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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
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: A
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.
Other Name: NET
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.

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

No publications provided

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

Keywords provided by University of Bergen:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013