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

BMC Psychiatry

Heleen Riper³  Pim Cuijpers³  Joran Lokkerbol²  Filip Smit⁴  Patricia van Oppen⁵  Jeroen Ruwaard¹  Jenneke E Wiersma⁵  Lisa C Kooistra¹ 

[1] EMGO institute for Health Care and Research, VU University Medical Centre, Van der Boechorststraat 7, Amsterdam, 1081, BT, the Netherlands;Trimbos Institute, Utrecht 3500, AS, the Netherlands;Leuphana University, Innovation Incubator, Division Health Trainings online, Rotenbleicher Weg 67, Lüneburg 21335, Germany;Department of Epidemiology and Biostatistics, VU University Medical Centre, Utrecht 3500, AS, the Netherlands;Department of Psychiatry, GGZ inGeest and VU University Medical Centre, Amsterdam 1007, MB, the Netherlands

关键词: Randomized controlled trial;    Pilot;    Specialized mental health care;    Outpatients;    Cost-effectiveness;    Blended treatment;    Cognitive behavioural therapy;    Internet-based treatment;    Depression;   

Others  :  1123308
DOI  :  10.1186/s12888-014-0290-z

 received in 2014-09-29, accepted in 2014-10-08,  发布年份 2014

【 摘 要 】

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/design

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.

Discussion

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.

Trial registration

Netherlands Trial Register NTR4650 webcite. Registered 18 June 2014.

【 授权许可】

   
2014 Kooistra et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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