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Comparison of Two Treatments for Post-Traumatic Stress Disorder
This study is ongoing, but not recruiting participants.
Study NCT00127673   Information provided by National Institute of Mental Health (NIMH)
First Received: August 5, 2005   Last Updated: May 26, 2009   History of Changes

August 5, 2005
May 26, 2009
September 2004
June 2011   (final data collection date for primary outcome measure)
  • PTSD symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
  • Depression symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
  • PTSD symptoms
  • depression symptoms
  • anxiety symptoms
Complete list of historical versions of study NCT00127673 on ClinicalTrials.gov Archive Site
Quality of life functioning [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
Quality of life functioning
 
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Effectiveness of PTSD Treatment: CBT Versus Sertraline

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

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.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Post-Traumatic Stress Disorder
  • Drug: Sertraline
  • Behavioral: Cognitive behavioral therapy (CBT)
  • Active Comparator: Participants will receive no choice cognitive behavioral therapy
  • Active Comparator: Participants will receive choice cognitive behavioral therapy
  • Active Comparator: Participants will receive no choice sertraline
  • Active Comparator: Participants will receive choice sertraline
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
360
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127673
Norah Feeny, PhD, Case Western Reserve University
R01 MH066347, R01 MH66348, DSIR 83-ATAS
National Institute of Mental Health (NIMH)
 
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
National Institute of Mental Health (NIMH)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP