GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
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.
详细描述
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.
- What are the baseline characteristics in individuals seeking gender-affirming care and do any of these predict outcomes of gender-affirmative care?
- Do individuals with gender dysphoria experience improved or reduced quality of life, gender congruence, or functional capacity after gender-affirming care?
- Does gender-affirming care reduce or increase psychiatric symptoms and self-concept clarity?
- 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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults (18+) referred to the NHV clinic for gender dysphoria assessment in Region Skåne.
排除标准
- •Inability to read/write Swedish
- •Protected identity status
研究组 & 干预措施
Gender dysphoria
结局指标
主要结局
Change in Quality of Life
时间窗: 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.
Generic quality of life
时间窗: At the beginning of the clinical assessment, end of the assessment (usually 1 year after start), at 24 months and 60 months.
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").
Gender Congruence Life Satisfaction Scale (GCLS)
时间窗: : At the beginning of the clinical assessment, end of the assessment (usually 1 year after start), at 24 months and 60 months.
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: At the beginning of the clinical assessment, end of the assessment (usually 1 year after start), at 24 months and 60 months.
次要结局
- Healthcare Utilization(Baseline and 60 months)
- Healthcare Utilization(Baseline and 60 months.)
- Gender Congruence and Life Satisfaction(Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months)
- Mortality(60 months)
- Substance use(Baseline, after assessment completion (an average of 1 year), 24 months, and 60 months.)
- Work Capacity and Socioeconomic Participation(Baseline 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)
- 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.)