Gender-Affirming Care and Mental Health

Not yet recruiting

• Conditions: Gender Dysphoria, Adult; Psychiatric Comorbidities

• Registration Number: NCT07171645
• Lead Sponsor: Region Skane

Brief Summary

Introduction 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 of gender-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 Method GLOW 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 gender dysphoria.

Detailed Description

The GLOW study is a longitudinal investigation designed to evaluate the effects of gender-affirming care on the well-being of individuals diagnosed with gender dysphoria in Sweden. Grounded in an interdisciplinary framework, the study adopts a mixed-methods approach to integrate quantitative registry data and longitudinal self-assessments with in-depth qualitative interviews. This design allows for anunderstanding of the medical, psychological, and social dimensions of gender-affirming care beyond the limitations of cross-sectional studies.

The project is embedded in Region Skåne's National Highly Specialized Care (NHV) unit, ensuring standardized data collection and uniform clinical procedures across participants. Thus, the study benefits from a stable clinical infrastructure and reliable access to a diverse cohort undergoing gender-affirming assessment and treatment. In addition, national health and population registries provide extensive data for long-term follow-up, including health service utilization, prescription records, socio-economic indicators, and mortality data.

GLOW is commited to a collaborative research practice. The project actively involves key stakeholders-healthcare professionals, policymakers, and patient advocacy groups such as Transammans and RFSL. Their input ensures that the study remains aligned with real-world clinical needs and community priorities, enhancing its relevance.

The study is conceptually anchored in the Biopsychosocial Model and draws on Minority Stress Theory, Self-Concept Clarity Theory, and Gender Affirmation Theory. These frameworks support the exploration of how social stressors, identity development, and access to affirming care interact to shape mental health trajectories. This theoretical integration provides a solid foundation for interpreting variability in treatment response and quality-of-life outcomes.

Statistical modeling will be employed to complement traditional analyses, offering probabilistic interpretations and greater flexibility in handling complex longitudinal data structures. Qualitative interviews will be analyzed using thematic methods, with findings triangulated against quantitative trends to increase the validity and depth of insights.

While many existing studies on gender-affirming care focus on short-term or medical outcomes, GLOW takes a broader and longer-term perspective. It includes economic implications, healthcare resource use, work life outcomes, and subjective experiences of identity and social integration. This holistic approach will generate knowledge applicable to clinical care, policy formulation, and public health planning.

Finally, the project emphasizes sustainability. Infrastructure and data collection protocols have been designed to support extended follow-up. In doing so, GLOW aims to contribute not only to scientific literature but also to the development of evidence-based guidelines and inclusive healthcare systems.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2026-01-01
• Primary Completion: 2032-08-31
• Study Completion: 2032-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Individuals aged 18 years and older.

Referred to the National Highly Specialized Care Unit (NHV) for gender dysphoria at Region Skåne.

Presenting for initial clinical assessment for gender-affirming care.

Able to provide informed consent for participation in the self-report portion of the study.

Participants may identify as female, male, or another gender identity.

Exclusion Criteria

Inability to read or write Swedish, as all self-report measures and consent forms are in Swedish.

Individuals with protected (secret) identities, such as those under special confidentiality protections or in high-security identity protection programs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.	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.

Trial Locations

Locations (1)

Department/Office of Psychiatry, National specialized medical care, Skåne University Hospital, Lund, Sweden.; 🇸🇪 Lund, Skåne County, Sweden