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Trial record 26 of 1046 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT00218959
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 27, 2017
Sponsor:
Collaborators:
Vivo international e.V.
University of Konstanz
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE September 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Clinician Administered PTSD Scale [ Time Frame: before treatment, 1 month after, 6 months after ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Clinican Administered PTSD Scale, before, after, 6m. after
Change History Complete list of historical versions of study NCT00218959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: before treatment, 1 month after, 6 months after ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Hamilton Depr. Scale, before, after, 6 months follow up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees
Official Title  ICMJE Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • 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).
  • Behavioral: treatment as usual
Study Arms  ICMJE
  • Experimental: Narrative Exposure Therapy
    carried out according to the manual as outlined by Schauer et al. (2005) (second revised edition 2011) 10 sessions of 90 min duration
    Intervention: Behavioral: Narrative Exposure Therapy
  • Active Comparator: treatment as usual
    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.
    Intervention: Behavioral: treatment as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2013)
81
Original Enrollment  ICMJE
 (submitted: September 20, 2005)
80
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Refugee or asylum seeker
  • Posttraumatic Stress Disorder diagnosis according to the DSM-IV criteria

Exclusion Criteria:

  • Psychosis
  • Substance abuse
  • Serious suicidal ideations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218959
Other Study ID Numbers  ICMJE 4.2005.1100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • Vivo international e.V.
  • University of Konstanz
  • St. Olavs Hospital
Investigators  ICMJE
Study Chair: Gunnar Gotestam, Phd Psychiatric Intitute, NTNU
PRS Account Norwegian University of Science and Technology
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP