Transition in Transgender

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-27

Study Completion Date

2023-08-01

Brief Summary

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The aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in FTM (female to male) and MTF (male to female) transgender (TG) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. Methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.

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Detailed Description

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Transgender (TG) is still a polarizing issue today. The lack of acceptance in society and often even in one's own family, the feeling of a lack of identity and connection with one's own body and the experienced discrimination all lead to a considerable degree of suffering in TG and elevated levels of psychiatric symptoms as well as a reduced quality of life. Many TG people seek hormonal treatment. Physical and psychological consequences of this treatment still need to be revealed.

To this aim, the investigators recruit TG people (MTF and FTM) who intend to seek gender-affirming hormonal treatment. Before treatment, various measures will be taken, including a semi-structured interview to assess psychiatric symptoms, self-ratings, behavioral experiments (to assess male/female face recognition and male/female voice perception), while functional MRI scans are taken to assess respective neural correlates. In addition, resting-state scans as well as anatomic images will be taken.

Six months after having started gender-affirming hormone treatment, participants will be reinvited to undergo the same study protocol.

In between testing sessions, patients will perform several online surveys regarding their psychological well-being.

Conditions

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Gender Dysphoria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient

Transgender people who seek hormone treatment

No interventions assigned to this group

Control participants

volunteers without gender dysphoria

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. a diagnosed gender dysphoria (DSM 5) or gender incongruence (ICD-11)
2. the pursuit of hormone therapy
3. native German speakers
4. age: 18-55
5. written informed consent following oral and written information
6. persons who are legally competent and mentally able to follow the instructions of the staff

Exclusion Criteria

1. drug abuse/addiction
2. first-degree relatives with psychotic disorders
3. pregnant or breastfeeding
4. traumatic brain injuries
5. neurological diseases
6. known internal, e.g. metabolic, endocrine or cardiac disorders
7. magnetic metal implants
8. hearing disorders, voice disorders and pronounced hoarseness
9. shift workers or irregular day-night rhythm
10. persons placed in an institution by order of the authorities or courts
11. persons who are in a dependent or employment relationship with the auditor
12. simultaneous participation in a clinical trial
13. hormone treatment already started

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes