The main objective of this study is to assess the efficiency of oxytocin compared to placebo as an addition to the exposure sessions in the treatment of PTSD. We hypothesize that adding oxytocin to exposure in TF-CBT produces acute changes in…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Posttraumatic Stress Disorder (PTSD) has a major health and economic burden on
patients, their relatives and society as a whole. It is therefore important to
have optimal treatment available for this disorder. Although Cognitive
Behavioral Therapy (CBT) is an effective treatment for PTSD, many patients fail
to attain remission with CBT. In the present study we propose to augment CBT
for PTSD with oxytocin.
Given that PTSD is marked by deficits in anxiety/stress regulation and in
social functioning, and that oxytocin is implicated in both these areas,
oxytocin seems a likely candidate for treatment of patients with PTSD. Oxytocin
has a combination of pharmacological effects that have been shown to reduce the
fear response (decreasing amygdala activation, inhibiting fear response and
enhancing extinction learning) and to increase social interaction (activating
social reward-related brain regions increasing engagement in the therapeutic
alliance). This all may result in a *sense of safety* to the client which is a
prerequisite to successful treatment of patients with PTSD.
Study objective
The main objective of this study is to assess the efficiency of oxytocin
compared to placebo as an addition to the exposure sessions in the treatment of
PTSD. We hypothesize that adding oxytocin to exposure in TF-CBT produces acute
changes in subjective distress and physiological reactivity (e.g., increase in
heart rate variability (HRV)) and fastens the reduction of PTSD-symptom levels
compared to placebo addition to exposure. Secondary, we assess effect on
oxytocin levels and HPA/axis hormones.
Study design
Patients will be randomized to TF-CBT + oxytocin (n = 10) or to TF-CBT +
placebo (n = 10). During exposure sessions, physiological parameters, immediate
subjective distress levels and PTSD symptom levels will be obtained in both
conditions.
Intervention
TF-CBT with oxytocine or TF-CBT with placebo.
Study burden and risks
The burden and risks associated with participation in this study is reasonable.
Participants receive Trauma-focused Cognitive Behavioural Therapy (TF-CBT),
which is considered to be the most effective treatment for PTSD. Oxytocin is a
relatively save drug except during pregnancy. Female patients of childbearing
potential therefore must have a negative pregnancy test.
Meibergdreef 5
1105 AZ
NL
Meibergdreef 5
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-CAPS score of * 50
-Age 18 years and above
-Written informed consent
-Eligible for exposure therapy
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017811-13-NL |
| CCMO | NL30877.018.09 |