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PROlonGed ExpoSure Sertraline (PROGrESS)

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ClinicalTrials.gov Identifier: NCT01524133
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : December 2016
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 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