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Published in: BMC Psychiatry 1/2014

Open Access 01-12-2014 | Study protocol

Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial

Authors: Jessie L Frijling, Mirjam van Zuiden, Saskia BJ Koch, Laura Nawijn, J Carel Goslings, Jan S Luitse, Tessa H Biesheuvel, Adriaan Honig, Fred C Bakker, Damiaan Denys, Dick J Veltman, Miranda Olff

Published in: BMC Psychiatry | Issue 1/2014

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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/Design

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.

Discussion

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.

Trial registration

Netherlands Trial Registry: NTR3190.
Appendix
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Metadata
Title
Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial
Authors
Jessie L Frijling
Mirjam van Zuiden
Saskia BJ Koch
Laura Nawijn
J Carel Goslings
Jan S Luitse
Tessa H Biesheuvel
Adriaan Honig
Fred C Bakker
Damiaan Denys
Dick J Veltman
Miranda Olff
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2014
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-14-92

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