Examining the Effectiveness of an Early Psychological Intervention to Prevent Post-Traumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT00895518|
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : September 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: Prolonged Exposure (PE) Therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
No Intervention: 1
Participants will receive assessments only.
Participants will receive prolonged exposure therapy.
Behavioral: Prolonged Exposure (PE) Therapy
Three PE sessions lasting 1 hour each, delivered 1 week apart
- PTSD Symptom Scale- I (PSS) [ Time Frame: Measured 4 and 12 weeks post-trauma ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895518
|United States, Georgia|
|Grady Memorial Hospital, Emergency Department|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Barbara O. Rothbaum, PhD||Emory University|