Top

Published in:

Open Access 01-12-2020 | Care | Study protocol

Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT)

Authors: Galia S. Moran, Jasmine Kalha, Annabel S. Mueller-Stierlin, Reinhold Kilian, Silvia Krumm, Mike Slade, Ashleigh Charles, Candelaria Mahlke, Rebecca Nixdorf, David Basangwa, Juliet Nakku, Richard Mpango, Grace Ryan, Donat Shamba, Mary Ramesh, Fileuka Ngakongwa, Alina Grayzman, Soumitra Pathare, Benjamin Mayer, Bernd Puschner

Published in: Trials | Issue 1/2020

Abstract

Background

Peer support is an established intervention involving a person recovering from mental illness supporting others with mental illness. Peer support is an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at multiple levels, including service user outcomes (psychosocial and clinical), peer support worker outcomes (work role and empowerment), service outcomes (cost-effectiveness and return on investment), and implementation outcomes (adoption, sustainability and organisational change).

Methods

UPSIDES-RCT is a pragmatic, parallel-group, multicentre, randomised controlled trial assessing the effectiveness of using peer support in developing empowering mental health services (UPSIDES) at four measurement points over 1 year (baseline, 4-, 8- and 12-month follow-up), with embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, UK, Israel, India, Uganda and Tanzania). The primary outcome is social inclusion of service users with severe mental illness (N = 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (using the Empowerment Scale), hope (using the HOPE scale), recovery (using Stages of Recovery) and health and social functioning (using the Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect and the implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support.

Discussion

The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention in different cultural, organisational and resource settings. By actively involving and empowering service users, UPSIDES will move mental health systems toward a recovery orientation, emphasising user-centredness, community participation and the realisation of mental health as a human right.

Trial registration

ISRCTN, ISRCTN26008944. Registered on 30 October 2019.

Repper J, Perkins R. Social inclusion and recovery: a model for mental health practice. Edinburgh: Baillière Tindall; 2003.

Puschner B. Peer support and global mental health. Epidemiol Psychiatr Sci. 2018;27:413–4. https://doi.org/10.1017/S204579601800015X.CrossRefPubMed

Solomon P. Peer support/peer provided services underlying processes, benefits, and critical ingredients. Psychiatr Rehabil J. 2004;27:392. https://doi.org/10.2975/27.2004.392.401.CrossRefPubMed

Simpson EL, House AO. Involving users in the delivery and evaluation of mental health services: systematic review. BMJ. 2002;325:1265. https://doi.org/10.1136/bmj.325.7375.1265.CrossRefPubMedPubMedCentral

Slade M, Amering M, Farkas M, Hamilton B, O'Hagan M, Panther G, et al. Uses and abuses of recovery: implementing recovery-oriented practices in mental health systems. World Psychiatry. 2014;13:12–20. https://doi.org/10.1002/wps.20084.CrossRefPubMedPubMedCentral

Pitt V, Lowe D, Hill S, Prictor M, Hetrick SE, Ryan R, Berends L. Consumer-providers of care for adult clients of statutory mental health services. Cochrane Database Syst Rev. 2013;3:CD004807. https://doi.org/10.1002/14651858.CD004807.pub2.CrossRef

Vally Z, Abrahams L. The effectiveness of peer-delivered services in the management of mental health conditions: a meta-analysis of studies from low- and middle-income countries. Int J Adv Couns. 2016;38:330–44. https://doi.org/10.1007/s10447-016-9275-6.CrossRef

Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012;11:123–8. https://doi.org/10.1016/j.wpsyc.2012.05.009.CrossRefPubMedPubMedCentral

Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013;36:28–34. https://doi.org/10.1037/h0094744.CrossRefPubMed

10.

Pathare S, Kalha J, Krishnamoorthy S. Peer support for mental illness in India: an underutilised resource. Epidemiol Psychiatr Sci. 2018;27:1–5. https://doi.org/10.1017/S2045796018000161.CrossRef

11.

Fan Y, Ma N, Ma L, Xu W, Steven Lamberti J, Caine ED. A community-based peer support service for persons with severe mental illness in China. BMC Psychiatr. 2018;18:170. https://doi.org/10.1186/s12888-018-1763-2.CrossRef

12.

Vandewalle J, Debyser B, Beeckman D, Vandecasteele T, van Hecke A, Verhaeghe S. Peer workers’ perceptions and experiences of barriers to implementation of peer worker roles in mental health services: a literature review. Int J Nurs Stud. 2016;60:234–50. https://doi.org/10.1016/j.ijnurstu.2016.04.018.CrossRefPubMed

13.

Puschner B, Repper J, Mahlke C, Nixdorf R, Basangwa D, Nakku J, et al. Using Peer Support in Developing Empowering Mental Health Services (UPSIDES): background, rationale and methodology. Ann Glob Health. 2019;85:1–10. https://doi.org/10.5334/aogh.2435.CrossRef

14.

Gillard S, Gibson SL, Holley J, Lucock M. Developing a change model for peer worker interventions in mental health services: a qualitative research study. Epidemiol Psychiatr Sci. 2015;24:435–45. https://doi.org/10.1017/S2045796014000407.CrossRefPubMed

15.

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50. https://doi.org/10.1186/1748-5908-4-50.CrossRefPubMedPubMedCentral

16.

Ibrahim N, Thompson D, Nixdorf R, Kalha J, Mpango R, Moran G, et al. A systematic review of influences on implementation of peer support work for adults with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2019. https://doi.org/10.1007/s00127-019-01739-1.

17.

Charles A, Thompson D, Nixdorf R, Shamba D, Kalha J, Moran G, et al. A systematic review of adaptations of peer support worker interventions for adults with mental health problems. Br J Psychiatry. 2020;29:1–7. https://doi.org/10.1192/bjp.2019.264.CrossRef

18.

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. https://doi.org/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

19.

Rosen A, Strathdee G, Slade M, Powell R. Threshold Assessment Grid (TAG): the development of a valid and brief scale to assess the severity of mental illness. Soc Psychiatry Psychiatr Epidemiol. 2000;35:78–85. https://doi.org/10.1007/s001270050011.CrossRefPubMed

20.

Stratford AC, Halpin M, Phillips K, Skerritt F, Beales A, Cheng V, et al. The growth of peer support: an international charter. J Ment Health. 2017;28:627–32. https://doi.org/10.1080/09638237.2017.1340593.CrossRefPubMed

21.

Repper J, Aldridge B, Gilfoyle S, Gillard S, Perkins R, Rennison J. Peer support workers: theory and practice (ImROC Briefing Paper 5). 2013. https://imroc.org/resources/5-peer-support-workers-theory-practice/. Accessed 3 Feb 2020.

22.

Utschakowski J, Sielaff G, Bock T, Winter A. Experten aus Erfahrung: Peerarbeit in der Psychiatrie [Experts from experience: peer work in psychiatry]. Cologne: Psychiatrie Verlag; 2016.

23.

Ryan GK, Kamuhiirwa M, Mugisha J, Baillie D, Hall C, Newman C, et al. Peer support for frequent users of inpatient mental health care in Uganda: protocol of a quasi-experimental study. BMC Psychiatr. 2019;19:374. https://doi.org/10.1186/s12888-019-2360-8.CrossRef

24.

World Health Organization. One-to-one peer support by and for people with lived experience. WHO QualityRights guidance module. 2019. https://apps.who.int/iris/bitstream/handle/10665/329591/9789241516785-eng.pdf. Accessed 4 Feb 2020.

25.

Pathare S, Kalha J, Joseph T, Funk M, Drew-Bold N, Khenti A. Quality rights Gujarat. In: Kerrigan P, Bhattacharya S, Peel S, Sá MR, Kishore R, Wade A, editors. Mental health: pasts, current trends and futures. York: Orient Blackswan; 2017. p. 64–78.

26.

Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, et al. Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania. BMC Public Health. 2020;20:80. https://doi.org/10.1186/s12889-019-7907-6.CrossRefPubMedPubMedCentral

27.

Peer2Peer. Vocational training course. 2015. https://scottishrecovery.net/wp-content/uploads/2016/01/p2pfinalmanual_eng.pdf. Accessed 4 Feb 2020.

28.

Moran GS. The consumer movement and peer providers in Israel. Epidemiol Psychiatr Sci. 2018;27:420–6.CrossRef

29.

Baumgartner JN, Burns JK. Measuring social inclusion—a key outcome in global mental health. Int J Epidemiol. 2014;43:354–64. https://doi.org/10.1093/ije/dyt224.CrossRefPubMed

30.

Secker J, Hacking S, Kent L, Shenton J, Spandler H. Development of a measure of social inclusion for arts and mental health project participants. J Ment Health. 2009;18:65–72. https://doi.org/10.1080/09638230701677803.CrossRef

31.

Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010;61:933–6. https://doi.org/10.1176/ps.2010.61.9.933.CrossRefPubMed

32.

Snyder CR, Harris C, Anderson JR, Holleran SA, et al. The will and the ways: development and validation of an individual-differences measure of hope. J Pers Soc Psychol. 1991;60:570–85. https://doi.org/10.1037//0022-3514.60.4.570.CrossRefPubMed

33.

Andresen R, Caputi P, Oades L. Development of a short measure of psychological recovery in serious mental illness: the STORI-30. Australas Psychiatry. 2013;21:267–70. https://doi.org/10.1177/1039856213476352.CrossRefPubMed

34.

Wing JK, Beevor AS, Curtis RH, Park SB, Hadden S, Burns A. Health of the Nation Outcome Scales (HoNOS). Research and development. Br J Psychiatry. 1998;172:11–8. https://doi.org/10.1192/bjp.172.1.11.CrossRefPubMed

35.

Wild D, Eremenco S, Mear I, Martin M, Houchin C, Gawlicki M, et al. Multinational trials—recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data. The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report. Value Health. 2009;12:430–40. https://doi.org/10.1111/j.1524-4733.2008.00471.x.CrossRefPubMed

36.

Raudenbush SW, Bryk AS. Hierarchical linear models: applications and data analysis methods. 2nd ed. Thousand Oaks: Sage; 2010.

37.

Chisholm D, Knapp M, Knudsen HC. Client socio-demographic and service receipt inventory — European version: development of an instrument for international research: EPSILON Study 5. Br J Psychiatry. 2000;177:28s–33. https://doi.org/10.1192/bjp.177.39.s28.CrossRef

38.

Vassall A, Sweeney S, Kahn J, Gomez Guillen G, Bollinger L, Marseille E, et al. Reference case for estimating the costs of global health services and interventions. 2017. https://ghcosting.org/pages/standards/reference_case. Accessed 12 Feb 2020.

39.

OECD Data. Conversion rates — purchasing power parities (PPP). 2019. https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm. Accessed 5 Feb 2020.

40.

Oppong R, Jowett S, Roberts TE. Economic evaluation alongside multinational studies: a systematic review of empirical studies. PLoS One. 2015;10:e0131949. https://doi.org/10.1371/journal.pone.0131949.CrossRefPubMedPubMedCentral

41.

Greiner W, Weijnen T, Nieuwenhuizen M, Oppe S, Badia X, Busschbach J, et al. A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ. 2003;4:222–31. https://doi.org/10.1007/s10198-003-0182-5.CrossRefPubMed

42.

Willan AR, Briggs AH. Statistical analysis of cost-effectiveness data. Chichester: Wiley; 2006.CrossRef

43.

Woods B, Revill P, Sculpher M, Claxton K. Country-level cost-effectiveness thresholds: initial estimates and the need for further research. Value Health. 2016;19:929–35. https://doi.org/10.1016/j.jval.2016.02.017.CrossRefPubMedPubMedCentral

44.

Leech AA, Kim DD, Cohen JT, Neumann PJ. Use and misuse of cost-effectiveness analysis thresholds in low- and middle-income countries: trends in cost-per-DALY studies. Value Health. 2018;21:759–61. https://doi.org/10.1016/j.jval.2017.12.016.CrossRefPubMedPubMedCentral

45.

Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ. 2002;11:415–30. https://doi.org/10.1002/hec.678.CrossRefPubMed

46.

White H. A heteroskedasticity-consistent covariance matrix estimator and a direct test for heteroskedasticity. Econometrica. 1980;48:817. https://doi.org/10.2307/1912934.CrossRef

47.

Huber PJ, Ronchetti E. Robust statistics. 2nd ed. Hoboken: Wiley; 2009.CrossRef

48.

Briggs AH, Sculpher M, Claxton K. Decision modelling for health economic evaluation. Oxford: Oxford University Press; 2006.

49.

Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014;17:5–14. https://doi.org/10.1016/j.jval.2013.08.2291.CrossRefPubMed

50.

Asaria M, Griffin S, Cookson R. Distributional cost-effectiveness analysis: a tutorial. Med Decis Mak. 2016;36:8–19. https://doi.org/10.1177/0272989X15583266.CrossRef

51.

Williams J, Leamy M, Bird V, Le Boutillier C, Norton S, Pesola F, Slade M. Development and evaluation of the INSPIRE measure of staff support for personal recovery. Soc Psychiatry Psychiatr Epidemiol. 2015;50:777–86. https://doi.org/10.1007/s00127-014-0983-0.CrossRefPubMed

52.

Moran GS. A recovery-oriented peer provider (ROPP) work-role model and prototype measure. Am J Psychiatr Rehabil. 2018;20:346–68. https://doi.org/10.1080/15487768.2017.1374895.CrossRef

53.

O'Connell M, Tondora J, Croog G, Evans A, Davidson L. From rhetoric to routine: assessing perceptions of recovery-oriented practices in a state mental health and addiction system. Psychiatr Rehabil J. 2005;28:378–86. https://doi.org/10.2975/28.2005.378.386.CrossRefPubMed

54.

Curry LA, Nembhard IM, Bradley EH. Qualitative and mixed methods provide unique contributions to outcomes research. Circulation. 2009;119:1442–52. https://doi.org/10.1161/CIRCULATIONAHA.107.742775.CrossRefPubMed

55.

Gabbidon J, Clement S, van Nieuwenhuizen A, Kassam A, Brohan E, Norman I, Thornicroft G. Mental Illness: Clinicians’ Attitudes (MICA) scale—psychometric properties of a version for healthcare students and professionals. Psychiatry Res. 2013;206:81–7. https://doi.org/10.1016/j.psychres.2012.09.028.CrossRefPubMed

56.

CFIR Research Team. CFIR interview guide tool 2014. http://cfirwiki.net/guide/app/index.html#/. Accessed 5 Feb 2020.

57.

Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357:1834–40. https://doi.org/10.1056/NEJMcp074045.CrossRefPubMed

58.

Gillard S. Peer support in mental health services: where is the research taking us, and do we want to go there? J Ment Health. 2019;28:341–4. https://doi.org/10.1080/09638237.2019.1608935.CrossRefPubMed

59.

Mahlke CI, Krämer UM, Becker T, Bock T. Peer support in mental health services. Curr Opin Psychiatr. 2014;27:276–81. https://doi.org/10.1097/YCO.0000000000000074.CrossRef

60.

Mancini MA. Strategic storytelling: an exploration of the professional practices of mental health peer providers. Qual Health Res. 2019;29:1266–76. https://doi.org/10.1177/1049732318821689.CrossRefPubMed

61.

Gillard S, Foster R, Gibson S, Goldsmith L, Marks J, White S. Describing a principles-based approach to developing and evaluating peer worker roles as peer support moves into mainstream mental health services. Ment Health Soc Incl. 2017;21:133–43. https://doi.org/10.1108/MHSI-03-2017-0016.CrossRef

Title: Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT)
Authors: Galia S. Moran
Jasmine Kalha
Annabel S. Mueller-Stierlin
Reinhold Kilian
Silvia Krumm
Mike Slade
Ashleigh Charles
Candelaria Mahlke
Rebecca Nixdorf
David Basangwa
Juliet Nakku
Richard Mpango
Grace Ryan
Donat Shamba
Mary Ramesh
Fileuka Ngakongwa
Alina Grayzman
Soumitra Pathare
Benjamin Mayer
Bernd Puschner
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Care
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-4177-7

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT)

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2020

Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial

Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB): study protocol for a randomized controlled trial

CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics

Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial

Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)