title: Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial.
abstract: OBJECTIVE
  To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants.
  
  
  METHODS
  The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde, Denmark.
  
  
  METHODS
  44 consecutive adult participants diagnosed with major depressive disorder.
  
  
  METHODS
  18 weeks of third-wave cognitive therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22).
  
  
  RESULTS
  The primary outcome was the Hamilton Rating Scale for Depression (HDRS) at end of treatment (18 weeks). Secondary outcomes were: remission (HDRS <8), Beck's Depression Inventory, Symptom Checklist 90 Revised and The WHO-Five Well-being Index 1999.
  
  
  RESULTS
  The trial inclusion lasted for about 2 years as planned but only 44 out of the planned 84 participants were randomised. Two mentalisation-based participants were lost to follow-up. The unadjusted analysis showed that third-wave participants compared with mentalisation-based participants did not differ significantly regarding the 18 weeks HDRS score (12.9 vs 17.0; mean difference -4.14; 95% CI -8.30 to 0.03; p=0.051). In the analysis adjusted for baseline HDRS score, the difference was favouring third-wave cognitive therapy (p=0.039). At 18 weeks, five of the third-wave participants (22.7%) were in remission versus none of the mentalisation-based participants (p=0.049). We recorded no suicide attempts or suicides during the intervention period in any of the 44 participants. No significant differences were found between the two intervention groups on the remaining secondary outcomes.
  
  
  CONCLUSIONS
  Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS. However, more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression.
  
  
  BACKGROUND
  Registered with Clinical Trials government identifier: NCT01070134.
authors.affiliation: Psychiatric Research Unit, Copenhagen University Hospital, Copenhagen, Denmark Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Janus Christian
authors.initials: JC
authors.lastname: Jakobsen
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Psychiatric Research Unit, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Mickey
authors.initials: M
authors.lastname: Kongerslev
authors.affiliation: Department of Psychiatry, Psychiatric Clinic, Roskilde, Denmark.
authors.forename: Kirsten Aaskov
authors.initials: KA
authors.lastname: Larsen
authors.affiliation: Mental Health Services, Psychotherapy Center Stolpegaard, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Sørensen
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.affiliation: Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Theis
authors.initials: T
authors.lastname: Lange
authors.affiliation: Department of Psychiatry, Psychiatric Clinic, Roskilde, Denmark.
authors.forename: Ulf
authors.initials: U
authors.lastname: Søgaard
authors.affiliation: Psychiatric Research Unit, Copenhagen University Hospital, Copenhagen, Denmark Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Erik
authors.initials: E
authors.lastname: Simonsen
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003718:Denmark; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D056345:Theory of Mind; D016896:Treatment Outcome