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Treatment Effects of Narrative Exposure Therapy

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ClinicalTrials.gov Identifier: NCT00660439
Recruitment Status : Unknown
Verified April 2008 by University of Bergen.
Recruitment status was:  Recruiting
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Sponsor:
Collaborator:
Norwegian Center for Violence and Traumatic Stress Studies
Information provided by:
University of Bergen

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Narrative Exposure Therapy Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Psychiatric symptoms [ Time Frame: 1 and 6 months after treatment ]

Secondary Outcome Measures :
  1. Cortisol in saliva [ Time Frame: 1 and 6 months after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

Keywords provided by University of Bergen:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders