PROlonGed ExpoSure Sertraline

Study Overview
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Brief Summary
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The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.

Official Title
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Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Sertraline
* Behavioral: Prolonged Exposure Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale [CAPS] >= 50) of at least 3 months duration Exclusion Criteria: Current, imminent risk of suicide (as indicated on C-SSRS) Active psychosis Alcohol or substance dependence in the past 8 weeks Unable to attend regular appointments Prior intolerance or failure of adequate trial of prolonged exposure (PE) or sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day) Medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam) Serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study) Concurrent antidepressants or antipsychotics Pregnant females
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertraline + enhanced medication management (SERT/EMM)<br>24 weeks of sertraline + enhanced medication management | Drug: Sertraline<br>* Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.<br>* Other names: Zoloft;|
| Active Comparator: Prolonged Exposure + sertraline (PE/SERT)<br>Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline | Drug: Sertraline<br>* Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.<br>* Other names: Zoloft;Behavioral: Prolonged Exposure Therapy<br>* up to 13 sessions of prolonged exposure<br>|
| Active Comparator: Prolonged Exposure + placebo (PE/PLB)<br>Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo | Behavioral: Prolonged Exposure Therapy<br>* up to 13 sessions of prolonged exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | Total Score; Range 0-136 with increasing PTSD severity as scores increase | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-15 | PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sertraline, combat-related PTSD, Posttraumatic stress disorder, prolonged exposure therapy, military, veterans, VA hospital, mental illness