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).

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Narrative Exposure Therapy

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
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psychiatric symptoms	1 and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Cortisol in saliva	1 and 6 months after treatment

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Norwegian Center for Violence and Traumatic Stress Studies
• Investigators: Study Director: Anne Marita Milde, PhD, University of Bergen

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): November 1, 2010

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 15, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 17, 2008
• Last Update Submitted That Met QC Criteria: April 15, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NET 40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No