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Mental Health Support for Transgender and Gender-expansive Individuals

NCT06229132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-16

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

LGBTQ-affirmative CBT for transgender individuals

The intervention addresses unique stressors encountered by transgender individuals due to discrimination and lack of adequate and affirming healthcare resources.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Corina Lelutiu-Weinberger, PhD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229132 on ClinicalTrials.gov