Clinical trial NCT06229132: Mental Health Support for Transgender and Gender-expansive Individuals
Official title: Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgender
Depression
Anxiety
Suicidality
HIV
Keywords: Transgender
Gender diverse
Mental health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Yale University
name: National Institute of Mental Health (NIMH)
First posted: 2024-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)
timeFrame: 5-month follow-up
Secondary outcomes:
measure: Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)
timeFrame: 5-month follow-up
measure: Psychological distress: Score on the Brief Symptom Inventory
timeFrame: 5-month follow-up
measure: Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale
timeFrame: 5-month follow-up
measure: Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: 5-month follow-up
measure: Anticipated Stigma: Score on the Negative Expectations for Future Events subscale of the Gender Minority Stress and Resilience Measure (GMSR)
timeFrame: 5-month follow-up
measure: Internalized Stigma: Score on the Internalized Transphobia subscale of the GMSR
timeFrame: 5-month follow-up
measure: Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale
timeFrame: 5-month follow-up
measure: Pride: Score on the Pride subscale of the GMSR
timeFrame: 5-month follow-up
measure: Community Connectedness: Score on the Community Connectedness subscale of the GMSR
timeFrame: 5-month follow-up
measure: Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
timeFrame: 5-month follow-up
measure: Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 5-month follow-up
measure: Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF)
timeFrame: 5-month follow-up
measure: Rumination: Score on the Brooding subscale from the Ruminative Responses Scale (RRS)
timeFrame: 5-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
Study officials:
affiliation: Columbia University
name: Corina Lelutiu-Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: