title: Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial.
abstract: BACKGROUND
  Depression is a prevalent disorder, associated with a high disease burden and substantial societal, economic and personal costs. Cognitive behavioural treatment has been shown to provide adequate treatment for depression. By offering this treatment in a blended format, in which online and face-to-face treatment are combined, it might be possible to reduce the number of costly face-to-face sessions required to deliver the treatment protocol. This could improve the cost-effectiveness of treatment, while maintaining clinical effects. This protocol describes the design of a pilot study for the evaluation of the feasibility, acceptability and cost-effectiveness of blended cognitive behavioural therapy for patients with major depressive disorder in specialized outpatient mental health care.
  
  
  METHODS
  In a randomized controlled trial design, adult patients with major depressive disorder are allocated to either blended cognitive behavioural treatment or traditional face-to-face cognitive behavioural treatment (treatment as usual). We aim to recruit one hundred and fifty patients. Blended treatment will consist of ten face-to-face and nine online sessions provided alternately on a weekly basis. Traditional cognitive behavioural treatment will consist of twenty weekly sessions. Costs and effects are measured at baseline and after 10, 20 and 30 weeks. Evaluations are directed at cost-effectiveness (with depression severity and diagnostic status as outcomes), and cost-utility (with costs per quality adjusted life year, QALY, as outcome). Costs will encompass health care uptake costs and productivity losses due to absence from work and lower levels of efficiency while at work. Other measures of interest are mastery, working alliance, treatment preference at baseline, depressive cognitions, treatment satisfaction and system usability.
  
  
  CONCLUSIONS
  The results of this pilot study will provide an initial insight into the feasibility and acceptability of blended cognitive behavioural treatment in terms of clinical and economic outcomes (proof of concept) in routine specialized mental health care settings, and an indication as to whether a well-powered clinical trial of blended cognitive behavioural treatment for depression in routine practice would be advisable. This will be determined based on the perspective of various stakeholders including patients, mental health service providers and health insurers. Strengths and limitations of the study are discussed.
  
  
  BACKGROUND
  Netherlands Trial Register NTR4650 . Registered 18 June 2014.
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. l.c.kooistra@vu.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. l.c.kooistra@vu.nl.
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Kooistra
authors.affiliation: EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. j.wiersma@ggzingeest.nl.|Department of Psychiatry, GGZ inGeest and VU University Medical Centre, P.O. Box 7057, Amsterdam, MB, 1007, the Netherlands. j.wiersma@ggzingeest.nl.
authors.forename: Jenneke E
authors.initials: JE
authors.lastname: Wiersma
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. j.j.ruwaard@vu.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. j.j.ruwaard@vu.nl.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Ruwaard
authors.affiliation: EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. p.vanoppen@ggzingeest.nl.|Department of Psychiatry, GGZ inGeest and VU University Medical Centre, P.O. Box 7057, Amsterdam, MB, 1007, the Netherlands. p.vanoppen@ggzingeest.nl.
authors.forename: Patricia
authors.initials: P
authors.lastname: van Oppen
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. fsmit@trimbos.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. fsmit@trimbos.nl.|Trimbos Institute, P.O. Box 725, Utrecht, AS, 3500, the Netherlands. fsmit@trimbos.nl.|Department of Epidemiology and Biostatistics, VU University Medical Centre, P.O. Box 725, Utrecht, AS, 3500, the Netherlands. fsmit@trimbos.nl.
authors.forename: Filip
authors.initials: F
authors.lastname: Smit
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. jlokkerbol@trimbos.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. jlokkerbol@trimbos.nl.|Trimbos Institute, P.O. Box 725, Utrecht, AS, 3500, the Netherlands. jlokkerbol@trimbos.nl.
authors.forename: Joran
authors.initials: J
authors.lastname: Lokkerbol
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. w.j.m.j.cuijpers@vu.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. w.j.m.j.cuijpers@vu.nl.|Leuphana University, Innovation Incubator, Division Health Trainings online, Rotenbleicher Weg 67, Lüneburg, 21335, Germany. w.j.m.j.cuijpers@vu.nl.
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.affiliation: Faculty of Psychology and Education, Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, BT, 1081, Amsterdam, the Netherlands. h.riper@vu.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, BT, 1081, Amsterdam, the Netherlands. h.riper@vu.nl.|Leuphana University, Innovation Incubator, Division Health Trainings online, Rotenbleicher Weg 67, Lüneburg, 21335, Germany. h.riper@vu.nl.
authors.forename: Heleen
authors.initials: H
authors.lastname: Riper
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003362:Cost-Benefit Analysis / Q000379:methods; D003865:Major Depressive Disorder / Q000191:economics* / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008605:Mental Health Services / Q000191:economics*; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010865:Pilot Projects; D016037:Single-Blind Method