The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: Pragmatic randomised controlled clinical trial

Abstract

Background Little evidence exists on the treatment of traumatised refugees. Aims To estimate treatment effects of flexible cognitive-behavioural therapy (CBT) and antidepressants (sertraline and mianserin) in traumatised refugees. Method Randomised controlled clinical trial with 2×2 factorial design (registered with Clinicaltrials.gov, NCT00917397, EUDRACT no. 2008-006714-15). Participants were refugees with war-related traumatic experiences, post-traumatic stress disorder (PTSD) and without psychotic disorder. Treatment was weekly sessions with a physician and/or psychologist over 6 months. Results A total of 217 of 280 patients completed treatment (78%). There was no effect on PTSD symptoms, no effect of psychotherapy and no interaction between psychotherapy and medicine. A small but significant effect of treatment with antidepressants was found on depression. Conclusions In a pragmatic clinical setting, there was no effect of flexible CBT and antidepressants on PTSD, and there was a small-tomoderate effect of antidepressants and psychoeducation on depression in traumatised refugees.