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Trial registered on ANZCTR


Registration number
ACTRN12619001496101
Ethics application status
Approved
Date submitted
27/09/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of an online mental health education program for physician supervisors
Scientific title
A Randomised Controlled Trial of an online mental health education program for physician supervisors
Secondary ID [1] 299345 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record
Pilot study for this trial is registered under ACTRN12619000858190

Health condition
Health condition(s) or problem(s) studied:
Supervisor physicians' behaviour towards mental health issues among trainees 314492 0
Supervisor physicians' confidence in supporting trainees experiencing mental health issues 314493 0
Supervisor physicians' confidence in supporting mental health needs of all trainees 314494 0
Condition category
Condition code
Mental Health 312836 312836 0 0
Depression
Mental Health 312837 312837 0 0
Anxiety
Mental Health 312838 312838 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, HeadCoach for Physicians, has been adapted from a previously evaluated comprehensive online training program for managers called HeadCoach in collaboration with psychiatrists with expertise in workplace mental health, mental health online training experts and senior physicians supervising doctors-in-training. The adaptation of the program for physician supervisors is informed by information provided by physician supervisors and organisations involved in medical education, as well as research literature on mental health issues among doctors. Further amendments to the program have been made following the feedback received at the completion of the program pilot study.
This version of the program aims to help supervisor physicians better recognise and understand mental health needs among trainee doctors and highlight what supervisors can do to help keep trainees as mentally healthy as possible. The online program is divided into 3 broad topics and each topic is divided into a set of 10-minute modules.
Topic 1. Common Mental Illnesses
- Recognising Mental Health Issues
- The Workplace and its People
- Providing Support
Topic 2. Helping Trainees you are Concerned About (Responsive Strategies)
- Identifying Trainees at Risk
- Having the Talk
- Facilitating Help Seeking
- Returning to Work
Topic 3. Minimising Mental Health Risks at Work (Preventive Strategies)
- Developing Work to Minimise Harm
- Building Organisational Resilience Through Good Supervision
Each module comprises of text material, activities, short videos and practice exercises to complete as part of the training. It is expected the entire program will take approximately 2 hours. The program has been designed so users in the intervention group can complete it at their own pace and preferred times across a 3-week period. The intervention will be delivered through a mobile responsive website and individuals can complete the intervention on a desktop, laptop, tablet or smart phone. Participants will receive an email or text message reminder to complete the program every week. An additional email or text message will be sent during the third week (day 20) to notify participants of the end of the 3-week period. Website analytics will also be used to monitor adherence of participants.

Intervention code [1] 315614 0
Behaviour
Comparator / control treatment
A waitlist control group will be included in this study. Participants in the control group will complete the baseline, post-intervention, 3- and 6-month questionnaires at the same 4 time points as the intervention group. At completion of the 6-month follow-up questionnaire for both groups, the waitlist control group will be offered the full training program. No post training assessment of the control group will be conducted.
Control group
Active

Outcomes
Primary outcome [1] 321448 0
Change in behaviour: supervisor physicians' change in the implementation of preventive and responsive behaviours aimed at creating a mentally healthy workplace and for the management of mental health issues within their team will be assessed through self-report measures based on the HSE Management Standards Indicator Tool (http://www.hse.gov.uk/stress/assets/docs/indicatortool.pdf) and also a questionnaire developed by the researchers used in a previously conducted RCT evaluating supervisor training (Gayed, A. et al., 2019).
Timepoint [1] 321448 0
Change from baseline in behaviour at 3-months. Post-intervention/3 weeks past baseline, and 6 months will also be assessed.
Secondary outcome [1] 374985 0
Supervisor self-reported confidence: confidence in managing mental health issues and promoting a mentally healthy workplace will be measured using a supervisor scale utilised in a previously conducted RCT evaluating supervisor training (Gayed, A., et al.,. 2019). This scale describes six workplace scenarios and asks supervisors to indicate their level of confidence in dealing with each of these, on a five-point Likert scale ranging from not at all to extremely confident. This results in an overall confidence score ranging from 6 to 30. The wording of these vignettes aims to focus on supervisors’ self-efficacy and perceived confidence.
Timepoint [1] 374985 0
Post-intervention/3 weeks past baseline, 3- and 6-months post baseline
Secondary outcome [2] 374986 0
Mental Health knowledge and attitudes: physician supervisors’ knowledge and attitudes about mental health in the workplace will be measured using a combined 22 item measure that includes questions used in a previously conducted RCT evaluating supervisor training (Gayed, A. et al., 2019) and items adapted from previously used questionnaires (Shann C et al., 2014; Martin A, & Giallo R. 2015).
Timepoint [2] 374986 0
Post-intervention/3 weeks past baseline, 3- and 6- months post baseline
Secondary outcome [3] 375873 0
Mental Health Knowledge: physician supervisors’ knowledge about mental health in the workplace will be measured using
• the Mental Health Knowledge Schedule (MAKS) (Evans-Lacks, S. et al., 2010) used in a previous evaluation of manager training (Gayed et al, 2019). The items are scored on a 5-point scale (1-5) with ‘don’t know’ coded as neutral (ie: 3) and assesses stigma-related mental health knowledge among the general public.
Timepoint [3] 375873 0
Post-intervention/3-weeks past baseline, 3-and 6- months post baseline
Secondary outcome [4] 375874 0
Mental Health attitudes: physician supervisors’ knowledge and attitudes about mental health in the workplace will be measured using
• a mental health literacy questionnaire that was used in a previously conducted RCT evaluating supervisor training (Gayed, A. et al., 2019). This 10-item measure asks a series of questions about the participants’ understanding of various mental health issues with a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Timepoint [4] 375874 0
Post-intervention/3-weeks past baseline, 3- and 6-months post baseline

Eligibility
Key inclusion criteria
Supervisor Physician Level:
18 years or older
Good English comprehension
Supervising a team of physician trainees
Currently residing in Australia or New Zealand
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
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 analysis will be conducted using SPSS statistical software. Primary analyses will be undertaken within an intent-to-treat framework, retaining all participants as randomised, regardless of extent of engagement with training or withdrawal from the study. Clustering will be accommodated by a random cluster membership (work site) factor. Likelihood based methods (mixed model repeated measures (MMRM)) will be used to assess significance of change in the primary and secondary outcomes.

Additional per-protocol analyses to assess effectiveness of the program will focus on supervising physicians who completed the online program. This subgroup will be compared to all responders in the waitlist control group and, secondarily, with supervising physicians who completed less of the training material. The latter comparison will inform the dose-response profile of the intervention and, in particular, whether completing only a subset of the earlier components of the online training program has a benefit comparable to the complete program.

All tests of treatment effects will be conducted using a two-sided alpha level of 0.05 and 95% confidence intervals. A member of the research team who is blinded to the intervention and waitlist control allocations will perform this analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21874 0
New Zealand
State/province [1] 21874 0

Funding & Sponsors
Funding source category [1] 303861 0
Government body
Name [1] 303861 0
Australian Government Department of Health
Address [1] 303861 0

Department of Health
GPO Box 9848,
Canberra ACT 2601
Country [1] 303861 0
Australia
Primary sponsor type
University
Name
Univeristy of New South Wales
Address
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 303998 0
None
Name [1] 303998 0
Address [1] 303998 0
Country [1] 303998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304371 0
UNSW HREC
Ethics committee address [1] 304371 0
Research Ethics and Compliance Support (RECS)
University of New South Wales
Level 3, Rupert Myers Building (South Wing)
Sydney NSW 2052
Ethics committee country [1] 304371 0
Australia
Date submitted for ethics approval [1] 304371 0
Approval date [1] 304371 0
20/09/2019
Ethics approval number [1] 304371 0
HC190628

Summary
Brief summary
Junior Doctors have significantly higher levels of psychological distress compared to other doctors further along in their career (BeyondBlue, 2013). To date, interventions for doctors have focused on individual factors (West et al, 2016), however, there is recognition that interventions positioned at the structural and organisational level also need to be implemented (Shanafelt and Noseworthy, 2017).
The aim is to develop an online, mobile responsive, education program for physician supervisors that enhances their confidence in supporting the mental health needs of their trainees and promote managerial behaviour most likely to result in a more mentally healthy workplace.
We hypothesise that supervisors’ confidence and behaviours in discussing mental health matters with their trainees will be enhanced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96722 0
A/Prof Samuel B. Harvey
Address 96722 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 96722 0
Australia
Phone 96722 0
+61 293824517
Fax 96722 0
Email 96722 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 96723 0
Dr Aimee Gayed
Address 96723 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 96723 0
Australia
Phone 96723 0
+61 293824517
Fax 96723 0
Email 96723 0
a.gayed@unsw.edu.au
Contact person for scientific queries
Name 96724 0
Dr Aimee Gayed
Address 96724 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 96724 0
Australia
Phone 96724 0
+61 293824517
Fax 96724 0
Email 96724 0
a.gayed@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified linked data for all measures.
When will data be available (start and end dates)?
December 2020 with no end date determined.
Available to whom?
To be assessed on a case-by-case basis.
Available for what types of analyses?
To be assessed on a case-by-case basis.
How or where can data be obtained?
Through email correspondence with the Chief Investigator. All inquiries can be sent to wmh@unsw.edu.au .
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4946 0
Informed consent form
Citation [1] 4946 0
Link [1] 4946 0
Email [1] 4946 0
wmh@unsw.edu.au
Other [1] 4946 0
Attachment [1] 4946 0
Type [2] 4947 0
Ethical approval
Citation [2] 4947 0
Link [2] 4947 0
Email [2] 4947 0
Other [2] 4947 0
Type [3] 5322 0
Study protocol
Citation [3] 5322 0
Link [3] 5322 0
Email [3] 5322 0
wmh@unsw.edu.au
Other [3] 5322 0
Attachment [3] 5322 0
Summary results
No Results