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. © The Royal College of Psychiatrists 2016.

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depression refugee unspecified side effect mindfulness clinical trial psychoeducation follow up multimodality cancer therapy human Refugees middle aged Combined Modality Therapy Denmark controlled study randomized controlled trial Depressive Disorder cognitive therapy Patient Education as Topic quality of life Humans psychology Treatment Outcome sleep disorder male female psychological rating scale Psychiatric Status Rating Scales sertraline Antidepressive Agents mianserin patient education Article drug substitution drug withdrawal major clinical study adult posttraumatic stress disorder Stress Disorders, Post-Traumatic acceptance and commitment therapy outcome assessment drug dose increase phase 4 clinical trial factorial design antidepressant agent perphenazine