Grady Memorial Hospital, Emergency Department
Atlanta, Georgia, 30303, United States
NCT Number: NCT00895518
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Atlanta, Georgia, 30303, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three PE sessions lasting 1 hour each, delivered 1 week apart
Time frame: Measured 4 and 12 weeks post-trauma
Emory University
Other
Effects of Early Psychological Intervention to Prevent PTSD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05512143
Cardiovascular Diseases, Hypertension
Providence, Rhode Island, United States
View Trial DetailsNCT03194386
Mental Disorders, Post-traumatic Stress Disorder
Bordeaux, France
View Trial DetailsNCT03519789
Mental Disorders, Post-traumatic Stress Disorder
Lille, France
View Trial DetailsNCT00739765
Anxiety Disorders, Mental Disorders
New York, United States
View Trial Details