Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03643120
Other study ID # 2018/1088/REK sør-øst C
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 20, 2018
Est. completion date September 1, 2021

Study information

Verified date August 2018
Source Oslo University Hospital
Contact Reidar Schei Jessen, Master of science
Phone 004745222800
Email reijes@ous-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to explore how gender dysphoria is experienced among adolescents aged 13 - 18 from a clinical population. The method is qualitative, with a phenomenological approach. Qualitative in-depth data on how gender dysphoria is experienced by the adolescents themselves is lacking in the research literature. As a consequence the within perspective from the clients is lacking. In addition, one aim is to help develop further hypothesis and clinical theory and rationale.


Description:

For some children and adolescents their ascribed gender at birth do not match with their gender expression or how they identify later in life. If the mismatch between ascribed gender at birth and gender identity and expression and how the body looks like is associated With distress or discomfort of any kind, this is referred to as gender dysphoria in the Research literature and DSM-V (DSM-V, 2014; Kreukels et al., 2012; Wren, 2014). After initial attempts with so called reparative therapy at changing clients' gender identity in accordance with their ascribed gender at birth, sex reassignment became the treatment of choice to gender dysphoria (Wierckx et al., 2014; Wren, 2014). Since the advent of sophisticated physical treatment like hormonal therapy and surgical techniques, capable of removing certain characteristics of the sexual body, an increasing number of clinics globally have started to offer puberty suppression to pubertal adolescents with gender dysphoria, in order to allow more time before making decisions regarding gender identity. This is referred to as the Dutch model, and the clinical aim is to reduce the pressure the youth are experiencing when the body is developing in a way that creates a lot of distress. Many countries have established special clinics, which focus on development of treatment programs, and there has been a steep increase in number of referrals the last years (Kaltiala-Heino, Sumia, Työläjärvi, & Lindberg, 2015). In Norway, 450 clients were referred to the Norwegian National Unit for Gender Dysphoria and Transsexualism (Nasjonal behandlingstjeneste for transseksualisme, NBTS) in 2016. Half of them were under 18, and the number has been multiplied the last years (Nasjonal behandlingstjeneste for transseksualisme, årsrapport 2016). However, clinical treatment has been initiated without clarifying what gender dysphoria is, how it is experienced by those suffering from it and how it should be understood theoretically. A common concern in the research literature and among clinicians has been that important medical interventions have been utilized while the understanding of gender dysphoria among adolescents and Young adults and its psychological implications could be better understood (Kaltiala-Heino et al., 2015; Wren, 2014). In addition, activists and clients have claimed that their perspectives have been overseen by researchers and clinicians (Wren, 2014). Furthermore, there has been increased attention toward gender dysphoria both nationally and internationally. The aim of this project is to do an interview study in collaboration with chief physician at the NBTS, Ira Haraldsen and a reference group with former clients, in order to produce knowledge on how clients between the ages of 13 and 18 years that are being treated at the NBTS experience the gender dysphoria, how they understand the condition and make sense of their experiences and how it affects their lives. Much of the research on gender dysphoria has been quantitative, based on self report from the clients themselves or reports from health professionals (Drescher & Byne, 2012). This means that the research has focused on predictors of good outcome, and delivered important knowledge on the treatment of gender dysphoria. However, there has not been done much research on the psychological nature of gender dysphoria, what psychosocial consequences this has for the development of gender identity and identity in general and how this is experienced by the young people themselves. There is also a lack of theoretical incorporation of gender dysphoria within the clinical and developmental psychological literature, and a psychological approach to it. Furthermore, studies on the outcome of puberty suppression and sex reassignment have demonstrated that although many adolescents improve mentally after transitioning into an other gender and gender dysphoria ameliorate, many are still suffering from severe psychiatric conditions and psychosocial adjustment (Kaltiala-Heinoet al., 2015). Studies have also demonstrated that adolescents undergoing this treatment is in need of psychological monitoring, but the research on how this should be implemented is lacking (de Vries et al., 2014).

NBTS has been at the forefront internationally implementing the Dutch model. The plan is to interview participants that have been referred to NBTS, consisting of clients that are in different phases of the treatment. The methodological approach will be qualitative and phenomenological, aiming to shed light on how gender dysphoria is experienced subjectively, and focusing on the diversity of presentations rather than searching for general principles. An other important aim is to contribute to theory development, drawing on clinical psychological theories as well as biological and medical knowledge and concepts from gender studies. In relation to this, an aim is to generate hypothesis and stimulate further studies. The collaboration between NBTS and the reference group is an opportunity to fill a gap in the international research between clients and activists one the one hand and researchers and clinicians on the other, and contribute to improved understanding of adolescents suffering from gender dysphoria and how clinicians can help them. This is in line with Standards of Care, the recommendations for treatment of gender dysphoria published by the World Professional Association for Transgender Health. According to this report, the perspectives of people having gender dysphoria are essential to ensure good health care, given the discrimination many are experiencing. Besides, in 2015, the Norwegian Directorate of Health published a report on the health services offered to people with gender dysphoria, named Rett til rett kjønn - helse til alle kjønn, based on the work of an expert group consisting of clinicians, activist and clients. The report concludes that there is a need to do more Research on how gender dysphoria is experienced and what consequences it has for young People living with it. Furthermore, the expert group concludes that there is a need for increased knowledge and awareness of gender dysphoria and how young people living with it should be helped among health professionals working in both specialist and primary health care.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 1, 2021
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Referred to the National Treatment Unit for Transsexuality/Gender dysphoria

Exclusion Criteria:

- Not referred to the National Treatment Unit for Transsexuality/Gender dysphoria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative interview
Explorative study of gender dysphoria.

Locations

Country Name City State
Norway Oslo university hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical sub-types The aim is to develop a typology to describe gender dysphoria. 2021
See also
  Status Clinical Trial Phase
Recruiting NCT06098781 - Gynaecological Gender-affirming Surgeries
Recruiting NCT04064671 - ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
Completed NCT03602222 - An LGBT-Competency Program for Mental Health Professionals in Romania N/A
Completed NCT04708600 - Effectiveness of Speech Therapy in Trans Women. N/A
Completed NCT04195659 - Chest Dysphoria in Transmasculine Spectrum Adolescents
Not yet recruiting NCT05903911 - Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria N/A
Not yet recruiting NCT04265885 - Gender Dysphoria and Transition
Not yet recruiting NCT04160364 - Gender Dysphoria in Children and Adolescents : Parents' Perspectives
Recruiting NCT06245681 - Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content
Active, not recruiting NCT05489159 - Sleep and IR in Transgender Adolescents
Recruiting NCT04736797 - Transition in Transgender
Recruiting NCT04979338 - Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries Phase 3
Recruiting NCT05829928 - Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
Recruiting NCT04993469 - Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery N/A
Recruiting NCT05884307 - Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria N/A
Recruiting NCT05883553 - Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients. N/A
Completed NCT04290286 - i2TransHealth: Interdisciplinary, Internet-based Trans Health Care N/A
Terminated NCT03078829 - The Relation of GnRH Treatment to QTc Interval in Transgender Females
Recruiting NCT05649605 - Early Mental Response - The EMRE Study N/A
Recruiting NCT05204732 - Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People N/A