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Trial registered on ANZCTR

Registration number

ACTRN12614000623695

Ethics application status

Approved

Date submitted

29/05/2014

Date registered

13/06/2014

Date last updated

9/12/2019

Date data sharing statement initially provided

19/12/2018

Date results provided

19/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

WorkplaceAid - A trial on improving mental health and physical first aid skills in the workplace

Scientific title

The effects of eLearning or blended (eLearning plus face-to-face training) mental health first aid training on public servants' knowledge, attitudes, confidence in providing support and actual supportive behaviours towards others in the workplace, as well as personal help-seeking and their own mental health.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1157-3138

Trial acronym

WorkplaceAid

Linked study record

Health condition

Health condition(s) or problem(s) studied:

mental health first aid knowledge

stigmatizing attitudes toward people with mental health problems

confidence in supporting someone who has a mental health problem

actual supportive behaviours toward someone who has a mental health problem

personal help-seeking for a mental health problem

participants' own mental health

first aid knowledge

actual supportive behaviours toward someone who has a physical health problem

confidence in supporting someone who has a physical health problem

Condition category

Condition code

Mental Health

Depression

Mental Health

Other mental health disorders

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Group 1: a 6-hour eLearning Mental Health First Aid course via online portal, which teaches an action plan for responding to disorders such as depression, anxiety, psychosis and substance misuse. The crises covered include suicidal thoughts and behaviours, non-suicidal self-injury, panic attacks, traumatic events, severe psychotic states, severe effects from alcohol misuse, severe effects from drug misuse, and aggressive behaviours. It has been tailored to incorporate information on policies, resources and help-seeking pathways of specific relevance to the Victorian public service. Participants will receive weekly emails for 6 weeks to pace them through the material. Weekly reports will be extracted to monitor course progress and flag completers.

Group 2: as per 6-hour eLearning course above plus a 3.5 hour face-to-face session, which reviews the contents of the online course through quizzes, discussion, case studies and includes a manual. It also uses role plays to give participants more concrete experience in applying the MHFA Action Plan in different situations and settings. Group training will be delivered between week 7 to 10 (minimum of 12 participants per group to a maximum of 24).

Intervention code [1]

Prevention

Comparator / control treatment

Group 3: a 4-hour eLearning Apply First Aid course via online portal, which teaches the fundamental principles, knowledge and skills to provide emergency care for injuries and illnesses in the home or the workplace. Participants will receive weekly emails for 6 weeks to pace them through the material. Weekly reports will be extracted to monitor course progress and flag completers.

Control group

Active

Outcomes

Primary outcome [1]

16-item true/false quiz based on the content of the Mental Health First Aid Manual (Kitchener et al., 2013).
Frequencies of correct responses converted to percentages.

Timepoint [1]

baseline, 2-months post training, one year post-training, two-years post training

Primary outcome [2]

Self-reported supportive behaviours if someone at work develops a mental health problem. "Describe all the things you did to help." (open-ended). Scoring based on MHFA Action Plan (Yap & Jorm, 2012).

Timepoint [2]

baseline, one-year post training, two-years post training

Primary outcome [3]

Stigmatizing attitudes of participants in relation to vignettes depicting i) depression and ii) PTSD, measured by Social Distance Scale (Link et al., 1999).

"Would you be happy:
a) To move next door to John/Paula?
b) To spend an evening socializing with John/Paula?
c) To make friends with John/Paula?
d) To work closely with John/Paula on a project at work?
e) To have John/Paula marry into your family?"

Response frame: 1 = Yes definitely (low social distance) to 4 = Definitely not (high social distance).

Timepoint [3]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [1]

Recognition of mental health problems in vignettes. "What, if anything do you think is wrong with John/Paula?" (open-ended response). Scoring based on DSM-5 classification for Major Depressive Disorder and PTSD.

Timepoint [1]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [2]

Supportive behaviours to assist characters in vignettes depicting depression and PTSD.
"If John/Paula was a co-worker, I would help him/her." 7-point scale ranging from 1 = Strongly Disagree to 7 = Strongly Agree.

"Describe all the things you would do to help John/Paula." (open-ended response) Scoring based on MHFA Action Plan (Yap & Jorm, 2012).

Timepoint [2]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [3]

Confidence in providing help to someone at work with depression or PTSD.
"How confident do you feel in helping someone at work with a problem like John/Paula?" 5-point scale ranging from 1 = Not at all to 5 = Extremely.

Timepoint [3]

baseline, two-months post training, one-year post training- two-years post training

Secondary outcome [4]

16-item scale on mental health literacy about depression with suicidal thoughts and PTSD. Scoring based on 2011 National Survey of Mental Health Literacy and Stigma (Reavley & Jorm, 2011). 5-point scale: 1 = Helpful, 2 = Neither, 3 = Harmful, 4 = Depends, 5 = Don't know.

Timepoint [4]

baseline, two-month post training, one-year post training, two-year post training

Secondary outcome [5]

Participants' personal stigma in relation to characters depicted in depression and PTSD vignettes, measured by Personal Stigma Scale, 9 items. Scored using 5-point scale ranging from 1 = Strongly Agree to 5 = Strongly Disagree. (Griffiths et al., 2004).

Timepoint [5]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [6]

Participants' self-reported supportive behaviours over the last 12 months towards people outside of their work with a mental health problem. "Describe all the things you did to help." (open-ended response)

Timepoint [6]

baseline, one-year post training, two-years post training

Secondary outcome [7]

Recognition of a mental health problem in someone outside of work, over the last 12 months. "What do you think the problem was?" (open-ended response)

Timepoint [7]

baseline, one-year post training, two-years post training

Secondary outcome [8]

Help seeking of participants for own mental health problem. If think they had a problem, "What do you think the problem was? Over the last 12 months, have you done anything to deal with this mental health problem? Describe all the things you did." (open-ended responses)

Timepoint [8]

baseline, one-year post training, two-years post training

Secondary outcome [9]

Mental health of participant measured by K6 12-month version (Kessler et al., 2003). It contains 6 items with responses ranging from 1 = All of the time to 5 = None of the time. The resulting score range is between 6 to 30, with a cut-off point of equal to or more than 19 indicating a high level of psychological distress in the anxiety and depression spectrum.

Timepoint [9]

baseline, one-year post training, two-years post training

Secondary outcome [10]

Recognition of a physical health problem which requires first aid using a vignette depicting a seizure. "What do you think is wrong with Rob?" (open-ended response)

Timepoint [10]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [11]

Supportive behaviours toward a character in a vignette depicting a seizure.

"If Rob was a co-worker, I would help him."
Scoring based on a 7-point scale ranging from 1 = Strongly Disagree to 7 = Strongly Agree.

"Describe all the things you would do to help Rob." (open-ended response)

Timepoint [11]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [12]

Confidence in providing support to someone at work who has a seizure. "How confident do you feel in helping someone at work with a problem like Rob's?" Scoring based on 5-point scale ranging from 1 = Not at all to 5 = Extremely.

Timepoint [12]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [13]

10-item first aid quiz based on Red Cross eLearning Apply First Aid course. Response frame: Agree, Disagree, Don't know.

Frequencies of correct responses converted to percentages.

Timepoint [13]

baseline, two-months post training, one-year post training, two-years post training

Secondary outcome [14]

Course satisfaction:

1. How much of the training did you complete? (1 = none of it, 2 = part of it, 3 = most of it, 4 = all of it).

2. How easy was the material to understand? (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult).

3. How much did you learn from the course? (1 = a great deal, 2 = a fair bit, 3 = not very much, 4 = almost nothing).

4. How useful was the course? (1 = very useful, 2 = useful, 3 = not very useful, 4 = not at all useful).

5. Do you think you will use the training material in the future? (1 = yes, 2 = no, 3 = not sure).

6. Would you recommend the course to others? (1 = yes definitely, 2 = probably, 3 = probably not, 4 = definitely not).

7 What did you like about the training materials?

8. What did you dislike about the training materials?

Timepoint [14]

at two-month post training only

Eligibility

Key inclusion criteria

Australian public service employees in Victoria and ACT.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Any Australian public servants from Victoria or the ACT who have undertaken a Mental Health First Aid course or a Provide First Aid course in the previous three years.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects will enrol online via the WorkplaceAid trial website. Allocation will be concealed as randomization will occur via computer, at the end of baseline survey completion.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomization will be carried out by a random integer generator programmed on the trial website to give values of 1 = eLearning MHFA; 2 = Blended eLearning MHFA and 3 = eLearning Apply First Aid (see http://php.net/manual/en/function.rand.php).

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

The data for this study will be analysed using mixed-effects models for continuous and binary outcome variables, with group-by-measurement-occasion interactions. This method of analysis is well suited to the data that will be collected for this study as it takes into account the hierarchical structure of the data in the analysis of differences between the groups, i.e. the correlation of measurement occasions within participants.

For the purpose of sample size calculation, the main hypothesis of interest is that MHFA training delivered in blended mode will be superior to MHFA training delivered in online mode in achieving the outcomes of interest. This hypothesis is of main interest because the sample size required to detect differences between these two modes of training will be larger than that required to detect differences between these modes and first aid training. Consequently, we chose a small effect size to evaluate the difference between the two modes of MHFA training. We believe that an effect size smaller than this may not be practically meaningful in terms of participant outcomes. According to Stata Release12, for a repeated measures design, with 1 pre-training measure and 3 post-training measures, using the change method of sample size calculation and assuming a conservative 0.70 correlation between pre-post measurements (see Means et al., 2010), to detect an effect size of Cohen’s d=0.20 (or h=0.20), with a power=0.80 and an alpha=0.05, 165 participants will be required per group. Increasing the sample size by 20% to account for attrition, the total sample size required is 594 (198 participants per group).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

27/06/2014

Actual

7/07/2014

Date of last participant enrolment

Anticipated

30/06/2016

Actual

15/01/2017

Date of last data collection

Anticipated

30/03/2019

Actual

5/04/2019

Sample size

Target

600

Accrual to date

Final

608

Recruitment in Australia

Recruitment state(s)

ACT,VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3051 - North Melbourne

Recruitment postcode(s) [3]

3032 - Ascot Vale

Recruitment postcode(s) [4]

3053 - Carlton

Recruitment postcode(s) [5]

3058 - Coburg

Recruitment postcode(s) [6]

3068 - Clifton Hill

Recruitment postcode(s) [7]

3066 - Collingwood

Recruitment postcode(s) [8]

3175 - Dandenong

Recruitment postcode(s) [9]

3108 - Doncaster

Recruitment postcode(s) [10]

3040 - Essendon

Recruitment postcode(s) [11]

3002 - East Melbourne

Recruitment postcode(s) [12]

3199 - Frankston

Recruitment postcode(s) [13]

3065 - Fitzroy

Recruitment postcode(s) [14]

3220 - Geelong

Recruitment postcode(s) [15]

3011 - Footscray

Recruitment postcode(s) [16]

3046 - Glenroy

Recruitment postcode(s) [17]

3029 - Hoppers Crossing

Recruitment postcode(s) [18]

3122 - Hawthorn

Recruitment postcode(s) [19]

3081 - Heidelberg Heights

Recruitment postcode(s) [20]

3036 - Keilor

Recruitment postcode(s) [21]

3079 - Ivanhoe

Recruitment postcode(s) [22]

3031 - Kensington

Recruitment postcode(s) [23]

3028 - Laverton

Recruitment postcode(s) [24]

3032 - Maribyrnong

Recruitment postcode(s) [25]

3337 - Melton

Recruitment postcode(s) [26]

3194 - Mentone

Recruitment postcode(s) [27]

3039 - Moonee Ponds

Recruitment postcode(s) [28]

3015 - Newport

Recruitment postcode(s) [29]

3174 - Noble Park

Recruitment postcode(s) [30]

3052 - Parkville

Recruitment postcode(s) [31]

3044 - Pascoe Vale

Recruitment postcode(s) [32]

3070 - Northcote

Recruitment postcode(s) [33]

3131 - Nunawading

Recruitment postcode(s) [34]

3181 - Prahran

Recruitment postcode(s) [35]

3072 - Preston

Recruitment postcode(s) [36]

3207 - Port Melbourne

Recruitment postcode(s) [37]

3121 - Richmond

Recruitment postcode(s) [38]

3101 - Kew

Recruitment postcode(s) [39]

3134 - Ringwood

Recruitment postcode(s) [40]

3141 - South Yarra

Recruitment postcode(s) [41]

3011 - Seddon

Recruitment postcode(s) [42]

3021 - St Albans

Recruitment postcode(s) [43]

3171 - Springvale

Recruitment postcode(s) [44]

3205 - South Melbourne

Recruitment postcode(s) [45]

3182 - St Kilda

Recruitment postcode(s) [46]

3020 - Sunshine

Recruitment postcode(s) [47]

3016 - Williamstown

Recruitment postcode(s) [48]

3125 - Burwood

Recruitment postcode(s) [49]

3124 - Camberwell

Recruitment postcode(s) [50]

3056 - Brunswick

Recruitment postcode(s) [51]

2602 - Ainslie

Recruitment postcode(s) [52]

2914 - Amaroo

Recruitment postcode(s) [53]

2600 - Canberra

Recruitment postcode(s) [54]

2606 - Chifley

Recruitment postcode(s) [55]

2603 - Griffith

Recruitment postcode(s) [56]

2612 - Turner

Recruitment postcode(s) [57]

2615 - Dunlop

Recruitment postcode(s) [58]

2906 - Banks

Recruitment postcode(s) [59]

2902 - Kambah

Recruitment postcode(s) [60]

2607 - Torrens

Recruitment postcode(s) [61]

2611 - Fisher

Recruitment postcode(s) [62]

2616 - Belconnen

Recruitment postcode(s) [63]

2905 - Calwell

Recruitment postcode(s) [64]

2913 - Palmerston

Recruitment postcode(s) [65]

2617 - Giralang

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
Marcus Clarke Street
CANBERRA ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Melbourne School of Population and Global Health
Centre for Mental Health
Level 4, 207 Bouverie Street
CARLTON VIC 3010

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Mental Health First Aid (MHFA) Australia

Address [1]

Level 6, 369 Royal Parade
PARKVILLE VIC 3052

Country [1]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Australian Red Cross

Address [1]

23-47 Villiers Street
NORTH MELBOURNE VIC 3051

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne School of Population and Global Health (MSPGH) Human Ethics Advisory Group

Ethics committee address [1]

The University of Melbourne
Melbourne School of Population and Global Health 
Level 3, 207 Bouverie Street 
CARLTON  VIC   3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2014

Approval date [1]

22/05/2014

Ethics approval number [1]

1341345.1

Summary

Brief summary

This study aims to evaluate whether Mental Health First Aid (MHFA) training, delivered in eLearning or Blended learning (eLearning plus face-to-face) modes, leads to improvements in mental health first aid knowledge, stigmatizing attitudes, confidence in supporting a person in the social network with a mental health problem, and self-reported supportive behaviours if someone in their social network develops a mental health problem. It will also evaluate the effects of the training on the participants’ personal help-seeking if they have a mental health problem and on their own mental health.

Trial website

workplaceaid.net.au

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/366410(v11-06-2014-16-32-29)-WorkplaceAid_advertising_flyer_FINAL.pdf

Contacts

Principal investigator

Name

A/Prof Nicola Reavley

Address

Principal Research Fellow, Centre for Mental Health, Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences. Level 4, 207 Bouverie Street, The University of Melbourne, Carlton, Victoria 3010

Country

Australia

Phone

+61 3 9035 7628

Fax

[email protected]

Contact person for public queries

Name

Nicola Reavley

Address

Country

Australia

Phone

+61 3 9035 7628

Fax

[email protected]

Contact person for scientific queries

Name

Nicola Reavley

Address

Country

Australia

Phone

+61 3 9035 7628

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Requests for data will be considered after 2- year follow-up data has been collected. Requests can be made to Assoc Professor Nicola Reavley.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
675	Ethical approval					366410-(Uploaded-10-12-2018-13-26-32)-Study-related document.pdf
676	Informed consent form					366410-(Uploaded-10-12-2018-13-26-57)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effectiveness of eLearning and blended modes of delivery of Mental Health First Aid training in the workplace: randomised controlled trial.	2018	https://dx.doi.org/10.1186/s12888-018-1888-3
Embase	Longer-term effectiveness of eLearning and blended delivery of Mental Health First Aid training in the workplace: 2-Year follow-up of a randomised controlled trial.	2021	https://dx.doi.org/10.1016/j.invent.2021.100434

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically