ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Scientific title

A Mixed-Methods Study of Mental Health and Associated Factors in Transgender and Transsexual (Trans) People

Secondary ID [1]

CB:gc:6722

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Transsexualism

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

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.

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Prevalence of depressive and anxiety disorders

Timepoint [1]

At time of entry into study (cross-sectional)

Primary outcome [2]

Perceived physical and mental health status

Timepoint [2]

At time of entry into study (cross-sectional)

Secondary outcome [1]

Use of alcohol, tobacco, and illicit drugs

Timepoint [1]

At time of entry into study (cross-sectional)

Secondary outcome [2]

Patient-doctor relationship between trans people and their general practitioners, and doctors generally

Timepoint [2]

At time of entry into study (cross-sectional)

Secondary outcome [3]

Body image

Timepoint [3]

At time of entry into study (cross-sectional)

Secondary outcome [4]

Factors that encourage and discourage trans people from accessing health care

Timepoint [4]

At time of entry into study (cross-sectional)

Secondary outcome [5]

Factors that protect and promote mental health in trans people

Timepoint [5]

At time of entry into study (cross-sectional)

Secondary outcome [6]

Use of hormone therapy and desire for, and uptake of transition-related surgery

Timepoint [6]

At time of entry into study (cross-sectional)

Secondary outcome [7]

Experiences of discrimination and harassment

Timepoint [7]

At time of entry into study (cross-sectional)

Secondary outcome [8]

Desire to, and success changing identifying documentation

Timepoint [8]

At time of entry into study (cross-sectional)

Eligibility

Key inclusion criteria

* Live in Australia
* Self-identify as trans

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* Aged less than 18 years

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/08/2013

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/12/2013

Sample size

Target

Accrual to date

Final

946

Recruitment in Australia

Recruitment state(s)

WA

Recruitment hospital [1]

Curtin University - Perth

Recruitment postcode(s) [1]

6102 - Perth

Funding & Sponsors

Primary sponsor type

Other

Name

Curtin University

Address

Country

Other collaborator category [1]

Other

Name [1]

Beyondblue (The National Depression Initiative)

Address [1]

Country [1]

Ethics approval

Ethics application status

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).

Trial website

https://clinicaltrials.gov/study/NCT02119377

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Zoë Hyde, MPH PhD

Address

Curtin University

Country

Phone

Fax

Email

Contact person for public queries

Name

Address

Country

Phone

Fax

Email

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