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Examining the Effectiveness of an Early Psychological Intervention to Prevent Post-Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895518
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : September 8, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University

Brief Summary:
This study will examine the use of prolonged exposure therapy on people who have recently experienced a trauma to prevent them from developing post-traumatic stress disorder.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Prolonged Exposure (PE) Therapy Phase 1

Detailed Description:

Post-traumatic stress disorder (PTSD) is a disorder that forms in response to a traumatic event. The symptoms of PTSD, such as hyper-arousal and re-experiencing the traumatic event, are common in all people who have recently experienced a trauma, but those who develop PTSD continue to have these symptoms more than a month after the trauma. Some researchers believe that developing PTSD is the result of a failure to adequately recover from the trauma. This study will determine whether providing a common form of treatment for PTSD, prolonged exposure (PE) therapy, to people who have recently experienced trauma will prevent them from developing PTSD. The study will also seek to identify predictive markers, such as hormone levels and genes, for developing PTSD.

Participation in this study will last 3 months. Participants will first undergo an evaluation session that will include an interview, questionnaires, and a medical chart review for blood pressure and heart rate measurements taken after their trauma. They will then be randomly assigned to receive either PE therapy or assessments only. Participants receiving PE therapy will complete three weekly treatment sessions, with the first occurring immediately after the evaluation session. Treatment will involve reviewing memories of a recent trauma out loud with a therapist and audio-recording these discussions for review at home. All participants will undergo assessments 1 and 3 months after the initial evaluation session. The 1-month assessment will involve an interview and questionnaires similar to the evaluation session, and the 3-month session will involve only a brief phone interview. Some participants will also be asked to complete an optional part of the study in which they provide two saliva samples to researchers: one to measure stress hormones and one to test for genetic bases of trauma response.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Early Psychological Intervention to Prevent PTSD
Study Start Date : April 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Participants will receive assessments only.
Experimental: 2
Participants will receive prolonged exposure therapy.
Behavioral: Prolonged Exposure (PE) Therapy
Three PE sessions lasting 1 hour each, delivered 1 week apart

Primary Outcome Measures :
  1. PTSD Symptom Scale- I (PSS) [ Time Frame: Measured 4 and 12 weeks post-trauma ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for rape in the past 72 hours
  • Meets DSM-IV diagnostic criterion A in which both of the following are present: (i) The person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others (ii) The person's response involved intense fear, helplessness, or horror
  • Speaks and understands spoken English
  • Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments
  • No significant traumatic injuries, as determined by the physician

Exclusion Criteria:

  • Current or history of mania, schizophrenia, or other psychoses
  • Current (past month) prominent suicidal ideation or recent (past 3 months) parasuicidal behavior or other self-injurious behavior, such as low lethality cutting
  • Current (past month) substance dependence; people who meet criteria for current substance abuse but not dependence, or past dependence and have been in remission for at least 1 month are eligible.
  • Experienced a loss of consciousness for more than 5 minutes as a result of injuries sustained during the trauma
  • Intoxicated, altered, or highly distressed to the degree that accurate completion of the study assessments or participation in study procedures is not possible
  • Blood alcohol level above .08, determined by breathalyzer in the emergency department
  • Not alert, oriented, and coherent
  • In severe pain, active labor, or respiratory distress or hemodynamically compromised in any way

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 identifier (NCT number): NCT00895518

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United States, Georgia
Grady Memorial Hospital, Emergency Department
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
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Principal Investigator: Barbara O. Rothbaum, PhD Emory University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Barbara O. Rothbaum, PhD, Professor in Psychiatry and Associate Vice Chair of Clinical Research, Emory University Identifier: NCT00895518    
Other Study ID Numbers: IRB00009260
DATR AD-TS ( Other Identifier: Other )
R34MH083078 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Keywords provided by Barbara O. Rothbaum, PhD, Emory University:
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders