title: Comparison of the effectiveness of trauma-focused cognitive behavioral therapy and paroxetine treatment in PTSD patients: design of a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch Trial registration: NTR2235.
authors.affiliation: Academic Medical Center, Department of Anxiety Disorders, University of Amsterdam, Meibergdreef 5, Amsterdam 1105 AZ, The Netherlands. a.r.polak@amc.nl
authors.forename: A Rosaura
authors.initials: AR
authors.lastname: Polak
authors.forename: Anke B
authors.initials: AB
authors.lastname: Witteveen
authors.forename: Rogier S
authors.initials: RS
authors.lastname: Visser
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: Nienke
authors.initials: N
authors.lastname: Vulink
authors.forename: Martijn
authors.initials: M
authors.lastname: Figee
authors.forename: Damiaan
authors.initials: D
authors.lastname: Denys
authors.forename: Miranda
authors.initials: M
authors.lastname: Olff
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D006801:Humans; D008875:Middle Aged; D017374:Paroxetine / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D012107:Research Design / Q000592:standards*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D017374:Paroxetine