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Transition in Transgender

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ClinicalTrials.gov Identifier: NCT04736797
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
RWTH Aachen University

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transition in Transgender: Physiological Changes in Brain and Behavior
Actual Study Start Date : November 27, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: LGBTQ+ Health

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


Outcome Measures
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Primary Outcome Measures :
  1. changes in anatomical MRI [ Time Frame: 7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls) ]
    measurment of anatomical differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment

  2. changes in Resting-state MRI measurements [ Time Frame: 10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    measurment of resting-state activation differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment

  3. changes in Functional MRI measurements [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  4. changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment : WHOQoL-BREF [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  5. changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment: Gender Congruence and Life Satisfaction Scale [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  6. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Brief Symptom Inventory [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  7. self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts ]
    5-point likert scale

  8. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: ENRICHD Social Support Inventory [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset ]
    5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  9. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Positive and negative affect scale [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  10. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Patient Health Questionnaire-9 [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset ]
    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

  11. changes in self-ratings regarding personality throughout gender-affirming hormone treatment: Personality Inventory for DSM-5 Brief Form [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  12. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Rosenberg Self-Esteem Scale [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  13. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stait-Trait-Angst Inventar [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  14. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stress- and Coping Inventar [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset ]
    7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  15. changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Strukturiertes Klinisches Interview für DSM 5 [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  16. changes in self-ratings regarding sexuality throughout gender-affirming hormone treatment: Multidimensional Sexuality Questionnaires [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  17. changes in self-ratings regarding gender congruence throughout gender-affirming hormone treatment:Transgender Congruence Scale [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  18. changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Assessment of Gender-Related Attributes [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset ]
    items regarding typicale male and female personality traits, cognition and interests, 7-point likert scale

  19. changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Bem Sex Role Inventory [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time

  20. changes in self-ratings regarding percpetion of and satisfaction with own body throughout gender-affirming hormone treatment : Fragebogen zur Beurteilung des eigenen Körpers [ Time Frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    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

  21. changes in Hormone/protein analyses throughout gender-affirming hormone treatment [ Time Frame: 5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset ]
    (free) testosterone, estradiol, progesterone, BDNF; changes are measured for TG, CG are used as a control for potential natural changes over time


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736797


Contacts
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Contact: Ute Habel, Prof. Dr. + 492418080368 uhabel@ukaachen.de
Contact: Birgit Derntl, Prof. Dr. + 49 7071 29 85437 Birgit.Derntl@med.uni-tuebingen.de

Locations
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Germany
Uniklinik RWTH Aachen Recruiting
Aachen, Germany, 52062
Contact: Ute Habel, Prof. Dr.    +49 241 80 80368    uhabel@ukaachen.de   
Universitätsklinikum Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Birgit Derntl, Prof. Dr.    + 49 7071 29 85437    Birgit.Derntl@med.uni-tuebingen.de   
Sponsors and Collaborators
RWTH Aachen University
University Hospital Tuebingen
Investigators
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Study Director: Ute Habel, Prof. Dr. Uniklinkum Aachen
Study Director: Birgit Derntl, Prof. Dr. Uniklinikum Tübingen
More Information
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04736797    
Other Study ID Numbers: 19-176
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
Transgender
female to male
male to female
Hormone treatment
Gender reassignment
Additional relevant MeSH terms:
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Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders