Treatment Effects of Narrative Exposure Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

April 10, 2008

Last Updated Date

April 15, 2008

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Psychiatric symptoms [ Time Frame: 1 and 6 months after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00660439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cortisol in saliva [ Time Frame: 1 and 6 months after treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment Effects of Narrative Exposure Therapy

Official Title ^ICMJE

Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder

Brief 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).

Detailed 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Posttraumatic Stress Disorder

Intervention ^ICMJE

Behavioral: Narrative Exposure Therapy

Study Arms / Comparison Groups

Experimental: Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.
No Intervention: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tove S. Nordling, Cand Psychol

+47 55976691

tsno@helse-bergen.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00660439

Responsible Party

PhD Anne Marita Milde, University of Bergen, Department of Biological and Medical Psychology

Study ID Numbers ^ICMJE

NET 40

Study Sponsor ^ICMJE

University of Bergen

Collaborators ^ICMJE

Norwegian Center for Violence and Traumatic Stress Studies

Investigators ^ICMJE

Study Director:

Anne Marita Milde, PhD

University of Bergen

Information Provided By

University of Bergen

Verification Date

April 2008

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