Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway |
- Clinician Administered PTSD Scale [ Time Frame: before treatment, 1 month after, 6 months aft. ] [ Designated as safety issue: No ]
- Hamilton Depr. Scale [ Time Frame: before treatment, 1 month after, 6 months after ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | September 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
-
Behavioral: Narrative Exposure Therapy
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 |
Inclusion Criteria:
- Posttraumatic Stress Disorder
Exclusion Criteria:
- Psychosis
- Substance abuse
- Serious suicidal ideations
Contacts and Locations| Norway | |
| Centre on violence, traumatic stress and suicide prevention - Mid Norway | |
| Trondheim, Norway, 7030 | |
| Study Chair: | Gunnar Gotestam, Phd | Psychiatric Intitute, NTNU |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hakon Stenmark, Centre on violence, traumatic stress and suicide prevention, Mid-Norway |
| ClinicalTrials.gov Identifier: | NCT00218959 History of Changes |
| Other Study ID Numbers: | 4.2005.1100 |
| Study First Received: | September 20, 2005 |
| Last Updated: | October 22, 2010 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by Norwegian University of Science and Technology:
|
PTSD trauma treatment refugees randomized controlled |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013