title: Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial.
abstract: BACKGROUND
  Currently few evidence based interventions are available for the prevention of PTSD within the first weeks after trauma. Increased risk for PTSD development is associated with dysregulated fear and stress responses prior to and shortly after trauma, as well as with a lack of perceived social support early after trauma. Oxytocin is a potent regulator of these processes. Therefore, we propose that oxytocin may be important in reducing adverse consequences of trauma. The 'BONDS' study is conducted in order to assess the efficacy of an early intervention with intranasal oxytocin for the prevention of PTSD.
  
  
  METHODS
  In this multicenter double-blind randomized placebo-controlled trial we will recruit 220 Emergency Department patients at increased risk of PTSD. Trauma-exposed patients are screened for increased PTSD risk with questionnaires assessing peri-traumatic distress and acute PTSD symptoms within 7 days after trauma. Baseline PTSD symptom severity scores and neuroendocrine and psychophysiological measures will be collected within 10 days after trauma. Participants will be randomized to 7.5 days of intranasal oxytocin (40 IU) or placebo twice a day. Follow-up measurements at 1.5, 3 and 6 months post-trauma are collected to assess PTSD symptom severity (the primary outcome measure). Other measures of symptoms of psychopathology, and neuroendocrine and psychophysiological disorders are secondary outcome measures.
  
  
  CONCLUSIONS
  We hypothesize that intranasal oxytocin administered early after trauma is an effective pharmacological strategy to prevent PTSD in individuals at increased risk, which is both safe and easily applicable. Interindividual and contextual factors that may influence the effects of oxytocin treatment will be considered in the analysis of the results.
  
  
  BACKGROUND
  Netherlands Trial Registry: NTR3190.
authors.affiliation: Department of Psychiatry, Academic Medical Center, University of Amsterdam, Meibergdreef 5, 1105 AZ Amsterdam, The Netherlands. j.l.frijling@amc.nl.
authors.forename: Jessie L
authors.initials: JL
authors.lastname: Frijling
authors.forename: Mirjam
authors.initials: M
authors.lastname: van Zuiden
authors.forename: Saskia B J
authors.initials: SB
authors.lastname: Koch
authors.forename: Laura
authors.initials: L
authors.lastname: Nawijn
authors.forename: J Carel
authors.initials: JC
authors.lastname: Goslings
authors.forename: Jan S
authors.initials: JS
authors.lastname: Luitse
authors.forename: Tessa H
authors.initials: TH
authors.lastname: Biesheuvel
authors.forename: Adriaan
authors.initials: A
authors.lastname: Honig
authors.forename: Fred C
authors.initials: FC
authors.lastname: Bakker
authors.forename: Damiaan
authors.initials: D
authors.lastname: Denys
authors.forename: Dick J
authors.initials: DJ
authors.lastname: Veltman
authors.forename: Miranda
authors.initials: M
authors.lastname: Olff
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005239:Fear / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010121:Oxytocin / Q000008:administration & dosage*; D013313:Stress Disorders, Post-Traumatic / Q000209:etiology* / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D010121:Oxytocin