Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)
研究概览
简要总结
Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •pregnancy or breast-feeding
结局指标
主要结局
Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)
时间窗: 10 years
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.
次要结局
- Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001)(10 years)
- Transgender Congruence Scale (TCS; Kozee et al., 2012)(10 years)
- Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)(10 years)
- Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)(10 years)
- Borderline Symptom List (BSL-23; Bohus et al., 2009)(10 years)
- Personality Inventory for DSM-5 Brief Form / Persönlichkeitsinventar für DSM-5 (PID-5-BF; Anderson et al., 2016)(10 years)
- ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003)(10 years)
- Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979)(10 years)
- Questionnaire for the Evaluation of Psychotherapy Processes / Fragebogen zur Evaluation von Psychotherapieverläufen (FEP-2; Lutz et al., 2009)(10 years)
- Questionnaire for Empathy and Changing Perspectives / Fragebogen für Empathie und Perspektivenübernahme (EP; Paulus, 2009)(10 years)
- Autism-Spektrum-Quotient (AQ-10; Sappok et al., 2015)(10 years)
- Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003)(10 years)
- Client Satisfaction Questionnaire (CTQ-8) / Fragebogen zur Patientenzufriedenheit (ZUF-8; Schmidt et al., 2002)(10 years)
- Short Form 36 (SF-36; Jenkinson et al., 1993)(10 years)
- Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004)(10 years)
- Barratt Impulsivity Scale / Barratt Impulsivitäts Skala (BIS-15; Meule et al., 2011)(10 years)
- Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017)(10 years)
- Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993)(10 years)
- Core Autogynephilia Scale (CAS; Blanchard, 1989)(10 years)
- OPD Structure Questionnaire Short Version / OPD Strukturfragebogen Kurzversion (OPD-SFK; Ehrenthal et al., 2015)(10 years)
- Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)(10 years)
- Side Effects of Hormonetherapy Inventory / Fragebogen zu Nebenwirkungen der Hormontherapie(10 years)
- 2 Subscales of the Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007): thrill- and adventure seeking & experience-seeking(10 years)
- Trust and Reciprocity Questionnaire (TR; Cox, 2004)(10 years)
- Sexual Desire Inventory (SDI; Spector et al., 1996)(10 years)
- Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)(10 years)
- Acrophobia Questionnaire (AQ; Cohen, 1977)(10 years)