Behavioral Intervention to Reduce Stress Among Black Gender Minority Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adaptive Intervention Approach.
- Who it may be relevant to
- Registry conditions: Psychological Distress, Stigma, Social. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma
Overview
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.
Detailed 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.
Interventions
- Behavioral Adaptive Intervention Approach
This is an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction; 1. weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, 2. supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and 3. additional social resources will be a
Primary outcome measures
- Intervention Retention Rate [Time frame: Throughout the intervention (up to 12 weeks)]
- Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts [Time frame: From screening to Baseline]
- Overall attendance/adherence [Time frame: 2 weeks post-intervention]
- Changes in the intervention fidelity [Time frame: Throughout the intervention (up to 12 weeks)]
- Changes in the proportion of acceptability [Time frame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention]
- Changes in the Intervention acceptability [Time frame: Throughout the intervention (up to 2 weeks post-intervention)]
- Accessibility of the intervention [Time frame: Throughout the intervention (up to 2 weeks post-intervention)]
Secondary outcome measures (2)
- Change in PTSD symptoms [Time frame: Baseline, Mid-intervention (3-6 weeks from baseline assessment) , 2 weeks post intervention, 3 months post-intervention]
- Change in Beck Depression Inventory II (BDI-II) [Time frame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Emory University School of Nursing — Atlanta
Identifiers
NCT: NCT05436106 · STUDY00003101 · 1K23NR020208-01 · 2025P009839