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

November 26, 2018 updated by: University of Pennsylvania

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Center for the Treatment and Study of Anxiety, University of Pennsylvania
    • Texas
      • Killeen, Texas, United States, 76544
        • Carl R. Darnall Army Medical Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT074199P13
  • W81XWH-08-2-0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Posttraumatic Stress Disorders

Clinical Trials on Minimal Contact Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe