Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
Completed · Phase 3
Conditions studied: Posttraumatic Stress Disorder
In brief
The specific aims of this study are: 1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline). 2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment. 3. To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment. 4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
Key facts
- Study ID
- NCT01600456
- Run by
- Case Western Reserve University
- People needed
- 150
- Starts
- 2011-03-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2021-08-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment if needed
You may not qualify if…
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
- No clear trauma memory or trauma before age 3
- Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
- Ongoing intimate relationship with the perpetrator of the traumatic event
- History of nonresponse to adequate trial of either CBT or sertraline
- Medical contraindication for sertraline
- Current high dose use of benzodiazepines
- Pregnant or sexually active female without adequate birth control
Where it is running
- Psychological Sciences Department Case Western Reserve University — Cleveland, Ohio, United States
- Psychology Department of University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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