Open Access Highly Accessed Study protocol

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

Jessie L Frijling1*, Mirjam van Zuiden1, Saskia BJ Koch1, Laura Nawijn1, J Carel Goslings2, Jan S Luitse2, Tessa H Biesheuvel3, Adriaan Honig46, Fred C Bakker3, Damiaan Denys15, Dick J Veltman6 and Miranda Olff17

Author Affiliations

1 Department of Psychiatry, Academic Medical Center, University of Amsterdam, Meibergdreef 5, 1105 AZ Amsterdam, The Netherlands

2 Trauma Unit, Department of Surgery, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

3 Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ Amsterdam, The Netherlands

4 Department of Psychiatry, Sint Lucas Andreas Hospital, Jan Tooropstraat 164, Amsterdam 1061 AE, The Netherlands

5 Netherlands Institute for Neuroscience, an Institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, 1105 BA Amsterdam, The Netherlands

6 Department of Psychiatry, VU University Medical Center, Amsterdam, De Boelelaan 1117, 1081 HZ Amsterdam, The Netherlands

7 Arq Psychotrauma Expert Group, Nienoord 5, Diemen 1112 XE, Netherlands

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BMC Psychiatry 2014, 14:92  doi:10.1186/1471-244X-14-92

Published: 28 March 2014

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.

Keywords:
Post-traumatic disorder; PTSD; Early intervention; Oxytocin; Neurobiology; Randomized controlled trial; Prevention