Phase 3
Completed N=200
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Source: ClinicalTrials.gov NCT00127673 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
May 2022
Primary outcomePrimary: PTSD Symptoms — 10.02; 10.87; 15.12; 10.78 units on a scale
◆ Published Evidence
Highly cited
121citations · ~17 / year
Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD.
Summary
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
Linked Publications (5)
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Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD.
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Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD).
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Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning.
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A network approach to posttraumatic stress disorder: Comparing interview and self-report networks.
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Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Symptoms |
10.02; 10.87; 15.12; 10.78 | — |
| PRIMARY Depression Symptoms |
10.33; 12.13; 15.24; 12.11 | — |
| PRIMARY State Anxiety |
39.16; 38.79; 46.89; 38.72 | — |
| SECONDARY Quality of Life Functioning |
8.82; 11.68; 14.06; 10.78 | — |
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of PTSD
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment
Exclusion Criteria
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
- 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 either CBT or sertraline
- Medical contraindication for sertraline
Data sourced from ClinicalTrials.gov (NCT00127673) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.