018), in order to detect a moderate effect size of 0.54 with 80% power using an alpha of 0.05, it was calculated that 126 participants were required. Anticipating a 20% dropout, we aimed to recruit 150 participants.

Gayed, A., Bryan, B. T., Petrie, K., Deady, M., Milner, A., LaMontagne, A. D., Calvo, R. A., Mackinnon, A., Christensen, H., & Mykletun, A. (2018). A protocol for the HeadCoach trial: the development and evaluation of an online mental health training program for workplace managers. BMC psychiatry, 18, 1-9.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2023
Date of last participant enrolment
Anticipated
Actual
4/04/2023
Date of last data collection
Anticipated
Actual
27/07/2023
Sample size
Target
150
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317330 0
Government body
Name [1] 317330 0
NHMRC Investigator Grant
Country [1] 317330 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 319615 0
None
Name [1] 319615 0
Address [1] 319615 0
Country [1] 319615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316062 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316062 0
Ethics committee country [1] 316062 0
Australia
Date submitted for ethics approval [1] 316062 0
28/07/2022
Approval date [1] 316062 0
01/08/2022
Ethics approval number [1] 316062 0
HC220374

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

Contacts
Principal investigator
Name 136650 0
Dr Aimee Gayed
Address 136650 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136650 0
Australia
Phone 136650 0
+610290659043
Fax 136650 0
Email 136650 0
[email protected]
Contact person for public queries
Name 136651 0
Aimee Gayed
Address 136651 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136651 0
Australia
Phone 136651 0
+610290659043
Fax 136651 0
Email 136651 0
[email protected]
Contact person for scientific queries
Name 136652 0
Aimee Gayed
Address 136652 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136652 0
Australia
Phone 136652 0
+610290659043
Fax 136652 0
Email 136652 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24159Ethical approval    388398-(Uploaded-04-09-2024-12-27-58)-UNSW Ethics Approval_01082022.Pdf



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.