PROlonGed ExpoSure Sertraline (PROGrESS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder	Drug: Sertraline; Behavioral: Prolonged Exposure Therapy	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	223 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).
Study Start Date :	November 2011
Actual Primary Completion Date :	December 2016
Actual Study Completion Date :	May 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Sertraline + enhanced medication management (SERT/EMM); 24 weeks of sertraline + enhanced medication management	Drug: Sertraline; 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.; Other Name: Zoloft
Active Comparator: Prolonged Exposure + sertraline (PE/SERT); Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline	Drug: Sertraline; 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.; Other Name: Zoloft Behavioral: Prolonged Exposure Therapy; up to 13 sessions of prolonged exposure
Active Comparator: Prolonged Exposure + placebo (PE/PLB); Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo	Behavioral: Prolonged Exposure Therapy; up to 13 sessions of prolonged exposure

Outcome Measures

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Primary Outcome Measures :

1. Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: 24 weeks ]
   Total Score; Range 0-136 with increasing PTSD severity as scores increase

Secondary Outcome Measures :

1. Patient Health Questionnaire-15 [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Georgia
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Savannah, Georgia, United States, 31406
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

VA Ann Arbor Healthcare System

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:	Sheila Rauch, PhD	VA Ann Arbor Healthcare System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sheila Rauch, Clinical Director of Wounded Warrior Project and Associate Professor at Emory University, Principal Investigator, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:	NCT01524133 History of Changes
Other Study ID Numbers:	PROGrESS
First Posted:	February 1, 2012
Results First Posted:	February 28, 2018
Last Update Posted:	February 28, 2018
Last Verified:	January 2018

Keywords provided by Sheila Rauch, Atlanta VA Medical Center:

combat-related PTSD; Posttraumatic stress disorder; prolonged exposure therapy; sertraline	military; veterans; VA hospital; mental illness

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sertraline; Antidepressive Agents; Psychotropic Drugs	Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs