Oxytocin in PTSD: Effectiveness in addition to NET.
- Conditions
- posttraumatic stress disorder (PTSD)posttraumatische stress stoornis (PTSS)
- Registration Number
- NL-OMON28355
- Lead Sponsor
- Academic Medical Center, University of Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patients with a diagnosis of chronic PTSD (> 3 months);
2. CAPS score of ≥ 50;
Exclusion Criteria
1. Suicidal risk;
2. 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary study endpoint is the PTSD symptom level. PTSD symptoms will be assessed by means of clinical diagnostic interview (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks post-treatment) and self-report questionnaire (Impact of Events Scale-Revised, measured at all assessment points).
- Secondary Outcome Measures
Name Time Method 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 post-treatment) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session). In addition, co-morbid depressive symptoms are a secondary endpoint. Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-16 weeks post-treatment).