Treatment Effects of Narrative Exposure Therapy - Full Text View

Purpose

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).

Condition	Intervention	Phase
Posttraumatic Stress Disorder	Behavioral: Narrative Exposure Therapy	Phase II

MedlinePlus related topics:

Post-Traumatic Stress Disorder Stress

ChemIDplus related topics:

Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study

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

Further study details as provided by University of Bergen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.	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.
B: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660439

Contacts


Contact: Tove S. Nordling, Cand Psychol	+47 55976691	tsno@helse-bergen.no

Locations


Norway
	Western Norway Violence and Traumatic Stress Resource Centre	Recruiting
	Bergen, Norway, 5021
	Contact: Tove S. Nordling, Cand Psychol +47 55 97 66 91 tsno@helse-bergen.no
	Sub-Investigator: Tove S. Nordling, Cand Psychol

Sponsors and Collaborators

University of Bergen

Norwegian Center for Violence and Traumatic Stress Studies

Investigators


Study Director:	Anne Marita Milde, PhD	University of Bergen

More Information

Responsible Party:	University of Bergen, Department of Biological and Medical Psychology ( PhD Anne Marita Milde )
Study ID Numbers:	NET 40
First Received:	April 10, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00660439
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Bergen:

PTSD

Study placed in the following topic categories:

Hydrocortisone

Cortisol succinate

Anxiety Disorders

Mental Disorders

Stress Disorders, Post-Traumatic

Stress

Hydrocortisone acetate

Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Bergen Norwegian Center for Violence and Traumatic Stress Studies
Information provided by:	University of Bergen
ClinicalTrials.gov Identifier:	NCT00660439