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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
  1. Daniela Heddaeus1,
  2. Jörg Dirmaier1,
  3. Christian Brettschneider2,
  4. Anne Daubmann3,
  5. Thomas Grochtdreis2,
  6. Olaf von dem Knesebeck4,
  7. Hans-Helmut König2,
  8. Bernd Löwe5,
  9. Kerstin Maehder5,
  10. Sarah Porzelt6,
  11. Moritz Rosenkranz7,
  12. Ingo Schäfer7,
  13. Martin Scherer6,
  14. Bernd Schulte7,
  15. Karl Wegscheider3,
  16. Angelika Weigel5,
  17. Silke Werner4,
  18. Thomas Zimmermann6,
  19. Martin Härter1
  1. 1Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  2. 2Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  3. 3Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  4. 4Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  5. 5Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  6. 6Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  7. 7Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  1. Correspondence to Daniela Heddaeus; d.heddaeus{at}uke.de

Abstract

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.

  • stepped care
  • collaborative care
  • mental disorders
  • comorbidity
  • guideline-based healthcare

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Footnotes

  • DH and JD are joint first authors.

  • Contributors MH, BL, OvdK, MS, IS, H-HK, KW and DH designed the study and obtained funding. MH, JD and DH are responsible for its conduct and overall supervision. H-HK, CB, TG, KW and AD contributed to specific methodical and health economic issues. DH, JD, SP, KM, SW, AW, TZ, BS, MR and MH worked out study processes, treatment pathways and materials. DH coordinates the study with support from JD and MH. DH, SP, KM and SW organise the network and carry out the recruitment process, network meetings and data collection. DH is responsible for data management. DH, JD and MH wrote the manuscript. All authors contributed to, reviewed and approved the final manuscript.

  • Funding The study is funded by the German Federal Ministry of Education and Research (BMBF) under the grant number 01GY1602. The sponsor does not have any influence on study design, collection, management, analysis, interpretation of data, writing or publication process.

  • Disclaimer The sponsor does not have any influence on study design, collection, management, analysis, interpretation of data, writing or publication process.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The ethics committee of the Hamburg Medical Association approved the study design and intervention (No. PV5595) in September 2017, prior to commencing recruitment. The study will be carried out in accordance with the principles of the Declaration of Helsinki.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no data in this work.

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