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Open Access Study protocol

Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial

Marjoliek A IJff12*, Klaas ML Huijbregts12, Harm WJ van Marwijk23, Aartjan TF Beekman124, Leona Hakkaart-van Roijen5, Frans F Rutten5, Jürgen Unützer6 and Christina M van der Feltz-Cornelis124

Author Affiliations

1 Program Diagnosis and Treatment, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands

2 Institute for Research in Extramural Medicine, VU Medical Centre, Amsterdam, The Netherlands

3 Department of General Practice, VU Medical Centre, Amsterdam, The Netherlands

4 Department of Psychiatry, VU Medical Centre, Amsterdam, The Netherlands

5 Institute for Medical Technology Assessment, Erasmus Medical Centre, Rotterdam, The Netherlands

6 Center for Health Services Research, UCLA Neuropsychiatric Institute, Los Angeles, California, USA

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BMC Health Services Research 2007, 7:34  doi:10.1186/1472-6963-7-34

Published: 1 March 2007

Abstract

Background

Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries.

Methods/design

This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months) are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36.

Discussion

In this study, an American model to enhance care for patients with a depressive disorder, the collaborative care model, will be evaluated for effectiveness in the primary care setting. If effective across the Atlantic and across different health care systems, it is also likely to be an effective strategy to implement in the treatment of major depressive disorder in the Netherlands.