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临床试验/NCT04605198
NCT04605198已完成不适用

Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women

University of California, Los Angeles4 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
4
主要终点
Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders).

研究概览

简要总结

Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response.

Hypotheses:

  1. Participation in an MBSR-based intervention will be associated with clinically significant reduction in PTSD (primary outcome), lower depression symptoms and greater drug and alcohol abstinence (secondary outcomes) compared to participation in an attention control.
  2. Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation.

At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.

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
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-reported homeless women
  • willing to provide informed consent
  • lifetime exposure to at least one Diagnostic and Statistical Manuel of Mental Disorders, version 5 (DSM-5) qualifying trauma
  • likely subthreshold or threshold PTSD, as measured by the PTSD Checklist for Civilians for DSM-
  • Note: A homeless person is defined as anyone who spent the previous night in a public or private shelter, or on the street.

排除标准

  • not speaking English
  • judged to be cognitively impaired; as indicated by score >9 on the Short-Blessed Screener (SBS).

结局指标

主要结局

Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders).

时间窗: Immediately post-intervention & 6-month follow-up

Change in Posttraumatic Stress Symptoms Disorder symptoms (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 "Not at all," 1 "A little bit," 2 "Moderately," 3 "Quite a bit," and 4 "Extremely." Higher scores indicate more PTSD symptoms.

次要结局

  • Depression(Immediately post-intervention & 6-month follow-up)
  • Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5)(Immediately post-intervention & 6-month follow-up)
  • Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup(Immediately post-intervention & 6-month follow-up)
  • Cortisol Reactivity(Immediately post-intervention & 6-month follow-up)
  • C-Reactive Protein (CRP)(Immediately post-intervention & 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dana Rose Garfin

Assistant Adjunct Professor

University of California, Irvine

研究点 (4)

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