Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001083785
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
26/09/2013
Date last updated
15/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of the effectiveness of Mental Health Guru, an internet-based workplace induction program for depression and anxiety.
Scientific title
A randomised controlled trial evaluating the effect of Mental Health Guru, an internet-based workplace mental health induction program, on mental health literacy, stigma and help-seeking in a workplace population.
Secondary ID [1] 283208 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking intentions and attitudes
 290070 0
Mental health literacy 290082 0
Mental illness related stigma 290083 0
Depression 290193 0
Anxiety 290194 0
Condition category
Condition code
Mental Health 290450 290450 0 0
Depression
Mental Health 290451 290451 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the effectiveness of a brief, internet-based, workplace mental health program- Mental Health Guru - using a randomised controlled trial design.

The Mental Health Guru program is an online educational program currently comprising two modules: 1) depression and 2) generalised anxiety disorder each of which comprises information about mental illness and the myths associated with it, personalised feedback and consumer videos. Participants randomly allocated to the intervention condition will be asked to complete one module per week, with each module requiring approximately 30 minutes to complete. The program can be completed via home or work computers.

Program usage data will be captured from the technology systems including program module access, number of site visits and an estimate of length of exposure derived from log analysis.
Intervention code [1] 287933 0
Behaviour
Comparator / control treatment
Wait-list

Individuals randomised to the wait-list control condition will receive access to the intervention program directly after completion of the 6-month assessment. If the participant has not accessed the 6 month assessment within one month, it will be closed. If a participant logs in after this time they will be provided with access to the intervention program. The intervention program will be available for a minimum period of 3-months from the date of the 6-month assessment notification.
Control group
Active

Outcomes
Primary outcome [1] 290476 0
Depression and Anxiety Literacy scores as measured by the Depression Literacy Scale (D-Lit) and Anxiety Literacy Scale (A-Lit).
Timepoint [1] 290476 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.
Primary outcome [2] 290477 0
Personal Depression and Anxiety Stigma scores as measured by the Depression Stigma Scale (DSS) and Generalised Anxiety Stigma Scale (GASS)
Timepoint [2] 290477 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.
Primary outcome [3] 290478 0
Help-seeking intention scores for depression and anxiety as measured by the General Help-Seeking Questionnaire (GHSQ)
Timepoint [3] 290478 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.
Secondary outcome [1] 304582 0
Depression and Anxiety Literacy scores as measured by the Depression Literacy Scale (D-Lit) and Anxiety Literacy Scale (A-Lit)
Timepoint [1] 304582 0
Follow-up: 6-months
Secondary outcome [2] 304583 0
Personal Depression and Anxiety Stigma scores as measured by the Depression Stigma Scale (DSS) and Generalised Anxiety Stigma Scale (GASS)
Timepoint [2] 304583 0
Follow-up: 6-months
Secondary outcome [3] 304584 0
Help-seeking intention scores for depression and anxiety as measured by the General Help-Seeking Questionnaire (GHSQ)
Timepoint [3] 304584 0
Follow-up: 6-months
Secondary outcome [4] 304585 0
Help-seeking attitude scores as measured by the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF)
Timepoint [4] 304585 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.

Follow-up: 6-months
Secondary outcome [5] 304586 0
Perceived Workplace Depression and Anxiety Stigma Scores as measured by the Depression Stigma Scale (Perceived Workplace) and Anxiety Stigma Scale (Perceived Workplace)
Timepoint [5] 304586 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.

Follow-up: 6-months
Secondary outcome [6] 304587 0
Level of symptoms of depression as measured by the Center for Epidemiologic Studies Depression Scale
Timepoint [6] 304587 0
Follow-up: 6-months
Secondary outcome [7] 304588 0
Level of generalised anxiety disorder symptoms as measured by the Generalised Anxiety Disorder 7-item Scale
Timepoint [7] 304588 0
Follow-up: 6-months
Secondary outcome [8] 304589 0
Usability, Acceptability and Satisfaction data as measured by a number of Likert, dichotomous and open-response items designed specifically for this study.
Timepoint [8] 304589 0
Post-test: Week 4 of the trial, one week after access is provided to the second module.

Eligibility
Key inclusion criteria
Participants must be employed by an organisation that has provided written consent to participate in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Participants will be recruited from organisations that have provided informed written consent. The trial will be advertised to employees via employer emails and other advertisement materials. All advertisement materials will contain a url address for the study, which provides detailed information about the scope, nature and potential outcomes of the trial. If they choose to proceed, employees will then be required to answer a series of questions to provide their informed consent. Only after this process is completed will the employee be enrolled into the trial and asked to begin the baseline assessment. After completion of the baseline assessment, participants will be randomised to the intervention or control condition by computer generated random number assignment and notified of their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by gender and by management/ general staff status, and will use block randomisation with randomly generated block sizes.
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
Analysis will be undertaken according to intention-to-treat principles, comparing outcomes from all participants allocated to the intervention group (regardless of whether they complete the intervention or not) with all participants in the wait-list control group. Emphasis in the statistical analyses will be on differences between the intervention and control group in terms of changes across time (i.e., baseline to post-intervention, baseline to 6-month follow-up, and post-intervention to 6-month follow-up). We will examine these differences using mixed models analyses. Additional analyses will be performed to compare outcomes for completers. Missing data patterns will be examined and analysis will be undertaken to identify any baseline differences between completers and non-completers.

For power calculations the effect sizes achieved for the primary outcomes of mental health literacy, stigma and help-seeking in the MH-Guru pilot trial were considered. Based on a power of 0.80, an alpha of 0.05, and an expected drop out rate of approximately 60% (based on the MH-Guru pilot trial), we aim to assign 440 employees to each condition to show an effect size of 0.30 (the smallest effect size achieved for a primary outcome in the MH-Guru pilot trial). Based on this determination the total sample size needed is 880.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/07/2014
Actual
11/07/2014
Date of last participant enrolment
Anticipated
1/10/2015
Actual
12/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
880
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 287951 0
Government body
Name [1] 287951 0
National Health and Medical Research Council
Country [1] 287951 0
Australia
Funding source category [2] 289550 0
Other
Name [2] 289550 0
ANU Connect Ventures
Country [2] 289550 0
Australia
Primary sponsor type
Individual
Name
Professor Kathleen Griffiths
Address
National Institute for Mental Health Research, The Australian National University, Acton, ACT 0200
Australia
Country
Australia
Secondary sponsor category [1] 286671 0
None
Name [1] 286671 0
Address [1] 286671 0
Country [1] 286671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289880 0
Human Research Ethics Committee
Ethics committee address [1] 289880 0
Ethics committee country [1] 289880 0
Australia
Date submitted for ethics approval [1] 289880 0
Approval date [1] 289880 0
26/07/2013
Ethics approval number [1] 289880 0
2013/387

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

Contacts
Principal investigator
Name 42914 0
Prof Kathleen Griffiths
Address 42914 0
National Institute for Mental Health Research, The Australian National University, Acton, ACT 0200
Country 42914 0
Australia
Phone 42914 0
+61 2 61259723
Fax 42914 0
+61 2 6125 0733
Email 42914 0
[email protected]
Contact person for public queries
Name 42915 0
Neera Odhavji
Address 42915 0
National Institute for Mental Health Research, The Australian National University, Acton, ACT 0200
Country 42915 0
Australia
Phone 42915 0
+61 2 61250938
Fax 42915 0
+61 2 6125 0733
Email 42915 0
[email protected]
Contact person for scientific queries
Name 42916 0
Neera Odhavji
Address 42916 0
National Institute for Mental Health Research, The Australian National University, Acton, ACT 0200
Country 42916 0
Australia
Phone 42916 0
+61 2 61250938
Fax 42916 0
+61 2 6125 0733
Email 42916 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of MH-Guru, a brief online mental health program for the workplace: A randomised controlled trial.2016https://dx.doi.org/10.1016/j.invent.2016.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.