N/A
N=25
Mental Health Support for Transgender and Gender-expansive Individuals
Transgender · Depression · Anxiety · Suicidality · HIV
Bottom Line
View on ClinicalTrials.gov: NCT06229132 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Sep 2025
Primary outcome: Primary: Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS) — 9.68; 4.82 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LGBTQ-affirmative CBT for transgender individuals (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS) |
9.68; 4.82 | — |
| SECONDARY Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS) |
10.1; 5.05 | — |
| SECONDARY Psychological Distress: Score on the Brief Symptom Inventory (BSI) |
1.46; 1.11 | — |
| SECONDARY Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS) |
8.00; 4.50 | — |
| SECONDARY Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C) |
2.92; 2.18 | — |
| SECONDARY Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR) |
25.7; 19.9 | — |
| SECONDARY Internalized Stigma: Score on the Internalized Transphobia Subscale of the Gender Minority Stress and Resilience Measure (GMSR) |
14.0; 12.3 | — |
| SECONDARY Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale (GRRS) |
38.1; 34.5 | — |
| SECONDARY Pride: Score on the Pride Subscale of the Gender Minority Stress and Resilience Measure (GMSR) |
14.7; 14.6 | — |
| SECONDARY Community Connectedness: Score on the Community Connectedness Subscale of the Gender Minority Stress and Resilience Measure (GMSR) |
12.2; 12.7 | — |
| SECONDARY Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) |
2.90; 2.61 | — |
| SECONDARY Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS) |
4.40; 4.82 | — |
| SECONDARY Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF) |
72.0; 67.3 | — |
| SECONDARY Rumination: Score on the Brooding Subscale From the Ruminative Responses Scale (RRS) |
13.9; 12.4 | — |
Summary
This study will evaluate an intervention's feasibility, acceptability and efficacy potential in a one-arm trial with Romanian transgender and gender diverse (e.g., gender non-binary) (TGD) individuals who report depression or anxiety. The intervention will consist of 16 1-hour sessions delivered by our trained therapists on Zoom. These sessions are based on 6 principles of LGBTQ-affirming CBT, as follows: (1) normalizing mood and anxiety as a common response to LGBTQ related stress; (2) challenging persistent, inflexible LGBQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression to effectively cope with the consequences of LGBTQ-related stress; (4) validating lesbian, gay, bisexual, and transgender (LGBTQ) clients' unique strengths; (5) building authentic relationships as an essential resource for LGBTQ people's mental health; and (6) recognizing intersectional identities as a source of stress and resilience.
Eligibility Criteria
Inclusion Criteria
- report an identity as transgender or gender expansive (e.g., gender non-binary) and a gender that is different from their assigned sex at birth;
- be ≥18 years old;
- report a score of ≥2.5 on either the two items measuring depression symptoms or the two items measuring anxiety symptoms using the Brief Symptom Inventory (BSI-4); and
- reside in Romania for the duration of the study (approximately 6 months).
Exclusion Criteria
- active suicidality, mania, or psychosis and
- having received CBT in the prior 12 months.
Data sourced from ClinicalTrials.gov (NCT06229132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.