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

Daniela Heddaeus, Jörg Dirmaier, Christian Brettschneider, Anne Daubmann, Thomas Grochtdreis, Olaf von dem Knesebeck, Hans-Helmut König, Bernd Löwe, Kerstin Maehder, Sarah Porzelt, Moritz Rosenkranz, Ingo Schäfer, Martin Scherer, Bernd Schulte, Karl Wegscheider, Angelika Weigel, Silke Werner, Thomas Zimmermann, Martin Härter, Daniela Heddaeus, Jörg Dirmaier, Christian Brettschneider, Anne Daubmann, Thomas Grochtdreis, Olaf von dem Knesebeck, Hans-Helmut König, Bernd Löwe, Kerstin Maehder, Sarah Porzelt, Moritz Rosenkranz, Ingo Schäfer, Martin Scherer, Bernd Schulte, Karl Wegscheider, Angelika Weigel, Silke Werner, Thomas Zimmermann, Martin Härter

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.

Keywords: collaborative care; comorbidity; guideline-based healthcare; mental disorders; stepped care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Participant timeline. CIDI, Composite International Diagnostic Interview; GP, general practitioner; ICD-10, 10th revision of the International Statistical Classification of Diseases and Related Health Problems; TAU, treatment as usual.

References

    1. Steel Z, Marnane C, Iranpour C, et al. . The global prevalence of common mental disorders: a systematic review and meta-analysis 1980-2013. Int J Epidemiol 2014;43:476–93. 10.1093/ije/dyu038
    1. Patel V, Chisholm D, Parikh R, et al. . Addressing the burden of mental, neurological, and substance use disorders: key messages from disease control priorities, 3rd edition. The Lancet 2016;387:1672–85. 10.1016/S0140-6736(15)00390-6
    1. WHO Mental health atlas 2011. Italy: World Health Organization, 2011.
    1. Demyttenaere K, Bruffaerts R, Posada-Villa J, et al. . Prevalence, severity, and unmet need for treatment of mental disorders in the world Health organization world mental health surveys. JAMA 2004;291:2581–90. 10.1001/jama.291.21.2581
    1. Roca M, Gili M, Garcia-Garcia M, et al. . Prevalence and comorbidity of common mental disorders in primary care. J Affect Disord 2009;119:52–8. 10.1016/j.jad.2009.03.014
    1. Jacobi F, Höfler M, Siegert J, et al. . Twelve-month prevalence, comorbidity and correlates of mental disorders in Germany: the mental health module of the German health interview and examination survey for adults (DEGS1-MH). Int J Methods Psychiatr Res 2014;23:304–19. 10.1002/mpr.1439
    1. Löwe B, Spitzer RL, Williams JBW, et al. . Depression, anxiety and somatization in primary care: syndrome overlap and functional impairment. Gen Hosp Psychiatry 2008;30:191–9. 10.1016/j.genhosppsych.2008.01.001
    1. Hanel G, Henningsen P, Herzog W, et al. . Depression, anxiety, and somatoform disorders: vague or distinct categories in primary care? results from a large cross-sectional study. J Psychosom Res 2009;67:189–97. 10.1016/j.jpsychores.2009.04.013
    1. Gunn J. Designing care for people with mixed mental and physical multimorbidity. BMJ 2015;350:h712 10.1136/bmj.h712
    1. Katon W, Von Korff M, Lin E, et al. . Population-Based care of depression: effective disease management strategies to decrease prevalence. Gen Hosp Psychiatry 1997;19:169–78. 10.1016/S0163-8343(97)00016-9
    1. Thota AB, Sipe TA, Byard GJ, et al. . Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. Am J Prev Med 2012;42:525–38.
    1. Archer J, Bower P, Gilbody S, et al. . Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev 2012;26 10.1002/14651858.CD006525.pub2
    1. Muntingh A, van der Feltz-Cornelis C, van Marwijk H, et al. . Effectiveness of collaborative stepped care for anxiety disorders in primary care: a pragmatic cluster randomised controlled trial. Psychother Psychosom 2014;83:37–44. 10.1159/000353682
    1. Von Korff M, Katon W, Bush T, et al. . Treatment costs, cost offset, and cost-effectiveness of collaborative management of depression. Psychosom Med 1998;60:143–9. 10.1097/00006842-199803000-00005
    1. Zimmermann T, Puschmann E, van den Bussche H, et al. . Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: cluster-randomised controlled trial (findings of the Smads study). Int J Nurs Stud 2016;63:101–11. 10.1016/j.ijnurstu.2016.08.007
    1. Sighinolfi C, Nespeca C, Menchetti M, et al. . Collaborative care for depression in European countries: a systematic review and meta-analysis. J Psychosom Res 2014;77:247–63. 10.1016/j.jpsychores.2014.08.006
    1. Grochtdreis T, Brettschneider C, Wegener A, et al. . Cost-Effectiveness of collaborative care for the treatment of depressive disorders in primary care: a systematic review. PLoS One 2015;10:e0123078 10.1371/journal.pone.0123078
    1. van Steenbergen-Weijenburg KM, van der Feltz-Cornelis CM, Horn EK, et al. . Cost-Effectiveness of collaborative care for the treatment of major depressive disorder in primary care. A systematic review. BMC Health Serv Res 2010;10:19 10.1186/1472-6963-10-19
    1. Atlantis E, Fahey P, Foster J. Collaborative care for comorbid depression and diabetes: a systematic review and meta-analysis. BMJ Open 2014;4:e004706 10.1136/bmjopen-2013-004706
    1. Firth N, Barkham M, Kellett S. The clinical effectiveness of stepped care systems for depression in working age adults: a systematic review. J Affect Disord 2015;170:119–30. 10.1016/j.jad.2014.08.030
    1. van Straten A, Hill J, Richards DA, et al. . Stepped care treatment delivery for depression: a systematic review and meta-analysis. Psychol Med 2015;45:231–46. 10.1017/S0033291714000701
    1. Härter M, Watzke B, Daubmann A, et al. . Guideline-based stepped and collaborative care for patients with depression in a cluster-randomised trial. Sci Rep 2018;8:9389 10.1038/s41598-018-27470-6
    1. Seekles W, van Straten A, Beekman A, et al. . Stepped care treatment for depression and anxiety in primary care. A randomized controlled trial. Trials 2011;12 10.1186/1745-6215-12-171
    1. van't Veer-Tazelaar PJ, van Marwijk HWJ, van Oppen P, et al. . Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry 2009;66:297–304. 10.1001/archgenpsychiatry.2008.555
    1. Goorden M, Muntingh A, van Marwijk H, et al. . Cost utility analysis of a collaborative stepped care intervention for panic and generalized anxiety disorders in primary care. J Psychosom Res 2014;77:57–63. 10.1016/j.jpsychores.2014.04.005
    1. Drummond C, James D, Coulton S, et al. . The effectiveness and cost-effectiveness of screening and stepped care interventions for alcohol use disorders in the primary care setting. Cardiff: Welsh Office of Research and Development, 2003.
    1. Bühringer G, Klein M, Reimer J, et al. . S3-Leitlinie screening, diagnose und Behandlung alkoholbezogener Störungen. Springer, 2015.
    1. Raistrick D. Review of the effectiveness of treatment for alcohol problems: national treatment agency for substance misuse 2006.
    1. Sobell MB, Sobell LC. Stepped care as a heuristic approach to the treatment of alcohol problems. J Consult Clin Psychol 2000;68:573–9. 10.1037/0022-006X.68.4.573
    1. Watson JM, Crosby H, Dale VM, et al. . AESOPS: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care. Health Technol Assess 2013;17:1–158. 10.3310/hta17250
    1. DG-Sucht S3-Leitlinie "Alkoholbezogene Störungen: Screening, Diagnose und Behandlung": AWMF 2015.
    1. van der Feltz-Cornelis CM, van Oppen P, Adèr HJ, et al. . Randomised controlled trial of a collaborative care model with psychiatric consultation for persistent medically unexplained symptoms in general practice. Psychother Psychosom 2006;75:282–9. 10.1159/000093949
    1. Shedden-Mora MC, Gross B, Lau K, et al. . Collaborative stepped care for somatoform disorders: a pre-post-intervention study in primary care. J Psychosom Res 2016;80:23–30. 10.1016/j.jpsychores.2015.11.004
    1. Murray AM, Toussaint A, Althaus A, et al. . The challenge of diagnosing non-specific, functional, and somatoform disorders: a systematic review of barriers to diagnosis in primary care. J Psychosom Res 2016;80:1–10. 10.1016/j.jpsychores.2015.11.002
    1. Kroenke K. Patients presenting with somatic complaints: epidemiology, psychiatric comorbidity and management. Int J Methods Psychiatr Res 2003;12:34–43. 10.1002/mpr.140
    1. Maehder K, Löwe B, Härter M, et al. . Management of comorbid mental and somatic disorders in stepped care approaches in primary care: a systematic review. Fam Pract 2019;36:38–52. 10.1093/fampra/cmy122
    1. Huijbregts KML, de Jong FJ, van Marwijk HWJ, et al. . A target-driven collaborative care model for major depressive disorder is effective in primary care in the Netherlands. A randomized clinical trial from the depression initiative. J Affect Disord 2013;146:328–37. 10.1016/j.jad.2012.09.015
    1. DGPPN, BÄK, KBV S3-Leitlinie/Nationale VersorgungsLeitlinie Unipolare depression. 2. Auflage. 2nd edn Berlin: DGPPN, BÄK, KBV, AWMF, 2015.
    1. Bandelow B, Wiltink J, Alpers GW, et al. . Deutsche S3-Leitlinie Behandlung von Angststörungen, 2014. Available:
    1. Hausteiner-Wiehle C, Sattel H, Ronel J, et al. . Interdisziplinäre S3-Leitlinie zum Umgang MIT Patienten MIT nicht-spezifischen, funktionellen und somatoformen Körperbeschwerden: AWMF 2012.
    1. Depression N. The treatment and management of depression in adults (updated edition). Leicester: The British Psychological Society, 2010.
    1. Melchior H, Schulz H, Härter M. Faktencheck Gesundheit: Regionale Unterschiede in Der Diagnostik und Behandlung von Depressionen. Faktencheck Gesundheit. Gütersloh: Bertelsmann Stiftung, 2014.
    1. Heddaeus D, Steinmann M, Daubmann A, et al. . Treatment selection and treatment initialization in guideline-based stepped and collaborative care for depression. PLoS One 2018;13:e0208882 10.1371/journal.pone.0208882
    1. Katon W, Russo J, Korff M, et al. . Long-Term effects of a collaborative care intervention in persistently depressed primary care patients. J Gen Intern Med 2002;17:741–8. 10.1046/j.1525-1497.2002.11051.x
    1. Bullinger M, Kirchberger I. Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe, 1998.
    1. Löwe B, Unutzer J, Callahan CM, et al. . Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care 2004;42:1194–201.
    1. Spitzer RL, Kroenke K, Williams JBW, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092–7. 10.1001/archinte.166.10.1092
    1. Löwe B, Spitzer RL, Zipfel S, et al. . Gesundheitsfragebogen für Patienten (PHQ-D): manual und Testunterlagen. Karlsruhe: Pfizer, 2002.
    1. Kroenke K, Spitzer RL, Williams JBW, et al. . The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010;32:345–59. 10.1016/j.genhosppsych.2010.03.006
    1. Löwe B, et al. Comparative validity of three screening questionnaires for DSM-IV depressive disorders and physicians? diagnoses. J Affect Disord 2004;78:131–40. 10.1016/S0165-0327(02)00237-9
    1. Toussaint A, Murray AM, Voigt K, et al. . Development and validation of the somatic symptom Disorder–B criteria scale (SSD-12). Psychosom Med 2016;78:5–12. 10.1097/PSY.0000000000000240
    1. Dybek I, Bischof G, Grothues J, et al. . The reliability and validity of the alcohol use disorders identification test (audit) in a German general practice population sample. J Stud Alcohol 2006;67:473–81. 10.15288/jsa.2006.67.473
    1. Roick C, Kilian R, Matschinger H, et al. . German adaptation of the client sociodemographic and service receipt inventory - an instrument for the cost of mental health care. Psychiat Prax 2001;28:84–90.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2nd edn Hillsdale, NJ, England: Lawrence Erlbaum Accociates, 1988.
    1. Borm GF, Fransen J, Lemmens WAJG. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol 2007;60:1234–8. 10.1016/j.jclinepi.2007.02.006
    1. Donner A. Some aspects of the design and analysis of cluster randomization trials. J Roy Stat Soc C-App 1998;47:95–113. 10.1111/1467-9876.00100
    1. Kessler RC, Ustün TB. The world mental health (WMH) survey initiative version of the world Health organization (who) composite international diagnostic interview (CIDI). Int J Methods Psychiatr Res 2004;13:93–121. 10.1002/mpr.168
    1. Radoschewski M, Bellach B-M. Der SF-36 im Bundesgesundheitssurvery - Möglichkeiten und Anforderungen der Nutzung auf Bevölkerungsebene. 61 Gesundheitswesen, 1999: 191–9.
    1. Gräfe K, Zipfel S, Herzog W, et al. . Screening psychischer Störungen mit dem “Gesundheitsfragebogen für Patienten (PHQ-D)“ Ergebnisse der deutschen Validierungsstudie. Diagnostica 2004;50:171–81.
    1. Spitzer RL, Kroenke K, Williams JB, et al. . Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. primary care evaluation of mental disorders. patient health questionnaire. JAMA 1999;282:1737–44. 10.1001/jama.282.18.1737
    1. Babor TF, Higgins-Biddle JC, Saunders JB, et al. . The alcohol use disorders identification test: guidelines for use in primary care. 2nd edn Geneva: World Health Organization, 2001.
    1. Barr PJ, Thompson R, Walsh T, et al. . The psychometric properties of collaborate: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res 2014;16:e2 10.2196/jmir.3085
    1. Ludwig K, Graf von der Schulenburg J-M, Greiner W. German value set for the EQ-5D-5L. Pharmacoeconomics 2018;36:663–74. 10.1007/s40273-018-0615-8
    1. Broadbent E, Wilkes C, Koschwanez H, et al. . A systematic review and meta-analysis of the brief illness perception questionnaire. Psychol Health 2015;30:1361–85. 10.1080/08870446.2015.1070851
    1. Scholl I, Hölzel L, Härter M, et al. . Fragebogen Zur Zufriedenheit in Der ambulanten Versorgung – Schwerpunkt Patientenbeteiligung (ZapA). Klinische Diagnostik und Evaluation 2011;4:50–62.
    1. Bock J-O, Brettschneider C, Seidl H, et al. . [Calculation of standardised unit costs from a societal perspective for health economic evaluation]. Gesundheitswesen 2015;77:53–61. 10.1055/s-0034-1374621
    1. Grupp H, König H, Konnopka A. Kostensätze Zur monetären Bewertung von Versorgungsleistungen bei psychischen Erkrankungen. Gesundheitswesen 2017;79:48–57.
    1. Bundesamt S. Earnings and labour costs, 2015. Available:
    1. Drummond MF. Methods for the economic evaluation of health care programmes. Oxford university press, 2005.
    1. Briggs AH, O'Brien BJ, Blackhouse G. Thinking outside the box: recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annu Rev Public Health 2002;23:377–401. 10.1146/annurev.publhealth.23.100901.140534
    1. Mayring P. Qualitative Inhaltsanalyse. Grundlagen und Techniken. Hamburg: Beltz Pädagogik, 2011.
    1. Makowski AC, Mnich EE, Kofahl C, et al. . [psychenet - Hamburg Network for Mental Health: Results of the Process Evaluation]. Psychiat Prax 2015;42:S65–9.
    1. Görlitz G. Self-Help for depression. Stuttgart: Klett-Cotta, 2010.
    1. Rauh E, Rief W. Ratgeber somatoforme Beschwerden und Krankheitsängste. Informationen für Betroffene und Angehörige. Göttingen: Hogrefe, 2006.
    1. Schmidt-Traub S. Angst bewältigen: Selbsthilfe bei Panik und Agoraphobie (5. vollst. überarb. Aufl). Berlin: Springer, 2013.
    1. K vC, Stangier U, Phobie RS. Informationen für Betroffene und Angehörige. Göttingen: Hogrefe, 2010.
    1. Becker ES, Margraf J, Sorgen Vlauter. Hilfe für Betroffene MIT Generalisierter Angststörung (gas) und deren Angehörige. Weinheim: Beltz, 2008.
    1. Körkel J. Kontrolliertes Trinken - So reduzieren Sie Ihren Alkoholkonsum. 2 ed. Stuttgart: Trias, 2014: 112.
    1. Meyer B, Bierbrodt J, Schröder J, et al. . Effects of an Internet intervention (Deprexis) on severe depression symptoms: randomized controlled trial. Internet Interv 2015;2:48–59. 10.1016/j.invent.2014.12.003
    1. Berger T, Urech A, Krieger T, et al. . Effects of a transdiagnostic unguided Internet intervention (‘velibra’) for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med 2017;47:67–80. 10.1017/S0033291716002270
    1. Zill JM, Christalle E, Meyer B, et al. . The effectiveness of an Internet intervention aimed at reducing alcohol consumption in adults. Dtsch Arztebl Intl 2019. 10.3238/arztebl.2019.0127

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