The purpose of this study is to compare the short- and long-term effectiveness of two different treatments for post-traumatic stress disorder (PTSD).

Study hypothesis: Both sertraline and cognitive behavior therapy (CBT), or prolonged exposure, will reduce symptoms of PTSD.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: Sertraline  Behavior: Cognitive behavior therapy (CBT)	Phase III

Further Study Details: 

Primary Outcomes: PTSD symptoms; depression symptoms; anxiety symptoms
Secondary Outcomes: Quality of life functioning
Expected Total Enrollment:  360

Exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00127673

Ohio
      Department of Psychiatry, University Hospitals Cleveland, Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Washington
      Department of Psychology, University of Washington, Seattle,  Washington,  98195,  United States; Recruiting

Study chairs or principal investigators

Norah C. Feeny, PhD,  Principal Investigator,  Department of Psychiatry, University Hospitals Cleveland, Case Western Reserve University   
Lori A. Zoellner, PhD,  Principal Investigator,  Department of Psychology, University of Washington   

Study ID Numbers:  MH066347; 1R01 MH066347; 1R01 MH066348
Last Updated:  August 5, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00127673
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23