Transition in Transgender

Transition in Transgender: Physiological Changes in Brain and Behavior

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Ute Habel, Prof. Dr.; Phone Number: + 492418080368; Email: uhabel@ukaachen.de
• Study Contact Backup: Name: Birgit Derntl, Prof. Dr.; Phone Number: + 49 7071 29 85437; Email: Birgit.Derntl@med.uni-tuebingen.de

Study Locations

• Germany
  • Aachen, Germany, 52062
    • Recruiting
    • Uniklinik RWTH Aachen
    • Contact: Ute Habel, Prof. Dr.; Phone Number: +49 241 80 80368; Email: uhabel@ukaachen.de
  • Tübingen, Germany, 72076
    • Not yet recruiting
    • Universitatsklinikum Tubingen
    • Contact: Birgit Derntl, Prof. Dr.; Phone Number: + 49 7071 29 85437; Email: Birgit.Derntl@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient; Transgender people who seek hormone treatment
Control participants; volunteers without gender dysphoria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in anatomical MRI	measurment of anatomical differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment	7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)
changes in Resting-state MRI measurements	measurment of resting-state activation differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment	10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in Functional MRI measurements	measurment of activation differences during a voice and a face gender-recognition task between the groups and changes in the TG group throughout the gender-affirming hormone treatment	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment : WHOQoL-BREF	items regarding different aspects of daily life, 5-point likert scale, changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment: Gender Congruence and Life Satisfaction Scale	items regarding influence of gender congruence on different aspects of daily life, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Brief Symptom Inventory	occurence of different symptoms during the last week, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire	5-point likert scale	1 hour; assessed before gender affirming hormone therapy starts
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: ENRICHD Social Support Inventory	5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Positive and negative affect scale	5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Patient Health Questionnaire-9	items regarding depressive symptoms, 4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding personality throughout gender-affirming hormone treatment: Personality Inventory for DSM-5 Brief Form	4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Rosenberg Self-Esteem Scale	4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stait-Trait-Angst Inventar	4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over timechanges are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stress- and Coping Inventar	7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Strukturiertes Klinisches Interview für DSM 5	interview conducted by investigator with questions regarding symptoms of different psychiatric disorders; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding sexuality throughout gender-affirming hormone treatment: Multidimensional Sexuality Questionnaires	items regarding sexual relationships, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding gender congruence throughout gender-affirming hormone treatment:Transgender Congruence Scale	5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Assessment of Gender-Related Attributes	items regarding typicale male and female personality traits, cognition and interests, 7-point likert scale	1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Bem Sex Role Inventory	7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding percpetion of and satisfaction with own body throughout gender-affirming hormone treatment : Fragebogen zur Beurteilung des eigenen Körpers	each item has to be rated as false or true, resulting in scores for the dimensions self-esteem, insecurities and external appearance; changes are measured for TG, CG are used as a control for potential natural changes over time	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in Hormone/protein analyses throughout gender-affirming hormone treatment	(free) testosterone, estradiol, progesterone, BDNF; changes are measured for TG, CG are used as a control for potential natural changes over time	5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: University Hospital Tuebingen
• Investigators: Study Director: Ute Habel, Prof. Dr., Uniklinkum Aachen; Study Director: Birgit Derntl, Prof. Dr., Uniklinikum Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Transgender; female to male; male to female; Hormone treatment; Gender reassignment
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 19-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No