Gender-Affirming Care and Mental Health

NCT07171645 | Not Yet Recruiting

• 1 other identifier: 2024-07577-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 1.What are the baseline characteristics in individuals seeking gender-affirming care and do any of these predict outcomes of gender-affirmative care?
2. 2.Do individuals with gender dysphoria experience improved or reduced quality of life, gender congruence, or functional capacity after gender-affirming care?
3. 3.Does gender-affirming care reduce or increase psychiatric symptoms and self-concept clarity?
4. 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?

Conditions

Gender Dysphoria, Adult; Psychiatric Comorbidities

Keywords

gender dysphoria; self-concept; National Highly Specialized Care (NHV); Identity; Stigma; Mixed Methods

Outcome Measures

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.

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

Other Outcomes (12)

• Generic quality of life

  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.

• Substance Use

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

Study Arms (2)

Individuals with gender dysphoria

The study cohort consists of adults (18+) with gender dysphoria who have been referred to the National Highly Specialized Care Unit (Nationell Högspecialiserad Vård, NHV) for gender dysphoria at Region Skåne, Sweden. This unit serves as one of the national centers for the assessment and treatment of individuals seeking gender-affirming care. Participants are recruited at the initiation of their clinical assessment-a standardized, multidisciplinary evaluation process typically involving psychiatrists, psychologists, and counselors, which spans approximately three months. This assessment constitutes the first formal step toward potential access to gender-affirming interventions.

Other: Assessment regarding gender-affirming care

Randomized comparison group

A matched randomized comparison group drawn from registries. This group will be used as a comparison for the registry data only.

Interventions

Assessment regarding gender-affirming care OTHER

No comparison

Individuals with gender dysphoria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults (18 years and older) diagnosed with gender dysphoria who have been referred to the National Highly Specialized Care (NHV) Unit for gender dysphoria at Region Skåne. This clinic is one of Sweden's national centers for gender-affirming care, receiving approximately 350-400 new referrals annually. Participants are enrolled at the start of their initial clinical assessment, which is the gateway to potential interventions such as hormone therapy, surgery, voice therapy, and psychological support. The study includes individuals of all gender identities (e.g., female, male, nonbinary) to reflect the diversity of the transgender population. Participants are followed longitudinally using self-report questionnaires, clinical records, and national registry data to assess mental health, identity development, and quality-of-life outcomes across time.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

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

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Gender Dysphoria; Social Stigma

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Social Behavior; Behavior

Central Study Contacts

Magnus Nilsson, PhD

CONTACT

+46 46174925; magnus.nilsson@med.lu.se

Emma Claesdotter-Knutsson, MD, PhD

CONTACT

emma.claesdotter-knutsson@skane.se

Study Design

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

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2032
• Study Completion (Estimated): August 31, 2032
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

SE (1)