About this trial
Gender-Affirming Care and Mental Health (GLOW) investigates the psychological, medical, and social factors that influence the outcomes of gender-affirming care, as well as its impact on mental health, work capacity, and quality of life. Gender dysphoria is defined as the incongruence of a person's experienced gender and sex assigned at birth. In Sweden, the prevalence of gender dysphoria has increased significantly in recent decades. Still there is no consensus on the long-term outcomes ofgender-affirming care. 1. What are the baseline characteristics in individuals seeking gender-affirming care and do any of these predict outcomes of gender-affirmative care?2. Do individuals with gender dysphoria experience improved or reduced quality of life, gender congruence, or functional capacity after gender-affirming care?3. Does gender-affirming care reduce or increase psychiatric symptoms and self-concept clarity?4. What are the effects of gender-affirming care on mortality, work capacity, and healthcare resource utilization as compared to an age and gender matched control group?Data and MethodGLOW targets patients at the Gender Dysphoria Clinic, Region Skåne a National Highly Specialized Care unit (NHV). Mixed methods will be used to analyze data from national registries and self-reported assessments.The NHV status ensures standardized high-quality data collection and clinical follow-up, making this project a unique opportunity to evaluate the care given to individuals with gender dysphoria.Societal Relevance and Utility The growing demand for gender-affirming care underscores the need for research to identify the most effective interventions. The results may also help reduce stigma and improve social integration for individuals with genderdysphoria.GLOW is a longitudinal mixed-methods study based at the NHV Gender Dysphoria Clinic in Region Skåne. It includes registry-based, qualitative interviews and repeated self-report measures up to 5 years after baseline assessment. Quantitative analyses will include regression models and Bayesian methods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adults (18+) referred to the NHV clinic for gender dysphoria assessment in Region Skåne.
Disqualifiers
Inability to read/write Swedish
Protected identity status
Trial population
Participant recruitment will take place at the NHV Gender Dysphoria Clinic in Malmö, Region Skåne, which is one of Sweden's national centers for the diagnosis and treatment of gender dysphoria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Quality of Life
World Health Organization Disability Assessment Schedule (WHODAS 2.0) to evaluate general health status and functioning. Score is converted to a 0-100 scale, where a higher score indicates greater disability or limitation in functioning.
Generic quality of life
Measured with EuroQoL-5 Dimension Questionnaire (EQ-5D) Describes five levels of problems ("no, mild, moderate, severe, extreme problem") and a scale that typically ranges from 0 ("worst imaginable health") to 100 ("best imaginable health").
Secondary outcomes
Generalized Anxiety Disorder Scale (GAD-7)
Substance use
AUDIT produces a score from 0 to 40, with higher scores indicating a greater likelihood of hazardous, harmful, or dependent drinking.
Substance use
Measured using the Drug Use Disorders Identification Test (DUDIT). DUDIT produces a score from 0 to 44, with higher scores indicating more severe drug-related problems or potential dependence.
Self-Concept Clarity and Identity Functioning
Measured via the Self-Concept and Identity Measure (SCIM) and Level of Personality Functioning Scale - Brief Form 2.0 (LPFS 2). SCIM has a total score range from 36 to 180, with higher scores indicating greater identity disturbance, LPFS has a range of 12 to 48, where a higher score indicates greater dysfunction.
Sponsors and contacts
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