PROlonGed ExpoSure Sertraline

Phase 4

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: Sertraline; Behavioral: Prolonged Exposure Therapy

• Registration Number: NCT01524133
• Lead Sponsor: VA Ann Arbor Healthcare System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Results First Submitted: 2017-12-06
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-30
• Last Update Submitted: 2018-01-30
• Results First Posted: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure + sertraline (PE/SERT)	Prolonged Exposure Therapy	Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Prolonged Exposure + placebo (PE/PLB)	Prolonged Exposure Therapy	Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Sertraline + enhanced medication management (SERT/EMM)	Sertraline	24 weeks of sertraline + enhanced medication management
Prolonged Exposure + sertraline (PE/SERT)	Sertraline	Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-15	24 weeks	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

Trial Locations

Locations (4)

Veterans Affairs Ann Arbor Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States

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