NCT01524133

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

January 1, 2018

Enrollment Period

5.1 years

First QC Date

January 27, 2012

Results QC Date

December 6, 2017

Last Update Submit

January 30, 2018

Conditions

Posttraumatic Stress Disorder

Keywords

combat-related PTSDPosttraumatic stress disorderprolonged exposure therapysertralinemilitaryveteransVA hospitalmental illness

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

    Total Score; Range 0-136 with increasing PTSD severity as scores increase

    24 weeks

Secondary Outcomes (1)

  • Patient Health Questionnaire-15

    24 weeks

Study Arms (3)

Sertraline + enhanced medication management (SERT/EMM)

ACTIVE COMPARATOR

24 weeks of sertraline + enhanced medication management

Drug: Sertraline

Prolonged Exposure + sertraline (PE/SERT)

ACTIVE COMPARATOR

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Drug: SertralineBehavioral: Prolonged Exposure Therapy

Prolonged Exposure + placebo (PE/PLB)

ACTIVE COMPARATOR

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Behavioral: Prolonged Exposure Therapy

Interventions

SertralineDRUG

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.

Also known as: Zoloft
Prolonged Exposure + sertraline (PE/SERT)Sertraline + enhanced medication management (SERT/EMM)
Prolonged Exposure TherapyBEHAVIORAL

up to 13 sessions of prolonged exposure

Prolonged Exposure + placebo (PE/PLB)Prolonged Exposure + sertraline (PE/SERT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic

Savannah, Georgia, 31406, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (9)

  • 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.

    PMID: 34147766DERIVED

  • 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.

    PMID: 34133087DERIVED

  • 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.

    PMID: 32668087DERIVED

  • 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.

    PMID: 32446108DERIVED

  • 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.

    PMID: 32306485DERIVED

  • 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.

    PMID: 32278278DERIVED

  • 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.

    PMID: 32216142DERIVED

  • 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.

    PMID: 30516797DERIVED

  • 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.

    PMID: 29081351DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMental Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Sheila Rauch
Organization
Atlanta VAMC
sheila.rauch@va.gov
404-321-6111

Study Officials

  • Sheila Rauch, PhD

    VA Ann Arbor Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of Wounded Warrior Project and Associate Professor at Emory University, Principal Investigator

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

February 28, 2018

Results First Posted

February 28, 2018

Record last verified: 2018-01

Locations

US(4)