title: 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.
  
  
  OBJECTIVE
  To estimate treatment effects of flexible cognitive-behavioural therapy (CBT) and antidepressants (sertraline and mianserin) in traumatised refugees.
  
  
  METHODS
  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.
authors.affiliation: Caecilie Böck Buhmann, MD, MPH, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Merete Nordentoft, MD, DMSc, Psychiatric Center Copenhagen, Copenhagen; Morten Ekstroem, MD, PhD, Jessica Carlsson, MD, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Erik Lykke Mortensen, MSc, Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark caecilie.boeck.buhmann@regionh.dk.
authors.forename: Caecilie Böck
authors.initials: CB
authors.lastname: Buhmann
authors.affiliation: Caecilie Böck Buhmann, MD, MPH, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Merete Nordentoft, MD, DMSc, Psychiatric Center Copenhagen, Copenhagen; Morten Ekstroem, MD, PhD, Jessica Carlsson, MD, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Erik Lykke Mortensen, MSc, Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
authors.affiliation: Caecilie Böck Buhmann, MD, MPH, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Merete Nordentoft, MD, DMSc, Psychiatric Center Copenhagen, Copenhagen; Morten Ekstroem, MD, PhD, Jessica Carlsson, MD, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Erik Lykke Mortensen, MSc, Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Ekstroem
authors.affiliation: Caecilie Böck Buhmann, MD, MPH, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Merete Nordentoft, MD, DMSc, Psychiatric Center Copenhagen, Copenhagen; Morten Ekstroem, MD, PhD, Jessica Carlsson, MD, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Erik Lykke Mortensen, MSc, Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jessica
authors.initials: J
authors.lastname: Carlsson
authors.affiliation: Caecilie Böck Buhmann, MD, MPH, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Merete Nordentoft, MD, DMSc, Psychiatric Center Copenhagen, Copenhagen; Morten Ekstroem, MD, PhD, Jessica Carlsson, MD, PhD, Competence Center for Transcultural Psychiatry, Psychiatric Center Ballerup, Ballerup; Erik Lykke Mortensen, MSc, Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Erik Lykke
authors.initials: EL
authors.lastname: Mortensen
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003718:Denmark; D003866:Depressive Disorder / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010353:Patient Education as Topic; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012036:Refugees / Q000523:psychology*; D020280:Sertraline / Q000008:administration & dosage*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D008803:Mianserin; D020280:Sertraline