Mental Health Support for Transgender and Gender-expansive Individuals

Columbia University

Status: Completed

Conditions: Suicidality; Transgender; HIV; Depression; Anxiety

Treatments: Behavioral: LGBTQ-affirmative CBT for transgender individuals

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06229132

AAAU2518-TGD

R01MH116829

Details and patient eligibility

About

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.

Full description

Transgender and gender diverse (e.g., gender non-binary) (TGD) individuals remain a hidden group in the Central Eastern European (CEE) country of Romania, with few protections, few equal rights, and many unmet needs. Emerging research with TGD persons in the region indicates that TGD Romanians report particularly high rates of HIV, depression, and hazardous alcohol use, primarily driven by the country's high structural stigma. Romania's healthcare system has little expertise for addressing these syndemic health threats. No targeted needs assessments or interventions exist to date in order to remedy these adversities and promote the wellbeing of TGD in Romania, or anywhere in CEE - the region with the fastest-growing HIV epidemic in the world. In response, the investigators propose to create and pilot-test the first intervention in CEE to address the sexual, mental, and behavioral health of TGD people. In Aim 1, the investigators will identify unique needs of TGD Romanians via interviews. Findings will be used in Aim 2 to modify an intervention manual to address gender minority stress and other TGD-specific determinants of mental health, hazardous alcohol use, and HIV risk. The intervention will be based on a Romanian-adapted EQuIP (Empowering Queer Identities in Psychotherapy) intervention d developed and successfully tested by our team in several global regions (e.g., the U.S., China). In Aim 3, the investigators will evaluate the adapted intervention's feasibility, acceptability, and efficacy potential in a one-arm trial with 25 TGD Romanians. By extending the intervention research to at-risk TGD populations, the investigators will ensure more equitable access to the interventions and embed them within a national infrastructure increasingly eager for and capable of reaching the full diversity of the Romanian LGBTQ population to address its currently unmet needs.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. be ≥18 years old;
3. 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
4. reside in Romania for the duration of the study (approximately 6 months).

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

LGBTQ-affirmative CBT treatment

Other group

Description:

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.

Treatment:

Behavioral: LGBTQ-affirmative CBT for transgender individuals