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Trial registered on ANZCTR


Registration number
ACTRN12616001169437
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
26/08/2016
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of the impact of the 'Man Up' documentary on men’s intentions to seek help
Scientific title
A randomised controlled trial of the impact of the 'Man Up' documentary on men’s intentions to seek help
Secondary ID [1] 290005 0
None
Universal Trial Number (UTN)
U1111-1186-1459
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 300018 0
Men's mental heallth 300019 0
Men's Health 300020 0
Well being 300021 0
Condition category
Condition code
Public Health 299912 299912 0 0
Health promotion/education
Mental Health 299913 299913 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 299914 299914 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: ‘Man up’ Documentary
Our project is based on the premise that the degrees to which men conform to traditionally held views of masculinity (such as stoicism, reliance on self, and avoidance of expression of emotion) can be changed, and that this will ultimately enhance their wellbeing. A three-part documentary has been developed in collaboration with our sub-contractor, Heiress Films, that will explore the impact of masculinity on mental health in Australia. It will be shown on free-to-air television in October 2016.
Prior to the the screening of the documentary this randomised controlled trial will be undertaken to evaluate the imapct of the documentary on male viewers. Adult male participants will attend a group meeting (maximum 20 participants) with the researchers participants, wherein they will individually complete baseline questionnaire measures on individual ipads (Time 1). These meetings will mostly take place at the researcher’s offices on campus in central Melbourne. Some meetings will also take place in outer suburban and regional Victorian locations. At the end of the meeting participants will then be randomly allocated to either view the documentary (intervention) or view an unrelated documentary (control) and emailed a web link to the documentary so that they can watch it at home. The documentary is in three parts of one hour each. Participants will use the link provided to access the documentary online and will view it at home, or other convenient place, either alone or with immediate family/household members. They will be asked to view the documentary within one week of their meeting with researchers. Immediately after viewing they will be asked a few questions about their impression of the documentary, also online (Time 2). Four weeks after viewing the documentary they will again be asked to complete an online questionnaire via email (Time 3). This questionnaire will repeat the baseline measures and will also ask for some qualitative feedback regarding the documentary. Participants will be asked to complete this questionnaire within two weeks of receiving it. Study conditions in the control arm of the study will be the same as those in the intervention arm, with the exception of the documentary that they view. Participants within arms will each experience the same study conditions.
Adherence to the trial method will be assessed in two ways. The dates that each participant completes each stage of the trial (Time 1, 2,3) will be automatically recorded at each stage, so that we can determine if participants completed these stages within the requested time frames. In order to determine whether participants viewed the documentary there will be a series of ‘test questions’ asked at the end of their viewing at Time 2.
Intervention code [1] 295714 0
Lifestyle
Intervention code [2] 295732 0
Prevention
Comparator / control treatment
Participants in the control arm will view an unrelated to the study documentary. All other conditions are the same as the intervention treatment. The control documentary is: Test Your Brain (2011). National Geographic.
Control group
Active

Outcomes
Primary outcome [1] 299396 0
A change in intentions to seek help as measured by an adapted version of the General Help Seeking Questionnaire (GHSQ) (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? eleven 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. Respondents rate the likelihood on a seven-point scale. We modified this scale by providing an additional three responses: online health chat rooms, online searches for health information, and social media. We also repeated the questionnaire twice asking the same question regarding recommending help for a male or female friend. The primary outcome is the questionnaire related to intentions to seek help for self.
Timepoint [1] 299396 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [1] 327067 0
A change in conformity to masculine norms as measured by the Conformity to Masculine Norms Inventory (CMNI-22)(Mahalik et al. (2003). Development of the Conformity to Masculine Norms Inventory. Psychology of Men & Masculinity, 4, 3-25).

The CMNI-22 is the 22 item version of the Conformity to masculine norms inventory. This is a self-report measure that assesses conformity to masculine norms across 11 norms including: winning, emotional control, risk-taking, violence, dominance, playboy, self-reliance, primacy of work, power over women, disdain for homosexuals, and pursuit of status.
Timepoint [1] 327067 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [2] 327068 0
A change in gender role conflict as measured by the Gender Role Conflict Scale Short Form (GRCS-SF). (Wester, SR., Vogel, DL., O’Neil, JM & Danforth, L. (2012). Development and evaluation of the Gender Role Conflict Scale Short From (GRCS-SF). Psychology of Men and Masculinity. 13(2): 199-210).

Gender role conflict is a condition in which rigid or overly restrictive male gender roles conflict with incompatible situational demands and lead to negative consequences for men and those around them. This 16 item scale is a brief version of the larger 37 item scale. The scale represents four factors: restricted emotionality; success, power and competition; restricted affectionate behavior between men; and conflicts between work and family relations.
Timepoint [2] 327068 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [3] 327069 0
A change in social support as measured by the MOS Social Support Survey (Sherbourne, CD, Stewart, AL. 1991. The MOS social support survey. Social Science & Medicine. 6, 705, 1991. ISSN: 0277-9536).

The MOS Social Support Survey is a 19 item scale that assesses four aspects of social support: tangible support, affectionate, positive social interaction and emotional or informational support
Timepoint [3] 327069 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [4] 327070 0
A change in psychological distress as measured by the Kessler-10 scale (K10) (Kessler RC, Andrews G, Colpe LJ e t al . Short screening scales to monitor population prevalences and trends in non-specifi c psychological distress. Psychol Med 2002; 32:959 – 976).

The K10 is a ten item scale that asks about symptoms of psychological distress in the past four weeks
Timepoint [4] 327070 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [5] 327071 0
A change in well-being as measured by the Personal Well Being Index – Adult (PWI-A) (International Wellbeing Group (2006). Personal Wellbeing Index. Melbourne: Australian Centre on Quality of Life, Deakin University).

The PWI-A contains seven items of satisfaction, each one corresponding to a quality of life domain as: standard of living, health, achieving in life, relationships, safety, community-connectedness, and future security
Timepoint [5] 327071 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [6] 327072 0
A change in resilience as measured by the Connor Davidson Resilience Scale (CD-RISC-10) (Kathryn M. Connor & Jonathan R.T., D. Development of a new resilience scale: The Connor-Davidson Resilience Scale (CD-RISC). Depression & Anxiety (1091-4269). 18, 2, 76, Sept. 2003. ISSN: 10914269).

The CD-RISC 10 is a briefer version of the full 25-item CD-RISC. The scale assesses one latent factor of resilience in individuals with items such as: ‘I am able to adapt when changes occur’ and ‘Under pressure, I stay focused and think clearly’
Timepoint [6] 327072 0
Baseline and at 4 weeks post viewing of the documentary
Secondary outcome [7] 327073 0
A change in suicidality as measured by the Adult Suicide Ideation Questionnaire (ASIQ) (Reynolds W.M. (1991). Psychometric characteristics of the Adult Suicidal Ideation Questionnaire in college students. Journal of Personality assessment, 56, 289-307)

The ASIQ is a 25 item scale that is designed to evaluate the presence and frequency of suicidal thoughts in an individual during the past month. It was chosen both for it’s potential to be used as an outcome measure and as a screener for the study. Participants who scored highly on this measure will be assessed by a study psychologist for their suitability for the study
Timepoint [7] 327073 0
Baseline and at 4 weeks post viewing of the documentary

Eligibility
Key inclusion criteria
Self-identifies as male who is aged 18 or more at time of meeting
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged 17 or less, self-identifies as female. If a participant scores highly on the Adult Suicide Ideation Questionnaire they will be assessed by a study psychologist. These individuals will be excluded from the study if they are assessed to be either actively suicidal or possibly further harmed by their involvement 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 randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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)
Efficacy
Statistical methods / analysis
The primary object of this study is to show a increase to seek help as measured by the General Help Seeking Questionnaire (GHSQ) in a sample of men aged 18 and over.

The primary endpoint is a mean difference between the intervention and control group at four weeks, after controlling for baseline scores on the same measure. Our sample size calculations assume a correlation of 0.45 between baseline and four week measurements, 90 percent power and alpha of 5 percent. We seek to detect a moderate difference between the groups (Cohen’s D = 0.3). This will give an initial sample size of 131 per group, but assuming a drop-out rate of 25% means were require a sample size of approximately 165 per group.

For the statistical methods: For our primary outcome, we will compare differences the groups on the GHSQ at four weeks. Our analysis will regress the change in GHSQ scores between baseline and follow-up on an indicator variable representing treatment or control group, and a variable representing baseline GHSQ scores. We will undertake a similar analysis on the following secondary outcomes: the Gender Role Conflict Scale – short form (GRCS – SF) Conformity to Masculine Norms Inventory (CMNI-22); the MOS Social Support Survey; the Kessler-10 scale (K10); the Personal Well Being Index – Adult (PWI-A) ;the Connor Davidson Resilience Scale (CD-RISC-10) ; the Adult Suicide Ideation Questionnaire (ASIQ).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14122 0
3053 - Carlton
Recruitment postcode(s) [2] 14124 0
3160 - Tecoma
Recruitment postcode(s) [3] 14125 0
3198 - Seaford
Recruitment postcode(s) [4] 14126 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 294376 0
Charities/Societies/Foundations
Name [1] 294376 0
The Movember Foundation
Address [1] 294376 0
PO Box 60, East Melbourne, Victoria, 8002, Australia
Country [1] 294376 0
Australia
Primary sponsor type
Individual
Name
Prof. Jane Pirkis
Address
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010, Australia
Country
Australia
Secondary sponsor category [1] 293220 0
None
Name [1] 293220 0
Address [1] 293220 0
Country [1] 293220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295800 0
The University of Melbourne, Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 295800 0
Office for Research Ethics and Integrity, Level 3, 780 Elizabeth Street, the University of Melbourne, Victoria, 3010, Australia.
Ethics committee country [1] 295800 0
Australia
Date submitted for ethics approval [1] 295800 0
29/10/2015
Approval date [1] 295800 0
03/12/2015
Ethics approval number [1] 295800 0
1545590.3

Summary
Brief summary
The randomised controlled trial aims to evaluate the impact of a three-part television documentary on men. The documentary was designed to improve men's wellbeing by reducing their conformity to traditional masculine norms (e.g., being stoic, ‘toughing it out’, coping alone) that have been shown to be associated with reduced likelihood of help seeking and poor mental health outcomes.

Before viewing the documentary adult male participants will complete a baseline regarding participants’ demographics, intentions to seek help, masculinity, gender role conflict, social support, resilience, psychological distress, suicidality and well-being . They will be then randomly allocated to either view the study documentary (intervention) or view an unrelated documentary (control) and emailed a web link to the documentary so that they can watch it at home. Immediately after viewing they will be asked a few questions about their impression of the documentary, also online (Time 2). Four weeks after viewing the documentary they will again be asked to complete an online questionnaire via email (Time 3). This final questionnaire will repeat the baseline measures and will also ask for some qualitative feedback regarding the documentary.

The study hypothesizes that participants who watch the documentary will show increases in their intentions to seek help, whilst also demonstrating reductions in negative attitudes related to masculinity, suicidal thoughts and psychological distress, and increases in their use of social support, resilience, and well-being when compared to participants who watch an alternative documentary.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1057 1057 0 0
/AnzctrAttachments/371366-HESC approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 68522 0
Prof Jane Pirkis
Address 68522 0
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010
Country 68522 0
Australia
Phone 68522 0
+61383440647
Fax 68522 0
+61393481174
Email 68522 0
j.pirkis@unimelb.edu.au
Contact person for public queries
Name 68523 0
Prof Jane Pirkis
Address 68523 0
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010
Country 68523 0
Australia
Phone 68523 0
+61383440647
Fax 68523 0
+61393481174
Email 68523 0
j.pirkis@unimelb.edu.au
Contact person for scientific queries
Name 68524 0
Prof Jane Pirkis
Address 68524 0
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010
Country 68524 0
Australia
Phone 68524 0
+61383440647
Fax 68524 0
+61393481174
Email 68524 0
j.pirkis@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary