title: Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants.
abstract: BACKGROUND
  Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However, in clinical practice most patients (up to 70-80%) are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT). However, it is unclear whether brief CT while tapering antidepressants (AD) is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial.
  
  
  METHODS
  Therefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes). This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276) will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective) and number, duration and severity of relapses/recurrences.
  
  
  CONCLUSIONS
  This will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment compared to antidepressant treatment alone and the combination of both. In addition, we explore explicit and implicit mediators of CT.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR1907.
authors.affiliation: Department of Clinical Psychology, Groningen University, The Netherlands. c.l.h.bockting@rug.nl
authors.forename: Claudi L H
authors.initials: CL
authors.lastname: Bockting
authors.forename: Hermien J
authors.initials: HJ
authors.lastname: Elgersma
authors.forename: Gerard D
authors.initials: GD
authors.lastname: van Rijsbergen
authors.forename: Peter
authors.initials: P
authors.lastname: de Jonge
authors.forename: Johan
authors.initials: J
authors.lastname: Ormel
authors.forename: Erik
authors.initials: E
authors.lastname: Buskens
authors.forename: A Dennis
authors.initials: AD
authors.lastname: Stant
authors.forename: Peter J
authors.initials: PJ
authors.lastname: de Jong
authors.forename: Frenk P M L
authors.initials: FP
authors.lastname: Peeters
authors.forename: Marcus J H
authors.initials: MJ
authors.lastname: Huibers
authors.forename: Arnoud
authors.initials: A
authors.lastname: Arntz
authors.forename: Peter
authors.initials: P
authors.lastname: Muris
authors.forename: Willem A
authors.initials: WA
authors.lastname: Nolen
authors.forename: Aart H
authors.initials: AH
authors.lastname: Schene
authors.forename: Steven D
authors.initials: SD
authors.lastname: Hollon
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000188:drug therapy / Q000517:prevention & control* / Q000628:therapy*; D005500:Follow-Up Studies; D006801:Humans; D017063:Outcome Assessment, Health Care; D016016:Proportional Hazards Models; D011614:Psychotherapy, Brief; D019057:Quality-Adjusted Life Years; D012107:Research Design; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents