Improving Traumatic Stress in Women Who Have Experienced Homelessness: Evaluation of a Stakeholder Engaged Intervention
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 420
- 主要终点
- Posttraumatic Stress Disorder (PTSD) symptoms
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •impaired decisional capacity (UC-San Diego Brief Assessment ≤14.5)
结局指标
主要结局
Posttraumatic Stress Disorder (PTSD) symptoms
时间窗: 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.
次要结局
- Depressive symptoms(Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16))
- Sleep symptoms(Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16))
- Anxiety(Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16))
- Somatization(Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16))
- Substance use(Pre-Assessment (week 0), Post-Assessment (week 4); Follow-up Assessments (weeks 10 and 16))