Trial results for a mental health support intervention for transgender and gender-expansive individuals with Depression were posted on ClinicalTrials.gov on 2025-09-16, indicating a reduction in mean depression scores from 9.68 to 4.82 on the Overall Depression Severity & Impairment Scale (ODSIS).
Background
Depression, anxiety, and suicidality are significant mental health concerns within the transgender and gender-expansive (TGE) community, often exacerbated by unique stressors related to gender identity and societal stigma. Effective and affirming mental health support is crucial for this population. Interventions tailored to address these specific challenges, such as those based on LGBTQ-affirming cognitive behavioral therapy (CBT) principles, aim to normalize mood and anxiety responses to stress, challenge negative cognitions, and encourage assertive behaviors.
Trial design
This completed study, identified as Phase NA, enrolled 25 participants. The trial evaluated the feasibility, acceptability, and efficacy potential of a one-arm intervention for Romanian transgender and gender diverse individuals who reported depression or anxiety. The intervention consisted of 16 one-hour sessions delivered via Zoom by trained therapists. These sessions were based on six principles of LGBTQ-affirming CBT, including normalizing mood and anxiety as responses to LGBTQ-related stress, challenging stress-induced cognitions, and encouraging assertive behavior. The study included participants with conditions such as Transgender, Depression, Anxiety, Suicidality, and HIV.
Key results
The trial results present pre- and post-intervention scores for various mental health and well-being measures in transgender and gender-expansive individuals:
- Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS) decreased from a mean of 9.68 (Standard Deviation 4.96) to a mean of 4.82 (Standard Deviation 5.04).
- Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS) decreased from a mean of 10.1 (Standard Deviation 3.72) to a mean of 5.05 (Standard Deviation 4.69).
- Psychological Distress: Score on the Brief Symptom Inventory (BSI) decreased from a mean of 1.46 (Standard Deviation 0.729) to a mean of 1.11 (Standard Deviation 0.745).
- Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS) decreased from a mean of 8.00 (Standard Deviation 10.70) to a mean of 4.50 (Standard Deviation 7.97).
- Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C) decreased from a mean of 2.92 (Standard Deviation 2.25) to a mean of 2.18 (Standard Deviation 1.97).
- Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR) decreased from a mean of 25.7 (Standard Deviation 5.73) to a mean of 19.9 (Standard Deviation 8.80).
What this means
The posted results suggest that the mental health support intervention, based on LGBTQ-affirming CBT principles, may be effective in reducing symptoms of depression, anxiety, psychological distress, suicidal ideation, hazardous drinking, and anticipated stigma among transgender and gender-expansive individuals. The consistent reduction in mean scores across multiple scales indicates a positive impact on the mental well-being of the participants. These findings underscore the potential benefit of tailored, affirming mental health interventions for this population, addressing specific stressors and promoting healthier coping mechanisms.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06229132, titled "Mental Health Support for Transgender and Gender-expansive Individuals", were posted on 2025-09-16 on clinicaltrials.gov.