PROlonGed ExpoSure Sertraline (PROGrESS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2014 by VA Ann Arbor Healthcare System
Sponsor:
VA Ann Arbor Healthcare System
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
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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
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 Central Nervous System Agents Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015