title: Preventive Cognitive Therapy versus Treatment as Usual in preventing recurrence of depression: protocol of a multi-centered randomized controlled trial.
abstract: BACKGROUND
  Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Therefore, part of the efforts to reduce the disabling effects of depression should focus on preventing recurrence, especially in patients at high risk of recurrence. The best established effective psychological intervention is cognitive therapy, with indications for prophylactic effects after remission.
  
  
  METHODS
  In this randomized controlled trial (cost-) effectiveness of Preventive Cognitive Therapy (PCT) after response to Acute Cognitive Therapy (A-CT) will be evaluated in comparison with Treatment As Usual (TAU). Remitted patients that responded to A-CT treatment with at least two previous depressive episodes will be recruited. Randomization will be stratified for number of previous episodes. Follow-ups are at 3, 6, 12 and 15 months. The primary outcome measure will be the time to relapse or recurrence of depression meeting DSM-IV criteria for a major depressive episode on the Structured Clinical Interview for DSM-VI Axis I Disorders (SCID-I). Costs will be measured from a societal perspective.
  
  
  CONCLUSIONS
  This study is the first to examine the addition of PCT to TAU, compared to TAU alone in patients that recovered from depressive disorder with A-CT. Alongside this effect study a cost effectiveness analysis will be conducted. Furthermore, the study explores potential moderators to examine what works for whom.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): 2599 , date of registration: 11-11-2010.
authors.affiliation: Department of research Arkin, Klaprozenweg 111, 1033 NN, Amsterdam, The Netherlands. margo.de.jonge@arkin.nl.
authors.forename: Margo
authors.initials: M
authors.lastname: de Jonge
authors.affiliation: Department of Clinical Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. c.l.h.bockting@uu.nl.
authors.forename: Claudi L H
authors.initials: CL
authors.lastname: Bockting
authors.affiliation: Department of research Arkin, Klaprozenweg 111, 1033 NN, Amsterdam, The Netherlands. martijn.kikkert@arkin.nl.
authors.forename: Martijn J
authors.initials: MJ
authors.lastname: Kikkert
authors.affiliation: Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, Vrije Universiteit, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. j.e.bosmans@vu.nl.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Bosmans
authors.affiliation: Department of research Arkin, Klaprozenweg 111, 1033 NN, Amsterdam, The Netherlands. jack.dekker@arkin.nl.
authors.forename: Jack J M
authors.initials: JJ
authors.lastname: Dekker
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000517:prevention & control* / Q000628:therapy*; D006801:Humans; D012008:Recurrence; D055502:Secondary Prevention; D016896:Treatment Outcome