drugset / Trial / NCT00917397

The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants

NCT00917397

Phase 4 Completed 280 enrolled Caecilie Buhmann
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.

Timeline

Start
2009-06
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Sertraline Small molecule