Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aims of this study are:

        1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE)
           to that of PE and medication (sertraline).

        2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months
           post-treatment.

        3. To compare those who have chosen their treatment to those who have not in terms of
           completion of treatment, treatment satisfaction, and short- and long-term effectiveness
           of the treatment.

        4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
    

Detailed description: 
      Exposure to traumatic events, such as automobile accidents and physical or sexual 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 (cognitive behavior therapy) 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 prolonged exposure and prolonged
      exposure plus the antidepressant sertraline.

      Participants will either be randomly assigned to prolonged exposure (PE) or PE plus
      sertraline, or they will be able to choose one of the two treatments,which will be given for
      10 weeks, followed by 9 months of follow-up assessments. Participants in the PE 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 PE plus sertraline group receive the same
      treatment as the PE group plus they will take sertraline daily for 10 weeks. These
      participants will be seen regularly 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 PE plus sertraline 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 9 months. Participants who do not
      respond to their assigned or chosen treatment will be offered booster sessions or 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, and 9 months after the study treatment period.
    

Intervention name(s): Prolonged exposure (PE); PE plus Sertraline
Intervention type(s): Behavioral; Other
Intervention description(s): PE will include 10 weekly sessions of individual cognitive behavioral therapy.; PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Antidepressants; Cognitive behavior therapy