Treatment Effects of Narrative Exposure Therapy

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00660439
• Other study ID #: NET 40
• Status: Recruiting
• Phase: Phase 2
• First received: April 10, 2008
• Last updated: April 15, 2008
• Start date: May 2007
• Est. completion date: November 2010

Study information

• Verified date: April 2008
• Source: University of Bergen
• Contact: Tove S. Nordling, Cand Psychol
• Phone: +47 55976691
• Email: tsno[@]helse-bergen.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Norway	Western Norway Violence and Traumatic Stress Resource Centre	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Center for Violence and Traumatic Stress Studies

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric symptoms		1 and 6 months after treatment	No
Secondary	Cortisol in saliva		1 and 6 months after treatment	No