Comparison of Two Treatments for Post-Traumatic Stress Disorder
NCT ID: NCT00127673
Last Updated: 2022-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2004-09-30
2011-08-31
Brief Summary
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Detailed Description
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Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months. Participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, 12, and 24 months after the study treatment period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT no choice
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
CBT choice
Participants will receive choice cognitive behavioral therapy (CBT choice)
Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
sertraline no choice
Participants will receive no choice sertraline (sertraline no choice)
Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
sertraline choice
Participants will receive choice sertraline (sertraline choice)
Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
Interventions
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Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Experienced traumatic event at least 12 weeks prior to study entry
* Willingness to discontinue current CBT or antidepressant treatment
Exclusion Criteria
* Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
* 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 either CBT or sertraline
* Medical contraindication for sertraline
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Case Western Reserve University
OTHER
Responsible Party
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Norah Feeny
Professor
Principal Investigators
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Norah C. Feeny, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Case Western Reserve University
Lori A. Zoellner, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, University of Washington
Locations
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Department of Psychology, University of Washington
Seattle, Washington, United States
Countries
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References
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Gauthier GM, PeConga EK, Mohr JL, Feeny NC, Zoellner LA. Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response. Psychol Trauma. 2025 Feb;17(2):429-437. doi: 10.1037/tra0001790. Epub 2024 Nov 7.
Rosencrans 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.
Graham B, Garcia NM, Bergman HE, Feeny NC, Zoellner LA. Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning. J Trauma Stress. 2020 Aug;33(4):488-499. doi: 10.1002/jts.22570. Epub 2020 Jul 13.
Zoellner LA, Roy-Byrne PP, Mavissakalian M, Feeny NC. Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD. Am J Psychiatry. 2019 Apr 1;176(4):287-296. doi: 10.1176/appi.ajp.2018.17090995. Epub 2018 Oct 19.
Le QA, Doctor JN, Zoellner LA, Feeny NC. Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD). Qual Life Res. 2018 Jun;27(6):1555-1562. doi: 10.1007/s11136-018-1833-4. Epub 2018 Mar 14.
Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014 Mar;75(3):222-30. doi: 10.4088/JCP.13m08719.
Le QA, Doctor JN, Zoellner LA, Feeny NC. Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59.
Related Links
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Click here for more information about the effectiveness of CBT and sertraline for PTSD
Other Identifiers
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