Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2011

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.

Intervention(s) in this Clinical Trial

• 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.
• Behavioral: Cognitive behavioral therapy (CBT)
  • CBT will include 10 weekly sessions of individual cognitive behavioral therapy.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Participants will receive no choice cognitive behavioral therapy
• Active Comparator: 2
  • Participants will receive choice cognitive behavioral therapy
• Active Comparator: 3
  • Participants will receive no choice sertraline
• Active Comparator: 4
  • Participants will receive choice sertraline

Primary Measures

• PTSD symptoms
  • Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment
    Safety Issue?: No
• Depression symptoms
  • Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment
    Safety Issue?: No
• Anxiety symptoms
  • Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment
    Safety Issue?: No

Secondary Measures

• Quality of life functioning
  • Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Norah C. Feeny, PhD Principal Investigator Department of Psychology, Case Western Reserve University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00127673

Study ID Number: R01 MH066347

ClinicalTrials.gov Identifier: NCT00127673

Health Authority: United States: Federal Government

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