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

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ClinicalTrials.gov Identifier: NCT01049516
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
University of Pennsylvania

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049516


Locations
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United States, Pennsylvania
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Carl R. Darnall Army Medical Center
Killeen, Texas, United States, 76544
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
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01049516    
Other Study ID Numbers: PT074199P13
W81XWH-08-2-0111
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Keywords provided by University of Pennsylvania:
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
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Combat Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders