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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02119377
Other study ID # CB:gc:6722
Secondary ID
Status Completed
Phase N/A
First received April 16, 2014
Last updated May 5, 2014
Start date August 2013
Est. completion date December 2013

Study information

Verified date May 2014
Source Curtin University of Technology
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 946
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Live in Australia

- Self-identify as trans

Exclusion Criteria:

- Aged less than 18 years

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
questionnaire


Locations

Country Name City State
Australia Curtin University Perth Western Australia

Sponsors (2)

Lead Sponsor Collaborator
Curtin University of Technology Beyondblue (The National Depression Initiative)

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of depressive and anxiety disorders Assessed by self-report, and with the Patient Health Questionnaire (PHQ) At time of entry into study (cross-sectional) No
Primary Perceived physical and mental health status Assessed with the 36-item Short Form Health Survey (SF-36) At time of entry into study (cross-sectional) No
Secondary Use of alcohol, tobacco, and illicit drugs Assessed by self-report At time of entry into study (cross-sectional) No
Secondary 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 At time of entry into study (cross-sectional) No
Secondary Body image Assessed with the Body Image Quality of Life Inventory (BIQLI) At time of entry into study (cross-sectional) No
Secondary Factors that encourage and discourage trans people from accessing health care Assessed with qualitative questions At time of entry into study (cross-sectional) No
Secondary Factors that protect and promote mental health in trans people Assessed with qualitative questions At time of entry into study (cross-sectional) No
Secondary Use of hormone therapy and desire for, and uptake of transition-related surgery Assessed with quantitative and qualitative questions At time of entry into study (cross-sectional) No
Secondary Experiences of discrimination and harassment Assessed with quantitative and qualitative questions At time of entry into study (cross-sectional) No
Secondary Desire to, and success changing identifying documentation Assessed with quantitative and qualitative questions At time of entry into study (cross-sectional) No
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