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)
研究组 & 干预措施
NurseNET-Narrative Exposure Therapy
Nurse-Delivered Narrative Exposure Therapy (NurseNET). Narrative Exposure Therapy (NET) is a brief, low-cost, trauma-focused treatment modality that is effective in treating mobile populations with complex PTSD. In NurseNET, NET is facilitated by a clinically experienced nurse, while peers/program support specialists offer scaffolded support, fostering trust, engagement, and retention. NurseNET begins with administration of a "diagnostic battery" and psychoeducation. Then, in subsequent NurseNET sessions, using gradual imaginative exposure, the nurse guides the participant to verbally express and re-frame their personal trauma narratives to shift unhelpful beliefs/symptoms around trauma. NurseNET utilizes a racism-conscious approach to create relational spaces in which narratives of WEH are positioned to challenge dominant social narratives. Each NurseNET session offers a brief soulfulness-based stress reduction activity to prompt emotional/affective grounding.
干预措施: NurseNET (Behavioral)
PAL: Peer Active Listening
Peer Active Listening (PAL). In the PAL active comparator/control, peers/program support specialists meet individually with participants in "active listening sessions", along the same visit sequence as NurseNET. During PAL sessions, peers/program support specialists allow participants to set each conversational agenda while practicing the tenets of active listening, including attending to body language, paraphrasing the participant's verbal expressions, reflecting feelings, and using tactful repetition. PAL sessions are not intended to center on topics of trauma, but rather designed to offer a supportive relationship (attentional control).
干预措施: PAL (Other)
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))