Posttraumatic Stress Disorders Clinical Trial
Official title:
Prolonged Exposure for PTSD Among OIF/OEF Personnel: Massed vs. Spaced Trials
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).
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.
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