PROlonGed ExpoSure Sertraline (PROGrESS)
This study is ongoing, but not recruiting participants.
Sponsor:
VA Ann Arbor Healthcare System
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, 2016
Last verified: June 2016
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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. 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 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: | November 2016 |
| Estimated Primary Completion Date: | November 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 |
| 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
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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
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, 2016 |
| 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, 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 September 26, 2016