Comparison of Two Treatments for Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

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

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.
    

Intervention name(s): Sertraline; Cognitive behavioral therapy (CBT)
Intervention type(s): Drug; Behavioral
Intervention description(s): The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.; CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other intervention name(s): Zoloft; Prolonged exposure (PE)
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antidepressants; Cognitive behavior therapy