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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
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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
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Secondary ID [1]
312835
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental health stigma
334951
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Responsive behaviour
334952
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Psychological distress
334954
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Condition category
Condition code
Mental Health
331483
331483
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0
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Depression
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Mental Health
331484
331484
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0
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Anxiety
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Mental Health
331485
331485
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329381
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Managers' confidence in supporting the mental health of employees.
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Assessment method [1]
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Managers' confidence is measured using a 6-item scale, presenting 6 mental health-based scenarios in which participants indicate their confidence for each scenario from 1 ("Not at all confident") to 5 ("Extremely confident"), resulting in an overall confidence score ranging from 6 to 30. This scale has been used in previous randomised controlled trials in manager mental health training research (Gayed et al., 2019)
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.
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Timepoint [1]
339226
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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Secondary outcome [1]
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Managers' stigmatising attitudes towards mental health
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Assessment method [1]
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Mental health stigma was assessed via a 10-item scale for which participants indicate their agreement to 10 statements from 1 (“Strongly disagree”) to 5 (“Strongly Agree”), giving an overall score ranging from 10-50 with higher scores indicating higher levels of stigma. The scale was used in previous randomised controlled trials for manager mental health training (Gayed et al., 2019)
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.
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Timepoint [1]
439170
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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Secondary outcome [2]
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Managers' knowledge about mental health
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Assessment method [2]
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Knowledge about mental health was measured using a 6-item scale for which participants indicate their agreement from 1 (“Strongly disagree”) to 5 (“Strongly Agree”). This scale was developed from the Mental Health Knowledge Schedule (Evans-Lacko et al., 2010) and has previously been used in randomised controlled trials of manager mental health training research (Gayed et al., 2019).
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.
Evans-Lacko, S., Little, K., Meltzer, H., Rose, D., Rhydderch, D., Henderson, C., & Thornicroft, G. (2010). Development and psychometric properties of the mental health knowledge schedule. The Canadian Journal of Psychiatry, 55(7), 440-448.
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Timepoint [2]
439172
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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Secondary outcome [3]
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Managers' behavioural responsiveness towards employee mental health
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Assessment method [3]
439173
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Behavioural responsiveness was measured using 6-item scales for which participants indicate their agreement from 1 (“Strongly disagree”) to 5 (“Strongly Agree”). The scale was used in previous randomised controlled trials for manager mental health training (Gayed et al., 2024).
Gayed, A., Strudwick, J., Kugenthiran, N., LaMontagne, A. D., Mackinnon, A., Christensen, H., ... & Harvey, S. Mental health training for physicians supervising resident physicians: a cluster randomised controlled trial. Medical Journal of Australia.
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Timepoint [3]
439173
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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Secondary outcome [4]
439174
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Managers' knowledge of their roles and responsibilities within employee mental health
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Assessment method [4]
439174
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Knowledge of managers’ roles with regard to workplace mental health was measured using an 8-item scale for which participants indicate their agreement to 8 statements from 1 (“Strongly disagree”) to 5 (“Strongly agree”).
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Timepoint [4]
439174
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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Secondary outcome [5]
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Managers' psychological distress
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Assessment method [5]
439176
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Kessler 6-item psychological distress scale (K6; Kessler et al., 2002)
Kessler RC, Andrews G, Colpe LJ, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959-976.
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Timepoint [5]
439176
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Baseline (48-hours prior to intervention), 1-month post-intervention, and 3-months follow-up
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Nil
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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 .
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/05/2023
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Date of last participant enrolment
Anticipated
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Actual
15/05/2023
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Date of last data collection
Anticipated
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Actual
15/08/2023
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Sample size
Target
150
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
317275
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NHMRC Investigator Grant
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Address [1]
317275
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Country [1]
317275
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Australia
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Primary sponsor type
Other
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Name
Black Dog Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
319553
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None
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Name [1]
319553
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Address [1]
319553
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Country [1]
319553
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316013
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
316013
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
316013
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Australia
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Date submitted for ethics approval [1]
316013
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28/07/2022
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Approval date [1]
316013
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01/08/2022
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Ethics approval number [1]
316013
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HC220374
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Summary
Brief summary
Research suggests that managers play an important role in workplace mental health. Indeed, positive managerial behaviours are a key predictor of employee wellbeing. The current study adapts previously successful manager mental health training programs to upskill managers in the university sector. The primary aim of this research is to evaluate whether this evidence-based training program will improve the confidence of managers in the university sector to support mental health and wellbeing in the workplace. Additional secondary aims include ascertaining the effectiveness of the training in improving managers' knowledge, attitudes and responsive behaviours with regard to employee mental health.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Aimee Gayed
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Address
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
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Australia
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Phone
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+610290659043
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
136503
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Aimee Gayed
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Address
136503
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
136503
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Australia
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Phone
136503
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+610290659043
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Fax
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Email
136503
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[email protected]
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Contact person for scientific queries
Name
136504
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Aimee Gayed
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Address
136504
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
136504
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Australia
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Phone
136504
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+610290659043
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Fax
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Email
136504
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24143
Ethical approval
388361-(Uploaded-29-08-2024-14-54-51)-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.
Download to PDF