Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care
Hans-Helmut König,
Olaf von dem Knesebeck,
Karl Wegscheider,
Martin Härter,
Jörg Dirmaier,
Bernd Löwe,
Bernd Schulte,
Daniela Heddaeus,
Christian Brettschneider,
Anne Daubmann,
Thomas Grochtdreis,
Kerstin Maehder,
Sarah Porzelt,
Moritz Rosenkranz,
Ingo Schäfer,
Martin Scherer,
Angelika Weigel,
Silke Werner,
Thomas Zimmermann
Affiliations
Hans-Helmut König
Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Olaf von dem Knesebeck
Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Center for Psychosocial Medicine, Hamburg, Germany
Karl Wegscheider
trial statistician and professor of medical biometry and epidemiology
Martin Härter
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Jörg Dirmaier
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Bernd Löwe
4 Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Bernd Schulte
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Daniela Heddaeus
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Christian Brettschneider
Department for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany
Anne Daubmann
Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
Thomas Grochtdreis
3 Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Kerstin Maehder
Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Sarah Porzelt
Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Center for Psychosocial Medicine, Hamburg, Germany
Moritz Rosenkranz
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Ingo Schäfer
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Martin Scherer
Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Angelika Weigel
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Silke Werner
Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Thomas Zimmermann
Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Center for Psychosocial Medicine, Hamburg, Germany
Introduction Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.Methods and analysis In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.Ethics and dissemination The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.Trial registration number NCT03226743.
