PROlonGed ExpoSure Sertraline (PROGrESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by VA Ann Arbor Healthcare System
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Sheila Rauch, VA Ann Arbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01524133
First received: January 27, 2012
Last updated: July 21, 2014
Last verified: July 2014
  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. 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


Further study details as provided by VA Ann Arbor Healthcare System:

Primary Outcome Measures:
  • Posttraumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic stress disorder (PTSD) related psychopathology, including depression, alcohol and substance abuse, and general anxiety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 441
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sertraline + enhanced medication managment (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

Genders Eligible for Study:   Both
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

Contacts
Contact: Sheila Rauch, PhD 734-845-3545 sherauch@med.umich.edu

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Mark West    858-642-3878    mwestsd@gmail.com   
Principal Investigator: Murray Stein, PhD         
United States, Georgia
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic Recruiting
Savannah, Georgia, United States, 31406
Contact: Michelle Pompei    912-920-0214 ext 2169    pompei@musc.edu   
Principal Investigator: Ron Acierno, PhD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Rogers    617-726-1579    AROGERS7@partners.org   
Principal Investigator: Naomi Simon, MD, MSc         
United States, Michigan
Veterans Affairs Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Margaret Venners, MPH, MSW    734-222-7441    Margaret.Venners@va.gov   
Principal Investigator: Sheila Rauch, PhD         
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

No publications provided

Responsible Party: Sheila Rauch, Director, Serving Returning Veterans' Mental Health, Principal Investigator, Assistant Professor, VA Ann Arbor Healthcare System
ClinicalTrials.gov Identifier: NCT01524133     History of Changes
Other Study ID Numbers: PROGrESS
Study First Received: January 27, 2012
Last Updated: July 21, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by VA Ann Arbor Healthcare System:
combat-related PTSD
Posttraumatic stress disorder
prolonged exposure therapy
sertraline
military
veterans
VA hospital
mental illness

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014