Top

Published in:

Open Access 01-12-2021 | Study protocol

Leipzig - Individual Placement and Support for people with mental illnesses (LIPSY): study protocol of a randomized controlled trial

Authors: Felix S. Hussenoeder, Maria Koschig, Ines Conrad, Uta Gühne, Alexander Pabst, Sophie-Elisabeth Kühne, Mathias Alberti, Katarina Stengler, Steffi G. Riedel-Heller

Published in: BMC Psychiatry | Issue 1/2021

Abstract

Background

Individuals receiving means-tested benefits are at a higher risk of being diagnosed with a psychiatric illness compared to those who are employed, and the rate of those working in the first labor market is low. The intervention (Individual Placement and Support, IPS) aims at maintaining or regaining working ability and at facilitating reintegration into the (first) labor market following a “first place, then train”-approach. The objective of the study is to conduct the first RCT in Germany that addresses a broad group of long-term unemployed individuals with severe mental illnesses that receive means-tested benefits, and to test the effectiveness of the IPS intervention.

Methods

In this randomized controlled trial, about 120 eligible participants aged between 18 years and local retirement age will be randomly allocated to an intervention group (IG) or to an active control group (CG) using a parallel arm design. The IG will receive IPS + high quality treatment as usual (TAU), the active CG will receive TAU + a booklet on integration measures. A block-randomization algorithm with a targeted assignment ratio of 1:1 for participants in IG and active CG will be used, stratified by sex and three age groups. Assessments will take place before the intervention at baseline (t0), and 6 (t1), 12 (t2), and 18 (t3) months later. Primary outcome will be the proportion of participants having worked at least 1 day in competitive employment since baseline, as assessed at t3. Secondary outcomes will be related to employment/ vocation and mental health. In addition, there will be a process evaluation. Treatment effects on outcomes will be tested using appropriate panel-data regression models, and acceptability, uptake and adherence will be evaluated using descriptive statistics and appropriate inference testing.

Discussion

The results of this trial are expected to generate a better understanding of the efficiency, feasibility, acceptance, and relevance of the IPS intervention in a German setting. They could be a first step towards the implementation of the method and towards improving the situation of long-term unemployed individuals with severe mental health problems.

Trial registration

German Clinical Trials Register (DRKS00023245), registered on 22.02.2021.

Gühne U, Stein J, Schwarzbach M, Riedel-Heller SG. Der Stellenwert von Arbeit und beruflicher Beschäftigung in der Behandlung psychisch kranker Menschen. Psychother Psychosom Med Psychol. 2017;67(11):457–64.CrossRefPubMed

Paul K, Zechmann A, Moser K. Psychische Folgen von Arbeitsplatzverlust und Arbeitslosigkeit. WSI-Mitteilungen. 2016;69(5):373–80. https://doi.org/10.5771/0342-300X-2016-5-373.CrossRef

Paul KI, Moser K. Incongruence as an explanation for the negative mental health effects of unemployment: Meta-analytic evidence. J Occup Organ Psychol. 2006;79(4):595–621. https://doi.org/10.1348/096317905X70823.CrossRef

Schubert M, Parthier K, Kupka P, Krüger U, Holke J, Fuchs P. Menschen mit psychischen Störungen im SGB II: IAB-Forschungsbericht; 2013.

Riedel-Heller SG, Gühne U. Teilhabe psychisch Kranker am Arbeitsleben–Forschungs-und Handlungsbedarf? Psychother Psych Med. 2015;65:383–6.CrossRef

Bundesarbeitsgemeinschaft Werkstätten für behinderte Menschen e. V. Anzahl der wesentlichen Behinderungsarten in den Mitgliedswerkstätten zum 1. Januar 2019; 2019 [cited 2020 Sep 9]. Available from: URL: https://www.bagwfbm.de/category/34.

Hoffmann H. Was macht supported employment so überlegen? Die Psychiatrie. 2013;10(2):95–101.CrossRef

Metcalfe JD, Drake RE, Bond GR. Economic, labor, and regulatory moderators of the effect of individual placement and support among people with severe mental illness: a systematic review and meta-analysis. Schizophr Bull. 2018;44(1):22–31. https://doi.org/10.1093/schbul/sbx132.CrossRefPubMed

Gühne U, Weinmann S, Riedel-Heller SG, Becker T. Psychosocial therapies in severe mental illness: update on evidence and recommendations. Curr Opin Psychiatry. 2020;33(4):414–21. https://doi.org/10.1097/YCO.0000000000000618.CrossRefPubMed

10.

Modini M, Tan L, Brinchmann B, Wang M-J, Killackey E, Glozier N, et al. Supported employment for people with severe mental illness: Systematic review and meta-analysis of the international evidence. Br J Psychiatry. 2016;209(1):14–22 Available from: https://www.cambridge.org/core/article/supported-employment-for-people-with-severe-mental-illness-systematic-review-and-metaanalysis-of-the-international-evidence/D87504A18AB7E908624FF3FC94AF8F5C.CrossRefPubMed

11.

Frederick DE, van der Weele TJ. Supported employment: Meta-analysis and review of randomized controlled trials of individual placement and support. PLoS One. 2019;14(2):e0212208. Available from:. https://doi.org/10.1371/journal.pone.0212208.CrossRefPubMedPubMedCentral

12.

Burns T, Catty J. IPS in Europe: the EQOLISE trial. Psychiatr Rehabil J. 2008;31(4):313–7. https://doi.org/10.2975/31.4.2008.313.317.CrossRefPubMed

13.

Khalifa N, Talbot E, Barber S, Schneider J, Bird Y, Attfield J, et al. A feasibility cluster randomized controlled trial of individual placement and support (IPS) for patients with offending histories. Frontiers Psychiatry. 2020;10:952 Available from: https://www.frontiersin.org/article/10.3389/fpsyt.2019.00952.CrossRef

14.

Killackey E, Cotton S. Employment and education outcomes from a RCT of individual placement and support for young people with first-episode psychosis. Schizophr Bull. 2017;43(Suppl 1):S50–1 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5475590/.CrossRefPubMedCentral

15.

Sveinsdottir V, Bull HC, Evensen S, Reme SE, Knutzen T, Lystad JU. A short history of individual placement and support in Norway. Psychiatr Rehabil J. 2020;43(1).

16.

Melleney L, Kendall T. Individual Placement and Support (IPS) in England. Psychiatr Rehabil J. 2020; (1559–3126(Electronic),1095-158X(Print):76–8.

17.

Kalkan R, Dorn W, Ehiosun U. Unterstützte Beschäftigung bei Menschen mit schweren psychischen Erkrankungen [Supported employment for people with severe mental illness]. Sozialpsychiatrische Informationen. 2009;39:40–5.

18.

Stengler K, Bechdolf A, Becker T, Döring A, Höhl W, Jäckel D, et al. Umsetzung der Prinzipien des Supported Employment in Deutschland. Nervenarzt. 2021:1–8.

19.

Becker DR, Swanson SJ, Reese SL, Bond GR, McLehman BM. Supported employment fidelity review manual. A companion guide to the evidence-based IPS Supported Employment Fidelity Scale; 2015.

20.

Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, et al. Performance of an abbreviated version of the Lubben social network scale among three European community-dwelling older adult populations. The Gerontologist. 2006;46(4):503–13. https://doi.org/10.1093/geront/46.4.503.CrossRefPubMed

21.

Borkin JR, Steffen JJ, Ensfield LB, Krzton K, Wishnick H, Wilder K, et al. Recovery attitudes questionnaire: development and evaluation. Psychiatr Rehabil J. 2000;24(2):95–102. https://doi.org/10.1037/h0095112.CrossRef

22.

Theissing J, Lepthin H-J, Mittag O. Veränderung der subjektiven Prognose der Erwerbstätigkeit im Verlauf der stationären Rehabilitation. Rehabilitation (Stuttg). 2005;44(2):75–81. https://doi.org/10.1055/s-2004-834609.CrossRef

23.

TNS Infratest Sozialforschung. SOEP 2011 – Methodenbericht zur Testerhebung 2011 des Sozio-oekonomischen Panels – „Gender Stereotypen, Finanzen und weitere Innovationsmodule“; 2012. Available from: http://www.diw.de/soepsurveypapers.

24.

Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A short scale for measuring loneliness in large surveys: results from two population-based studies. Research on aging. 2004;26(6):655–72. https://doi.org/10.1177/0164027504268574.CrossRefPubMedPubMedCentral

25.

Glaesmer H, Hoyer J, Klotsche J, Herzberg PY. Deutsche Version der Revision des Life-Orientation-Tests (LOT-R). Zugriff am. 2003;2:2007.

26.

Glaesmer H, Hoyer J, Klotsche J, Herzberg PY. Die deutsche version des Life-Orientation-Tests (LOT-R) zum dispositionellen Optimismus und Pessimismus. Zeitschrift für Gesundheitspsychologie. 2008;16(1):26–31. https://doi.org/10.1026/0943-8149.16.1.26.CrossRef

27.

Grupp H, König H-H, Riedel-Heller S, Konnopka A. FIMPsy – Fragebogen zur Inanspruchnahme medizinischer und nicht medizinischer Versorgungsleistungen bei psychischen Erkrankungen: Entwicklung und Verwendung. Psychiatr Prax. 2018;45(2):87–94. https://doi.org/10.1055/s-0042-118033.CrossRefPubMed

28.

Üstün TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, et al. Developing the World Health Organization disability assessment schedule 2.0. Bull World Health Organ. 2010;88(11):815–23. https://doi.org/10.2471/BLT.09.067231.CrossRefPubMedPubMedCentral

29.

Purdon SE. The screen for cognitive impairment in psychiatry (SCIP): administration manual and normative data. Edmonton, Alberta: PNL Inc; 2005.

30.

Buchholz I, Thielker K, Feng Y-S, Kupatz P, Kohlmann T. Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res. 2015;24(4):829–35. https://doi.org/10.1007/s11136-014-0838-x.CrossRefPubMed

31.

Wirtz MA, Morfeld M, Glaesmer H, Brähler E. Konfirmatorische Prüfung der Skalenstruktur des SF-12 Version 2.0 in einer deutschen bevölkerungs-repräsentativen Stichprobe. Diagnostica. 2018;64(2):84–96. https://doi.org/10.1026/0012-1924/a000194.CrossRef

32.

Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. https://doi.org/10.1046/j.1525-1497.2001.016009606.x.CrossRefPubMedPubMedCentral

33.

Löwe B, Kroenke K, Herzog W, Gräfe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the patient health questionnaire (PHQ-9). J Affect Disord. 2004;81(1):61–6. https://doi.org/10.1016/S0165-0327(03)00198-8.CrossRefPubMed

34.

Klein JP, Berger T, Schröder J, Späth C, Meyer B, Caspar F, et al. Effects of a psychological internet intervention in the treatment of mild to moderate depressive symptoms: results of the EVIDENT study, a randomized controlled trial. Psychother Psychosom. 2016;85(4):218–28. https://doi.org/10.1159/000445355.CrossRefPubMed

35.

Franke GH. BSCL: brief-symptom-checklist. 1. Auflage. Göttingen: Hogrefe; 2017.

36.

Franke GH. Mini-SCL: Mini-symptom-checklist. 1. Auflage. Göttingen: Hogrefe; 2017.

37.

Gual A, Segura L, Contel M, Heather N, Colom J. Audit-3 and audit-4: effectiveness of two short forms of the alcohol use disorders identification test. Alcohol Alcohol. 2002;37(6):591–6. https://doi.org/10.1093/alcalc/37.6.591.CrossRefPubMed

38.

Maurer F, Kliem S, Bode K, del Pozo MA, Kröger C. Effektivität von kognitiver Verhaltenstherapie bei arbeitslosen und erwerbstätigen Patienten mit prävalenten psychischen Störungen–Eine naturalistische Studie. Psychother Psychosom Med Psychol. 2017;67(2):66–75.CrossRefPubMed

39.

Brackmann N, Kroeger C. German translation of the RTW-SE; 2013.

40.

INQA-WAI-Netzwerk. Wie steht es um Ihre Arbeitsfähigkeit? WAI*-Fragebogen & Auswertung (Kurzversion); 2017. Available from: https://www.wainetzwerk.de/uploads/content/pdf/WAI-Fragebogen-Kurzversion%20mit%20Auswertungsbogen.pdfhttps://www.wainetzwerk.de/uploads/z-neue%20Uploads/WAI-Netzwerk/WAI%20Fragebogen/WAI-Kurzversion_mit%20Auswertung_2017.pdf.

41.

Ranft A, Fiedler R, Greitemann B, Heuft G. Optimierung und Konstruktvalidierung des Diagnostikinstruments für Arbeitsmotivation (DIAMO). Psychother Psychosom Med Psychol. 2009;59(1):21–30. https://doi.org/10.1055/s-2007-986296.CrossRefPubMed

42.

Abele AE, Stief M, Andrä MS. Zur ökonomischen Erfassung beruflicher Selbstwirksamkeitserwartungen - Neukonstruktion einer BSW-Skala. Zeitschrift für Arbeits- und Organisationspsychologie A&O. 2000;44(3):145–51. https://doi.org/10.1026//0932-4089.44.3.145.CrossRef

43.

van Buuren S. Flexible imputation of missing data: CRC press; 2018. https://doi.org/10.1201/9780429492259.

44.

Schulz KF, Altman DG, Moher D, Consort Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11(1):32.CrossRefPubMedPubMedCentral

45.

Gühne U, Pabst A, Löbner M, Breilmann J, Hasan A, Falkai P, et al. Employment status and desire for work in severe mental illness: results from an observational, cross-sectional study. Soc Psychiatry Psychiatr Epidemiol. 2021. Available from:. https://doi.org/10.1007/s00127-021-02088-8.

Title: Leipzig - Individual Placement and Support for people with mental illnesses (LIPSY): study protocol of a randomized controlled trial
Authors: Felix S. Hussenoeder
Maria Koschig
Ines Conrad
Uta Gühne
Alexander Pabst
Sophie-Elisabeth Kühne
Mathias Alberti
Katarina Stengler
Steffi G. Riedel-Heller
Publication date: 01-12-2021
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03416-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Leipzig - Individual Placement and Support for people with mental illnesses (LIPSY): study protocol of a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Validity of the patient health questionnaire 9-item in autistic youths: a pilot study

Interpersonal counselling versus perinatal-specific cognitive behavioural therapy for women with depression during pregnancy offered in routine psychological treatment services: a phase II randomised trial

Comparison of the target-controlled infusion and the manual infusion of propofol anesthesia during electroconvulsive therapy: an open-label randomized controlled trial

A cross-sectional study on the association of serum uric acid levels with depressive and anxiety symptoms in people with epilepsy

Coronary artery calcium in patients with schizophrenia

Caffeine-clozapine interaction associated with severe toxicity and multiorgan system failure: a case report