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

This study is currently recruiting participants.

Verified by Norwegian University of Science and Technology, November 2008

First Received: September 20, 2005 Last Updated: November 14, 2008 History of Changes

Sponsors and Collaborators:	Norwegian University of Science and Technology Vivo International University of Konstanz Centre on violence, traumatic stress and suicide prevention, Mid-Norway
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00218959

Purpose

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.

Condition	Intervention	Phase
Posttraumatic Stress Disorder	Behavioral: Narrative Exposure Therapy	Phase III

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Clinician Administered PTSD Scale [ Time Frame: before treatment, 1 month after, 6 months aft. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hamilton Depr. Scale [ Time Frame: before treatment, 1 month after, 6 months after ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Posttraumatic Stress Disorder

Exclusion Criteria:

Psychosis
Substance abuse
Serious suicidal ideations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218959

Contacts

Contact: Hakon Stenmark, Cand Psychol

47 90862914

hakon.stenmark@stolav.no

Locations

Norway
Centre on violence, traumatic stress and suicide prevention - Mid Norway	Recruiting
Trondheim, Norway, 7030
Contact: Hakon Stenmark, Cand Psychol 47 90862914 hakon.stenmark@stolav.no
Principal Investigator: Hakon Stenmark, Cand Psychol

Sponsors and Collaborators

Norwegian University of Science and Technology

Vivo International

University of Konstanz

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

Investigators

Study Chair:

Gunnar Gotestam, Phd

Psychiatric Intitute, NTNU

More Information

Additional Information:

The developers of Narrative Exposure Therapy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Centre on violence, traumatic stress and suicide prevention, Mid-Norway ( Hakon Stenmark )
Study ID Numbers:	4.2005.1100
Study First Received:	September 20, 2005
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00218959 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

PTSD
trauma treatment
refugees
randomized controlled

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009