Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel
NCT01049516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366
Last updated 2018-11-27
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).
Conditions
- Posttraumatic Stress Disorders
- Combat Disorders
Interventions
- 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.
- 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.
- 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.
- 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
Sponsors & Collaborators
-
The University of Texas Health Science Center at San Antonio
collaborator OTHER -
U.S. Army Medical Research and Development Command
collaborator FED - lead OTHER
Principal Investigators
-
Edna B. Foa, Ph.D. · Center for the Treatment and Study of Anxiety, University of Pennsylvania
-
Elna Yadin, Ph.D. · Center for the Treatment and Study of Anxiety, University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- United States
Study Locations
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