title: Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study.
abstract: BACKGROUND
  Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT?
  
  
  METHODS
  Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio.
  
  
  CONCLUSIONS
  Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00928980.
authors.affiliation: Department of Psychiatry, Radboud University Nijmegen Medical Center, Reinier Postlaan 10, Nijmegen 6525 GC, The Netherlands. M.Huijbers@psy.umcn.nl
authors.forename: Marloes J
authors.initials: MJ
authors.lastname: Huijbers
authors.forename: Jan
authors.initials: J
authors.lastname: Spijker
authors.forename: A Rogier T
authors.initials: AR
authors.lastname: Donders
authors.forename: Digna J F
authors.initials: DJ
authors.lastname: van Schaik
authors.forename: Patricia
authors.initials: P
authors.lastname: van Oppen
authors.forename: Henricus G
authors.initials: HG
authors.lastname: Ruhé
authors.forename: Marc B J
authors.initials: MB
authors.lastname: Blom
authors.forename: Willem A
authors.initials: WA
authors.lastname: Nolen
authors.forename: Johan
authors.initials: J
authors.lastname: Ormel
authors.forename: Gert Jan
authors.initials: GJ
authors.lastname: van der Wilt
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.forename: Philip
authors.initials: P
authors.lastname: Spinhoven
authors.forename: Anne E M
authors.initials: AE
authors.lastname: Speckens
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D006801:Humans; D018579:Patient Selection; D012106:Research; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents