Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Posttraumatic Stress Disorders, Combat Disorders

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure Therapy - Massed
* Behavioral: Prolonged Exposure Therapy - Spaced
* Behavioral: Minimal Contact Control
* Behavioral: Present-Centered Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Minimal Contact Control<br> | Behavioral: Minimal Contact Control<br>* 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.<br>* Other names: Wait List;|
| Experimental: PE-Massed<br> | Behavioral: Prolonged Exposure Therapy - Massed<br>* 10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.<br>* Other names: Massed-PE;|
| Active Comparator: PE-Spaced<br> | Behavioral: Prolonged Exposure Therapy - Spaced<br>* 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.<br>* Other names: Spaced-PE;|
| Active Comparator: Present-Centered Therapy (PCT)<br> | Behavioral: Present-Centered Therapy<br>* 10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment | Affect of treatment on this measure of PTSD symptomology | Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist-Stressor-specific version (PCL-S) | Affect of treatment on a PTSD Assessment of stress | Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE) | 
| PTSD Checklist-Stressor-specific version (PCL-S) | Changes in PTSD stress symptomology upon commencement of treatment | Post-treatment to 2-week follow-up | 
| PTSD Checklist-Stressor-specific version (PCL-S) | Changes in PTSD stress symptomology upon commencement of treatment | 2-week follow-up to 12-week follow-up | 
| PTSD Checklist-Stressor-specific version (PCL-S) | Changes in PTSD stress symptomology upon commencement of treatment | 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 | PTSD Assessment | 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 | PTSD Assessment | Post-treatment to 2-week follow-up | 
| Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment | PTSD Assessment | 2-week follow-up to 12-week follow-up | 
| Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment | PTSD Assessment | 12-week follow-up to 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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