title: A randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus treatment-as-usual (TAU) for chronic, treatment-resistant depression: study protocol.
abstract: BACKGROUND
  Major depression is a common psychiatric disorder, frequently taking a chronic course. Despite provision of evidence-based treatments, including antidepressant medication and psychological treatments like cognitive behavioral therapy or interpersonal therapy, a substantial amount of patients do not recover. Mindfulness-Based Cognitive Therapy (MBCT) has been found to be effective in reducing relapse in recurrent depression, as well as lowering symptom levels in acute depression. The effectiveness of MBCT for chronic, treatment-resistant depression has only be studied in a few pilot trials. A large randomized controlled trial is necessary to examine the effectiveness of MBCT in reducing depressive symptoms in chronic, treatment-resistant depression.
  
  
  METHODS
  A randomized-controlled trial is conducted to compare MBCT with treatment-as-usual (TAU). Patients with chronic, treatment-resistant depression who have received antidepressant medication and cognitive behavioral therapy or interpersonal therapy are included. Assessments take place at baseline and post intervention/TAU-period. The primary outcome are depressive symptoms. Secondary outcomes are: remission rates, quality of life, rumination, mindfulness skills and self-compassion. Patients in the TAU condition are offered to participate in the MBCT after the post TAU-period assessment. From all completers of the MBCT (MBCT condition and patients participating after the TAU-period), follow-up assessments are taken at three and six months after the completion of the MBCT.
  
  
  CONCLUSIONS
  This trial will result in valuable information about the effectiveness of MBCT in chronic, treatment-resistant depressed patients who previously received antidepressant medication and psychological treatment.
  
  
  BACKGROUND
  trialregister.nl NTR4843, registered 14th October 2014.
authors.affiliation: Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands. m.cladder-micus@psych.ru.nl.|Pro Persona Expertisecentrum Depressie, Institute for Mental Health Care, Nijmegen, The Netherlands. m.cladder-micus@psych.ru.nl.|Department of Psychiatry, Radboud university medical centre, Nijmegen, The Netherlands. m.cladder-micus@psych.ru.nl.
authors.forename: Mira B
authors.initials: MB
authors.lastname: Cladder-Micus
authors.affiliation: Pro Persona Expertisecentrum Depressie, Institute for Mental Health Care, Nijmegen, The Netherlands. Janna.Vrijsen@radboudumc.nl.|Department of Psychiatry, Radboud university medical centre, Nijmegen, The Netherlands. Janna.Vrijsen@radboudumc.nl.
authors.forename: Janna N
authors.initials: JN
authors.lastname: Vrijsen
authors.affiliation: Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands. e.becker@psych.ru.nl.
authors.forename: Eni S
authors.initials: ES
authors.lastname: Becker
authors.affiliation: Department for Health Evidence, Radboud university medical centre, Nijmegen, The Netherlands. Rogier.Donders@radboudumc.nl.
authors.forename: Rogier
authors.initials: R
authors.lastname: Donders
authors.affiliation: Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands. j.spijker@propersona.nl.|Pro Persona Expertisecentrum Depressie, Institute for Mental Health Care, Nijmegen, The Netherlands. j.spijker@propersona.nl.
authors.forename: Jan
authors.initials: J
authors.lastname: Spijker
authors.affiliation: Department of Psychiatry, Radboud university medical centre, Nijmegen, The Netherlands. Anne.Speckens@radboudumc.nl.
authors.forename: Anne E M
authors.initials: AE
authors.lastname: Speckens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use; D002908:Chronic Disease; D003865:Major Depressive Disorder / Q000628:therapy; D061218:Depressive Disorder, Treatment-Resistant / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D055815:Young Adult; D015928:Cognitive Behavioral Therapy
chemical_list: D000928:Antidepressive Agents