Transgender In Transition (TRANSIT)

Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment

Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.

Study Overview

• Status: Recruiting
• Conditions: Gender Incongruence
• Intervention / Treatment: Diagnostic test: Online surveys

Detailed Description

Gender-affirming hormone treatment impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. This project aims to investigate the consequences and health-related outcomes of various hormone therapies in the treatment of gender dysphoric patients. The main scientific interest lies in the research of the effects of sex hormones on psychological, metabolic and behavioural parameters. For this purpose, various investigations are aimed at, including a clinical-diagnostic interview (external rating) and psychometric measurements in self-rating, behavioral experiments (e.g. in a virtual reality Elevated Plus Maze and the computer-based Ultimatum Game) and genetic investigation of the body's own materials (blood samples, stool samples, hair samples and saliva samples). The results of this study should form the basis to better understand consequences of the long-term administration of sex hormones.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

• Study Contact: Name: Johannes Fuß, MD; Phone Number: +49 (0)40 7410-54232; Email: jo.fuss@uke.de
• Study Contact Backup: Name: Johanna Schröder, PhD; Phone Number: +49 (0)40 7410-57763; Email: jo.schroeder@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
  • Munich, Germany
    • Not yet recruiting
    • Medical Center of the Ludwig-Maximilians-University of Munich
    • Contact: Matthias Auer, Dr.; Email: Matthias.Auer@med.uni-muenchen.de
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Not yet recruiting
      • Universitatsklinikum Frankfurt
      • Contact: Gesine Meyer, Dr.; Email: gesine.meyer@kgu.de
• Switzerland
  • Basel, Switzerland, 4031
    • Not yet recruiting
    • Universitatsspital Basel
    • Contact: Garcia Nunez, Dr.; Email: David.Garcia@usb.ch
  • Zürich, Switzerland, 8091
    • Not yet recruiting
    • Universitätsspital Zürich
    • Contact: Lena Jellestadt, Dr.; Email: Lena.Jellestad@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with gender incongruence undergoing gender-affirming hormone treatment

Description

Inclusion Criteria:

• diagnosis of gender incongruence (ICD-11) or gender dysphoria (DSM-5)
• written informed consent following adequate oral and written Information
• before gender-affirming hormonal treatment

Exclusion Criteria:

• pregnancy or breast-feeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transgender patients; Gender dysphoric patients undergoing hormone treatment	Diagnostic test: Online surveys; Psychometric measures within 14 online surveys, which is one at each assessment point (before and 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 months after hormonal therapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)	The Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)	The Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014) measures the consumption of alcohol in the past 12 months via a self-rating of 3 items. For the planned study, further equivalent versions for the consumption of nicotine and cannabis were adapted with 9 items covering consumption behaviour.	10 years
Transgender Congruence Scale (TCS; Kozee et al., 2012)	The Transgender Congruence Scale (TCS; Kozee et al., 2012) measures gender congruence via self-rating through twelve items and two subscales (congruence with appearance & acceptance of gender identity) within the past two weeks.	10 years
Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)	The Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018) measures gender congruence and life satisfaction via self-rating through 38 items and seven subscales (genitals, breast, other secondary sexual characteristics, recognition of gender role, physical and emotional intimacy, physiological function and life satisfaction) with a time frame of six months.	10 years
Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)	The Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983) measures psychiatric symptoms via self-rating with a total of 53 items in the areas of somatisation, compulsivity, insecurity in social contact, depression, anxiety, aggression, phobic fear, paranoid thinking and psychoticism. The inventory refers to a description of the symptoms within the past week.	10 years
Short Form 36 (SF-36; Jenkinson et al., 1993)	The Short Form 36 (SF-36; Jenkinson et al., 1993) measures the health-related quality of life in the past month via self-rating with a total of 36 items, whereby it refers to the following areas: Vitality, physical functioning, physical pain, general health perception, physical role function, emotional role function, social functioning and psychological well-being.	10 years
Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004)	The Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004) measures the severity of depression symptoms via self-rating. The PHQ-9 is one of the most widely used depression questionnaires worldwide and enables the estimation of realistic basic rates of diagnosis of major depression.	10 years
Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979)	The Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979) measures the degree of suicidal tendencies within the past week by self-rating with 21 items.	10 years
Questionnaire for the Evaluation of Psychotherapy Processes / Fragebogen zur Evaluation von Psychotherapieverläufen (FEP-2; Lutz et al., 2009)	The questionnaire for the evaluation of psychotherapy processes (FEP-2; Lutz et al., 2009) is a self-rating instrument comprising 40 items and is used for quality assurance in psychiatric/psychotherapeutic treatments. This questionnaire covers the areas of well-being, symptom burden, interpersonal problems and incongruity within the past week.	10 years
Barratt Impulsivity Scale / Barratt Impulsivitäts Skala (BIS-15; Meule et al., 2011)	The short form of the Barratt Impulsivity Scale (BIS-15; Meule et al., 2011) measures various forms of impulsivity (motor, planning, attention) via self-rating based on 15 items.	10 years
Questionnaire for Empathy and Changing Perspectives / Fragebogen für Empathie und Perspektivenübernahme (EP; Paulus, 2009)	The Questionnaire for Empathy and Changing Perspectives (EP; Paulus, 2009) uses self-rating with a total of 18 items to determine the ability to empathize and to change perspectives in the areas of empathy, social sensitivity and prosocial behaviour.	10 years
Autism-Spektrum-Quotient (AQ-10; Sappok et al., 2015)	The short version of the autism spectrum quotient (AQ-10; Sappok et al., 2015) is a screening instrument for recording autistic traits via self-rating that comprises 10 items.	10 years
Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001)	The Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001) measures self-esteem via self-rating with 10 items.	10 years
Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017)	The Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017) measures the tendency towards self-stigmatization in psychiatric populations via self-rating with 9 items.	10 years
Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993)	The Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993) is a self-rating instrument for recording various psychological dimensions of sexuality. For economic reasons, a selection of three subscales (sexual anxiety, depression and satisfaction) will be specified in the current project. This selection comprises a total of 14 items.	10 years
Sexual Desire Inventory (SDI; Spector et al., 1996)	The Sexual Desire Inventory (SDI; Spector et al., 1996) measures sexual desire in the past month via self-rating with 13 items. There are two different subscales for desire with and desire without social interaction (solitary and dyadic sexual desire).	10 years
Side Effects of Hormonetherapy Inventory / Fragebogen zu Nebenwirkungen der Hormontherapie	This specially for the current study developed questionnaire on side effects of hormone therapy uses self-rating to record various psychological and physiological symptoms that were observed during transition treatments with gender, sexual desire and sexual desire in 23 items.	10 years
Borderline Symptom List (BSL-23; Bohus et al., 2009)	The Borderline Symptom List (BSL-23; Bohus et al., 2009) measures symptoms that typically occur in the context of borderline personality disorder via self-rating with 34 items. The time frame refers to the previous week.	10 years
Core Autogynephilia Scale (CAS; Blanchard, 1989)	The Core Autogynephilia Scale (CAS; Blanchard, 1989) meassures autogynephile tendencies via self-rating with 9 items. For the planned study, an equivalent version (Core Autoandrophilia Scale) was adapted to be able to measure autoandrophilic tendencies equally.	10 years
OPD Structure Questionnaire Short Version / OPD Strukturfragebogen Kurzversion (OPD-SFK; Ehrenthal et al., 2015)	The OPD Structure Questionnaire Short Version (OPD-SFK; Ehrenthal et al., 2015) uses self-rating with a total of 12 items in order to measure structural abilities in the dimensions of self-perception, contact design and relationship model.	10 years
Personality Inventory for DSM-5 Brief Form / Persönlichkeitsinventar für DSM-5 (PID-5-BF; Anderson et al., 2016)	The personality inventory for DSM-5 Brief Form (PID-5 BF; Anderson et al., 2016) measures pathological personality traits via self-rating with a total of 25 items, which are described by the following subscales: Negative affectivity, closure, antagonism, disinhibition and psychoticism.	10 years
Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003)	The Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003) is a self-evaluation tool suitable for retrospectively recording abuse and neglect in childhood and adolescence. The CTQ measures more than traumatic events in the narrower sense (according to DSM-IV and ICD-10). The CTQ scales include abuse (with three subscales: emotional, physical, sexual) and neglect (with two subscales: emotional and physical). The subscales consist of five items each. In addition, a further scale (three items) is provided to measure tendencies to trivialize or deny child abuse experiences. The items are rated on a 5-level scale (1-5 from 'not at all' to 'very often').	10 years
ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003)	The ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003) measures the perception of social support via self-rating with 5 items.	10 years
Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)	The Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011) measures the extent of brooding thoughts via self-rating with 15 items.	10 years
2 Subscales of the Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007): thrill- and adventure seeking & experience-seeking	The Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007) measures individual differences in sensation seeking via self-rating on the basis of various dimensions, which are: Thrill and Adventure Seeking (TAS), Disinhibition (Dis), Experience Seeking (ES), and Boredom Susceptibility (BS). Each subscale contains 10 items. For economic reasons, only two subscales (TAS & ES) are used in the current project.	10 years
Acrophobia Questionnaire (AQ; Cohen, 1977)	The Acrophobia Questionnaire (AQ; Cohen, 1977) is a self-rating questionnaire measuring acrophobia (fear of heights). The AQ describes 20 situations (e.g. standing next to an open window in an upper floor), which are often regarded by acrophobic patients as anxiety provoking and asks the extent of the anxiety (0-6) and avoidance behaviour (0-3). A total of 0-180 points can be achieved.	10 years
Trust and Reciprocity Questionnaire (TR; Cox, 2004)	The Trust and Reciprocity Questionnaire (TR; Cox, 2004) measures trust and reciprocity via self-rating with 9 items.	10 years
Client Satisfaction Questionnaire (CTQ-8) / Fragebogen zur Patientenzufriedenheit (ZUF-8; Schmidt et al., 2002)	The Client Satisfaction Questionnaire CSQ-8 (ZUF-8; Schmidt et al., 2002) is a validated self-rating questionnaire on satisfaction with treatment in psychiatric clinics. This questionnaire has been adapted for the current study so that patient satisfaction with hormone treatment is measured.	10 years

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Johannes Fuß, MD, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): May 15, 2024
• Study Completion (Anticipated): May 15, 2034

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: TRANSIT

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