The treatment of traumatised refugees with sertraline versus venlafaxine in combination with psychotherapy – a randomised clinical study

Abstract

Background and aimToday we lack sufficient evidence to conclude which type of treatment approach that is most efficient when it comes to trauma-affected refugees. That is a problem for both patients and doctors as well as for society. Also there is a lack of studies, which examine the relation between psychosocial resources and treatment efficiency, in order to find reliable predictors of treatment outcome. This study therefore aims to produce new evidence within this field in order to optimise treatment for trauma-affected refugees with complex PTSD.MethodsThe study included 207 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 on 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.ResultsData are presently being analysed and results will be ready for the conference.ConclusionThe study is among the largest randomised studies ever conducted on pharmacological treatment among traumatised refugees. It is expected to bring forward new knowledge about clinical evaluation and medical treatment of traumatised refugees.Disclosure of interestThe authors have not supplied their declaration of competing interest.