Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel
Condition: Posttraumatic Stress Disorders; Combat Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Prolonged Exposure Therapy - Massed; Prolonged Exposure Therapy - Spaced; Minimal Contact Control; Present-Centered Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.; 10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions 1-3 occur in the first two weeks, Sessions 4-5 occur in Weeks 3-4, and Sessions 6-10 occur in Weeks 5-10.; Participants receive minimal contact for 4 weeks after randomization and thereafter are offered PE-Spaced or PE-Massed, according to their preference. Participants receive 10-15 minute phone calls once per week by the study therapist or independent evaluator in order to monitor their status and to provide support as needed.; 10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants
Other intervention name(s): Massed-PE; Spaced-PE; Wait List
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Military; Combat; Psychological Treatment; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder; PTSD; Prolonged Exposure; Exposure therapy; Behavior Therapy; Cognitive Behavior Therapy; Post-Traumatic Stress Disorders; Stress Disorders, Post-traumatic