An interventional study of 1-Session Exposure Therapy and 3-Session Exposure Therapy in Posttraumatic Stress Disorder, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
The overall aim of this study is to determine the optimal dose, 3-session exposure intervention versus 1-session exposure intervention compared to no treatment, for the delivery of exposure therapy in the immediate aftermath of trauma for preventing the development of posttraumatic stress disorder.
The precipitant for adult posttraumatic stress disorder (PTSD) is a known event, which allows for immediate intervention and presents the potential to prevent the occurrence of this serious condition. However, there currently are no accepted interventions for the early intervention and prevention of PTSD in the immediate aftermath of trauma. This study will determine whether providing exposure therapy to people who have recently experienced trauma will significantly reduce the severity of PTSD symptoms post-trauma and if delivery of three exposure sessions will result in larger reductions in the symptoms of PTSD post-trauma than one exposure session. This study will also examine predictors for treatment response.
Participation in this study will last 12 months. Participants will first undergo an evaluation session that will include an interview and questionnaires. They will then be randomly assigned to one of the following three conditions: 1-session exposure therapy, 3-session exposure therapy, or assessment only. Participants receiving 1-session exposure therapy will complete one treatment session in the emergency department (ED). Participants receiving 3-session exposure therapy will complete three weekly treatment sessions, with the first occurring in the ED. 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, 3, 6, and 12 months after the initial evaluation session.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 95 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Participants will receive assessment only.
Participants will receive one session of exposure therapy.
Behavioral: 1-Session Exposure Therapy
Participants will receive three sessions of exposure therapy.
Behavioral: 3-Session Exposure Therapy
One exposure therapy session lasting one hour
Three exposure therapy sessions lasting one hour each, delivered one week apart
Change in PTSD Symptom Scale-I (PSS)
Time frame: Measured 1, 3, 6, 12 months post-trauma
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Emory University