posttraumatic stress disorder (PTSD) and stress disorder
Conditions
Interventions
Half of the participants will self-administer a total of 15 doses of intranasal
oxytocin (40 IU, 5 sprays per nostril) or placebo (5 sprays per nostril). The
first treatment will be at the AMC. 14 t
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Presentation at the Trauma Room or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV (either as a patient or direct witness); * Trauma Screening Questionnaire (TSQ) 5 and/or Peritraumatic Distress Inventory (PDI ) 17 preferably between 24 and 72 hours after trauma exposure (in case of contacting difficulties up to 7 days after trauma); * Age 18 * 65 years; * Capable to read and comprehend either the Dutch or English language;
Exclusion criteria
Exclusion criteria: * 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 certain medication: prostaglandins, certain anti-migraine medications (ergot alkaloids), bèta-adrenergic receptor-blocking agents, and systemic glucocorticoids; * 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) (objectified by Glasgow Coma Scale lower than 13 at time of inclusion) * Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcome is the difference in PTSD symptoms severity (CAPS scores) between the two trial arms (i.e. OT versus placebo) at one month post intervention follow-up. The main study outcomes for the fMRI substudy are differences in amygdala activation to emotional faces and differences in brain functional connectivity after stress induction between the two study conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Differences between intervention groups in depression and general anxiety symptoms, neuroendocrine / psychophysiological measures, perceived social support and psychological functioning between the two groups after one week of OT treatments, and one and a half, three and six months post trauma exposure. * Differences between intervention groups in PTSD symptoms severity (CAPS scores) between the two trial arms (i.e. OT versus placebo) at three and six months post trauma follow-up. * Potential associations between the main study outcome and gender, genetic variation, perceived social support, representations of attachment style, coping style, subjective health complaints, quality of life, trauma type, history of (childhood) trauma and life events. fMRI substudy only: * Differences in salivary cortisol, DHEAS, and OT reactivity after intranasal OT between the two study groups. * Differences in the role of endogenous steroid hormone levels (i.e. estrogen, progesterone and testosterone) in the effect of intranasal OT on neural (stress) reactivity between the two groups. * Potential associations between the main study outcome and gender, genetic variation, perceived social support, representations of attachment style, coping style, subjective health complaints, quality of life, trauma type, history of (childhood) trauma and life events. | — |
Countries
Netherlands
Outcome results
None listed