Mental Health Support for Transgender and Gender-expansive Individuals

NCT06229132 | Completed Results DMC

• 2 other identifiers: AAAU2518-TGDR01MH116829
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Transgender; Depression; Anxiety; Suicidality; HIV

Keywords

Transgender; Gender diverse; Mental health

Outcome Measures

Primary Outcomes (1)

• Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)

  Participants will complete the Overall Depression Severity \& Impairment Scale (ODSIS) to assess past-week frequency, severity, and impairment related to depression symptoms. The ODSIS is comprised of five items (e.g., "In the past week, how often have you felt depressed?") each measured on a five-point scale ranging from 0 (no depression in the past week) to 4 (constant depression: felt depressed all of the time). Item scores will be summed to obtain a total score ranging from 0 (min) to 20 (max), with a higher total score indicating greater depressive symptoms (worse outcome).

  Measured at baseline and 5 months post-baseline

Secondary Outcomes (13)

• Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)

  Measured at baseline and 5 months post-baseline

• Psychological Distress: Score on the Brief Symptom Inventory (BSI)

  Measured at baseline and 5 months post-baseline

• Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS)

  Measured at baseline and 5 months post-baseline

• Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)

  Measured at baseline and 5 months post-baseline

• Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR)

  Measured at baseline and 5 months post-baseline

Study Arms (1)

LGBTQ-affirmative CBT treatment

OTHER

LGBTQ-affirmative CBT includes client case conceptualizations to personalize treatment delivery and functional relevance. Modules raise awareness of the impact of sexual minority stress on mental, behavioral, and sexual health; instill cognitive flexibility toward minority stress cognitions; and reduce maladaptive avoidance tendencies rooted in minority stress. The treatment is guided by six principles: (1) normalizing mood and anxiety as a common response to LGBTQ-related stress; (2) challenging persistent, inflexible LGBTQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression in safe situations to effectively cope with the consequences of LGBTQ-related stress; (4) validating 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. The intervention consists of 16 sessions delivered on Zoom.

Behavioral: LGBTQ-affirmative CBT for transgender individuals

Interventions

LGBTQ-affirmative CBT for transgender individuals BEHAVIORAL

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

LGBTQ-affirmative CBT treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals who 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 will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• active suicidality, mania, or psychosis and
• having received CBT in the prior 12 months.

Sponsors & Collaborators

• Columbia University: lead
• Yale University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University School of Nursing

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Suicidal Ideation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Suicide; Self-Injurious Behavior; Personal Satisfaction

Results Point of Contact

• Title: Corina Lelutiu-Weinberger, PhD
• Organization: Columbia University

cl4265@cumc.columbia.edu

(212) 342-1502

Study Officials

• Corina Lelutiu-Weinberger, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Sciences Research

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: March 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)