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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria, Adult

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.

Research Questions Taken together, understanding the trajectories of gender dysphoria is crucial. Such research can help determine which individuals benefit most from gender-affirming care and who might dropout during the process or experience dissatisfaction post-transition. Adapting current services to meet individual needs is essential. The current project will employ both quantitative and qualitative methods integrated into the clinical practice at the Gender Dysphoria Clinic, Region Skåne a National Highly Specialized Care unit (NHV), along with information from relevant databases and registries to achieve this goal.

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-controlled comparison group?

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Emma Claesdotter-Knutsson, MD; Ass prof; Phone Number: +46768871765; Email: emma.claesdotter-knutsson@regionskane.se

Study Locations

• Sweden
  • Malmö
    • Malmö, Malmö, Sweden
      • Recruiting
      • The Gender Dysphoria Clinic at Skåne University Hospital, Malmö, Sweden
      • Contact: Emma Claesdotter-Knutsson, MD; PhD; Phone Number: 0046768871765; Email: emma.claesdotter-knutsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to read/write Swedish
• Protected identity status

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gender dysphoria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Source: Cause of Death Register (CDR)	60 months
Work Capacity and Socioeconomic Participation	Derived from the Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA), including employment status and income.	Baseline and 60 months
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	AUDIT produces a score from 0 to 40, with higher scores indicating a greater likelihood of hazardous, harmful, or dependent drinking.	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.
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.	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.
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.	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.
Change in Mental Health Symptoms	Measured using the Generalized Anxiety Disorder Scale (GAD-7). The range of GAD 7 is 0 to 21. Higher scores indicate greater severity of anxiety symptoms.	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months
Change in Mental Health Symptoms	Questions regarding number of suicidal behavior.	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months
Gender Congruence and Life Satisfaction	Measured using the Gender Congruence Life Satisfaction Scale (GCLS). Range is 0 to 50. A higher score indicates a more positive outcome (higher gender congruence, better gender-related mental well-being, and better general life satisfaction).	Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months
Healthcare Utilization	Source: National Patient Register (NPR) Metrics: Number of hospital visits.	Baseline and 60 months
Healthcare Utilization	Source: Prescribed Drug Register Metrics: Use of medications (number of doses)	Baseline and 60 months
Healthcare Utilization	Source: National Patient Register (NPR) Metrics: Psychiatric diagnoses.	Baseline and 60 months.

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: longitudinal study; gender dyshoria; regsiter study
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 2024-07577-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No