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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00660439
Other study ID # NET 40
Secondary ID
Status Recruiting
Phase Phase 2
First received April 10, 2008
Last updated April 15, 2008
Start date May 2007
Est. completion date November 2010

Study information

Verified date April 2008
Source University of Bergen
Contact Tove S. Nordling, Cand Psychol
Phone +47 55976691
Email tsno@helse-bergen.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

This study compares Narrative Exposure Therapy with a Waiting list control group, both consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no intervention).


Description:

In this study we want to compare Narrative Exposure Therapy (NET) to Waiting list controls. Adult patients with diagnosed Posttraumatic Stress Disorder following different types of trauma, will be included. Clinicians in psychiatric outpatient clinics will treat patients with NET, either immediately after assessment, or after a second assessment 3 months later. All patients will also be assessed 1 and 6 months after treatment completion. All patients will be assessed for psychiatric symptoms by the Mini International Neuropsychiatric Interview (version 5.0.0) and the Clinician-Administered PTSD Scale. Patients will also answer several questionnaires (IES-R, SCL-90, BDI-II, DES and UCL). Baseline level of the stress hormone cortisol will be collected in saliva for measuring the diurnal cycle. We will investigate if patients with Posttraumatic Stress Disorder will show more symptom improvement with NET than those on the waiting list (i.e. no intervention) in addition to measuring potential differences in cortisol between the groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Posttraumatic Stress Disorder (PTSD)

- Age above 18 years

- Understands, speaks and writes Norwegian

- Informed, written consent

Exclusion Criteria:

- Active psychosis

- Active suicidality

- Serious self mutilation

- Active alcohol or drug abuse

- Serious dissociative symptoms

- Disease in nervous system or head injury

- Hormonal disease

- Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Narrative Exposure Therapy
Psychological treatment, with narration of positive and traumatic events in patients history, including "in vivo" exposure of traumatic events. The narrative is written down by the therapist.

Locations

Country Name City State
Norway Western Norway Violence and Traumatic Stress Resource Centre Bergen

Sponsors (2)

Lead Sponsor Collaborator
University of Bergen Norwegian Center for Violence and Traumatic Stress Studies

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychiatric symptoms 1 and 6 months after treatment No
Secondary Cortisol in saliva 1 and 6 months after treatment No
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