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Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Narrative Exposure Therapy
treatment as usual
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, trauma treatment, refugees, randomized controlled

Eligibility Criteria

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

Inclusion Criteria: Refugee or asylum seeker Posttraumatic Stress Disorder diagnosis according to the DSM-IV criteria Exclusion Criteria: Psychosis Substance abuse Serious suicidal ideations

Sites / Locations

  • Centre on violence, traumatic stress and suicide prevention - Mid Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narrative Exposure Therapy

treatment as usual

Arm Description

carried out according to the manual as outlined by Schauer et al. (2005) (second revised edition 2011) 10 sessions of 90 min duration

mainly help with such as sleep problems, depressive symptoms, problems related to asylum status, and other practical matters. Focus on everyday issues and the limited focus on the traumatic events, in line with reports from the National Center on Violence and Traumatic Stress.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale

Secondary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D)

Full Information

First Posted
September 20, 2005
Last Updated
January 25, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Vivo international e.V., University of Konstanz, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00218959
Brief Title
Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees
Official Title
Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Vivo international e.V., University of Konstanz, St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study we want to compare Narrative Exposure Therapy to Treatment as Usual for traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric outpatient clinics will deliver the two conditions to asylum seekers and refugees that qualifies for Posttraumatic Stress Disorder. We will investigate if refugees and asylum seekers will improve more with Narrative Exposure Therapy or Treatment as Usual, and if there will be any differences between improvement for asylum seekers compared to improvement for refugees with residential status.
Detailed Description
Narrative Exposure Therapy (NET) will in a randomized controlled trial be compared to Treatment as Usual(TAU) for traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric outpatient clinics in the region will deliver the two conditions to asylum seekers and refugees that qualifies for Posttraumatic Stress Disorder. Each patient will receive 10 sessions of either NET or TAU. Assessment tools in the study will be MINI International Neuropsychiatric Interview, Clinician Administered PTSD Scale and the Hamilton Rating Scale for Depression. Exclusion criteria will be psychosis, substance abuse and serious suicidal ideations. The age group in focus will be adults of 18 years or more. Refugees and asylum seekers from all countries will be accepted in the study, and there will be used qualified interpreters if the refugees do not speak English or Norwegian fluently.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, trauma treatment, refugees, randomized controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
carried out according to the manual as outlined by Schauer et al. (2005) (second revised edition 2011) 10 sessions of 90 min duration
Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
mainly help with such as sleep problems, depressive symptoms, problems related to asylum status, and other practical matters. Focus on everyday issues and the limited focus on the traumatic events, in line with reports from the National Center on Violence and Traumatic Stress.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Intervention Description
Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Time Frame
before treatment, 1 month after, 6 months after
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Time Frame
before treatment, 1 month after, 6 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Refugee or asylum seeker Posttraumatic Stress Disorder diagnosis according to the DSM-IV criteria Exclusion Criteria: Psychosis Substance abuse Serious suicidal ideations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Gotestam, Phd
Organizational Affiliation
Psychiatric Intitute, NTNU
Official's Role
Study Chair
Facility Information:
Facility Name
Centre on violence, traumatic stress and suicide prevention - Mid Norway
City
Trondheim
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
23916633
Citation
Stenmark H, Catani C, Neuner F, Elbert T, Holen A. Treating PTSD in refugees and asylum seekers within the general health care system. A randomized controlled multicenter study. Behav Res Ther. 2013 Oct;51(10):641-7. doi: 10.1016/j.brat.2013.07.002. Epub 2013 Jul 8.
Results Reference
result
PubMed Identifier
24762779
Citation
Halvorsen JO, Stenmark H, Neuner F, Nordahl HM. Does dissociation moderate treatment outcomes of narrative exposure therapy for PTSD? A secondary analysis from a randomized controlled clinical trial. Behav Res Ther. 2014 Jun;57:21-8. doi: 10.1016/j.brat.2014.03.010. Epub 2014 Apr 12.
Results Reference
derived
Links:
URL
http://www.vivo.org
Description
The developers of Narrative Exposure Therapy

Learn more about this trial

Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees

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