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临床试验/NCT02081417
NCT02081417已完成不适用

Patient-Centered Trauma Treatment for PTSD and Substance Abuse: Is it an Effective Treatment Option?

University of New Mexico2 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
291
试验地点
2
主要终点
Change in Coping Skills

研究概览

简要总结

Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships.

Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs?

The investigators have three specific aims:

  1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes.
  2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups.
  3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.

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
Single (Investigator)

入排标准

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

入选标准

  • Be a member of INSIDE OUT, a peer-run wellness center
  • Be at least 18 years old
  • Have a history of trauma
  • Meet DSM-IV diagnostic criteria for lifetime and current full or sub-threshold PTSD
  • Meet DSM-IV diagnostic criteria for current substance abuse or dependence
  • Be able to provide informed consent to participate in the study.

排除标准

  • Live outside of catchment area
  • Pending immediate incarceration

结局指标

主要结局

Change in Coping Skills

时间窗: baseline, 3 months

The Coping Scale will be used to assess coping skills. The Coping Scale directly assesses the degree to which participants report using 17 specific coping skills from SS, scaled from 0 (not at all) to 5 (extremely). This scale was selected as it is the most widely used measure of coping in the SS literature. As a result we will be able to directly compare our findings to other studies. Higher scores indicate greater frequency of use of coping skills with the range of total scores being 0 to 90

Change in Post-traumatic Stress Disorder Symptoms

时间窗: baseline, 3 months

PTSD Symptoms will be measured by the post-traumatic symptom checklist - civilian version. Responses are summed to yield a total severity score, with the full range for total scores being 17 to 85 (higher scores mean higher severity).

次要结局

  • Change in Substance Use - Alcohol Use(baseline, 3 months)
  • Change in Substance Use - Drug Use(Baseline, 3-Month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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