Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05436106
Status
Recruiting
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Conditions

  • Psychological Distress
  • Stigma, Social

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Adaptive Intervention Approach — BEHAVIORAL
    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 available through the online portal or app.

Study Details

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.

Key Dates

Start date
May 2, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: intervention educational content
    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).

Primary Outcome Measure

Intervention Retention Rate [ Time Frame: Throughout the intervention (up to 12 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University School of NursingAtlantaGeorgia30322-

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By research site
Emory University School of Nursing· Atlanta, GA

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