PROlonGed ExpoSure Sertraline (PROGrESS)
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ClinicalTrials.gov Identifier: NCT01524133 |
Recruitment Status
:
Completed
First Posted
: February 1, 2012
Results First Posted
: February 28, 2018
Last Update Posted
: February 28, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Posttraumatic Stress Disorder | Drug: Sertraline Behavioral: Prolonged Exposure Therapy | Phase 4 |
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 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sertraline + enhanced medication management (SERT/EMM)
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
|
- Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: 24 weeks ]Total Score; Range 0-136 with increasing PTSD severity as scores increase
- Patient Health Questionnaire-15 [ Time Frame: 24 weeks ]PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Sheila Rauch, PhD | VA Ann Arbor Healthcare System |
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 |
Results First Posted: | February 28, 2018 |
Last Update Posted: | February 28, 2018 |
Last Verified: | January 2018 |
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 |