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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00127673 |
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
Condition | Intervention | Phase |
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Post-Traumatic Stress Disorder |
Drug: Sertraline Behavioral: Cognitive behavioral therapy (CBT) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of PTSD Treatment: CBT Versus Sertraline |
Estimated Enrollment: | 360 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive no choice cognitive behavioral therapy
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Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
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2: Active Comparator
Participants will receive choice cognitive behavioral therapy
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Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
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3: Active Comparator
Participants will receive no choice sertraline
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Drug: Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
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4: Active Comparator
Participants will receive choice sertraline
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Drug: Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
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Exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of CBT and the antidepressant sertraline.
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.
Study hypothesis: Both sertraline and cognitive behavior therapy (CBT), or prolonged exposure, will reduce symptoms of PTSD.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christie Jackson, PhD | christie.jackson@nyumc.org |
United States, Ohio | |
Department of Psychology, Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Jennifer Fabritius, BA 216-368-0338 jennifer.fabritius@case.edu | |
Principal Investigator: Norah C. Feeny, PhD | |
United States, Washington | |
Department of Psychology, University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Kelly Parker-Maloney, BS 206-685-3617 kelita@u.washington.edu | |
Principal Investigator: Lori A. Zoellner, PhD |
Principal Investigator: | Norah C. Feeny, PhD | Department of Psychology, Case Western Reserve University |
Principal Investigator: | Lori A. Zoellner, PhD | Department of Psychology, University of Washington |
Responsible Party: | Case Western Reserve University ( Norah Feeny, PhD ) |
Study ID Numbers: | R01 MH66347, R01 MH66348, DSIR 83-ATAS |
Study First Received: | August 5, 2005 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00127673 |
Health Authority: | United States: Federal Government |
Antidepressants Cognitive behavior therapy |
Anxiety Disorders Mental Disorders Sertraline Stress Disorders, Post-Traumatic |
Stress Serotonin Stress Disorders, Traumatic |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Central Nervous System Agents Antidepressive Agents |