Phase 3
N=200
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00127673 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
May 2022
Primary outcome: Primary: PTSD Symptoms — 10.02; 10.87; 15.12; 10.78 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sertraline (Drug); Cognitive behavioral therapy (CBT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Aug 2011
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 | — |
Summary
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
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). 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.