Post-Traumatic Stress Disorder Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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