Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001008819
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
30/07/2021
Date last updated
27/01/2022
Date data sharing statement initially provided
30/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of the Effectiveness of a Media-based Intervention on Intentions to Seek Help for Mental Health Difficulties among Australian Men
Scientific title
A Randomised Controlled Trial of the Effectiveness of a Media-based Intervention on Intentions to Seek Help for Mental Health Difficulties among Australian Men
Secondary ID [1] 304425 0
MRF1199972
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 322259 0
Wellbeing 322260 0
Condition category
Condition code
Public Health 319943 319943 0 0
Health promotion/education
Mental Health 319944 319944 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 320379 320379 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a music video developed for this study of approximately four minutes' duration. The video takes a well-known song and adapts the lyrics with the intention to encourage men to seek support from others when they are experiencing mental health difficulties. The lyrics focus on how men are typically encouraged to remain stoic, to keep their difficulties to themselves, and to never cry, but encourages them to express their feelings and seek support when they are not coping well.

The video focuses on a group of diverse men who meet in a large community hall; it has the appearance of a support group. The video begins with a single man beginning to sing the lyrics to the adapted song; he is gradually joined by others until all men have stood and are taking part in this spontaneous 'choir'. The video ends with the call to action printed on the screen 'When the going gets tough. Get Talking' and a link to a website, which will house information for gaining various types of mental health support.

Participation in this RCT is open to all men living in Australia, given the trial will be conducted completely online. Potential participants will register their interest online and be sent a Plain Language Statement detailing the study. All participants will attend an online orientation session in which the researchers and a study psychologist will further discuss the trial protocol, and participants will sign an online consent form and complete the T1 questionnaire. They will then be randomised. A psychologist will contact any participant who scores 2 or above on the suicide risk screening questionnaire, the Depression Symptom Inventory - Suicidality Subscale. Participants will be excluded if they are at imminent suicide risk or likely to experience harm from continued participation. Participants will be referred for further mental health support as needed. All participants have access to the study psychologist up to four weeks following completion of the trial.

The men participating in the trial will access this intervention video or a control video online using a link sent from the online data collection system via email as soon as they are randomised (T1). Participants will be encouraged to watch the video multiple times over one week. They will receive the video link via email again on days 3 and 7. Participants will receive the Time 2 (T2) questionnaire one week post-baseline (T1). Participants will be sent a follow-up questionnaire (T3) four weeks after completing T2.

To assess participants' viewing behaviour related to the intervention and control videos, and thereby their adherence to the intervention, we will record at an individual level how many times the video was started, how many times it was watched beginning to end, when the video was paused, the number of times the participant tried to navigate away from the video page (e.g., by closing the tab or browser) and at what timepoints in the video the participant left the video page (e.g., 14 secs). At T2, participants will be asked if they have watched the video, if they indicate 'no', they will skip all questions related to the video. We will ask all participants who have watched the video one 'attention' question related to the content of the intervention or control video at T2. This is a question the participant can only answer by attentively watching the video.

Participants will be reimbursed for their time with up to AUD100 in vouchers for completion of all three questionnaires (T1 = AUD30, T2 = AUD30, T3=AUD40).
Intervention code [1] 320792 0
Prevention
Comparator / control treatment
The control video is a four-minute excerpt from an unrelated documentary previously aired on Australian television called, 'Redesign My Brain'. Like the intervention video, it is an Australian production, featuring only men. The video shows the central figure learning to play table tennis from two champions in order to increase his cognitive processing speed. It shows his training by the two champions in order to improve his game.
Control group
Active

Outcomes
Primary outcome [1] 327822 0
A change in intentions to seek help as measured by the General Help Seeking Questionnaire - Self (GHSQ-Self) (Wilson et al. 2005. Measuring help seeking intentions: Properties of the General Help Seeking Questionnaire. Canadian Journal of Counselling, Vol. 39(1), 15-28.).

This questionnaire asks: If you were having a personal or emotional problem, how likely is it that you would seek help from the following people or services? Ten responses are provided: intimate partner, friend, parent, other family member, mental health professional, phone helpline, doctor, minister or religious leader, I would not seek help from anyone, I would seek help from another not listed above. We modified this scale by providing an additional three responses: online health chat rooms, online searches for health information, and social media. Respondents rate the likelihood on a seven-point scale (1 = Extremely unlikely to 7 = Extremely likely); scores are summed and a higher total score indicates greater intentions to seek help.
Timepoint [1] 327822 0
Baseline (T1) to post-intervention (T2 = one week from baseline).
Secondary outcome [1] 396702 0
A change in intentions to encourage other males to seek help as measured by an adapted version of the General Help Seeking Questionnaire (GHSQ - Other male) (as outlined for the primary outcome).

The format is as appears for the primary outcome, with the variation that the question prompt asks: 'If a male friend or family member of yours was having a personal or emotional problem, how likely is it that you would recommend to that person to seek help from the following people?'
Timepoint [1] 396702 0
Baseline (T1) to post-intervention (T2 = one week from T1).
Secondary outcome [2] 396703 0
A change in scores on the Conformity to Masculine Norms Inventory-30 Self-Reliance (CMNI-30:SR) subscale (Levant, R. F., McDermott, R., Parent, M. C., Alshabani, N., Mahalik, J. R., & Hammer, J. H. (2020, February 3). Development and Evaluation of a New Short Form of the Conformity to Masculine Norms Inventory (CMNI-30). Journal of Counseling Psychology. Advance online publication. http://dx.doi.org/10.1037/cou0000414).

This is a self-report measure that assesses conformity to traditional masculine norms, across 11 norms, including self-reliance. We are using only the three-item self-reliance subscale, as is relates to willingness to ask for help when needed. Participants rate their agreement (Strongly disagree to Strongly agree) with three items, such as 'It bothers me when I have to ask for help'. Subscale scores are a sum of responses, with higher scores indicating higher conformity to masculine norms.
Timepoint [2] 396703 0
Baseline (T1) to post-intervention (T2 = one week from T1).
Secondary outcome [3] 396715 0
A change in intentions to seek help as measured by the General Help Seeking Questionnaire - Self (GHSQ-Self), as in the primary outcome, but measured at four-week follow-up (T3).
Timepoint [3] 396715 0
Baseline (T1) to four weeks post-intervention (T3 = four weeks from T2).
Secondary outcome [4] 396875 0
A change in intentions to encourage other males to seek help as measured by the General Help Seeking Questionnaire - Other male (GHSQ-Other male), as in secondary outcome [1], but measured at four-week follow-up (T3).
Timepoint [4] 396875 0
Baseline (T1) to four weeks post-intervention (T3 = four weeks from T2).
Secondary outcome [5] 396958 0
A change in scores on the Conformity to Masculine Norms Inventory-30 Self-Reliance (CMNI-30:SR) subscale, as in secondary outcome [2], at four-week follow-up (T3).
Timepoint [5] 396958 0
Baseline (T1) to four weeks post-intervention (T3 = four weeks from T2).
Secondary outcome [6] 397201 0
Change in scores on the Male Depression Risk Scale-7 (MDRS-7). (Herreen D, Rice SM, Zajac I. Brief assessment of male depression in clinical care: Validation of the Male Depression Risk Scale Short Form in a mixed cross-sectional cohort study of Australian men. Submitted to BMJ Open.) from baseline (T1) to four-week follow-up (T3).

The MDRS-7 is a 7-item scale measuring male-specific depression symptoms. It assesses symptoms in six domains: emotion suppression, drug use, alcohol use, anger and aggression, somatic symptoms, and risk-taking. Each item is rated for how much the symptoms has applied to the respondent over the last month from 0 = None of the time to 3 = All of the time.
Timepoint [6] 397201 0
Baseline (T1) to four weeks post-intervention (T3 = four weeks from T2).
Secondary outcome [7] 397202 0
Change in past four-week health service use as measured by the Health Service Use Questionnaire (HSUQ). The HSUQ is a modified version of the Resource Use Questionnaire (Le LK-D, Sanci L, Chatterton ML, Kauer S, Buhagiar K, Mihalopoulos C. The Cost-Effectiveness of an Internet Intervention to Facilitate Mental Health Help-Seeking by Young Adults: Randomized Controlled Trial. J Med Internet Res. 2019;21(7):e13065), developed for use in this study. It assesses participants' use of a range of health services for mental health difficulties over the past four weeks. Use of a range of services is measured, including primary health services such as consultations with a general practitioner or psychologist; psychotropic medications (e.g., sleeping tablets, antidepressants); inpatient admissions (e.g. hospital, community care unit); internet-based services (e.g., information pages, online support group); and phone counselling. The HSUQ also contains questions related to the effects of mental health difficulties on functioning at work/in education.
Timepoint [7] 397202 0
Baseline (T1) to four weeks post-intervention (T3 = four weeks from T2).

Eligibility
Key inclusion criteria
Identifies as male. Aged 18 years or over at the time of consenting to participate in the trial. Lives in Australia. Can read and understand English to a level sufficient to complete the trial participant tasks.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will complete the suicide risk screening questionnaire, the Depression Symptom Inventory -Suicidality Subscale, at T1 (Joiner, T. E., Pfaff, J. J., & Acres, J. G. (2002). A brief screening tool for suicidal symptoms in adolescents and young adults in general health settings: Reliability and validity data from the Australian National General Practice Youth Suicide Prevention Project. Behaviour Research and Therapy, 40(4), 471–481). Those participants who score 2 or above on the scale will be contacted by a study psychologist. Together, the participant and psychologist will determine whether the participant will continue in the study. The participant will be excluded if the psychologist determines the participant is at imminent risk of suicide or could be harmed by further participation in the study.

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)
Central randomization by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants receiving the intervention will not be made aware of the existence of both an intervention and control group until the end of their participation at T3. Therefore, they will not know whether they are watching the intervention or control video. However, because they are aware of which video they are watching (i.e., the content of the video), they are not completely blinded. Therefore, we have indicated they are not blinded, though they will be blinded to the degree that it is possible within this trial design.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We aim to recruit 446 Australian men aged 18 and over from the general population. This sample size is calculated to detect a 0.25 standardised difference in mean on the General Help-Seeking Questionnaire-Self score between the intervention and control group (90% power, 2-sided 5% significance level). This calculation is based on an assumed correlation between baseline and endpoint scores of 0.67. This sample size also allows for 20% loss to follow-up.

Analyses of continuous outcomes will be undertaken on an intent-to-treat basis, including all participants randomized, regardless of actual receipt of the intervention or withdrawal from the study. Mixed-model repeated measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data. Effectiveness of the intervention will be assessed by a test of the difference between groups in change from baseline to post-intervention. An unstructured residual variance-covariance matrix will accommodate within-participant dependency. Tests of significance will use degrees of freedom adjusted using the Kenward-Roger method based on the observed information matrix. Where necessary, transformation of the outcome variable will be undertaken to ensure distributional assumptions of the model are met.

If the intervention video is shown to have a significant positive effect on the primary outcome, we will conduct a secondary analysis assessing the cost-effectiveness of the intervention. To conduct the cost-effectiveness analysis, mental health services costs will be calculated by applying standard Australian unit costs (i.e, Independent Hospital Pricing Authority, Medicare Benefit Scheme fees) to the resource use units collected through the HSUQ.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2021
Actual
16/08/2021
Date of last participant enrolment
Anticipated
13/09/2021
Actual
2/10/2021
Date of last data collection
Anticipated
29/10/2021
Actual
18/11/2021
Sample size
Target
446
Accrual to date
Final
477
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308790 0
Government body
Name [1] 308790 0
Australian Government Department of Health - Medical Research Future Fund
Country [1] 308790 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 309725 0
None
Name [1] 309725 0
Address [1] 309725 0
Country [1] 309725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308702 0
University of Melbourne Human Research Ethics Committee STEMM 1
Ethics committee address [1] 308702 0
Ethics committee country [1] 308702 0
Australia
Date submitted for ethics approval [1] 308702 0
28/09/2020
Approval date [1] 308702 0
04/06/2021
Ethics approval number [1] 308702 0
2021-14638-18028-3

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

Contacts
Principal investigator
Name 111614 0
Prof Jane Pirkis
Address 111614 0
Centre for Mental Health - Level 4
207 Bouverie Street
University of Melbourne
Carlton, Victoria 3053
Country 111614 0
Australia
Phone 111614 0
+61 3 83440647
Fax 111614 0
Email 111614 0
[email protected]
Contact person for public queries
Name 111615 0
Angela Nicholas
Address 111615 0
Centre for Mental Health - Level 4
207 Bouverie Street
University of Melbourne
Carlton, Victoria 3053
Country 111615 0
Australia
Phone 111615 0
+61 3 90359663
Fax 111615 0
Email 111615 0
[email protected]
Contact person for scientific queries
Name 111616 0
Angela Nicholas
Address 111616 0
Centre for Mental Health - Level 4
207 Bouverie Street
University of Melbourne
Carlton, Victoria 3053
Country 111616 0
Australia
Phone 111616 0
+61 3 90359663
Fax 111616 0
Email 111616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual quantitative participant data collected during the trial.
When will data be available (start and end dates)?
Data will be available after publication of the main results. The end date has not yet been determined.
Available to whom?
Only researchers who can provide a methodologically sound proposal and who have ethics approval from a research institution. This will be determined on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For analyses conducted to achieve the aims in the approved research proposed for which the data is being requested.
How or where can data be obtained?
Access subject to approval by Principal Investigator, Professor Jane Pirkis, Phone: +61 3 83440647, Email: [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12114Study protocol  [email protected] By email to the trial coordinator, Dr Angela Nicho... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of a media-based intervention promoting help-seeking for mental health difficulties by Australian men: study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-022-06210-2
N.B. These documents automatically identified may not have been verified by the study sponsor.