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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Barbara O. Rothbaum, PhD | 404-712-8866 | brothb@emory.edu |
| Contact: Cathrine Arndt-Jordan, MA | 404-727-3662 | carndt@emory.edu |
| 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 | |
| Principal Investigator: | Barbara O. Rothbaum, PhD | Emory University |
More Information
| 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 |
|
PTSD |
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |