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Open Access Study protocol

‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

Janus Christian Jakobsen12*, Christian Gluud2, Mickey Kongerslev1, Kirsten Aaskov Larsen3, Per Sørensen4, Per Winkel2, Theis Lange5, Ulf Søgaard3 and Erik Simonsen1

Author Affiliations

1 Psychiatric Research Unit, Copenhagen University Hospital and Region Zealand, Roskilde, Denmark

2 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Department 3344, Rigshospitalet, Copenhagen, Denmark

3 Psychiatric clinic, Psychiatry, Roskilde, Denmark

4 Psychiatric clinic, Psychiatry, Bispebjerg, Denmark

5 Department of Public Health, University of Copenhagen, Copenhagen, Denmark

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BMC Psychiatry 2012, 12:232  doi:10.1186/1471-244X-12-232

Published: 19 December 2012

Abstract

Background

Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression.

Methods/ design

We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999.

Discussion

Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions.

Trial registration

ClinicalTrials: NCT01070134