Intervention Evaluation WEH (Women Who Have Experienced Homelessness)
- Conditions
- Posttraumatic Stress Disorder
- Registration Number
- NCT06570525
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
Homelessness and associated traumas disproportionately impact women relative to men. Women who have experienced homelessness (WEH) universally face traumatic stress, often before becoming homeless and while experiencing homelessness.
For WEH who are incarcerated, additional trauma may occur while in correctional settings. Black WEH are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma).
- Detailed Description
Homelessness and associated traumas disproportionately impact women relative to men. Women who have experienced homelessness (WEH) universally face traumatic stress, often before becoming homeless and while experiencing homelessness. For WEH who are incarcerated, additional trauma may occur while in correctional settings. Black WEH are disproportionately impacted by trauma, homelessness, and incarceration, as is related to structural and individual racism and discrimination (racial trauma). In our stepwise, multi-year research process, across hundreds of interviews, WEH identified trauma as their priority health issue. In response to a dearth of culturally acceptable trauma care models, our team pilot tested Narrative Exposure Therapy (NET)-a brief, human rights-informed treatment for complex PTSD in resource-limited settings. In this randomized controlled trial (RCT), we seek to understand whether supplementing nurse-delivered NET with peer/program support will strengthen its effects on PTSD, co-occurring symptoms, and social determinants of health outcomes compared to an attentional control, while optimizing implementation outcomes.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 420
- self-identifies as a woman
- ≥18 years of age
- history of homelessness or currently experiencing homelessness (HRSA criteria)
- affected by trauma-related distress (≥1 on Life Events Checklist + PTSD Checklist for DSM-5 ≥28)
- at least 75% of the sample must self-identify as Black/African American
• impaired decisional capacity (UC-San Diego Brief Assessment ≤14.5)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Posttraumatic Stress Disorder (PTSD) symptoms Eligibility Screening; Pre-/Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5). Higher score = worse outcome. Range: 0-80.
- Secondary Outcome Measures
Name Time Method Depressive symptoms Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) Patient Depression Questionnaire (PHQ-9). Higher score = worse outcome. Range: 0-27.
Sleep symptoms Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) Regensburg Insomnia Scale (RIS). Higher score = worse outcome. Range: 0-40.
Anxiety Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) Generalized Anxiety Disorder (GAD-7). Higher score = worse outcome. Range: 0-21.
Somatization Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) Somatic Symptoms Scale (SSS-8). Higher score = worse outcome. Range: 0-32.
Substance use Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16) Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool. TAPS-1, is a four-item screening that asks about substance use in the past 12 months.