Open Access Study protocol
Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care
Birgit Watzke12*, Daniela Heddaeus1, Maya Steinmann1, Hans-Helmut König3, Karl Wegscheider4, Holger Schulz1 and Martin Härter1
* Corresponding author: Birgit Watzke firstname.lastname@example.org
Department of Medical Psychology (W26), University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany
Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, Zurich, CH-8050, Switzerland
Department of Health Economics and Health Services Research (W37), Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany
Department of Medical Biometry and Epidemiology (W34), University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany
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BMC Psychiatry 2014, 14:230 doi:10.1186/s12888-014-0230-y
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1471-244X/14/230
Received: 10 July 2014
Accepted: 5 August 2014
Published: 20 August 2014
© 2014 Watzke et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease. The lack of integration between different care providers impedes guideline-based treatment. This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs. To face these challenges, the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting, including low-intensity treatments using innovative technologies.
The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year. A cluster randomization at the level of participating primary care units divides the general practitioners into two groups. In the intervention group patients (n = 660) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners, psychotherapists, psychiatrists and inpatient care facilities, whereas patients in the control condition (n = 200) receive routine care. The main research question concerns the effectiveness of the stepped-care model from baseline to t3 (12 months). Primary outcome is the change in depressive symptoms measured by the PHQ-9; secondary outcomes include response, remission and relapse, functional quality of life (SF-12 and EQ-5D-3 L), other clinical and psychosocial variables, direct and indirect costs, and the incremental cost-effectiveness ratio. Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed.
This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression; it elaborates innovative and evidence-based treatment elements, follows a stratified approach and is implemented in routine care as opposed to standardized conditions. In case of positive results, its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels.
This study is registered with ClinicalTrials.gov, number NCT01731717 webcite (date of registration: 24 June 2013).