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

No results posted yet for this study

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
  • University of Pennsylvania

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01049516 on ClinicalTrials.gov