Treatment Effects of Narrative Exposure Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Bergen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Norwegian Center for Violence and Traumatic Stress Studies
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00660439
First received: April 10, 2008
Last updated: April 15, 2008
Last verified: April 2008

April 10, 2008
April 15, 2008
May 2007
December 2009   (final data collection date for primary outcome measure)
Psychiatric symptoms [ Time Frame: 1 and 6 months after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00660439 on ClinicalTrials.gov Archive Site
Cortisol in saliva [ Time Frame: 1 and 6 months after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment Effects of Narrative Exposure Therapy
Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Posttraumatic Stress Disorder
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.
Other Name: NET
  • Experimental: A
    Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.
    Intervention: Behavioral: Narrative Exposure Therapy
  • No Intervention: B
    Waiting list control group, receives no intervention for 3 months after first assessment. A second assessment is then administered and patients receives Narrative Exposure Therapy. Patients are assessed 1 and 6 months after treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tove S. Nordling, Cand Psychol +47 55976691 tsno@helse-bergen.no
Norway
 
NCT00660439
NET 40
No
PhD Anne Marita Milde, University of Bergen, Department of Biological and Medical Psychology
University of Bergen
Norwegian Center for Violence and Traumatic Stress Studies
Study Director: Anne Marita Milde, PhD University of Bergen
University of Bergen
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP