Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
OPT
Optimizing PTSD Treatment: PE Versus PE Plus Sertraline
3 other identifiers
interventional
150
1 country
2
Brief Summary
The specific aims of this study are:
- 1.To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline).
- 2.To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment.
- 3.To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment.
- 4.To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2011
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedAugust 3, 2021
August 1, 2021
5.8 years
May 11, 2012
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Posttraumatic stress disorder (PTSD) Symptoms
Interview measure to assess PTSD symptoms.
Measured up to 9 months.
Secondary Outcomes (1)
Depression symptoms
Measured up to 9 months.
Study Arms (4)
Choice: Prolonged exposure (PE)
ACTIVE COMPARATORParticipants randomized to "choice" who choose prolonged exposure (PE).
Choice: PE plus sertraline
ACTIVE COMPARATORParticipants randomized to "choice" who choose PE plus sertraline.
No choice: Prolonged exposure (PE)
ACTIVE COMPARATORParticipants randomized to "no choice" who are then randomized to PE.
No Choice: PE plus sertraline
ACTIVE COMPARATORParticipants randomized to "no choice" who are then randomized to PE plus sertraline.
Interventions
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.
Eligibility Criteria
You may qualify if:
- DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment if needed
You may not qualify if:
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
- No clear trauma memory or trauma before age 3
- Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
- Ongoing intimate relationship with the perpetrator of the traumatic event
- History of nonresponse to adequate trial of either CBT or sertraline
- Medical contraindication for sertraline
- Current high dose use of benzodiazepines
- Pregnant or sexually active female without adequate birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- University of Washingtoncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Psychological Sciences Department Case Western Reserve University
Cleveland, Ohio, 44106, United States
Psychology Department of University of Washington
Seattle, Washington, 98195, United States
Related Publications (3)
Rosencrans PL, Walker RSW, Coyne AE, Baier AL, Klein AB, Shekhtman K, Bowling AR, Feeny NC, Zoellner LA. Reciprocal relationships between posttraumatic stress disorder symptoms and positive and negative affect in evidence-based treatments for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):630-640. doi: 10.1037/ccp0000898.
PMID: 39418460DERIVEDCoyne AE, Mattson E, Bagley JM, Klein AB, Shekhtman K, Payat S, Levine DS, Feeny NC, Zoellner LA. Within-patient association between emotion regulation and outcome in prolonged exposure for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):582-593. doi: 10.1037/ccp0000837. Epub 2023 Nov 16.
PMID: 37971811DERIVEDRosencrans PL, Zoellner LA, Feeny NC. A network approach to posttraumatic stress disorder: Comparing interview and self-report networks. Psychol Trauma. 2024 Feb;16(2):340-346. doi: 10.1037/tra0001151. Epub 2021 Oct 21.
PMID: 34672659DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norah C Feeny, PhD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
Lori A Zoellner, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 17, 2012
Study Start
March 1, 2011
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
August 3, 2021
Record last verified: 2021-08