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

BMC Psychiatry

Martin Härter¹  Holger Schulz¹  Karl Wegscheider²  Hans-Helmut König³  Maya Steinmann¹  Daniela Heddaeus¹  Birgit Watzke⁴ 

[1] Department of Medical Psychology (W26), 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;Department of Health Economics and Health Services Research (W37), Hamburg Center for Health Economics, 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

关键词: e-Mental health;    Low intensity treatments;    Secondary care;    Primary care;    Complex intervention;    Collaborative care;    Stepped care;    Depression;   

Others  :  1123383
DOI  :  10.1186/s12888-014-0230-y

 received in 2014-07-10, accepted in 2014-08-05,  发布年份 2014

【 摘 要 】

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

This study is registered with ClinicalTrials.gov, number NCT01731717 webcite (date of registration: 24 June 2013).

【 授权许可】

   
2014 Watzke et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carull L, Simon R, Steinhausen HC: The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol 2011, 21(Suppl 9):655-679.
• [2]The World Health Report 2001 - Mental Health: New Understanding, New Hope. World Health Organization, Geneva; 2001.
• [3]Von Korff M, Katon W, Bush T, Lin EHB, Simon GE, Saunders K, Ludman E, Walker E, Unutzer J: Treatment costs, cost offset, and cost effectiveness of collaborative management of depression. Psychosom Med 1997, 60:143-149.
• [4]Härter M, Baumeister H, Reuter K, Wunsch A, Bengel J: Epidemiologie komorbider psychischer Störungen bei Rehabilitanden mit muskuloskelettalen und kardiovaskulären Erkrankungen. Rehabilitation 2002, 41(06):367-374.
• [5]Jacobi F, Höfler M, Meister W, Wittchen H-U: Prävalenz, Erkennens- und Verschreibungsverhalten bei depressiven Syndromen. Eine bundesdeutsche Hausarztstudie. Nervenarzt 2002, 73(Suppl 7):651-658.
• [6]Steinmann M, Watzke B, Lehmann C, Härter M: Epidemiologie depressiver Störungen. In Depressive Störungen über die Lebensspanne. Edited by Freitag CM, Barocka A, Fehr C, Grube M, Hampel H. Kohlhammer, Stuttgart; 2013:17-28.
• [7]Jacobi F, Wittchen H-U, Holting C, Höfler M, Pfister H, Müller N, Lieb R: Prevalence, co-morbidity and correlates of mental disorders in the general population: results from the German Health Interview and Examination Survey (GHS). Psychol Med 2004, 34(Suppl 4):594-611.
• [8]Duhoux A, Fournier L, Gauvin L, Roberge P: Quality of care for major depression and its determinants: A multilevel analysis. Boston Med Center Psychiatry 2012, 12:142.
• [9]Katon WJ, Unützer J, Simon G: Treatment of depression in Primary Care - Where we are, where we can go. Med Care 2004, 42:1153-1157.
• [10]BPtK-Studie zu Wartezeiten in der ambulanten psychotherapeutischen Versorgung. Bundespsychotherapeutenkammer, Berlin; 2011.
• [11]Barkham M, Mullin T, Leach C, Stiles WB, Lucock M: Stability of the CORE-OM and the BDI-I prior to therapy: evidence from routine practice. Psychol Psychotherapy 2007, 80:269-278.
• [12]Bower P, Gilbody S: Stepped care in psychological therapies: access, effectiveness and efficiency. Brit J Psychiat 2005, 186:11-17.
• [13]Gutachten 2005: Koordination und Qualität im Gesundheitswesen. Nomos, Baden-Baden; 2005.
• [14]Scogin F, Hanson A, Welsh D: Self administered treatment in stepped-care models of depression treatment. J Clin Psychol 2003, 59:341-349.
• [15]Simon GE, Katon WJ, VonKorff M, Unützer J, Lin EHB, Walker EA, Bush T, Rutter C, Ludman E: Cost-Effectiveness of a Collaborative Care Program for Primary Care Patients With Persistent Depression. Am J Psychiatry 2001, 158:1638-1644.
• [16]ür die Leitliniengruppe Unipolare Depression. S3-Leitlinie/Nationale VersorgungsLeitlinie Unipolare Depression. DGPPN, ÄZQ, AWMF, Berlin, Düsseldorf; 2009.
• [17]Depression: Management of depression in primary and secondary care (Clinical guideline 22). National Institute for Clinical Excellence, London; 2004.
• [18]Härter M, Klesse C, Bermejo I, Schneider F, Berger M: Unipolar depression: diagnostic and therapeutic recommendations from the current S3/National Clinical Practice Guideline. Deutsches Arzteblatt Int 2010, 107(Suppl 40):700-708.
• [19]Katon W, VonKorff M, Lin E, Walker E, Simon GE, Bush T, Robinson P, Russo J: Collaborative management to achieve treatment guidelines: impact on depression in primary care. JAMA 1995, 273:1026-1031.
• [20]Katon W, Robinson P, VonKorff M, Lin E, Bush T, Ludman E, Simon G, Walker E: A multifaceted intervention to improve treatment of depression in primary care. Arch Gen Psychiatry 1996, 53:924-932.
• [21]Katon W, VonKorff M, Lin E, Simon G, Walker G, Unützer J, Bush T, Russo J, Ludman E: Stepped collaborative care for primary care patients with persistent symptoms of depression: a randomized trial. Arch Gen Psychiatry 1999, 56:1109-1115.
• [22]Van’t Veer-Tazelaar PJ, Van Marwijk HWJ, Van Oppen P, Van Hout HPJ, Van der Horst HE, Cuijpers P, Smit F, Beekman ATF: Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry 2009, 66:297-304.
• [23]Christensen H, Griffiths KM, Jorm AF: Delivering interventions for depression by using the internet: Randomised controlled trial. Br Med J 2004, 328:265.
• [24]Härter M, Kentgens M, Brandes A, Bock T, Dirmaier J, Erzberger M, Furstenberg W, Hillebrandt B, Karow A, von dem Knesebeck O, König HH, Löwe B, Meyer HJ, Romer G, Rouhiainen T, Scherer M, Thomasius R, Watzke B, Wegscheider K, Lambert M: Rationale and content of psychenet: the Hamburg Network for Mental Health. Eur Arch Psychiatry Clin Neurosci 2012, 262(Suppl 2):57-63.
• [25]Coppens E, Van Audenhove C, Scheerder G, Arensmann E, Coffey C, Costa S, Koburger N, Gottlebe K, Gusmao R, O’Connor R, Postuvan V, Sarchiapone M, Sisask M, Székely A, van der Feltz-Cornelis C, Hegerl U: Public attitudes toward depression and help-seeking in four European countries baseline survey prior to the OSPI-Europe intervention. J Affect Disord 2013, 150:320-329.
• [26]Cohen J: Statistical power analysis for the behavioral sciences. Lawrence Erlbaum Associates, Hillsdale, NJ, England; 1988.
• [27]Görlitz G: Selbsthilfe bei Depression. Klett-Cotta, Stuttgart; 2010.
• [28]Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M: Effectiveness of a Novel Integrative Online Treatment for Depression (Deprexis): Randomized Controlled Trial. J Med Int Res 2009, 11(Suppl 2):e15.
• [29]Tutty S, Spangler DL, Poppleton LE, Ludman EJ, Simon GE: Evaluating the effectiveness of cognitive-behavioral teletherapy in depressed adults. Behav Ther 2010, 41:229-236.
• [30]Tutty S, Ludman EJ, Simon G: Feasibility and acceptability of a telephone psychotherapy program for depressed adults treated in primary care. Gen Hosp Psychiat 2005, 27:400-410.
• [31]Steinmann M, Heddaeus D, Härter M, Liebherz S, Weymann N, Watzke B: Telefongestützte Psychotherapie bei Depression: Ein kognitiv-verhaltenstherapeutisches Behandlungsmanual für den deutschen Sprachraum. Preparation 2014.
• [32]Härter M, Bermejo I, Niebling W: Praxismanual Depression - Diagnostik und Therapie erfolgreich umsetzen. Deutscher Ärzte Verlag, Köln; 2007.
• [33]Härter M, Bermejo I, Schneider F, Kratz S, Gaeber W, Hegerl U, Niebling , Berger : Versorgungsleitlinien für depressive Störungen in der ambulanten Praxis. Zeitschrift für ärztliche Fortbildung und Qualitätssicherung 2003, 97(Suppl 4):16-35.
• [34]Härter M, Bermejo I, Ollenschläger G, Schneider F, Gaebel W, Hegerl U, Niebling W, Berger M: Improving quality of care for depression: the German Action Programme for the implementation of evidence-based guidelines. Int J Qual Health C 2006, 18(Suppl 2):113-119.
• [35]Loh A, Meier K, Simon D, Hänselmann S, Jahn H, Niebling W, Härter M: Entwicklung und Evaluation eines Fortbildungsprogramms zur Partizipativen Entscheidungsfindung für die hausärztliche Versorgung depressiver Patienten. Bundesgesundheitsbl - Gesundheitsforsch -Gesundheitsschutz 2004, 47:977-984.
• [36]Löwe B, Spitzer RL, Zipfel S, Herzog W: Gesundheitsfragebogen für Patienten (PHQ-D): Manual und Testunterlagen. Karlsruhe, Pfizer; 2002.
• [37]Gräfe K, Zipfel S, Herzog W, Löwe B: Screening psychischer Störungen mit dem “Gesundheitsfragebogen für Patienten (PHQ-D)” Ergebnisse der deutschen Validierungsstudie. Diagnostica 2004, 50(Suppl 4):171-181.
• [38]Spitzer RL, Kroenke K, Williams JBW: Validation and utility of a self-report version of PRIME-MD. J Am Med Assoc 1999, 282:1737-1744.
• [39]Bullinger M, Kirchberger I: SF-36. Fragebogen zum Gesundheitszustand. Hogrefe, Göttingen; 1998.
• [40]EuroQol–a new facility for the measurement of health-related quality of life Health Policy 1990, 16(Suppl 3):199-208.
• [41]Schulenburg Gvd J, Claes C, Greiner W, Uber A: Die deutsche Version des EuroQol-Fragebogens. Zeitschrift für Gesundheitswissenschaften 1998, 6(Suppl 1):3-20.
• [42]Dolan P: Modeling valuations for EuroQol health states. Med Care 1997, 35(Suppl 11):1095-1108.
• [43]Ferring D, Filipp H-S: Messung des Selbstwertgefühls: Befunde zu Reliabilität, Validität und Stabilität der Rosenberg-Skala. Diagnostica 1996, 42:284-292.
• [44]Schwarzer R, Jerusalem M: Skalen zur Erfassung von Lehrer- und Schülermerkmalen. Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Freie Universität Berlin, Berlin; 1999.
• [45]Bush T, Russo JE, Ludman E, Lin E, Von Korff M, Simon G, Katon W, Walker E: Perceived self-efficacy for depression self-management. A reliable and valid self-report measure with predictive validity. ᅟ.
• [46]Ludman E, Katon W, Bush T, Rutter C, Lin E, Simon G, Von Korff M, Walker E: Behavioural factors associated with symptom outcomes in a primary care-based depression prevention intervention trial. Psychol Med 2003, 33(Suppl 6):1061-1070.
• [47]Kriz D, Nübling R, Steffanowski A, Wittmann WW, Schmidt J: Patientenzufriedenheit in der stationären Rehabilitation: Psychometrische Reanalyse des ZUF-8 auf der Basis multizentrischer Stichproben verschiedener Indikation. Z Med Psychol 2008, 17:67-79.
• [48]Attkinson CC, Zwick R: The Client Satisfaction Questionnaire: Psychometric properties and correlation with service utilization and psychotherapy outcome. Evaluation Program Plan 1982, 5:233-237.
• [49]Bassler M, Potratz B, Krauthauser H: Der “Helping Alliance Questionnaire” (HAQ) von Luborsky - Möglichkeiten zur Evaluation von stationärer Psychotherapie. Psychotherapeut 1995, 40(Suppl 1):23-32.
• [50]Fydrich T, Sommer G, Brähler E: Fragebogen zur Sozialen Unterstützung (F-SozU). Hogrefe, Göttingen; 2003.
• [51]Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M: The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Counsel 2010, 80(Suppl 1):94-99.
• [52]Schulz H, Lang K, Nübling R, Koch U: Psychometrische Überprüfung einer Kurzform des Fragebogens zur Psychotherapiemotivation - FPTM-23. Diagnostica 2003, 49:83-93.