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

Posttraumatic Stress Disorders Clinical Trial

— STRONG STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049516
• Other study ID #: PT074199P13
• Secondary ID: W81XWH-08-2-0111
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: August 2018

Study information

• Verified date: November 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure Therapy - Massed
10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.
• Prolonged Exposure Therapy - Spaced
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.
• Minimal Contact Control
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.
• Present-Centered Therapy
10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants

Locations

Country	Name	City	State
United States	Carl R. Darnall Army Medical Center	Killeen	Texas
United States	Center for the Treatment and Study of Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	The University of Texas Health Science Center at San Antonio, U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	PTSD Checklist-Stressor-specific version (PCL-S)	Changes in PTSD stress symptomology upon commencement of treatment	Post-treatment to 2-week follow-up
Secondary	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
Secondary	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
Secondary	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)
Secondary	Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment	PTSD Assessment	Post-treatment to 2-week follow-up
Secondary	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
Secondary	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

External Links

•   Link to Strong Star research consortium