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Examining the Effectiveness of an Early Psychological Intervention to Prevent Post-Traumatic Stress Disorder
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Institute of Mental Health (NIMH).   Recruitment status was  Recruiting

First Received on May 7, 2009.   Last Updated on June 25, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00895518
  Purpose

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 Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: Prolonged Exposure (PE) Therapy
Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Early Psychological Intervention to Prevent PTSD

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • PTSD Symptom Scale- I (PSS) [ Time Frame: Measured 4 and 12 weeks post-trauma ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895518

Contacts
Contact: Barbara O. Rothbaum, PhD 404-712-8866 brothb@emory.edu
Contact: Cathrine Arndt-Jordan, MA 404-727-3662 carndt@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital, Emergency Department Recruiting
Atlanta, Georgia, United States, 30303
Contact: Shakiyla Smith, MS     404-616-6575     lrsmit3@emory.edu    
Sub-Investigator: Debra Houry, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara O. Rothbaum, PhD Emory University
  More Information

No publications provided

Responsible Party: Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier: NCT00895518     History of Changes
Other Study ID Numbers: R34 MH083078, DATR AD-TS
Study First Received: May 7, 2009
Last Updated: June 25, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012