Clinical trial NCT00218959: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
trauma treatment
refugees
randomized controlled
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Vivo international e.V.
name: University of Konstanz
name: St. Olavs Hospital
First posted: 2005-09-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale
timeFrame: before treatment, 1 month after, 6 months after
Secondary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: before treatment, 1 month after, 6 months after
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Centre on violence, traumatic stress and suicide prevention - Mid Norway
Study officials:
affiliation: Psychiatric Intitute, NTNU
name: Gunnar Gotestam, Phd
role: STUDY_CHAIR
References:
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.
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.