Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001027000
Ethics application status
Approved
Date submitted
11/10/2010
Date registered
23/11/2010
Date last updated
11/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
MindWise - Promoting mental health literacy at Victoria University
Scientific title
MindWise - an evaluation of an educational campaign to raise mental health literacy amongst students and staff of Victoria University
Secondary ID [1] 252591 0
Nil
Secondary ID [2] 295515 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 258087 0
anxiety 258088 0
alcohol misuse 258089 0
Condition category
Condition code
Public Health 258267 258267 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following intervention elements will carried out at intervals throughout the study period of two years.


MindWise stalls at pre-existing Victoria University campus events (such as Orientation Week, Safety Week and Wellness Day). Each event will last for between one and five days and there will be several such events throughout the study period.

MindWise website/Facebook page will be available throughout the study period for participants to access when they wish.

Mailout of Taking Care of Yourself and Your Family to staff members. Mailout 12-hour Mental Health First Aid (MHFA) course via e-learning CD to interested parties. These will be done twice during the study period.

Links to MindWise student factsheets on student electronic learning portal (always available).

Monthly emails to staff containing MindWise factsheets.


The following resources or information will be provided. Participants can access these at their own pace: mental health factsheets from beyondblue, Reachout and MindWise, National Health and Medical Research Council (NHMRC) alcohol guidelines, MindWise coffee mugs with mental health message and MindWise showbags containing beyondblue materials and Victoria University services for students and staff, check your drinking quiz, pour a standard drink activity and self-care ideas activity.



The overall duration of the study is two years.
Intervention code [1] 257116 0
Prevention
Comparator / control treatment
Campuses not given the intervention (active no-treatment group)
Control group
Active

Outcomes
Primary outcome [1] 259167 0
depression and anxiety levels (using K6 questionnaire measure of psychological distress)
Timepoint [1] 259167 0
at baseline, at end of year 1 and end of year 2
Primary outcome [2] 259168 0
alcohol usage (using Alcohol Use Disorders Identification Test (AUDIT))
Timepoint [2] 259168 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [1] 265499 0
recognition of mental health problem (using depression vignette from Kitchener & Jorm, 2002b)
Timepoint [1] 265499 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [2] 265500 0
help-seeking actions for mental health problem (using depression vignette from Kitchener & Jorm, 2002b)
Timepoint [2] 265500 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [3] 265501 0
beliefs about which interventions are helpful for mental health problems (adapted from Kitchener & Jorm, 2002b)
Timepoint [3] 265501 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [4] 265502 0
social distance towards people with mental health problems (using scale by Link et al, 1999)
Timepoint [4] 265502 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [5] 265503 0
stigmatizing attitudes towards people with mental health problems (personal stigma) (using scale by Griffiths et al, 2004)
Timepoint [5] 265503 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [6] 265504 0
help-seeking actions for own mental health problem (scale adapted from Kitchener & Jorm, 2002b)
Timepoint [6] 265504 0
at baseline at end of year 1 and end of year 2
Secondary outcome [7] 265505 0
mental health first aid actions given to anyone in your family or close circle of friends (assessed by questionnaire dapted from Kitchener & Jorm, 2002b)
Timepoint [7] 265505 0
at baseline at end of year 1 and end of year 2
Secondary outcome [8] 265506 0
perceptions of how well the Victoria University community supports students/staff with mental health problems (assessed by questionnaire)
Timepoint [8] 265506 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [9] 265507 0
knowledge of NHMRC alcohol guidelines (assessed by questionnaire)
Timepoint [9] 265507 0
at baseline, at end of year 1 and end of year 2
Secondary outcome [10] 265508 0
help-seeking for alcohol misuse (assessed by questionnaire)
Timepoint [10] 265508 0
at baseline, at end of year 1 and end of year 2

Eligibility
Key inclusion criteria
student or staff member of Victoria University
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants undertaking a course equal to or less than 3 months duration. If parental consent was denied for participants aged between 16 to 17. Students who did not feel proficient in English.

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)
A cluster randomized controlled design will be used, with campuses constituting the clusters. Reply paid registration forms were given out by researchers to students and staff at 9 Victoria University campuses. Potential participants across all campuses were given a standardized introduction to the project and encouraged to register for the trial on the spot, without knowing whether their campus was intervention or control. Allocation was not concealed from the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nine of Victoria University’s campuses have been paired (some pairs contain a cluster of several campuses) on the basis of similar size and course type. One of the researchers used Random.org to assign random numbers for each campus cluster. These random numbers (without campus codes) were given to a second researcher, who used a coin flipper option from Random.org and ascertained that 'heads' determined that the first campus of a pair was randomly assigned to the intervention group, while the second campus of the pair was randomized the control group. A 'tail' determined that the second member of the pair was randomized to the intervention group (and the first member of the pair was randomized to the control group). Both researchers emailed their information to a third researcher, who was also given the campus codes from the first researcher. The third researcher matched the codes to the randomization sequence. The study will follow the requirements of the CONSORT statement for cluster randomized trials (Campbell, Elbourne et al. 2004).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/03/2010
Actual
10/03/2010
Date of last participant enrolment
Anticipated
Actual
10/05/2010
Date of last data collection
Anticipated
Actual
9/12/2011
Sample size
Target
1500
Accrual to date
Final
1189
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3219 0
3020
Recruitment postcode(s) [2] 3220 0
3030
Recruitment postcode(s) [3] 3221 0
3015
Recruitment postcode(s) [4] 3222 0
3000
Recruitment postcode(s) [5] 3223 0
3021
Recruitment postcode(s) [6] 3224 0
3011

Funding & Sponsors
Funding source category [1] 257631 0
Government body
Name [1] 257631 0
NHMRC Australia Fellowship awarded to Professor Anthony Jorm
Country [1] 257631 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Orygen Youth Health Research Centre
Centre for Youth Mental Health
35 Poplar Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 256852 0
University
Name [1] 256852 0
Victoria University
Address [1] 256852 0
PO Box 14428
Melbourne Victoria 8001
Australia
Country [1] 256852 0
Australia
Other collaborator category [1] 251495 0
Charities/Societies/Foundations
Name [1] 251495 0
beyondblue
Address [1] 251495 0
PO Box 6100
Hawthorn West 3122
Country [1] 251495 0
Australia
Other collaborator category [2] 251496 0
Commercial sector/Industry
Name [2] 251496 0
Social Research Centre
Address [2] 251496 0
Level 1, 262 Victoria Street
North Melbourne Vic 3051
Country [2] 251496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259647 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 259647 0
Ethics committee country [1] 259647 0
Australia
Date submitted for ethics approval [1] 259647 0
Approval date [1] 259647 0
01/09/2009
Ethics approval number [1] 259647 0
HRETH 09/145

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

Contacts
Principal investigator
Name 31586 0
A/Prof Nicola Reavley
Address 31586 0
Melbourne School of Population and Global Health
207 Bouverie Street
Parkville
VIC 3010
Country 31586 0
Australia
Phone 31586 0
+61 3 90357628
Fax 31586 0
Email 31586 0
[email protected]
Contact person for public queries
Name 14833 0
Dr Nicola Reavley
Address 14833 0
Melbourne School of Population and Global Health, 207 Bouverie Street, University of Melbourne, VIC 3010
Country 14833 0
Australia
Phone 14833 0
+61 3 9035 7628
Fax 14833 0
+61 3 9349 5815
Email 14833 0
[email protected]
Contact person for scientific queries
Name 5761 0
Dr Nicola Reavley
Address 5761 0
Melbourne School of Population and Global Health, University of Melbourne, VIC 3010
Country 5761 0
Australia
Phone 5761 0
+61 3 9035 7628
Fax 5761 0
+61 3 9349 5815
Email 5761 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
No additional documents have been identified.