Clinical trial NCT01049516: Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel
Official title: Prolonged Exposure for PTSD Among OIF/OEF Personnel: Massed vs. Spaced Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorders
Combat Disorders
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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: U.S. Army Medical Research and Development Command
First posted: 2010-01-14
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment
timeFrame: Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE
Secondary outcomes:
measure: PTSD Checklist-Stressor-specific version (PCL-S)
timeFrame: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
measure: PTSD Checklist-Stressor-specific version (PCL-S)
timeFrame: Post-treatment to 2-week follow-up
measure: PTSD Checklist-Stressor-specific version (PCL-S)
timeFrame: 2-week follow-up to 12-week follow-up
measure: PTSD Checklist-Stressor-specific version (PCL-S)
timeFrame: 12-week follow-up to 6-month follow-up
measure: Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment
timeFrame: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
measure: Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
timeFrame: Post-treatment to 2-week follow-up
measure: Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
timeFrame: 2-week follow-up to 12-week follow-up
measure: Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
timeFrame: 12-week follow-up to 6-month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for the Treatment and Study of Anxiety, University of Pennsylvania
state: Pennsylvania
city: Killeen
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Center for the Treatment and Study of Anxiety, University of Pennsylvania
name: Edna B. Foa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for the Treatment and Study of Anxiety, University of Pennsylvania
name: Elna Yadin, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Taylor DJ, Pruiksma KE, Hale W, McLean CP, Zandberg LJ, Brown L, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Dondanville KA, Litz BT, Roache J, Foa EB. Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes. Sleep. 2020 Oct 13;43(10):zsaa065. doi: 10.1093/sleep/zsaa065.
citation: Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.
citation: Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.