跳至主要内容
临床试验/NCT01049516
NCT01049516已完成不适用

Prolonged Exposure for PTSD Among OIF/OEF Personnel: Massed vs. Spaced Trials

University of Pennsylvania6 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2010年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
366
试验地点
6
主要终点
Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment

研究概览

简要总结

The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).

详细描述

The purpose of this study is to improve the efficiency of treatment for post-traumatic stress disorder (PTSD) with prolonged exposure (PE), an efficacious treatment for PTSD typically administered in once- or twice-weekly sessions. We will evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) will evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT). Randomization was initially set at 3:11:11:11 for MCC:M-PE:S-PE:PCT. Due to the urgent need for data to inform military clinical practice, enrollment in MCC was accelerated by changing the ratio to 1:1:1:1 in order to report the comparison between M-PE and MCC. When 30 participants were enrolled in MCC, randomization resumed to approximately 3:11:11:11. Prolonged Exposure (PE; Foa, Hembree, & Rothbaum, 2007; Foa & Rothbaum, 1998) was developed by the PI, Edna Foa, and colleagues in the Center for the Treatment & Study of Anxiety (CTSA), University of Pennsylvania. It has been found quite efficacious in reducing PTSD and related psychopathology with various types of trauma in PTSD centers around the world. Furthermore, PE has been identified in the joint VA-Department of Defense Clinical Practice Guideline for PTSD (VA-DoD Clinical Practice Guideline Working Group, 2003) as "strongly recommended" for use with veterans with PTSD, based on the strong empirical support for PE.

This study is part of the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) (Consortium Director: Alan L. Peterson, Ph.D., ABPP, Professor, Behavioral Wellness Center for Clinical Trials, Department of Psychiatry-Mail Code 7792, University of Texas Health Science Center at San Antonio (UTHSCSA), 7703 Floyd Curl Drive, San Antonio, TX 78229-3900). Dr. Edna Foa is the overall PI of the study, and the on-site PI is COL Jeffrey Yarvis, Ph.D.,Chief, Soldier Behavioral Health/Outpatient Psychiatry, Carl R. Darnall Army Medical Center, 36000 Darnall Loop, Fort Hood, TX, 76544. The study will be conducted at Fort Hood, Texas.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male and female active-duty OIF/OEF military personnel and recently separated OIF/OEF veterans ages 18-65 seeking treatment for PTSD
  • Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSS-I).

排除标准

  • Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
  • Current alcohol dependence (as determined by the AUDIT)
  • Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
  • Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
  • Other psychiatric disorders severe enough to warrant designation as the primary disorder

研究组 & 干预措施

Minimal Contact Control

Other

干预措施: Minimal Contact Control (Behavioral)

PE-Massed

Experimental

干预措施: Prolonged Exposure Therapy - Massed (Behavioral)

PE-Spaced

Active Comparator

干预措施: Prolonged Exposure Therapy - Spaced (Behavioral)

Present-Centered Therapy (PCT)

Active Comparator

干预措施: Present-Centered Therapy (Behavioral)

结局指标

主要结局

Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment

时间窗: Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE

Affect of treatment on this measure of PTSD symptomology

次要结局

  • PTSD Checklist-Stressor-specific version (PCL-S)(12-week follow-up to 6-month follow-up)
  • Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment(Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE))
  • Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment(12-week follow-up to 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验