Although it is well established that both pharmacological and psychological therapies are relatively effective in treating chronic posttraumatic stress disorder (PTSD), the recent Institute of Medicine (IOM, 2007) report highlights vast gaps in our current knowledge noting a lack of knowledge regarding factors influencing treatment acceptance and completion, the combined effectiveness of these pharmacological and psychological treatment, and their efficacy in common subpopulations (e.g., those with diagnostic co-occurrence). To address these gaps, we propose the first large-scale trial to directly focus on individualizing PTSD care across several key parameters: choice of treatment, the effects of combined psychotherapy and pharmacological PTSD treatment, and the presence of co-occurring major depression. Building on our previous psychotherapy and pharmacotherapy trial on PTSD treatment, we will conduct a doubly randomized preference trial in which female and male trauma survivors with chronic PTSD will be randomly assigned to either choice or no choice treatment conditions. In the choice condition, patients will choose between prolonged exposure (PE) and prolonged exposure plus sertraline (PE + SER). In the no choice condition, patients will be randomly assigned to either prolonged exposure alone (PE) or prolonged exposure plus sertraline (PE + SER). In addition, we will specifically recruit and examine patients with co-occurring major depressive disorder (MDD). Outcome, as measured by both psychopathology and broader functioning measures, will be assessed at post-treatment and through 24-month follow-up. We will also examine biopsychosocial markers of response, psychotherapy change processes, and cost-effectiveness of these treatments.
The Specific Aims are: 1) To compare the short-term and long-term effectiveness of PE to that of PE + SER;2) To systematically compare patients who have chosen their treatment to those who have not in terms of treatment adherence, treatment completion, and effectiveness;and 3) To compare individuals with PTSD alone to those with PTSD and co-occurring major depression. In line with the NIMH's strategic plan, this application focuses on more personalized medicine, focusing on patients'choices and better understanding individual trajectories of outcome.

Public Health Relevance

The present study is critically important for better personalizing care for patients with PTSD. We will focus on individualizing PTSD care across key parameters: choice of treatment, combined psychotherapy and pharmacological treatment, and the presence of co-occurring major depression (MDD). The results of the proposed research will inform clinicians about clients'treatment preferences, the relative short- and long-term effectiveness of combined PE and sertraline, provide information about more complex patients and when more or less treatment is desired and/or needed, and provide contextual information about biological, psychosocial, and process markers of therapeutic change.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH066348-10
Application #
8635383
Study Section
Special Emphasis Panel (ZMH1-ERB-F (06))
Program Officer
Pearson, Jane L
Project Start
2002-08-01
Project End
2015-01-31
Budget Start
2014-03-01
Budget End
2015-01-31
Support Year
10
Fiscal Year
2014
Total Cost
$600,428
Indirect Cost
$217,990
Name
Case Western Reserve University
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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Jun, Janie J; Zoellner, Lori A; Feeny, Norah C (2013) Sudden gains in prolonged exposure and sertraline for chronic PTSD. Depress Anxiety 30:607-13
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Rytwinski, Nina K; Avena, Jennifer S; Echiverri-Cohen, Aileen M et al. (2013) The relationships between posttraumatic stress disorder severity, depression severity and physical health. J Health Psychol :

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