Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01049516
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2010-01-12
Brief Title:
Prolonged Exposure for Post Traumatic Stress Disorder PTSD Among Operation Iraqi FreedomOperation Enduring Freedom OIFOEF Personnel
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Prolonged Exposure for PTSD Among OIFOEF Personnel Massed vs Spaced Trials
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRONG STAR
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 3111111 for MCCM-PES-PEPCT Due to the urgent need for data to inform military clinical practice enrollment in MCC was accelerated by changing the ratio to 1111 in order to report the comparison between M-PE and MCC When 30 participants were enrolled in MCC randomization resumed to approximately 3111111 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 PhD 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 PhDChief Soldier Behavioral HealthOutpatient Psychiatry Carl R Darnall Army Medical Center 36000 Darnall Loop Fort Hood TX 76544 The study will be conducted at Fort Hood Texas
This study is part of the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience STRONG STAR Consortium Director Alan L Peterson PhD 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 PhDChief Soldier Behavioral HealthOutpatient Psychiatry Carl R Darnall Army Medical Center 36000 Darnall Loop Fort Hood TX 76544 The study will be conducted at Fort Hood Texas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-08-2-0111 | None | None | None |