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
- guideline-based healthcare
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
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.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.