Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000270617
Ethics application status
Approved
Date submitted
17/02/2023
Date registered
13/03/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The HeLiPaD Trial: Brief online training to support workplace mental health
Scientific title
The HeLiPaD Trial: Brief online training to support workplace mental health on help-seeking intentions
Secondary ID [1] 309018 0
None
Universal Trial Number (UTN)
Trial acronym
HeLiPaD: Help-seeking Enhancement through Lived Experience Participatory Design
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General mental health problems 329066 0
Condition category
Condition code
Mental Health 326045 326045 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Helipad program has been co-designed by a group of clinicians, people with lived experience, web developers, and employees from relevant divisions of organisations such as human relations (HR). The program consists of five interactive modules addressing the core issues described by the co-design group as being important to facilitating help seeking in workplaces. The modules have been designed to be highly interactive, including clickable diagrams, videos of health professionals and people with lived experience, and interactive quizzes.
1. Recognizing symptoms: Explores signs and symptoms via a ‘traffic light’ model (red, orange, and green indicators) of mental health. This module comprises an interactive map of the body that explains how we can recognize signs, symptoms or ‘indicators’ in our minds and bodies that tell us we might need to pay some attention to our mental health, and suggests what we can do about it.
2. Getting support: Answers questions about how, where, and from which health professionals to seek help for mental health support, and how each provides assistance. Also ‘demystifies’ the process of seeking help by providing specific example pathway [i.e., accessing a psychologist with or without a referral from a general practitioner (GP)] and three individual videos of health professionals (Employee Assistance Program (EAP, Psychologist, GP) explaining what they do to support people’s mental health.
3. Treatment options: Provides information about evidence-based treatment options including psychological, medication, exercise and lifestyle treatments for common mental health problems, including depression and anxiety. These were focused primarily on the psychological strategies approved by the Australian Government Medicare Benefits Schedule (MBS: health.gov.au), which are the most accessible psychological treatments available through the MBS, such as Cognitive Behavioral Therapy (CBT), Relaxation strategies, and Interpersonal Therapy, with further medical and lifestyle treatments suggested by members from the co-design group. This module also contains a practical example of how a specific CBT strategy called “cognitive restructuring”, may work when delivered practice, and an exercise on identifying people in our lives who may support us during challenging times.
4. Helping others: This module explores how to help others in the workplace who may disclose their experiences of mental ill-health, and provides some examples about how different responses to this disclosure can affect the outcome for the person experiencing a mental health issue. It also contains a video of a manager discussing their experience of an employee who disclosed their mental health issue.
5. Supportive workplaces: This final module primarily addresses stigmatizing attitudes towards mental ill-health, help-seeking and disclosure in the workplace. It contains three videos of peers describing positive experiences of disclosing in the workplace, myth-busting information in the form of a quiz on common mental disorders of depression and anxiety, and information targeting fears and concerns around disclosure of mental ill-health in the workplace.

Participants will be provided a link to the Helipad intervention program from their workplace. They can access the program from a website that they can access anywhere. Participants will need to access to a device (desktop, laptop, tablet, and/or smart phone) and reliable internet to complete the online program. The program is designed to be completed in a single session, which will take approximately 20 minutes to work through. However, if participants do not complete the program they will be sent a weblink with a reminder to complete it to the email address they provide. Because the program is designed to be competed in a discrete timeframe, this link will expire 1 week after the reminder email is sent. Basic website analytics will be recorded and analysed on aggregate to assess factors such as the time taken to view a webpage, or whether a link was accessed.
Intervention code [1] 325461 0
Early detection / Screening
Intervention code [2] 325462 0
Behaviour
Comparator / control treatment
The program comprises five time-matched standard written psychoeducation modules about mental health and wellbeing. The modules comprise written content from the National Institutes of Health (NIH) NIH News in Health newsletters (newsinhealth.nih.gov) that was minimally edited by the research team. Written content focused on education on signs and symptoms on common mental health conditions of depression and anxiety disorders, and how aspects of our lives (i.e., sleep, exercise, relationships, stress) impact on our mental health.

As for the Helipad intervention program, participants will be provided a link to the control intervention program from their workplace. They can access the program from a website that they can access anywhere. Participants will need to access to a device (desktop, laptop, tablet, and/or smart phone) and reliable internet to complete the online program. The program is designed to be completed in a single session, which will take approximately 20 minutes to work through. However, if participants do not complete the program they will be sent a weblink with a reminder to complete it to the email address they provide. Because the program is designed to be competed in a discrete timeframe, this link will expire 1 week after the reminder email is sent. Basic website analytics will be recorded and analysed on aggregate to assess factors such as the time taken to view a webpage, or whether a link was accessed.
Control group
Active

Outcomes
Primary outcome [1] 333907 0
Help seeking intentions (Primary outcome; General Help-seeking Questionnaire)
Timepoint [1] 333907 0
Immediately post-intervention
Secondary outcome [1] 418688 0
Mental illness stigma - adapted ‘stigma to others’ scale from the Stigma and Self-Stigma Scales (SASS)
Timepoint [1] 418688 0
Immediately post-intervention
6 months post-intervention
Secondary outcome [2] 418689 0
Mental health literacy - Composite Depression Literacy Scale/Anxiety Literacy Scale (+ 1 new item).
Timepoint [2] 418689 0
Immediately post-intervention
6 months post-intervention
Secondary outcome [3] 418690 0
Functioning - Work & Social Adjustment Scale
Timepoint [3] 418690 0
6 months post-intervention
Secondary outcome [4] 418691 0
Social distance - Social Distance Scale
Timepoint [4] 418691 0
Immediately post-intervention
Secondary outcome [5] 418692 0
Help seeking attitudes - Attitudes toward seeking professional psychological help- short form
Timepoint [5] 418692 0
Immediately post-intervention
6 months post-intervention
Secondary outcome [6] 418693 0
Help-seeking behaviour - Actual help-seeking scale
Timepoint [6] 418693 0
6 months post-intervention
Secondary outcome [7] 418694 0
Symptoms of depression - PROMIS-Depression
Timepoint [7] 418694 0
6 months post-intervention
Secondary outcome [8] 418695 0
Symptoms of anxiety- PROMIS-Anxiety
Timepoint [8] 418695 0
6 months post-intervention
Secondary outcome [9] 418696 0
General psychological distress - Distress Questionnaire 5
Timepoint [9] 418696 0
6 months post-intervention
Secondary outcome [10] 418697 0
Acceptability of Intervention - (Acceptability of Intervention Measure; Weiner 2017)
Timepoint [10] 418697 0
Immediately post-intervention
Secondary outcome [11] 418698 0
Intervention Appropriateness - (Intervention Appropriateness Measure; Weiner 2017)
Timepoint [11] 418698 0
Immediately post-intervention
Secondary outcome [12] 418699 0
Feasibility of Intervention - (Feasibility of Intervention Measure; Weiner 2017)
Timepoint [12] 418699 0
Immediately post-intervention
Secondary outcome [13] 433864 0
Quality of Life (ReQoL-10)
Timepoint [13] 433864 0
Secondary outcome [14] 433865 0
Quality of Life (ReQoL-10)
Timepoint [14] 433865 0
6 months post-intervention

Eligibility
Key inclusion criteria
Australian workplaces will be eligible if they:
(1) report having at least 50 employees, to ensure that each cluster is viable,
(2) have an Employee Assistance Program available for their staff to ensure that employees experiencing mental health concerns can access effective and immediate care.

Individuals must:
1) Be an employee in a participating Australian workplace.
2) Be aged 18 years or over and living in Australia and fluent in reading and understanding English.
3) Have access to a device (desktop, laptop, tablet, and/or smart phone) and reliable internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
We will use a pre-programmed computer algorithm that will assign each new workplace recruited into the trial into a condition. This process will aim to balance across conditions on the following key workplace characteristics: 1) workplace type (office-based vs. non-office based); 2) organization size <200 vs. 200+); and location (ACT/NSW/VIC vs. Other Australian state/territory).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use minimisation approach to randomisation. Minimisation is a type of randomisation where the first participant (or cluster) is randomised, and subsequent selections are allocated in a way that minimises the imbalance on specific factors between groups. This method is helpful for a design with few participants (or clusters) and has the advantage of making each condition more closely matched on certain key factors across the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Our power and sample size estimations were informed by the primary outcome measure: the level of intention to seek help from professional sources, as measured by the General Help-Seeking Questionnaire (GHSQ). Using data from the MATES trial in construction workplaces [1] a conservative ICC of 0.02 was assumed to estimate the design effect. A randomized clinical trial [2] exploring the potential effectiveness of an online program designed to increase help seeking intentions for social anxiety disorder informed the anticipated difference between pre and post-test GHSQ scores (standardized mean difference = 0.2). Because the size of the workplace clusters could not be anticipated ahead of time, a conservative average cluster size of between 25-35 was assumed. We assumed 15% attrition in participant numbers from pre- to post-intervention, a conservative assumption based on previous workplace trials [3] and accounting for the single-session nature of the intervention. To detect the effect of d=0.2 between intervention and comparison arms with 80% power using type I error level of 0.05 (two-tailed) required recruiting between 30-36 workplaces (assuming n=25 to n=35 per workplace), such that minimum N=900 employees.

1. LaMontagne, A.D., et al., Correction: Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing. BMC Psychiatry, 2023. 23(1): p. 98.

2. Griffiths, K.M., J. Walker, and P.J. Batterham, Help seeking for social anxiety: A pilot randomised controlled trial. DIGITAL HEALTH, 2017. 3: p. 2055207617712047.

3. Moll, S.E., et al., Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees. The Canadian Journal of Psychiatry, 2018. 63(12): p. 826-833.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
Date of last participant enrolment
Anticipated
4/03/2025
Actual
Date of last data collection
Anticipated
2/08/2025
Actual
Sample size
Target
900
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313169 0
Government body
Name [1] 313169 0
National Health and Medical Research Council
Country [1] 313169 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Batterham
Address
Centre for Mental Health Research
63 Eggleston Road
Acton
Canberra ACT
2600
Australia
Country
Australia
Secondary sponsor category [1] 314875 0
Individual
Name [1] 314875 0
Dr Amelia Gulliver
Address [1] 314875 0
Centre for Mental Health Research
63 Eggleston Road
Acton
Canberra ACT
2600
Australia
Country [1] 314875 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312411 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 312411 0
48A Linnaeus Way
Acton
Canberra ACT 2600
Australia
Ethics committee country [1] 312411 0
Australia
Date submitted for ethics approval [1] 312411 0
13/03/2023
Approval date [1] 312411 0
21/09/2023
Ethics approval number [1] 312411 0
2023/053

Summary
Brief summary
This cluster randomised controlled trial will test the effectiveness of a co-designed online educational help-seeking program against a psychoeducation alone (active control condition) program on improving help-seeking intentions in workplaces.
Trial website
https://magnetctn.com/about-us/our-signature-trials/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124562 0
Prof Philip Batterham
Address 124562 0
Centre for Mental Health Research
63 Eggleston Road
Acton
Canberra ACT
2600
Australia
Country 124562 0
Australia
Phone 124562 0
+61 2 6125 1031
Fax 124562 0
Email 124562 0
philip.batterham@anu.edu.au
Contact person for public queries
Name 124563 0
Dr Amelia Gulliver
Address 124563 0
Centre for Mental Health Research
63 Eggleston Road
Acton
Canberra ACT
2600
Australia
Country 124563 0
Australia
Phone 124563 0
+61261259472
Fax 124563 0
Email 124563 0
amelia.gulliver@anu.edu.au
Contact person for scientific queries
Name 124564 0
Dr Amelia Gulliver
Address 124564 0
Centre for Mental Health Research
63 Eggleston Road
Acton
Canberra ACT
2600
Australia
Country 124564 0
Australia
Phone 124564 0
+61261259472
Fax 124564 0
Email 124564 0
amelia.gulliver@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We do not intend to make the line by line data public. However, deidentified data will be shared upon reasonable request to the Principal Investigator.
When will data be available (start and end dates)?
Requests for data may be considered by the Principal Investigator after the publication of the main results. Data will be archived for future use with no end date specified.
Available to whom?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
Available for what types of analyses?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
How or where can data be obtained?
Access to data will be subject to approval by Principal Investigator (Prof Philip Batterham, contact email: philip.batterham@anu.edu.au)


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.