Open Access Study protocol

Comparison of the effectiveness of trauma-focused cognitive behavioral therapy and paroxetine treatment in PTSD patients: Design of a randomized controlled trial

A Rosaura Polak1*, Anke B Witteveen1, Rogier S Visser1, Brent C Opmeer2, Nienke Vulink1, Martijn Figee1, Damiaan Denys13 and Miranda Olff14

Author Affiliations

1 Academic Medical Center (AMC), Department of Anxiety Disorders, University of Amsterdam (UvA), Meibergdreef 5, Amsterdam, 1105 AZ, The Netherlands

2 Academic Medical Center (AMC), Clinical Research Unit, University of Amsterdam, Meibergdreef 5, Amsterdam, 1105 AZ, The Netherlands

3 The Netherlands Institute for Neuroscience (NIN), an institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, 1105 BA, The Netherlands

4 Arq Psychotrauma Expert Group the Netherlands, Nienoord 5, Diemen, 1112 XE, The Netherlands

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BMC Psychiatry 2012, 12:166  doi:10.1186/1471-244X-12-166

Published: 9 October 2012



The two most common interventions for Posttraumatic Stress Disorder (PTSD) are pharmacological treatment with SSRIs such as paroxetine and psychological treatment such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). International guidelines recommend trauma-focused psychological interventions for all PTSD patients as first-line treatment (NICE). However, no clear-cut evidence is available to support this recommendation.


In order to compare pharmacological treatment (paroxetine) and psychological treatment (TF-CBT) in (cost-) effectiveness on the short and the long term, we will randomize 90 patients with chronic PTSD to either paroxetine (24 weeks) or TF-CBT (10–12 weeks). We will assess symptom severity and costs before and after the intervention with the Clinician Administered PTSD Scale (CAPS), the Clinical Global Impression Scale (CGI) and the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).


This study is unique for its direct comparison of the most commonly used psychological intervention (TF-CBT) and pharmacological intervention (paroxetine) on (cost-) effectiveness on the short and the long term. The anticipated results will provide relevant evidence concerning long-term effects and relapse rates and will be beneficial in reducing societal costs. It may also provide information on who may benefit most from which type of intervention. Some methodological issues will be discussed.

Trial Registration

Dutch Trial registration: NTR2235

PTSD; TF-CBT; Paroxetine; Effectiveness; Cost-effectiveness