Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

Emory University

Status: Enrolling

Conditions: Stigma, Social; Psychological Distress

Treatments: Behavioral: Adaptive Intervention Approach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05436106

STUDY00003101

2025P009839 (Other Identifier)

1K23NR020208-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The research objectives of this study are to first, develop a culturally informed community-based intervention with guidance from community members (via focus groups and theater testing) to reduce the effect of chronic stigma exposure on psychological distress symptoms (PTS and depressive symptoms) among transgender women. Second, the research team will conduct a proof-of-concept trial to determine the feasibility and preliminary efficacy of the resulting intervention.

Full description

The proposed research builds on our previous work with Black gender minority (GM) women and addresses research gaps. The researchers propose to develop and examine the feasibility of an intervention to improve psychological distress symptom management related to chronic stigma exposure among Black GM women. A hybrid delivery model is proposed where a) weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, b) supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and c) additional social resources will be available through the online portal or app. Researchers will use an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction. The investigators will use standard qualitative and mixed-method approaches (focus groups, key informant interviews with the community advisory board, and a quantitative survey) and iterative design to develop/adapt, refine, and evaluate a culturally informed intervention for transgender women experiencing chronic stigma and psychological distress.

Participants will be recruited via convenience sampling using multiple strategies including passively distributing flyers to LGBTQ+ organizations and clinics, universities, and community colleges; LGBTQ+ and transgender and gender diverse (TGD) group social media platforms; peer referral, and word of mouth; and actively through collaborations with the Casa Ruby case management team and providers at Emory Healthcare and Grady Health Gender Center.

Investigators will use standard qualitative and mixed-method approaches (focus groups, key informant interviews with the community advisory board, and a quantitative survey) and iterative design to develop/adopt, refine, and evaluate a culturally informed intervention for transgender women experiencing chronic stigma and psychological distress. The research team will conduct 4 focus groups of 5 people to address Aim 1. Focus group sessions will last no longer than 2 hours and will be virtual via Zoom.

The research team will conduct a proof-of-concept study to establish the feasibility, including recruitment, retention, and outcome measurement of the developed intervention. Researchers will collect quantitative assessment data on internet-accessible devices via self-administered surveys collected at the time point (T)1; baseline enrollment, T2; Mid-intervention (3-6 weeks from baseline assessment), T3. immediately post-intervention (within 2 weeks of study completion), and T4. 3-months post-intervention.

The phase 2 intervention trial includes transgender women of any race or ethnicity and will be delivered hybrid with 3 in-person sessions (in Atlanta, GA) and 4 online sessions via Zoom.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• gender is woman/transgender feminine/female
• assigned male sex at birth
• speak/read English

Exclusion criteria

• Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

intervention educational content

Experimental group

Description:

The base intervention design will contain educational content informed by the Transgender Resilience Intervention Model (TRIM) and adapted from Seeking Safety specific to a) identifying symptoms of psychological distress, b) managing symptoms via coping (individual resilience), and c) developing a social network and using social support/community connection (group resilience).

Treatment:

Behavioral: Adaptive Intervention Approach