Posttraumatic Stress Disorder | Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
Posttraumatic Stress Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Posttraumatic Stress Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Prolonged exposure (PE)PE will include 10 weekly sessions of individual cognitive behavioral therapy.
Other:PE plus SertralinePE 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Choice: Prolonged exposure (PE)Participants randomized to "choice" who choose prolonged exposure (PE).
Choice: PE plus sertralineParticipants randomized to "choice" who choose PE plus sertraline.
No choice: Prolonged exposure (PE)Participants randomized to "no choice" who are then randomized to PE.
No Choice: PE plus sertralineParticipants randomized to "no choice" who are then randomized to PE plus sertraline.
Active, not recruiting
Start Date: March 2011
Completed Date: January 2017
Phase: Phase 3
Primary Outcome: Posttraumatic stress disorder (PTSD) Symptoms
Secondary Outcome: Depression symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Norah C Feeny, PhD
Lead Sponsor: Case Western Reserve University
Collaborator: University of Washington