PROlonGed ExpoSure Sertraline

VA Ann Arbor Healthcare System223 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

223

Conditions

Posttraumatic Stress Disorder

Interventions

SertralineDRUG

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.

Prolonged Exposure TherapyBEHAVIORAL

up to 13 sessions of prolonged exposure

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (4)

VA San Diego Healthcare System

San Diego, California, United States

Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic

Savannah, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 24 weeks

Secondary Outcomes

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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