TranssexualismNCT02119377
First Australian National Trans Mental Health Study
An observational study of Transsexualism, run by Curtin University at 1 site in Australia.
Trial summary
This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years and older living in Australia. This population has received limited attention from public health researchers, planners, and practitioners. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transsexualism
- What is being tested?
- questionnaire
- How many people
- 946 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a study of trans people living in Australia aged 18 years or older. The investigators used the term trans in an inclusive way, and included people who use (or used) words like transsexual, transgender, sistergirl, brotherboy, androgynous, or genderqueer to describe themselves. All trans people, including those who just describe themselves as men or women were encouraged to participate.
Who may be able to join
- Live in Australia
- Self-identify as trans
Who cannot join
- Aged less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-Methods Study of Mental Health and Associated Factors in Transgender and Transsexual (Trans) People
This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years and older living in Australia. This population has received limited attention from public health researchers, planners, and practitioners. However, a growing body of evidence suggests that trans people experience disparities in several important areas of health compared with the population generally. In particular, trans people are more likely to experience mental health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit drugs, and think about or attempt suicide. Additionally, trans people commonly report that their physical and mental health needs are not met, and underutilise preventive health care.
Participants were recruited using several non-probability sampling techniques, (including purposive sampling and snowball sampling), because random sampling is not possible with this population. Medical, social, support, and advocacy networks used by trans people were used to promote the study. A mixed quantitative and qualitative methodology was used. Validated quantitative instruments were used to obtain measures of health and well-being, which will be compared against population norms. Qualitative items complement these measures, providing rich experiential data.
Read more
The investigators hypothesised that:
- the prevalence of depressive and anxiety disorders will be higher than for the population generally, and that these conditions will commonly be undiagnosed and untreated;
- depressive and anxiety disorders will be associated with risky behaviours, such as tobacco, alcohol, and illicit drug use; and,
- trans people will report poor relationships with medical practitioners.
The investigators hypothesised that poor mental health is a consequence of several interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing medical treatment to alter sexual characteristics); societal discrimination and stigma (including harassment and violence); institutionalised discrimination (including difficulty changing identifying documents, and exclusion of surgical procedures and related treatments from public and private health systems); social isolation; and the belief held by many clinicians that transsexualism is a mental disorder (which may be a barrier to trans people forming trusting relationships with medical practitioners).
- Conditions
- Transsexualism
- Being tested
- questionnaire
- Keywords
- trans, transsexual, transgender, sistergirl, brotherboy, androgynous, genderqueer
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Transgender and Transsexual People | Transgender and transsexual (trans) people aged 18 years or older living in Australia were invited to complete a questionnaire assessing a range of mental and physical health domains. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depressive and anxiety disorders
Assessed by self-report, and with the Patient Health Questionnaire (PHQ)
Measured: At time of entry into study (cross-sectional)
Perceived physical and mental health status
Assessed with the 36-item Short Form Health Survey (SF-36)
Measured: At time of entry into study (cross-sectional)
Secondary outcomes (8)
Use of alcohol, tobacco, and illicit drugs
Assessed by self-report
Measured: At time of entry into study (cross-sectional)
Patient-doctor relationship between trans people and their general practitioners, and doctors generally
Assessed with the Patient-Doctor Relationship Questionnaire (PDRQ-9) and other quantitative and qualitative questions
Measured: At time of entry into study (cross-sectional)
Body image
Assessed with the Body Image Quality of Life Inventory (BIQLI)
Measured: At time of entry into study (cross-sectional)
Factors that encourage and discourage trans people from accessing health care
Assessed with qualitative questions
Measured: At time of entry into study (cross-sectional)
Factors that protect and promote mental health in trans people
Assessed with qualitative questions
Measured: At time of entry into study (cross-sectional)
Use of hormone therapy and desire for, and uptake of transition-related surgery
Assessed with quantitative and qualitative questions
Measured: At time of entry into study (cross-sectional)
Experiences of discrimination and harassment
Assessed with quantitative and qualitative questions
Measured: At time of entry into study (cross-sectional)
Desire to, and success changing identifying documentation
Assessed with quantitative and qualitative questions
Measured: At time of entry into study (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TranssexualismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Beyondblue (The National Depression Initiative)
- Responsible party
- Principal investigator, Zoë Hyde, Curtin University
- Investigators
- Zoë Hyde, MPH PhD, Principal investigator, Curtin UniversityMaryanne Doherty, MSc PhD, Principal investigator, Curtin UniversityPeter Tilley, MPsych, Principal investigator, Curtin UniversityKieran A. McCaul, MPH PhD, Principal investigator, The University of Western AustraliaRosanna Rooney, MPsych PhD, Principal investigator, Curtin UniversityJonine Jancey, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119377
- Sponsor's protocol ID
- CB:gc:6722
- Status last verified
- May 2014
- First submitted
- 16 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Study of Mental Health and Associated Factors in Transgender and Transsexual (Trans) People
- ClinicalTrials.gov ID
- NCT02119377
- Acronym / sponsor ID
- CB:gc:6722
- Conditions
- Transsexualism
- Keywords
- trans, transsexual, transgender, sistergirl, brotherboy, androgynous, genderqueer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Beyondblue (The National Depression Initiative)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years and older living in Australia. This population has received limited attention from public health researchers, planners, and practitioners. However, a growing body of evidence suggests that trans people experience disparities in several important areas of health compared with the population generally. In particular, trans people are more likely to experience mental health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit drugs, and think about or attempt suicide. Additionally, trans people commonly report that their physical and mental health needs are not met, and underutilise preventive health care.
Participants were recruited using several non-probability sampling techniques, (including purposive sampling and snowball sampling), because random sampling is not possible with this population. Medical, social, support, and advocacy networks used by trans people were used to promote the study. A mixed quantitative and qualitative methodology was used. Validated quantitative instruments were used to obtain measures of health and well-being, which will be compared against population norms. Qualitative items complement these measures, providing rich experiential data.
The investigators hypothesised that:
- the prevalence of depressive and anxiety disorders will be higher than for the population generally, and that these conditions will commonly be undiagnosed and untreated;
- depressive and anxiety disorders will be associated with risky behaviours, such as tobacco, alcohol, and illicit drug use; and,
- trans people will report poor relationships with medical practitioners.
The investigators hypothesised that poor mental health is a consequence of several interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing medical treatment to alter sexual characteristics); societal discrimination and stigma (including harassment and violence); institutionalised discrimination (including difficulty changing identifying documents, and exclusion of surgical procedures and related treatments from public and private health systems); social isolation; and the belief held by many clinicians that transsexualism is a mental disorder (which may be a barrier to trans people forming trusting relationships with medical practitioners).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender and Transsexual People | – | Other: questionnaireTransgender and transsexual (trans) people aged 18 years or older living in Australia were invited to complete a questionnaire assessing a range of mental and physical health domains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a study of trans people living in Australia aged 18 years or older. The investigators used the term trans in an inclusive way, and included people who use (or used) words like transsexual, transgender, sistergirl, brotherboy, androgynous, or genderqueer to describe themselves. All trans people, including those who just describe themselves as men or women were encouraged to participate.
Key inclusion criteria (2 listed)
- Live in Australia
- Self-identify as trans
Key exclusion criteria (1 listed)
- Aged less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire | Other | Transgender and Transsexual People |
Primary outcome
Prevalence of depressive and anxiety disorders
Time frame: At time of entry into study (cross-sectional)
Assessed by self-report, and with the Patient Health Questionnaire (PHQ)
Perceived physical and mental health status
Time frame: At time of entry into study (cross-sectional)
Assessed with the 36-item Short Form Health Survey (SF-36)
8 secondary outcomes
Use of alcohol, tobacco, and illicit drugs
Time frame: At time of entry into study (cross-sectional)
Patient-doctor relationship between trans people and their general practitioners, and doctors generally
Time frame: At time of entry into study (cross-sectional)
Body image
Time frame: At time of entry into study (cross-sectional)
Factors that encourage and discourage trans people from accessing health care
Time frame: At time of entry into study (cross-sectional)
Factors that protect and promote mental health in trans people
Time frame: At time of entry into study (cross-sectional)
Use of hormone therapy and desire for, and uptake of transition-related surgery
Time frame: At time of entry into study (cross-sectional)
Experiences of discrimination and harassment
Time frame: At time of entry into study (cross-sectional)
Desire to, and success changing identifying documentation
Time frame: At time of entry into study (cross-sectional)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Study websiteLink provided by the sponsor.
Related trials for Transsexualism
Enrolling by invitation
Metoidioplasty and Phalloplasty Surgery Decision Making
Gender Dysphoria, Gender Dysphoria, Adult
RecruitingPhase 4
Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Transgenderism, Reproductive Issues
RecruitingObservational study
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Transsexualism, Transgenderism
Active, not recruitingObservational study
Cardiometabolic Health in Transgender Males
Transgender, Transgenderism
RecruitingObservational study
Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
Transgenderism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoë Hyde, MPH PhD principal investigator
Curtin University
Maryanne Doherty, MSc PhD principal investigator
Curtin University
Peter Tilley, MPsych principal investigator
Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transsexualism, run by Curtin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of depressive and anxiety disorders (time frame: At time of entry into study (cross-sectional)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.