posttraumatic stress disorder
Conditions
Interventions
Patients will be randomized to NET + oxytocin (n = 12) or to NET + placebo (n =
12). During exposure sessions,
physiological parameters, therapeutic alliance, PTSD symptom levels and overall
functio
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with a diagnosis of chronic PTSD (> 3 months) -CAPS score of - 50 -Age 18-65 years -Written informed consent -Eligible for exposure therapy - Capable to read and comprehend either the Dutch or English language
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, or excessive substance related or eating disorder over the past 6 months. - Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month). - Female patients with an active pregnancy wish. - Female patients giving lactation to their child. - Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent). - An organic disorder/cognitive impairment. - Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used. -Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers. -Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat) -Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints are levels of PTSD and co-morbid depressive symptoms. PTSD symptoms will be assessed by means of clinical diagnostic interviews (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and self-report questionnaires (Impact of Events Scale-Revised, measured at all assessment points). Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are measures of stress-reactivity, both self-reported (Perceived Stress Reactivity scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session). | — |
Countries
Netherlands
Outcome results
None listed