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Gender Dysphoria, AdultGLOWNCT07480590

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

An observational study of Gender Dysphoria, Adult, run by Region Skane at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gender Dysphoria, Adult
How many people
500 participants
Where
1 siteSweden
Study dates
1 Dec 2025to 1 Dec 2030
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Inability to read/write Swedish
  • Protected identity status

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emma Claesdotter-Knutsson, MD; Ass prof contact

+46768871765

emma.claesdotter-knutsson@regionskane.se

Sweden1 site, 1 recruiting
  • The Gender Dysphoria Clinic at Skåne University Hospital, Malmö, Sweden

    Malmö, Malmö

    Emma Claesdotter-Knutsson, MD; PhD, 0046768871765, emma.claesdotter-knutsson@med.lu.se

    Recruiting

Other trials in Sweden

About this study

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 and Linköping 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.

Read the 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 Linköping and 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?
Keywords
gender dyshoria, longitudinal study, regsiter study
Medical subject headings
Gender Dysphoria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07480590
Study groupRoleWhat they receive
Gender dysphoriaNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)
  1. Generalized Anxiety Disorder Scale (GAD-7)

    Generalized Anxiety Disorder Scale (GAD-7). The range of GAD 7 is 0 to 21. Higher scores indicate greater severity of anxiety symptoms.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. Change in Mental Health Symptoms

    Questions regarding number of suicidal behavior.

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

  7. 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).

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

  8. Mortality

    Source: Cause of Death Register (CDR)

    Measured: 60 months

  9. Work Capacity and Socioeconomic Participation

    Derived from the Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA), including employment status and income.

    Measured: Baseline and 60 months

  10. Healthcare Utilization

    Source: National Patient Register (NPR) Metrics: Number of hospital visits.

    Measured: Baseline and 60 months

  11. Healthcare Utilization

    Source: Prescribed Drug Register Metrics: Use of medications (number of doses)

    Measured: Baseline and 60 months

  12. Healthcare Utilization

    Source: National Patient Register (NPR) Metrics: Psychiatric diagnoses.

    Measured: Baseline and 60 months.

  13. EQ5d

    The EuroQol 5-Dimension (EQ-5D) assesses health-related quality of life. In the EQ-5D, each response generates a single-digit code between 1 and 5, where 1 = no problems and 5 = extreme problems. These single-digit codes can be combined to form a five-digit code corresponding to a specific health profile. Each dimension has five possible responses, meaning that together they can generate 3,125 different health profiles.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start1 Dec 2025
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07480590
Sponsor's protocol ID
2024-07577-02
Acronym
GLOW
Status last verified
Sep 2026
First submitted
13 Mar 2026
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Dysphoria, Adult, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emma Claesdotter-Knutsson, MD; Ass prof (+46768871765, emma.claesdotter-knutsson@regionskane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life (time frame: Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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