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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] 284669 0
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 291997 0
stigmatizing attitudes toward people with mental health problems 291998 0
confidence in supporting someone who has a mental health problem 291999 0
actual supportive behaviours toward someone who has a mental health problem 292000 0
personal help-seeking for a mental health problem 292001 0
participants' own mental health 292002 0
first aid knowledge 292003 0
actual supportive behaviours toward someone who has a physical health problem 292004 0
confidence in supporting someone who has a physical health problem 292005 0
Condition category
Condition code
Mental Health 292345 292345 0 0
Depression
Mental Health 292346 292346 0 0
Other mental health disorders
Public Health 292347 292347 0 0
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] 289451 0
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] 292204 0
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] 292204 0
baseline, 2-months post training, one year post-training, two-years post training
Primary outcome [2] 292207 0
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] 292207 0
baseline, one-year post training, two-years post training
Primary outcome [3] 292214 0
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] 292214 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [1] 308427 0
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] 308427 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [2] 308428 0
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] 308428 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [3] 308432 0
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] 308432 0
baseline, two-months post training, one-year post training- two-years post training
Secondary outcome [4] 308433 0
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] 308433 0
baseline, two-month post training, one-year post training, two-year post training
Secondary outcome [5] 308496 0
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] 308496 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [6] 308497 0
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] 308497 0
baseline, one-year post training, two-years post training
Secondary outcome [7] 308498 0
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] 308498 0
baseline, one-year post training, two-years post training
Secondary outcome [8] 308500 0
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] 308500 0
baseline, one-year post training, two-years post training
Secondary outcome [9] 308502 0
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] 308502 0
baseline, one-year post training, two-years post training
Secondary outcome [10] 308503 0
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] 308503 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [11] 308504 0
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] 308504 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [12] 308505 0
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] 308505 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [13] 308506 0
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] 308506 0
baseline, two-months post training, one-year post training, two-years post training
Secondary outcome [14] 308518 0
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] 308518 0
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] 8156 0
3000 - Melbourne
Recruitment postcode(s) [2] 8157 0
3051 - North Melbourne
Recruitment postcode(s) [3] 8158 0
3032 - Ascot Vale
Recruitment postcode(s) [4] 8159 0
3053 - Carlton
Recruitment postcode(s) [5] 8160 0
3058 - Coburg
Recruitment postcode(s) [6] 8161 0
3068 - Clifton Hill
Recruitment postcode(s) [7] 8162 0
3066 - Collingwood
Recruitment postcode(s) [8] 8163 0
3175 - Dandenong
Recruitment postcode(s) [9] 8164 0
3108 - Doncaster
Recruitment postcode(s) [10] 8165 0
3040 - Essendon
Recruitment postcode(s) [11] 8166 0
3002 - East Melbourne
Recruitment postcode(s) [12] 8167 0
3199 - Frankston
Recruitment postcode(s) [13] 8168 0
3065 - Fitzroy
Recruitment postcode(s) [14] 8169 0
3220 - Geelong
Recruitment postcode(s) [15] 8170 0
3011 - Footscray
Recruitment postcode(s) [16] 8171 0
3046 - Glenroy
Recruitment postcode(s) [17] 8172 0
3029 - Hoppers Crossing
Recruitment postcode(s) [18] 8173 0
3122 - Hawthorn
Recruitment postcode(s) [19] 8174 0
3081 - Heidelberg Heights
Recruitment postcode(s) [20] 8175 0
3036 - Keilor
Recruitment postcode(s) [21] 8176 0
3079 - Ivanhoe
Recruitment postcode(s) [22] 8177 0
3031 - Kensington
Recruitment postcode(s) [23] 8178 0
3028 - Laverton
Recruitment postcode(s) [24] 8179 0
3032 - Maribyrnong
Recruitment postcode(s) [25] 8180 0
3337 - Melton
Recruitment postcode(s) [26] 8181 0
3194 - Mentone
Recruitment postcode(s) [27] 8182 0
3039 - Moonee Ponds
Recruitment postcode(s) [28] 8183 0
3015 - Newport
Recruitment postcode(s) [29] 8184 0
3174 - Noble Park
Recruitment postcode(s) [30] 8185 0
3052 - Parkville
Recruitment postcode(s) [31] 8186 0
3044 - Pascoe Vale
Recruitment postcode(s) [32] 8187 0
3070 - Northcote
Recruitment postcode(s) [33] 8188 0
3131 - Nunawading
Recruitment postcode(s) [34] 8189 0
3181 - Prahran
Recruitment postcode(s) [35] 8190 0
3072 - Preston
Recruitment postcode(s) [36] 8191 0
3207 - Port Melbourne
Recruitment postcode(s) [37] 8192 0
3121 - Richmond
Recruitment postcode(s) [38] 8193 0
3101 - Kew
Recruitment postcode(s) [39] 8194 0
3134 - Ringwood
Recruitment postcode(s) [40] 8195 0
3141 - South Yarra
Recruitment postcode(s) [41] 8196 0
3011 - Seddon
Recruitment postcode(s) [42] 8197 0
3021 - St Albans
Recruitment postcode(s) [43] 8198 0
3171 - Springvale
Recruitment postcode(s) [44] 8199 0
3205 - South Melbourne
Recruitment postcode(s) [45] 8200 0
3182 - St Kilda
Recruitment postcode(s) [46] 8201 0
3020 - Sunshine
Recruitment postcode(s) [47] 8202 0
3016 - Williamstown
Recruitment postcode(s) [48] 8203 0
3125 - Burwood
Recruitment postcode(s) [49] 8204 0
3124 - Camberwell
Recruitment postcode(s) [50] 8205 0
3056 - Brunswick
Recruitment postcode(s) [51] 25219 0
2602 - Ainslie
Recruitment postcode(s) [52] 25220 0
2914 - Amaroo
Recruitment postcode(s) [53] 25221 0
2600 - Canberra
Recruitment postcode(s) [54] 25222 0
2606 - Chifley
Recruitment postcode(s) [55] 25223 0
2603 - Griffith
Recruitment postcode(s) [56] 25224 0
2612 - Turner
Recruitment postcode(s) [57] 25225 0
2615 - Dunlop
Recruitment postcode(s) [58] 25226 0
2906 - Banks
Recruitment postcode(s) [59] 25227 0
2902 - Kambah
Recruitment postcode(s) [60] 25228 0
2607 - Torrens
Recruitment postcode(s) [61] 25229 0
2611 - Fisher
Recruitment postcode(s) [62] 25230 0
2616 - Belconnen
Recruitment postcode(s) [63] 25231 0
2905 - Calwell
Recruitment postcode(s) [64] 25232 0
2913 - Palmerston
Recruitment postcode(s) [65] 25233 0
2617 - Giralang

Funding & Sponsors
Funding source category [1] 289311 0
Government body
Name [1] 289311 0
National Health and Medical Research Council
Country [1] 289311 0
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] 287982 0
Charities/Societies/Foundations
Name [1] 287982 0
Mental Health First Aid (MHFA) Australia
Address [1] 287982 0
Level 6, 369 Royal Parade
PARKVILLE VIC 3052
Country [1] 287982 0
Australia
Other collaborator category [1] 277981 0
Charities/Societies/Foundations
Name [1] 277981 0
Australian Red Cross
Address [1] 277981 0
23-47 Villiers Street
NORTH MELBOURNE VIC 3051
Country [1] 277981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291076 0
Melbourne School of Population and Global Health (MSPGH) Human Ethics Advisory Group
Ethics committee address [1] 291076 0
Ethics committee country [1] 291076 0
Australia
Date submitted for ethics approval [1] 291076 0
04/04/2014
Approval date [1] 291076 0
22/05/2014
Ethics approval number [1] 291076 0
1341345.1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 71 71 0 0
/AnzctrAttachments/366410(v11-06-2014-16-32-29)-WorkplaceAid_advertising_flyer_FINAL.pdf

Contacts
Principal investigator
Name 48698 0
A/Prof Nicola Reavley
Address 48698 0
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 48698 0
Australia
Phone 48698 0
+61 3 9035 7628
Fax 48698 0
Email 48698 0
nreavley@unimelb.edu.au
Contact person for public queries
Name 48699 0
Nicola Reavley
Address 48699 0
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 48699 0
Australia
Phone 48699 0
+61 3 9035 7628
Fax 48699 0
Email 48699 0
nreavley@unimelb.edu.au
Contact person for scientific queries
Name 48700 0
Nicola Reavley
Address 48700 0
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 48700 0
Australia
Phone 48700 0
+61 3 9035 7628
Fax 48700 0
Email 48700 0
nreavley@unimelb.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
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.TypeCitationLinkEmailOther DetailsAttachment
675Ethical approval    366410-(Uploaded-10-12-2018-13-26-32)-Study-related document.pdf
676Informed 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of eLearning and blended modes of delivery of Mental Health First Aid training in the workplace: randomised controlled trial.2018https://dx.doi.org/10.1186/s12888-018-1888-3
EmbaseLonger-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.2021https://dx.doi.org/10.1016/j.invent.2021.100434
N.B. These documents automatically identified may not have been verified by the study sponsor.