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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01049516

Collaborator

The University of Texas Health Science Center at San Antonio (Other), U.S. Army Medical Research and Development Command (U.S. Fed)

366

Enrollment

Locations

Arms

Duration (Months)

122

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorders Combat Disorders	Behavioral: Prolonged Exposure Therapy - Massed Behavioral: Prolonged Exposure Therapy - Spaced Behavioral: Minimal Contact Control Behavioral: Present-Centered Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Minimal Contact Control	Behavioral: 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. Other Names: Wait List
Experimental: PE-Massed	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. Other Names: Massed-PE
Active Comparator: PE-Spaced	Behavioral: 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. Other Names: Spaced-PE
Active Comparator: Present-Centered Therapy (PCT)	Behavioral: 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for the Treatment and Study of Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Carl R. Darnall Army Medical Center	Killeen	Texas	United States	76544
3	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

University of Pennsylvania
The University of Texas Health Science Center at San Antonio
U.S. Army Medical Research and Development Command

Investigators

Principal Investigator: Edna B. Foa, Ph.D., Center for the Treatment and Study of Anxiety, University of Pennsylvania
Study Director: Elna Yadin, Ph.D., Center for the Treatment and Study of Anxiety, University of Pennsylvania