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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218959
• Other study ID #: 4.2005.1100
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: January 25, 2017
• Start date: September 2005
• Est. completion date: August 2009

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Refugee or asylum seeker

• Posttraumatic Stress Disorder diagnosis according to the DSM-IV criteria

Exclusion Criteria:

• Psychosis

• Substance abuse

• Serious suicidal ideations

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy
Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).
• treatment as usual

Locations

Country	Name	City	State
Norway	Centre on violence, traumatic stress and suicide prevention - Mid Norway	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, University of Konstanz, Vivo international e.V.

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale		before treatment, 1 month after, 6 months after
Secondary	Hamilton Rating Scale for Depression (HAM-D)		before treatment, 1 month after, 6 months after

External Links

•   The developers of Narrative Exposure Therapy