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Comparison of Two Treatments for Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00127673
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : February 3, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Norah Feeny, Case Western Reserve University

Brief Summary:
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: Sertraline Behavioral: Cognitive behavioral therapy (CBT) Phase 3

Detailed Description:

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of PTSD Treatment: CBT Versus Sertraline
Study Start Date : September 2004
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Participants will receive no choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Name: Prolonged exposure (PE)
Active Comparator: 2
Participants will receive choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Name: Prolonged exposure (PE)
Active Comparator: 3
Participants will receive no choice sertraline
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.
Other Name: Zoloft
Active Comparator: 4
Participants will receive choice sertraline
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.
Other Name: Zoloft



Primary Outcome Measures :
  1. PTSD symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ]
  2. Depression symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ]
  3. Anxiety symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ]

Secondary Outcome Measures :
  1. Quality of life functioning [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of PTSD
  • Experienced traumatic event at least 12 weeks prior to study entry
  • Willingness to discontinue current CBT or antidepressant treatment

Exclusion Criteria:

  • Current diagnosis of schizophrenia or delusional disorder
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127673


Locations
United States, Washington
Department of Psychology, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Case Western Reserve University
National Institute of Mental Health (NIMH)
Investigators
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norah Feeny, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00127673     History of Changes
Other Study ID Numbers: R01MH066347 ( U.S. NIH Grant/Contract )
R01MH066347 ( U.S. NIH Grant/Contract )
R01MH066348 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by Norah Feeny, Case Western Reserve University:
Antidepressants
Cognitive behavior therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs