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Behavioral Intervention for Stress

N/A

Recruiting

Led By Athena DF Sherman, PhD, PHN, RN

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Gender is woman/transgender feminine/female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to create a community-based program with input from community members to help transgender women deal with the mental health effects of stigma. They will then test this program to see if it is practical and

Who is the study for?

This trial is for Black or mixed-race individuals including Black, assigned male at birth but now identify as women/transgender feminine/female, aged 18+, who experience psychological distress. They must speak/read English and have certain scores on PTSD or depression scales indicating stress.

What is being tested?

The study is testing a community-based intervention designed with input from focus groups to help reduce the impact of chronic stigma on mental health symptoms like PTSD and depression in transgender women.

What are the potential side effects?

Since this is a behavioral intervention focusing on reducing stress through community support rather than medication, there are no direct physical side effects expected. However, discussing sensitive topics may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I identify as a woman, transgender feminine, or female.

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I was assigned male at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accessibility of the intervention

Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts

Changes in the Intervention acceptability

+4 more

Secondary study objectives

Change in Beck Depression Inventory II (BDI-II)

Change in PTSD symptoms

Other study objectives

Changes in sleep

Changes in the coping self-efficacy scale (CSE)

Changes in the coping strategies inventory short form (CSI-SF)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: intervention educational contentExperimental Treatment1 Intervention

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).

0 / 3Eligibility criteria met