Boosting the oxytocin system in acute trauma: The effectiveness of intranasal oxytocin treatments and stimulation of social support on preventing trauma related psychopathology - Oxytocin and social support as early interventions in acute trauma

Academic Medical Center0 个研究点开始时间: 2011年9月7日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•?Presentation at the Trauma Unit or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV
•?Trauma Screening Questionnaire (TSQ) > 5 between 24 and 72 hours after trauma exposure
•?Age 18 – 65 years
•?Significant other (i.e. best friend, partner or family member) willing to join the social support intervention
•?Capable to read and comprehend either the Dutch or English language
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 260
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•?Any severe or chronic systemic disease
•?Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation
•?Current severe depressive disorder
•?Prominent current suicidal risk or homicidal ideation
•?Severe cognitive impairment or a history of organic mental disorder
•?Evidence of PTSD or depression immediately prior to the index trauma
•?History of neurological disorders (e.g., traumatic brain injury, seizure history)
•?Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma)
•?Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative such as cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year
•?Use of prostaglandins and certain anti-migraine medications (ergot alkaloids)
•?Sensitivity or allergy for OT or its components (e.g., methylhydroxybenzoate and propylhydroxybenzoate)
•?Impaired consciousness, or amnesia or confusion (due to for example head injury) (Glasgow Coma Scale lower than 13)
•?Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).

发起方

Academic Medical Center