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Little evidence exists on the treatment of traumatised refugees.
To estimate treatment effects of flexible cognitive–behavioural therapy
(CBT) and antidepressants (sertraline and mianserin) in traumatised
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.
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.
In a pragmatic clinical setting, there was no effect of flexible CBT and
antidepressants on PTSD, and there was a small-to-moderate effect of
antidepressants and psychoeducation on depression in traumatised
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