title: Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care.
abstract: BACKGROUND
  Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease. The lack of integration between different care providers impedes guideline-based treatment. This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs. To face these challenges, the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting, including low-intensity treatments using innovative technologies.
  
  
  METHODS
  The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year. A cluster randomization at the level of participating primary care units divides the general practitioners into two groups. In the intervention group patients (n = 660) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners, psychotherapists, psychiatrists and inpatient care facilities, whereas patients in the control condition (n = 200) receive routine care. The main research question concerns the effectiveness of the stepped-care model from baseline to t3 (12 months). Primary outcome is the change in depressive symptoms measured by the PHQ-9; secondary outcomes include response, remission and relapse, functional quality of life (SF-12 and EQ-5D-3 L), other clinical and psychosocial variables, direct and indirect costs, and the incremental cost-effectiveness ratio. Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed.
  
  
  CONCLUSIONS
  This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression; it elaborates innovative and evidence-based treatment elements, follows a stratified approach and is implemented in routine care as opposed to standardized conditions. In case of positive results, its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels.
  
  
  BACKGROUND
  This study is registered with ClinicalTrials.gov, number NCT01731717 (date of registration: 24 June 2013).
authors.forename: Birgit
authors.initials: B
authors.lastname: Watzke
authors.forename: Daniela
authors.initials: D
authors.lastname: Heddaeus
authors.forename: Maya
authors.initials: M
authors.lastname: Steinmann
authors.forename: Hans-Helmut
authors.initials: HH
authors.lastname: König
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Holger
authors.initials: H
authors.lastname: Schulz
authors.forename: Martin
authors.initials: M
authors.lastname: Härter
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D001638:Bibliotherapy / Q000191:economics / Q000379:methods; D016000:Cluster Analysis; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics; D003866:Depressive Disorder / Q000191:economics / Q000523:psychology / Q000628:therapy*; D006801:Humans; D020407:Internet / Q000191:economics; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation; D017060:Patient Satisfaction; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods; D011446:Prospective Studies; D011613:Psychotherapy / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D012648:Self Care / Q000191:economics / Q000379:methods; D012649:Self Concept; D020377:Self Efficacy; D012944:Social Support; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000191:economics / Q000379:methods; D016896:Treatment Outcome