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

Emory University

Status and phase

Completed

Phase 1

Conditions

Post-Traumatic Stress Disorder

Treatments

Behavioral: Prolonged Exposure (PE) Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00895518

R34MH083078 (U.S. NIH Grant/Contract)

IRB00009260

DATR AD-TS

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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