Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229132
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2024-01-19
Brief Title:
Mental Health Support for Transgender and Gender-expansive Individuals
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate an interventions feasibility acceptability and efficacy potential in a one-arm trial with Romanian transgender and gender diverse eg 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 peoples mental health and 6 recognizing intersectional identities as a source of stress and resilience
Detailed Description:
Transgender and gender diverse eg 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 countrys high structural stigma Romanias 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 eg the US China In Aim 3 the investigators will evaluate the adapted interventions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH116829 | NIH | None | httpsreporternihgovquickSearchR01MH116829 |