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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00895518
First received: May 7, 2009
Last updated: October 7, 2014
Last verified: October 2014

May 7, 2009
October 7, 2014
April 2008
January 2012   (final data collection date for primary outcome measure)
PTSD Symptom Scale- I (PSS) [ Time Frame: Measured 4 and 12 weeks post-trauma ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895518 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Examining the Effectiveness of an Early Psychological Intervention to Prevent Post-Traumatic Stress Disorder
Effects of Early Psychological Intervention to Prevent PTSD

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Post-Traumatic Stress Disorder
Behavioral: Prolonged Exposure (PE) Therapy
Three PE sessions lasting 1 hour each, delivered 1 week apart
  • No Intervention: 1
    Participants will receive assessments only.
  • Experimental: 2
    Participants will receive prolonged exposure therapy.
    Intervention: Behavioral: Prolonged Exposure (PE) Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00895518
IRB00009260, DATR AD-TS, R34 MH083078
Yes
Barbara O. Rothbaum, PhD, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Barbara O. Rothbaum, PhD Emory University
Emory University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP