Chinese gender incongruence population mental health research

ISRCTN	ISRCTN18336816
DOI	https://doi.org/10.1186/ISRCTN18336816
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Shanghai Mental Health Center
Funder	Shanghai Mental Health Center

Submission date: 11/04/2024
Registration date: 06/05/2024
Last edited: 28/08/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Gender incongruence refers to an individual's experienced gender not conforming with their assigned sex at birth, which could both affect appearance and personal feelings and may cause social problems and mental health crises. China may have the largest population of gender incongruence, which requires medical care and societal understanding. However, the cause of gender incongruence is still unknown. This study aims to search for possible social and psychological characteristics and biological markers to support the healthcare of people with gender incongruence.

Who can participate?
Individuals aged 18 to 45 years who come to Shanghai Mental Health Center and meet the ICD-11 diagnostic criteria for gender incongruence

What does the study involve?
Participants complete mental health and gender incongruence screening scales and questionnaires. They also undergo an MRI scan and provide a blood sample for genetic sequencing and hormone tests.

What are the possible benefits and risks of participating?
Participants are recommended to clinical qualified consultants and HRT doctors for further healthcare. The possible risks include the required blood sample.

Where is the study run from?
Shanghai Mental Health Center (China)

When is the study starting and how long is it expected to run for?
January 2021 to December 2030

Who is funding the study?
Shanghai Mental Health Center (China)

Who is the main contact?
Liu Na, liunamsx@126.com

Contact information

Dr Liu Na
Principal investigator

Shanghai Mental Health Center
Affiliated Shanghai Jiaotong University School Of Medicine
600 Wanping South Road
Shanghai
200030
China

Phone	+86 (0)137 7426 2925
Email	liunamsx@126.com

Prof Lu Zheng
Scientific

Tongji Hospital of Tongji University
389 Xincun Road
Shanghai
200065
China

Phone	+86 (0)136 7190 2719
Email	Luzheng@tongji.edu.cn

Dr Bai JingYi
Public

Tongji Hospital of Tongji University
389 Xincun Road
Shanghai
200065
China

Phone	+86 (0)13500017019
Email	2211512@tongji.edu.cn

Study information

Primary study design	Observational
Study design	Observational cross-sectional study
Secondary study design	Cause/relative factors study
Study type	Participant information sheet
Scientific title	Social psychological characteristics and related biological studies of gender incongruence populations
Study objectives	1. Based on the Gender Incongruence population in the outpatient clinic of Shanghai Mental Health Center, investigate the basic situation and psychosomatic health level of the gender incongruence population, and explore the psychological characteristics and related influencing factors of the gender incongruence population. 2. Develop a screening questionnaire for gender incongruence populations and form a localized screening tool. 3. Preliminarily explore the biological characteristics of genetics and imaging in gender incongruence populations, so as to provide a theoretical basis for the diagnosis of gender incongruence.
Ethics approval(s)	Approved 28/02/2022, Shanghai Mental Health Center Ethics Committee (SMHC-IRB） (Shanghai Mental Health Center, Shanghai, 200030, China; +86 (0)34773308; wuyanru_qiushui@aliyun.com), ref: 2021-76
Health condition(s) or problem(s) studied	Social psychological characteristics and related biological markers of gender incongruence populations
Intervention	Based on the gender incongruence population in the outpatient clinic of Shanghai Mental Health Center, this study will investigate the basic situation and psychosomatic health level of the gender incongruence population, and explore the psychological characteristics and related influencing factors of the gender incongruence population. Participants complete mental health and gender incongruence screening scales and questionnaires. They also undergo an MRI scan and provide a blood sample for genetic sequencing and hormone tests.
Intervention type	Other
Primary outcome measure(s)	1. Psychological characteristics measured using the Minnesota Multiphasic Personality Inventory (MMPI), the self-report symptom inventory, Symptom Checklist (SCL-90), the Self-rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Life Events Scale (LES) and Yale-Brown Obsessive-Compulsive Scale at baseline 2. Biological characteristics measured using MRI, whole exome sequencing and hormone test at baseline
Key secondary outcome measure(s)	1. Degree of gender incongruence measured using the Gender Incongruence Screening scale at baseline 2. The basic information of the gender incongruence population measured using a self-made questionnaire at baseline
Completion date	31/12/2030

Eligibility

Participant type(s)	Patient, Population
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	All
Target sample size at registration	10000
Key inclusion criteria	Meets ICD-11 diagnostic criteria for gender incongruence
Key exclusion criteria	Mental retardation and/or inable to complete the questionnaires and scale assessments
Date of first enrolment	03/06/2022
Date of final enrolment	31/12/2030

Locations

Countries of recruitment

China

Study participating centres

Shanghai Mental Health Center

Affiliated Shanghai Jiaotong University School Of Medicine
600 Wanping South Road
Shanghai
200030
China

Tongji Hospital of Tongji University

389 Xincun Road
Shanghai
200065
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	This study chooses not to provide raw data because it involves GI populations' personal privacy. It may be provided in a statistical format and images. Please contact Liu Na (liunamsx@126.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		22/08/2025	28/08/2025	Yes	No
Other files			11/04/2024	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

45303_InformedConsent.pdf: Other files

Editorial Notes

28/08/2025: Publication reference added.
11/04/2024: Study's existence confirmed by Shanghai Mental Health Center Ethics Committee.