NCT00218959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

September 20, 2005

Last Update Submit

January 25, 2017

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDtrauma treatmentrefugeesrandomized controlled

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale

    before treatment, 1 month after, 6 months after

Secondary Outcomes (1)

  • Hamilton Rating Scale for Depression (HAM-D)

    before treatment, 1 month after, 6 months after

Study Arms (2)

Narrative Exposure Therapy

EXPERIMENTAL

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

treatment as usual

ACTIVE COMPARATOR

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

Interventions

Narrative Exposure TherapyBEHAVIORAL

Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos \& Monelli).

Narrative Exposure Therapy
treatment as usualBEHAVIORAL
treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychosis
  • Substance abuse
  • Serious suicidal ideations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre on violence, traumatic stress and suicide prevention - Mid Norway

Trondheim, Trondheim, 7030, Norway

Location

Related Publications (2)

  • 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.

    PMID: 23916633RESULT

  • 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.

    PMID: 24762779DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Gunnar Gotestam, Phd

    Psychiatric Intitute, NTNU

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

NO(1)