Clinical trial NCT04736797: Transition in Transgender
Official title: Transition in Transgender: Physiological Changes in Brain and Behavior
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Keywords: Transgender
female to male
male to female
Hormone treatment
Gender reassignment
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2021-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in anatomical MRI
timeFrame: 7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)
measure: changes in Resting-state MRI measurements
timeFrame: 10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in Functional MRI measurements
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment : WHOQoL-BREF
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment: Gender Congruence and Life Satisfaction Scale
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Brief Symptom Inventory
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: ENRICHD Social Support Inventory
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Positive and negative affect scale
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Patient Health Questionnaire-9
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
measure: changes in self-ratings regarding personality throughout gender-affirming hormone treatment: Personality Inventory for DSM-5 Brief Form
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Rosenberg Self-Esteem Scale
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stait-Trait-Angst Inventar
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stress- and Coping Inventar
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
measure: changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Strukturiertes Klinisches Interview für DSM 5
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding sexuality throughout gender-affirming hormone treatment: Multidimensional Sexuality Questionnaires
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding gender congruence throughout gender-affirming hormone treatment:Transgender Congruence Scale
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Assessment of Gender-Related Attributes
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset
measure: changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Bem Sex Role Inventory
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in self-ratings regarding percpetion of and satisfaction with own body throughout gender-affirming hormone treatment : Fragebogen zur Beurteilung des eigenen Körpers
timeFrame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measure: changes in Hormone/protein analyses throughout gender-affirming hormone treatment
timeFrame: 5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Uniklinkum Aachen
name: Ute Habel, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Uniklinikum Tübingen
name: Birgit Derntl, Prof. Dr.
role: STUDY_DIRECTOR
References: