title: Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Major depressive disorder (MDD) places a significant disease burden on individuals as well as on societies. Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms. However, it is not known whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression.
  
  
  METHODS
  This study is a currently recruiting pragmatic randomized controlled trial (RCT) that compares regular psychotherapy plus a web-based depression program ("deprexis") with a control condition exclusively receiving regular psychotherapy. Adults with a depressive disorder (N = 800) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions. The primary outcome is depressive symptoms measured with the Beck Depression Inventory (BDI-II) at three months post randomization. Secondary outcomes include changes on various indicators such as anxiety, somatic symptoms and quality of life. All outcomes are again assessed at the secondary endpoint six months post randomization. In addition, the working alliance and feasibility/acceptability of the treatment condition will be explored.
  
  
  CONCLUSIONS
  This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care.
  
  
  BACKGROUND
  ISRCTN20165665.
authors.affiliation: Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland. tobias.krieger@psy.unibe.ch.
authors.forename: Tobias
authors.initials: T
authors.lastname: Krieger
authors.forename: Björn
authors.initials: B
authors.lastname: Meyer
authors.forename: Kerstin
authors.initials: K
authors.lastname: Sude
authors.forename: Antoine
authors.initials: A
authors.lastname: Urech
authors.forename: Andreas
authors.initials: A
authors.lastname: Maercker
authors.forename: Thomas
authors.initials: T
authors.lastname: Berger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D019114:Remote Consultation; D012107:Research Design; D055815:Young Adult