PROlonGed ExpoSure Sertraline (PROGrESS)

This study has been completed.

Sponsor:

Collaborator:

U.S. Army Medical Research and Materiel Command

Information provided by (Responsible Party):

Sheila Rauch, Atlanta VA Medical Center

ClinicalTrials.gov Identifier:

NCT01524133

First received: January 27, 2012

Last updated: June 16, 2017

Last verified: June 2017

History of Changes

Purpose

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	Intervention	Phase
Posttraumatic Stress Disorder	Drug: Sertraline Behavioral: Prolonged Exposure Therapy	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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).

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Sheila Rauch, Atlanta VA Medical Center:

Primary Outcome Measures:

Posttraumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Posttraumatic stress disorder (PTSD) related psychopathology, including depression, alcohol and substance abuse, and general anxiety [ Time Frame: 24 weeks ]


Enrollment:	223
Study Start Date:	November 2011
Study Completion Date:	May 2017
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sertraline + enhanced medication management (SERT) 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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524133

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


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
Study First Received:	January 27, 2012
Last Updated:	June 16, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017

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