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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Narrative Exposure Therapy
* Behavioral: treatment as usual


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrative Exposure Therapy<br>carried out according to the manual as outlined by Schauer et al. (2005) (second revised edition 2011) 10 sessions of 90 min duration | Behavioral: Narrative Exposure Therapy<br>* Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).<br>|
| Active Comparator: treatment as usual<br>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. | Behavioral: treatment as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale |  | before treatment, 1 month after, 6 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) |  | before treatment, 1 month after, 6 months after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, trauma treatment, refugees, randomized controlled