PTSD and stress disorder
Conditions
Interventions
TF-CBT with oxytocine or TF-CBT with placebo.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -CAPS score of * 50 -Age 18 years and above -Written informed consent -Eligible for exposure therapy
Exclusion criteria
Exclusion criteria: -Suicidal risk - Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, depression with psychotic features, or excessive substance related disorder over the past 6 months Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test) - Female patients with an active pregnancy wish - Female pregnant patients (patients with childbearing potential must have a negative pregnancy test) - Primary diagnosis of severe depressive disorder - Presence of primary or co-morbid personality disorder - An organic disorder - Taking any psychotropic medications at present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The acute effects of oxytocin addition will be assessed by measuring change in: heart rate (HR), heart rate variability (HRV), breathing frequency and saliva cortisol during exposure sessions, and the change on the Subjective Units of Distress (SUDS) during the sessions as well as the change on the Impact of Event Scale-Revised (IES-R) from session to session. | — |
Secondary
| Measure | Time frame |
|---|---|
| Before and after treatment blood will be drawn from patients in both conditions to assess the central hormone oxytocine, arginine vasopressine (AVP), and the HPA-axis hormone cortisol. | — |
Countries
Netherlands
Outcome results
None listed