Clinical trial NCT05436106: Behavioral Intervention to Reduce Stress Among Black Gender Minority Women
Official title: Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Stigma, Social
Keywords: Transgender women
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-06-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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)

Primary outcomes:
measure: Intervention Retention Rate
timeFrame: Throughout the intervention (up to 12 weeks)
measure: Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts
timeFrame: From screening to Baseline
measure: Overall attendance/adherence
timeFrame: 2 weeks post-intervention
measure: Changes in the intervention fidelity
timeFrame: Throughout the intervention (up to 12 weeks)
measure: Changes in the proportion of acceptability
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the Intervention acceptability
timeFrame: Throughout the intervention (up to 2 weeks post-intervention)
measure: Accessibility of the intervention
timeFrame: Throughout the intervention (up to 2 weeks post-intervention)
Secondary outcomes:
measure: Change in PTSD symptoms
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment) , 2 weeks post intervention, 3 months post-intervention
measure: Change in Beck Depression Inventory II (BDI-II)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
Other outcomes:
measure: Changes in the transgender community connection scale (TCC)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the multidimensional scale of perceived social support (MSPSS)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the coping strategies inventory short form (CSI-SF)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the coping self-efficacy scale (CSE)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the self-efficacy to manage chronic disease scale (SECMCD)
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in sleep
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the quality of life
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
measure: Changes in the disability/social functioning scale
timeFrame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
Locations:
city: Atlanta
country: United States
facility: Emory University School of Nursing
state: Georgia
Study officials:
affiliation: Emory University
name: Athena DF Sherman, PhD, PHN, RN
role: PRINCIPAL_INVESTIGATOR
References: