GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Gender dysphoria

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months
2

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").

Time frame
At the beginning of the clinical assessment, end of the assessment (usually 1 year after start), at 24 months and 60 months.

Secondary outcomes

1

Generalized Anxiety Disorder Scale (GAD-7)

Time frame
At the beginning of the clinical assessment, end of the assessment (usually 1 year after start), at 24 months and 60 months.
2

Substance use

AUDIT produces a score from 0 to 40, with higher scores indicating a greater likelihood of hazardous, harmful, or dependent drinking.

Time frame
Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.
3

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.

Time frame
Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.
4

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.

Time frame
Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.

Other outcomes

Sponsors and contacts

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