Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000279325
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
23/02/2017
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The development and evaluation of an online mental health training program for managers
Scientific title
The development and evaluation of an online mental health training program for managers
Secondary ID [1] 290465 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Managers' behaviour towards mental health issues in the workplace 300792 0
Manager's Mental Health literacy 302156 0
Managers’ Attitudes towards mental health issues in the workplace 302157 0
Managers’ Confidence in supporting employees/direct reports with mental health issues 302158 0
Condition category
Condition code
Mental Health 300619 300619 0 0
Depression
Mental Health 300620 300620 0 0
Anxiety
Mental Health 301137 301137 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A newly developed comprehensive online training program for managers will be evaluated through a clustered randomised controlled trial conducted within industry partner organisations. The intervention has been developed from evidence-based training resources and in collaboration with psychiatrists with expertise in workplace mental health and mental health online training experts. The program aims to help managers and supervisors in male-dominated industries better recognise and understand mental health in the workplace, and highlight what managers can do to help keep workers as mentally healthy as possible. The training 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

Topic 2. How to Help an Employee you are Concerned About
- Identifying People at Risk
- Having the Talk
- Providing Support
- Facilitating Help Seeking
- Modifying work to help recovery
- Returning to Work

Topic 3. Minimising Mental Health Risks in the Workplace
- How to be a respectful and responsible manager
- Managing existing and future work
- Managing individuals within a team
- Managing difficult emotions

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 2-2.5 hours. The program has been designed so users can complete it at their own pace and preferred times across a 6 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 6 week training period, Data will be available through the research platform on how many modules each participant completed during the trial, and how many minutes they spent completing the training program.
Intervention code [1] 296284 0
Prevention
Intervention code [2] 296692 0
Early detection / Screening
Intervention code [3] 297186 0
Rehabilitation
Comparator / control treatment
A waitlist control design will be utilised for this study. Participants in the control group will complete the pre- post- 4-month questionnaires at the same 3 time points as the intervention group. At completion of the 4-month follow up questionnaire for both groups, the waitlist control group will be offered the intervention training program. No post training assessment of the control group will be conducted.

Direct reports of the managers in the intervention and control group will be invited to complete a survey prior to the commencement of the intervention and at 4 month follow up.
Control group
Active

Outcomes
Primary outcome [1] 300077 0
Managers' 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.
Timepoint [1] 300077 0
4 months post-baseline (will also be measured at 6 weeks).
Primary outcome [2] 301165 0
Managers’ change in behaviour from baseline for the management of mental health issues within their team assessed through self-report responses to possible mental health complaints among their staff (questionnaire developed by the research team).
Timepoint [2] 301165 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [1] 328948 0
Managers’ 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 [1] 328948 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [2] 328949 0
Managers’ attitudes about mental health in the workplace. The measure used to assess these will be a questionnaire developed by the researchers
Timepoint [2] 328949 0
4 months post-baseline (will also be measured at 6 weeks)
Secondary outcome [3] 328950 0
Managers’ change in behaviour 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 and also a questionnaire developed by the researchers.
Timepoint [3] 328950 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [4] 328951 0
Employees' perceived level of supervisor support will be measured using adaptations of the HSE Management Standards Indicator Tool, Utrecht Work Engagement Scale and the Psychological Safety Climate Scale.
Timepoint [4] 328951 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [5] 328952 0
Employee well-being will be measured using the 7-item Short Warwick-Edinburgh Mental Well-Being Scale.
Timepoint [5] 328952 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [6] 331929 0
Employee levels of psychological distress will be measured using the 6-item Kessler Psychological Distress Scale (K6).
Timepoint [6] 331929 0
4 months post-baseline (will also be measured at 6 weeks).
Secondary outcome [7] 331930 0
Employee absenteeism and presenteeism will be measured using employee's self report of recent sickness absence and the World Health Organisation HPQ (WHOHPQ) Presenteeism Questions
Timepoint [7] 331930 0
4 months post-baseline (will also be measured at 6 weeks).

Eligibility
Key inclusion criteria
Manager Level:
18 years or older
Current residing in Australia
Good English comprehension
Work for NSW Ambulance, Ambulance Victoria or Coates Hire
Manage a team of 3 or more employees

Employee Level:
18 years or older
Current residing in Australia
Good English comprehension
Work for NSW Ambulance, Ambulance Victoria or Coates Hire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age
Inability to understand English
Not a current employee of NSW Ambulance, Ambulance Victoria or Coates Hire
Not managing at least 3 employees (Manager level)

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)
Our industry partners have agreed to provide a list of branch/station locations across their state and the subjects will be cluster randomised by location. Allocation will be concealed and completed by an individual independent of the research team. It is planned that half the managers will received the online training program and the other half will be waitlist controls that will receive access to the training 4 months post-baseline after data collection has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation computer software will be used to provide a random assignment of branch locations to each group. Stratification will be based on the number of managers per site.
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
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. Likelihood based methods (mixed-model repeated measures (MMRM)) will be used to assess significance of change in the two primary manager outcome measures. Clustering will be accommodated by a random cluster membership (work site) factor. A priori planned comparisons of change from baseline to the 4-month endpoint will test the primary hypothesis. An unstructured variance-covariance matrix will be used to accommodate relationships between observations at different occasions of measurement. Stratification variables, partner employer , and any variables found to be substantially imbalanced between intervention arms post randomisation will be tentatively included in these models and retained if statistically significant and influential on outcomes. Length of time from baseline to complete training and associated post-intervention assessment will also be introduced tentatively into models to evaluate the effects of adjustment for possible effects associated with some managers undertaking these assessments earlier than others and earlier than control group participants.

Similar analyses of scaled secondary manager outcomes will assess differential change due to intervention arm. Mathematical transformation or categorisation of raw scores may be undertaken to meet distributional assumptions and address any violation of assumptions attributable to outliers. Comparable analyses of employee measures will additionally accommodate the nesting of employees within managers by including a random effect for managers where this is possible.
Additional per-protocol analyses to assess effectiveness of the program will focus on managers who completed at least one of the three topics. This subgroup will be compared to all responders in the waitlist control group and, secondarily, with managers 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 HeadCoach 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.


An effect size of 0.4 would be considered a significant shift in such a measure. In order to achieve 80% power to detect an effect of this size, with an alpha value of 0.05 and two tailed tests, 200 managers will need to complete this trial.

Our industry partners estimate that they will be able to provide us with the details of 415 managers meeting the eligibility criteria for this study. Based on previous research we have conducted regarding this type of training, we expect to be able to recruit 60% of these managers and to have a drop out rate of around 30%. As a result, we should be able to comfortably recruit 200 managers to this study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2017
Actual
19/04/2017
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
31/01/2018
Actual
31/12/2017
Sample size
Target
200
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 294866 0
Charities/Societies/Foundations
Name [1] 294866 0
Beyondblue
Country [1] 294866 0
Australia
Funding source category [2] 294869 0
Charities/Societies/Foundations
Name [2] 294869 0
Movember
Country [2] 294869 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 293707 0
Other Collaborative groups
Name [1] 293707 0
Black Dog Institute
Address [1] 293707 0
Hospital Rd
Randwick
2031 NSW
Country [1] 293707 0
Australia
Secondary sponsor category [2] 293708 0
University
Name [2] 293708 0
University of Sydney
Address [2] 293708 0
Sydney
NSW 2006
Country [2] 293708 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296249 0
South Eastern Sydney Local Health District (SESLHD)
Ethics committee address [1] 296249 0
Ethics committee country [1] 296249 0
Australia
Date submitted for ethics approval [1] 296249 0
25/11/2016
Approval date [1] 296249 0
09/02/2017
Ethics approval number [1] 296249 0
HREC ref no: 16/348 (HREC/16/POWH/684)

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

Contacts
Principal investigator
Name 70094 0
A/Prof Samuel Harvey
Address 70094 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 70094 0
Australia
Phone 70094 0
+61 2 9382 8356
Fax 70094 0
Email 70094 0
[email protected]
Contact person for public queries
Name 70095 0
Samuel Harvey
Address 70095 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 70095 0
Australia
Phone 70095 0
+61 2 9382 8356
Fax 70095 0
Email 70095 0
[email protected]
Contact person for scientific queries
Name 70096 0
Samuel Harvey
Address 70096 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 70096 0
Australia
Phone 70096 0
+61 2 9382 8356
Fax 70096 0
Email 70096 0
[email protected]

No information has been provided regarding IPD availability


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
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