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

NCT07480590 | Recruiting

• 1 other identifier: 2024-07577-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gender Dysphoria, Adult

Keywords

gender dyshoria; longitudinal study; regsiter study

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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").

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

Secondary Outcomes (12)

• Generalized Anxiety Disorder Scale (GAD-7)

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

• Substance use

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

• Substance use

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

• Self-Concept Clarity and Identity Functioning

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

• Change in Mental Health Symptoms

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

Study Arms (1)

Gender dysphoria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• All adults (18+) referred to the NHV clinic for gender dysphoria assessment in Region Skåne.

You may not qualify if:

• Inability to read/write Swedish
• Protected identity status

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

The Gender Dysphoria Clinic at Skåne University Hospital, Malmö, Sweden

Malmö, Malmö, Sweden

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Emma Claesdotter-Knutsson, MD; Ass prof

CONTACT

+46768871765; emma.claesdotter-knutsson@regionskane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)