跳至主要内容
临床试验/NCT00057629
NCT00057629已完成2 期

Effectiveness of Treatment for PTSD in Community Agencies

University of Pennsylvania2 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1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
187
试验地点
2
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
否

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

研究组 & 干预措施

1 Prolonged Exposure

Active Comparator

Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.

干预措施: Prolonged Exposure (PE) (Behavioral)

2 Individual and group therapy

Active Comparator

TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises.

Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.

干预措施: Treatment as usual group therapy (TUGT) (Behavioral)

2 Individual and group therapy

Active Comparator

TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises.

Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.

干预措施: Supportive counseling (SC) (Behavioral)

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 (2)

Loading locations...

相似试验

Prolonged Exposure Therapy for Post Traumatic Stress... | 临床试验