Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
223 participants
INTERVENTIONAL
2011-11-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sertraline + enhanced medication management (SERT/EMM)
24 weeks of sertraline + enhanced medication management
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.
Prolonged Exposure + sertraline (PE/SERT)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
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.
Prolonged Exposure Therapy
up to 13 sessions of prolonged exposure
Prolonged Exposure + placebo (PE/PLB)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy
up to 13 sessions of prolonged exposure
Interventions
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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.
Prolonged Exposure Therapy
up to 13 sessions of prolonged exposure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
VA Ann Arbor Healthcare System
FED
Responsible Party
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Sheila Rauch
Clinical Director of Wounded Warrior Project and Associate Professor at Emory University, Principal Investigator
Principal Investigators
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Sheila Rauch, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System
Locations
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VA San Diego Healthcare System
San Diego, California, United States
Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic
Savannah, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Countries
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References
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Allard CB, Norman SB, Straus E, Kim HM, Stein MB, Simon NM, Rauch SAM; PROGrESS Study Team. Reductions in guilt cognitions following prolonged exposure and/or sertraline predict subsequent improvements in PTSD and depression. J Behav Ther Exp Psychiatry. 2021 Dec;73:101666. doi: 10.1016/j.jbtep.2021.101666. Epub 2021 Jun 1.
Rauch SAM, Kim HM, Lederman S, Sullivan G, Acierno R, Tuerk PW, Simon NM, Venners MR, Norman SB, Allard CB, Porter KE, Martis B, Bui E, Baker AW; PROGrESS Team. Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD. J Clin Psychiatry. 2021 Jun 15;82(4):20m13752. doi: 10.4088/JCP.20m13752.
Sheynin J, Duval ER, King AP, Angstadt M, Phan KL, Simon NM, Rauch SAM, Liberzon I. Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Oct;37(10):1037-1046. doi: 10.1002/da.23075. Epub 2020 Jul 15.
Rauch SAM, King A, Kim HM, Powell C, Rajaram N, Venners M, Simon NM, Hamner M, Liberzon I. Cortisol awakening response in PTSD treatment: Predictor or mechanism of change. Psychoneuroendocrinology. 2020 Aug;118:104714. doi: 10.1016/j.psyneuen.2020.104714. Epub 2020 May 15.
Duval ER, Sheynin J, King AP, Phan KL, Simon NM, Martis B, Porter KE, Norman SB, Liberzon I, Rauch SAM. Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Jul;37(7):670-681. doi: 10.1002/da.23022. Epub 2020 Apr 19.
Joshi SA, Duval ER, Sheynin J, King AP, Phan KL, Martis B, Porter KE, Liberzon I, Rauch SAM. Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Psychiatry Res Neuroimaging. 2020 May 30;299:111062. doi: 10.1016/j.pscychresns.2020.111062. Epub 2020 Mar 5.
Goetter EM, Hoeppner SS, Khan AJ, Charney ME, Wieman S, Venners MR, Avallone KM, Rauch SAM, Simon NM. Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support. J Trauma Stress. 2020 Jun;33(3):276-284. doi: 10.1002/jts.22496. Epub 2020 Mar 26.
Rauch SAM, Kim HM, Powell C, Tuerk PW, Simon NM, Acierno R, Allard CB, Norman SB, Venners MR, Rothbaum BO, Stein MB, Porter K, Martis B, King AP, Liberzon I, Phan KL, Hoge CW. Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Feb 1;76(2):117-126. doi: 10.1001/jamapsychiatry.2018.3412.
Rauch SAM, Simon NM, Kim HM, Acierno R, King AP, Norman SB, Venners MR, Porter K, Phan KL, Tuerk PW, Allard C, Liberzon I, Rothbaum BO, Martis B, Stein MB, Hoge CW. Integrating biological treatment mechanisms into randomized clinical trials: Design of PROGrESS (PROlonGed ExpoSure and Sertraline Trial). Contemp Clin Trials. 2018 Jan;64:128-138. doi: 10.1016/j.cct.2017.10.013. Epub 2017 Oct 29.
Other Identifiers
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PROGrESS
Identifier Type: -
Identifier Source: org_study_id
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