Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

-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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints are levels of PTSD and co-morbid depressive symptoms.<br /><br>PTSD symptoms will be assessed by means of clinical diagnostic interviews<br /><br>(Clinician-Administered PTSD Scale, assessed before the first session and at<br /><br>1-3 and 14-6 weeks after the final NET session) and self-report questionnaires<br /><br>(Impact of Events Scale-Revised, measured at all assessment points). Depressive<br /><br>symptoms will be assessed by self-report questionnaire (Beck Depression<br /><br>Inventory, assessed before the first session and at 1-3 and 14-6 weeks after<br /><br>the final NET session). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are measures of stress-reactivity, both self-reported<br /><br>(Perceived Stress Reactivity scale, assessed before the first session and at<br /><br>1-3 and 14-6 weeks after the final NET session) and physiological stress<br /><br>reactivity (heart rate, heart rate variability and salivary cortisol, assessed<br /><br>after each NET session).</p><br>