The treatment of traumatised refugees with Sertraline versus Venlafaxine in combination with psychotherapy – a randomised c

​1. Title: 

The treatment of traumatised refugees with Sertraline versus Venlafaxine in combination with psychotherapy – a randomised clinical study (PTF3) 

2. Project period: 

1-11-2011 – 31-12-2015 

3. Investigators: 

Charlotte Sonne, MD, PhD student and Jessica Carlsson Lohmann, MD, PhD (coinvestigator) 

4. Supervisors 

  • Prof. Ask Elklit (University of Southern Denmark) 
  • Prof. Erik Lykke Mortensen (University of Copenhagen) 
  • Prof. Per Bech (University of Copenhagen) 
  • Jessica Carlsson Lohmann, MD, PhD (CTP) 

5. Background: 

Today we lack sufficient evidence to conclude as to which type of treatment approach is the most efficient when it comes to traumatised refugees. This is a problem for both patients and doctors as well as for society. Also, there is a lack of studies examining the relation between psychosocial resources and treatment efficiency, in order to find reliable predictors of treatment outcome. 

6. Aim: 

To produce new evidence within this field in order to optimise treatment for traumatised refugees with PTSD. 

7. Methods 

7.1 Number of participants: 

207 

7.2 Population: 

Adult trauma-affected refugees 

7.3 Description of data and data collection 

The study included patients referred to Competence Centre for Transcultural Psychiatry between April 2012 and September 2013. Patients were randomised into one of the two treatment groups: a Sertraline group (n=109) or a Venlafaxine group (n=98). Patients in both groups received the same manual-based Cognitive Behavioural Therapy, specially adapted to this group of patients. The trial endpoints were PTSD-and depression symptoms and social functioning, all measured using validated ratings scales. 

Furthermore, the study examined the relation between expected outcome of treatment from a range of predictors and the relation to the treatment results for the individual patient. 

7.4 Application/acceptance from the Danish Data Protection Agency, the National Committee on Health Research Ethics: 

Yes 

7.5 Analysis: 

Data-analyses are currently undertaken

8. Expected results: 

The study is among the largest randomised studies ever conducted on medical treatment among traumatised refugees. It is expected to bring forward new knowledge about clinical evaluation and medical treatment of traumatised refugees. 

9. Dissemination of results: 

Winter 2015/Spring 2016. Planned publications: 

  • Treatment effect of Sertraline compared with Venlafaxine in traumatised refugees 
  • Correlations between practitioner-assessed expected treatment outcome and observed treatment effect in traumatised refugees
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