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

Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.

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-to-moderate effect of antidepressants and psychoeducation on depression in traumatised refugees.

Publication types

  • Clinical Trial, Phase IV
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antidepressive Agents / administration & dosage*
  • Cognitive Behavioral Therapy*
  • Combined Modality Therapy
  • Denmark
  • Depressive Disorder / drug therapy
  • Female
  • Humans
  • Male
  • Mianserin / administration & dosage*
  • Mianserin / adverse effects
  • Middle Aged
  • Patient Education as Topic
  • Psychiatric Status Rating Scales
  • Quality of Life
  • Refugees / psychology*
  • Sertraline / administration & dosage*
  • Stress Disorders, Post-Traumatic / drug therapy
  • Stress Disorders, Post-Traumatic / therapy*
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Mianserin
  • Sertraline

Associated data

  • ClinicalTrials.gov/NCT00917397
  • EudraCT/2008-006714-15