Behavioral Intervention to Reduce Stress Among Black Gender Minority Women
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Adaptive Intervention Approach.
- Кому может быть актуально
- Состояния в реестре: Psychological Distress, Stigma, Social. Базовые параметры: 18 лет — 99 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Intervention Retention Rate [Срок оценки: Throughout the intervention (up to 12 weeks)]
- Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts [Срок оценки: From screening to Baseline]
- Overall attendance/adherence [Срок оценки: 2 weeks post-intervention]
- Changes in the intervention fidelity [Срок оценки: Throughout the intervention (up to 12 weeks)]
- Changes in the proportion of acceptability [Срок оценки: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention]
- Changes in the Intervention acceptability [Срок оценки: Throughout the intervention (up to 2 weeks post-intervention)]
- Accessibility of the intervention [Срок оценки: Throughout the intervention (up to 2 weeks post-intervention)]
Вторичные конечные точки (2)
- Change in PTSD symptoms [Срок оценки: 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) [Срок оценки: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention]
Критерии участия
Критерии включения
- 18 years or older
- gender is woman/transgender feminine/female
- assigned male sex at birth
- speak/read English
Критерии исключения
- Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Emory University School of Nursing — Atlanta
Идентификаторы
NCT: NCT05436106 · STUDY00003101 · 1K23NR020208-01 · 2025P009839