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Trial registered on ANZCTR


Registration number
ACTRN12619000858190
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
17/06/2019
Date last updated
18/10/2021
Date data sharing statement initially provided
17/06/2019
Date results provided
18/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The development and pilot evaluation of an online mental health education program for physician supervisors
Scientific title
The development and pilot evaluation of an online mental health education program for physician supervisors
Secondary ID [1] 298175 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supervisor physicians' behaviour towards mental health issues among trainees 312746 0
Supervisor physicians' confidence in supporting trainees experiencing mental health issues 312747 0
Supervisor physicians' confidence in supporting mental health needs of all trainees 312748 0
Condition category
Condition code
Mental Health 311245 311245 0 0
Depression
Mental Health 311246 311246 0 0
Anxiety
Mental Health 311247 311247 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A recently evaluated comprehensive online training program for managers will be adapted for senior physicians supervising physician trainees and the feasibility, usability and possible effectiveness of the online program will be pilot tested with a group of supervisor physicians. The intervention has been developed and adapted from evidence-based training resources and in collaboration with psychiatrists with expertise in workplace mental health and mental health online training experts. 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. How to Help an Employee you are Concerned About
- Identifying Trainees at Risk
- Having the Talk
- Facilitating Help Seeking
- Returning to Work

Topic 3. Minimising Mental Health Risks in the Workplace
- 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 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.

Adherence to the online training program will be monitored through the online research platform. Reminder emails will be sent to participants who have not completed the program throughout the 3-week training period. Data will be available through the research platform on how many modules each participant completed during the pilot study.
Intervention code [1] 314406 0
Behaviour
Comparator / control treatment
No control group in this pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319995 0
Supervisor physicians' change in confidence from baseline to respond more effectively to the needs of staff experiencing mental health issues and to increase the use of managerial techniques that create a more mentally healthy workplace. The measure used to assess these will be a modified version of previously published supervisor scales (Nieuwenhuijsen K, Verbeek JH, de Boer AG, Blonk RW, van Dijk FJ. Supervisory behaviour as a predictor of return to work in employees absent from work due to mental health problems. Occupational & Environmental Medicine. 2004;61(10):817–23) used in a previously conducted RCT evaluating supervisor training (Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med, Epub ahead of print.). .
Timepoint [1] 319995 0
Post-intervention (3-weeks post baseline).
Primary outcome [2] 320196 0
User experience and engagement. This will be measured via a questionnaire used in a previously conducted RCT evaluating supervisor training asking about usefulness of each aspect of the program on a likert scale (Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med, Epub ahead of print.).
Timepoint [2] 320196 0
post-intervention (3-weeks post baseline)
Secondary outcome [1] 370141 0
Supervisor physicians' change in behaviour at post-intervention from baseline for the implementation of techniques aimed at creating a mentally healthy workplace and for the management of mental health issues within their team. This will be assessed through a 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., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med, Epub ahead of print.).
Timepoint [1] 370141 0
Post-intervention (3 weeks post baseline)
Secondary outcome [2] 370142 0
Supervisor physicians’ knowledge about common mental health conditions within the workplace. The measurement used is the Mental Health knowledge schedule (MAKS) consists of 12 items 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.

Measurement: Mental health knowledge schedule (MAKS): Evans-Lacko, S., Little, K., Meltzer, H., Rose, D., Rhydderch, D., Henderson , C., and Thornicroft, G. Development and Psychometric Properties of the Mental Health Knowledge Schedule. (2010). Can J Psychiatry. 55: 440-448.
Timepoint [2] 370142 0
Post-intervention (3 weeks post baseline)
Secondary outcome [3] 370143 0
Physician supervisors’ attitudes about mental health in the workplace. The measure used to assess these will be a questionnaire developed by the researchers that was used in a previously conducted RCT evaluating supervisor training (Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med, Epub ahead of print.).
Timepoint [3] 370143 0
Post-intervention (3 weeks post baseline)

Eligibility
Key inclusion criteria
Supervisor Physician Level:
18 years or older
Good English comprehension
Supervising a team of physician trainees
Minimum age
18 Years
Maximum age
No limit
Sex
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
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary analyses will be conducted using paired samples t tests to assess the differences in the mean percentage scores of each of the outcomes between baseline and post intervention collected at the 3-week follow-up. The parameters to be measured include managers’ confidence in managing mental health issues within the workplace and application of managerial techniques that promote a mentally healthy workplace, Additional analyses to assess level of mental health literacy and non-stigmatising attitude toward mental illness will also be assessed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2019
Actual
19/07/2019
Date of last participant enrolment
Anticipated
22/07/2019
Actual
2/09/2019
Date of last data collection
Anticipated
15/08/2019
Actual
14/09/2019
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302710 0
Government body
Name [1] 302710 0
Australian Government Department of Health
Country [1] 302710 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Black Dog Institute
Hospital Road,
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 303006 0
None
Name [1] 303006 0
Address [1] 303006 0
Country [1] 303006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303320 0
UNSW HREC
Ethics committee address [1] 303320 0
Ethics committee country [1] 303320 0
Australia
Date submitted for ethics approval [1] 303320 0
01/02/2019
Approval date [1] 303320 0
08/04/2019
Ethics approval number [1] 303320 0
HC190052

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

Contacts
Principal investigator
Name 93262 0
A/Prof Samuel B. Harvey
Address 93262 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 93262 0
Australia
Phone 93262 0
+61 293824517
Fax 93262 0
Email 93262 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 93263 0
Aimee Gayed
Address 93263 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 93263 0
Australia
Phone 93263 0
+61 293824517
Fax 93263 0
Email 93263 0
a.gayed@unsw.edu.au
Contact person for scientific queries
Name 93264 0
Aimee Gayed
Address 93264 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 93264 0
Australia
Phone 93264 0
+61 293824517
Fax 93264 0
Email 93264 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
Data can be made available upon request


What supporting documents are/will be available?

No Supporting Document Provided



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.