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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Effects of Early Psychological Intervention to Prevent PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895518
• Other study ID #: IRB00009260
• Secondary ID: DATR AD-TSR34MH0
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: September 7, 2016
• Start date: April 2008
• Est. completion date: January 2012

Study information

• Verified date: September 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure (PE) Therapy
Three PE sessions lasting 1 hour each, delivered 1 week apart

Locations

Country	Name	City	State
United States	Grady Memorial Hospital, Emergency Department	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Scale- I (PSS)		Measured 4 and 12 weeks post-trauma	No