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临床试验/NCT00057629
NCT00057629已完成2 期

Effectiveness of Treatment for PTSD in Community Agencies

University of Pennsylvania4 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
187
试验地点
4
主要终点
Severity of PTSD, depression, anxiety and general function

研究概览

简要总结

This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post Traumatic Stress Disorder (PTSD).

详细描述

PE is a brief cognitive behavioral therapy that can ameliorate symptoms of PTSD, depression, and anxiety in survivors of various types of trauma. PE has been successfully implemented by counselors at a community rape crisis clinic (Women Organized Against Rape [WOAR]) who received extensive training and weekly supervision from PE experts. Such extensive expert involvement is not a practical model for long-term clinical practice in a community-based clinic. Therefore, Part 1 of this study will examine whether counselors at WOAR can maintain their PE implementation success with reduced expert involvement. In Part 2 of this study, PE will be implemented by counselors at another community clinic (Joseph J. Peters Institute [JJPI]) to examine its effectiveness in treating PTSD and to determine the generalizability of training procedures.

Participants in this study are randomly assigned to either PE or to individual and group therapy. Treatment sessions are conducted weekly for 10 to 20 weeks, based on participants' rates of improvement. Participants are assessed before treatment, after 10 weeks, and again in the follow-up phase at 3, 6, 12, and 24 months post-treatment.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • DSM-IV criteria for PTSD at least 12 weeks after sexual assault
  • PTSD symptoms that result from sexual assault and not from another traumatic experience

排除标准

  • DSM-IV criteria for schizophrenia or delusional disorder
  • Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
  • Substance dependence
  • Continued intimate relationship with the assailant

结局指标

主要结局

Severity of PTSD, depression, anxiety and general function

时间窗: Measured pre- and post-treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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