Recruiting

Behavioral Intervention

Sponsor:

Emory University

Code:

NCT05436106

Conditions

Psychological Distress

Stigma, Social

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Adaptive Intervention Approach

Study Details

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.

Conditions

Psychological Distress

Stigma, Social

Study ID

NCT05436106

Start date

May 2, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

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 available through the online portal or app.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Athena DF Sherman, PhD, PHN, RN

408-401-2456Adfsherman@emory.edu

Locations

Emory University School of Nursing

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Transgender women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-30.