跳至主要内容
临床试验/NCT05873517
NCT05873517撤回1 期

Pragmatic, Waitlist Randomized Controlled Trial of a Trauma-Focused Intervention With Women Experiencing Homelessness

Rush University Medical Center4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
入组人数
50
试验地点
4
主要终点
Post-Traumatic Stress Disorder Symptoms

研究概览

简要总结

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

详细描述

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. We have systematically adapted a trauma-focused intervention protocol (Narrative Exposure Therapy [NET]) to the self-identified needs and preferences of trauma-affected women experiencing homelessness. This adapted intervention, "NET+", incorporates strengths and preferences identified by women themselves, embedding principles of cognitive behavioral therapy (CBT) into conventional NET. NET+ aims to both employ core NET principles to re-process past trauma in parallel with building present-centered skills to address avoidant coping motives in PTSD+SUD. Via a pragmatic, waitlist randomized controlled trial, we will further assess the feasibility, acceptability, and preliminary effects of a 3-week NET+ intervention protocol with up to 100 women experiencing homelessness. We will determine pre- and post-NET+ intervention PTSD and trauma-related symptom scores (depression, anxiety, somatization, sleep), substance use behaviors, and effect sizes. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • self-identifies as a woman;
  • greater than or equal to 18 years;
  • positive screen on TAPS-1 (reflecting problematic substance use);
  • recently (within 1 year) or currently homeless (HRSA definition);
  • affected by a traumatic life event and trauma-related distress (+Life Events Checklist for DSM-5 Standard [LEC-5] response ≥1 and PTSD Checklist for DSM-5 [PCL-5] score ≥28).

排除标准

  • impaired decisional capacity to consent to participation (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] score ≤14.5)

结局指标

主要结局

Post-Traumatic Stress Disorder Symptoms

时间窗: 6 weeks

PTSD Checklist for DSM-5 (PCL-5), range 0-80, higher scores = worse outcome

次要结局

  • Depression(6 weeks)
  • Anxiety(6 weeks)
  • Sleep Problems(6 weeks)
  • Substance Use(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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