Abstract
BackgroundDepression 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/designIn 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.DiscussionThe 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 registrationNetherlands Trial Register NTR4650. Registered 18 June 2014.
Highlights
Depression is a prevalent disorder, associated with a high disease burden and substantial societal, economic and personal costs
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 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
Sample size Given the nature of our pilot study, we chose to conduct a cost-effectiveness study, in which we focus on the probability of cost-effectiveness of blended cognitive behavioural treatment (bCBT) in comparison with Cognitive behavioural treatment-as-usual (CBTAU) for various ‘willingness to pay’ ceilings, i.e., the cost-effectiveness acceptability curve (CEAC; Fenwick et al 2001)
Summary
Major Depressive disorder is a highly prevalent disorder, with a major impact on personal, professional and family life and is associated with considerable medical and nonmedical costs. In order to facilitate the decision-making process, the study is designed to closely adhere to established procedures in routine practice in outpatient specialized mental health care This is reflected in the decision to deliver blended CBT over a ten-week period, while adhering to the usual time frame of 20 weeks for the face-to-face CBT. The proposed study is designed to contribute to the body of knowledge on the possible value of blended treatment for depression when applied in outpatient specialized mental health care. It aims to underpin future decisions on whether further research on blended treatment for depression in routine practice is advisable and feasible.
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