Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

Study Overview
=================
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.

Official Title
-----------------
Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma

Conditions
-----------------
Stigma, Social, Psychological Distress

Intervention / Treatment
-----------------
* Behavioral: Adaptive Intervention Approach


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention educational content<br>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). | Behavioral: Adaptive Intervention Approach<br>* This is an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction; weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and additional social resources will be available through the online portal or app.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Retention Rate | number screened per month; number enrolled per month and per source; rate of eligibility ≥40%); (≥50% retention rate; reasons for dropouts; acute crisis or avoidance behaviors; incentive structure); | Throughout the intervention (up to 12 weeks) | 
| Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts | The average time it takes for participants to be screened and complete enrollment depending on the study cohorts | From screening to Baseline | 
| Overall attendance/adherence | Session attendance ≥67%; online engagement with educational material via click counts | 2 weeks post-intervention | 
| Changes in the intervention fidelity | Fidelity rates within and between interventionists; range from 0-3, with 2 or higher indicative of high fidelity per domain via the Seeking Safety Adherence Scale (SASS). Tailoring of the SASS will be based on the format used to deliver the intervention content and the focus of the content. For example, the original scale has the following items that may not be appropriate for the created intervention: Focused on how the topic related to substance use; Gave handouts and made use of them during the session. Thus, these items may be removed or modified to align with content delivery and subject matter. The SASS will be used to periodically assess the fidelity of intervention delivery among each interventionist. Mean scores will be compared between interventionists and scores below 80% will require remediation in the form of individual training with the PI and the interventionist. | Throughout the intervention (up to 12 weeks) | 
| Changes in the proportion of acceptability | assessment acceptability will be assessed by calculating the proportion of planned assessments that are completed and satisfaction ratings ≥75%; duration of assessment visits; reasons for dropouts); | Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention | 
| Changes in the Intervention acceptability | intervention acceptability (acceptability ≥75%; qualitative assessments; reasons for dropouts; preference/satisfaction ratings ≥75% via Client satisfaction questionnaire); Client satisfaction questionnaire (CSQ-8; Cronbach's alpha .93; 8-item; 4-point Likert) will be administered at the end of every intervention session to address individual session utility and at T3 for overall satisfaction | Throughout the intervention (up to 2 weeks post-intervention) | 
| Accessibility of the intervention | intervention accessibility (qualitative assessments; reasons for dropouts and adherence; technological literacy; ability to access reliable internet). There is no scale for this instrument. | Throughout the intervention (up to 2 weeks post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms | Psychological distress symptom severity will be measured using the PCL-5 which is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptoms, and changes during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Evidence for the PCL for the diagnostic and Statistical Manual of Mental Disorders (DSM)-IV suggests that a 5-10-point change represents reliable change (i.e., change not due to chance) and a 10-20-point change represents a clinically significant change. Therefore, it was recommended to use 5 points as a minimum threshold for determining whether the improvements are clinically meaningful using the PCL for DSM-IV. | 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) | The BDI-II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total BDI-II score, which can range from 0 to 63. (BDI-II total score, alpha-0.90; cognitive factor, alpha .81; Somatic factor, alpha .87) Scoring the Beck Depression Inventory: Low (1-10)-Normal ups and downs; (11-16)-Mild mood disturbance Mild mood disturbance (17-20) Borderline clinical depression; (21-30)=Moderate depression Significant (31-40)-Severe depression; over 40-extreme depression | Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transgender women