Open Access Study protocol

Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

L Esther de Graaf1*, Sylvia AH Gerhards1, Silvia MAA Evers2, Arnoud Arntz1, Heleen Riper3, Johan L Severens24, Guy Widdershoven5, Job FM Metsemakers6 and Marcus JH Huibers1

Author Affiliations

1 Department of Clinical Psychological Science, Faculty of Psychology, Maastricht University, The Netherlands

2 Department of Health Organization, Policy and Economics, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands

3 Trimbos-institute, Utrecht, The Netherlands

4 Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, The Netherlands

5 Department of Health, Ethics and Society/Metamedica, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands

6 Department of General Practice, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands

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BMC Public Health 2008, 8:224  doi:10.1186/1471-2458-8-224

Published: 30 June 2008

Abstract

Background

Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care.

Methods/Design

In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life.

Discussion

Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed.

Trial registration

The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236).