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Treatment Effects of Narrative Exposure Therapy

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Norway Violence and Traumatic Stress Resource CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.

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.

Outcomes

Primary Outcome Measures

Psychiatric symptoms

Secondary Outcome Measures

Cortisol in saliva

Full Information

First Posted
April 10, 2008
Last Updated
April 15, 2008
Sponsor
University of Bergen
Collaborators
Norwegian Center for Violence and Traumatic Stress Studies
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1. Study Identification

Unique Protocol Identification Number
NCT00660439
Brief Title
Treatment Effects of Narrative Exposure Therapy
Official Title
Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bergen
Collaborators
Norwegian Center for Violence and Traumatic Stress Studies

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.
Arm Title
B
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychiatric symptoms
Time Frame
1 and 6 months after treatment
Secondary Outcome Measure Information:
Title
Cortisol in saliva
Time Frame
1 and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tove S. Nordling, Cand Psychol
Phone
+47 55976691
Email
tsno@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marita Milde, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Director
Facility Information:
Facility Name
Western Norway Violence and Traumatic Stress Resource Centre
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tove S. Nordling, Cand Psychol
Phone
+47 55 97 66 91
Email
tsno@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Tove S. Nordling, Cand Psychol

12. IPD Sharing Statement

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Treatment Effects of Narrative Exposure Therapy

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