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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02119377
Registration number
NCT02119377
Ethics application status
Date submitted
16/04/2014
Date registered
21/04/2014
Date last updated
6/05/2014
Titles & IDs
Public title
First Australian National Trans Mental Health Study
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Scientific title
A Mixed-Methods Study of Mental Health and Associated Factors in Transgender and Transsexual (Trans) People
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Secondary ID [1]
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CB:gc:6722
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transsexualism
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of depressive and anxiety disorders
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Assessment method [1]
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Assessed by self-report, and with the Patient Health Questionnaire (PHQ)
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Timepoint [1]
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At time of entry into study (cross-sectional)
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Primary outcome [2]
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Perceived physical and mental health status
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Assessment method [2]
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Assessed with the 36-item Short Form Health Survey (SF-36)
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Timepoint [2]
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At time of entry into study (cross-sectional)
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Secondary outcome [1]
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Use of alcohol, tobacco, and illicit drugs
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Assessment method [1]
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Assessed by self-report
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Timepoint [1]
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At time of entry into study (cross-sectional)
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Secondary outcome [2]
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Patient-doctor relationship between trans people and their general practitioners, and doctors generally
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Assessment method [2]
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Assessed with the Patient-Doctor Relationship Questionnaire (PDRQ-9) and other quantitative and qualitative questions
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Timepoint [2]
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At time of entry into study (cross-sectional)
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Secondary outcome [3]
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Body image
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Assessment method [3]
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Assessed with the Body Image Quality of Life Inventory (BIQLI)
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Timepoint [3]
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At time of entry into study (cross-sectional)
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Secondary outcome [4]
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Factors that encourage and discourage trans people from accessing health care
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Assessment method [4]
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Assessed with qualitative questions
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Timepoint [4]
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At time of entry into study (cross-sectional)
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Secondary outcome [5]
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Factors that protect and promote mental health in trans people
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Assessment method [5]
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Assessed with qualitative questions
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Timepoint [5]
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At time of entry into study (cross-sectional)
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Secondary outcome [6]
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Use of hormone therapy and desire for, and uptake of transition-related surgery
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Assessment method [6]
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Assessed with quantitative and qualitative questions
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Timepoint [6]
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At time of entry into study (cross-sectional)
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Secondary outcome [7]
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Experiences of discrimination and harassment
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Assessment method [7]
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Assessed with quantitative and qualitative questions
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Timepoint [7]
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At time of entry into study (cross-sectional)
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Secondary outcome [8]
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Desire to, and success changing identifying documentation
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Assessment method [8]
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Assessed with quantitative and qualitative questions
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Timepoint [8]
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At time of entry into study (cross-sectional)
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Eligibility
Key inclusion criteria
* Live in Australia
* Self-identify as trans
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Aged less than 18 years
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
946
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Curtin University - Perth
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Recruitment postcode(s) [1]
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6102 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Curtin University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Beyondblue (The National Depression Initiative)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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. 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).
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Trial website
https://clinicaltrials.gov/study/NCT02119377
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Zoë Hyde, MPH PhD
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Address
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Curtin University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02119377
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