Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)

Matilda Cederberg, Lilas Ali, Inger Ekman, Kristina Glise, Ingibjörg H Jonsdottir, Hanna Gyllensten, Karl Swedberg, Andreas Fors, Matilda Cederberg, Lilas Ali, Inger Ekman, Kristina Glise, Ingibjörg H Jonsdottir, Hanna Gyllensten, Karl Swedberg, Andreas Fors

Abstract

Introduction: The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.

Methods and analysis: This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.

Ethics and dissemination: This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.

Trial registration number: NCT03404583.

Keywords: information technology; mental health; primary care; public health; quality in health care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

References

    1. OECD Mental health and work: Sweden. Paris: OECD Publishing, 2013.
    1. Henderson M, Glozier N, Holland Elliott K, Elliott KH. Long term sickness absence. BMJ 2005;330:802–3. 10.1136/bmj.330.7495.802
    1. Henderson M, Harvey SB, Øverland S, et al. . Work and common psychiatric disorders. London, England, 2011: 198–207.
    1. Försäkringskassan [Swedish Social Insurance Agency] Social insurance in figures, 2019. Available:
    1. Försäkringskassan [Swedish Social Insurance Agency] Uppföljning AV sjukfrånvarons utveckling, 2019. Available:
    1. Lidwall U. Sick leave diagnoses and return to work: a Swedish register study. Disabil Rehabil 2015;37:396–410. 10.3109/09638288.2014.923521
    1. Försäkringskassan [Swedish Social Insurance Agency] Sjukfrånvarons utveckling, 2017. Available:
    1. Dewa CS, Loong D, Bonato S. Work outcomes of sickness absence related to mental disorders: a systematic literature review. BMJ Open 2014;4:e005533. 10.1136/bmjopen-2014-005533
    1. Sundquist J, Ohlsson H, Sundquist K, et al. . Common adult psychiatric disorders in Swedish primary care where most mental health patients are treated. BMC Psychiatry 2017;17:235. 10.1186/s12888-017-1381-4
    1. Socialstyrelsen [National Board of Health and Welfare] Nationella riktlinjer för vård vid depression och ångestsyndrom; 2017.
    1. Soegaard HJ. Variation in effect of intervention studies in research on sickness absence. Open Access J Clin Trials 2012;4:1–20. 10.2147/OAJCT.S25651
    1. Nieuwenhuijsen K, Bültmann U, Neumeyer-Gromen A, et al. . Interventions to improve occupational health in depressed people. Cochrane Database Syst Rev 2008;2:CD006237. 10.1002/14651858.CD006237.pub2
    1. van der Klink JJL, Blonk RWB, Schene AH, et al. . Reducing long term sickness absence by an activating intervention in adjustment disorders: a cluster randomised controlled design. Occup Environ Med 2003;60:429–37. 10.1136/oem.60.6.429
    1. Blank L, Peters J, Pickvance S, et al. . A systematic review of the factors which predict return to work for people suffering episodes of poor mental health. J Occup Rehabil 2008;18:27–34. 10.1007/s10926-008-9121-8
    1. Vogel N, Schandelmaier S, Zumbrunn T, et al. . Return-To-Work coordination programmes for improving return to work in workers on sick leave. Cochrane Database Syst Rev 2017;3:Cd011618. 10.1002/14651858.CD011618.pub2
    1. van Vilsteren M, van Oostrom SH, de Vet HCW, et al. . Workplace interventions to prevent work disability in workers on sick leave. Cochrane Database Syst Rev 2015;10:Cd006955. 10.1002/14651858.CD006955.pub3
    1. Arends I, Bruinvels DJ, Rebergen DS, et al. . Interventions to facilitate return to work in adults with adjustment disorders. Cochrane Database Syst Rev 2012;12:Cd006389. 10.1002/14651858.CD006389.pub2
    1. Nieuwenhuijsen K, Faber B, Verbeek JH, et al. . Interventions to improve return to work in depressed people. Cochrane Database Syst Rev 2014;12:Cd006237. 10.1002/14651858.CD006237.pub3
    1. Mikkelsen MB, Rosholm M. Systematic review and meta-analysis of interventions aimed at enhancing return to work for sick-listed workers with common mental disorders, stress-related disorders, somatoform disorders and personality disorders. Occup Environ Med 2018;75:675–86. 10.1136/oemed-2018-105073
    1. Etuknwa A, Daniels K, Eib C. Sustainable return to work: a systematic review focusing on personal and social factors. J Occup Rehabil 2019;29:679–700. 10.1007/s10926-019-09832-7
    1. Volker D, Zijlstra-Vlasveld MC, Brouwers EPM, et al. . Return-To-Work self-efficacy and actual return to work among long-term Sick-Listed employees. J Occup Rehabil 2015;25:423–31. 10.1007/s10926-014-9552-3
    1. Nigatu YT, Liu Y, Uppal M, et al. . Prognostic factors for return to work of employees with common mental disorders: a meta-analysis of cohort studies. Soc Psychiatry Psychiatr Epidemiol 2017;52:1205–15. 10.1007/s00127-017-1402-0
    1. Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol 2001;52:1–26. 10.1146/annurev.psych.52.1.1
    1. Bandura A. Self-Efficacy: toward a unifying theory of behavioral change. Psychol Rev 1977;84:191–215. 10.1037/0033-295X.84.2.191
    1. Seggelen - Damen Ivan, Dam Kvan. Self-reflection as a mediator between self-efficacy and well-being. Journal of Managerial Psychology 2016;31:18–33. 10.1108/JMP-01-2013-0022
    1. Fors A, Ekman I, Taft C, et al. . Person-centred care after acute coronary syndrome, from hospital to primary care - A randomised controlled trial. Int J Cardiol 2015;187:693–9. 10.1016/j.ijcard.2015.03.336
    1. Fors A, Taft C, Ulin K, et al. . Person-Centred care improves self-efficacy to control symptoms after acute coronary syndrome: a randomized controlled trial. Eur J Cardiovasc Nurs 2016;15:186–94. 10.1177/1474515115623437
    1. Fors A, Blanck E, Ali L, et al. . Effects of a person-centred telephone-support in patients with chronic obstructive pulmonary disease and/or chronic heart failure – a randomized controlled trial. PLoS One 2018;13:e0203031 10.1371/journal.pone.0203031
    1. Ekman I, Swedberg K, Taft C, et al. . Person-centered care--ready for prime time. Eur J Cardiovasc Nurs 2011;10:248–51. 10.1016/j.ejcnurse.2011.06.008
    1. Entwistle VA, Watt IS. Treating patients as persons: a capabilities approach to support delivery of person-centered care. Am J Bioeth 2013;13:29–39. 10.1080/15265161.2013.802060
    1. Leplege A, Gzil F, Cammelli M, et al. . Person-centredness: conceptual and historical perspectives. Disabil Rehabil 2007;29:1555–65. 10.1080/09638280701618661
    1. Mccormack B, Mccance T. Personhood and Person‐Centredness : Person‐Centred nursing. Oxford, UK: Wiley‐Blackwell, 2010: 5–20.
    1. Brännström M, Boman K. Effects of person-centred and integrated chronic heart failure and palliative home care. prefer: a randomized controlled study. Eur J Heart Fail 2014;16:1142–51. 10.1002/ejhf.151
    1. Wolf A, Vella R, Fors A. The impact of person-centred care on patients' care experiences in relation to educational level after acute coronary syndrome: secondary outcome analysis of a randomised controlled trial. Eur J Cardiovasc Nurs 2019;18:299–308. 10.1177/1474515118821242
    1. Dudas K, Olsson L-E, Wolf A, et al. . Uncertainty in illness among patients with chronic heart failure is less in person-centred care than in usual care. Eur J Cardiovasc Nurs 2013;12:521–8. 10.1177/1474515112472270
    1. Hansson E, Ekman I, Swedberg K, et al. . Person-centred care for patients with chronic heart failure - a cost-utility analysis. Eur J Cardiovasc Nurs 2016;15:276–84. 10.1177/1474515114567035
    1. Gyllensten H, Koinberg I, Carlström E, et al. . Economic evaluation of a person-centred care intervention in head and neck oncology: results from a randomized controlled trial. Support Care Cancer 2019;27:1825–34. 10.1007/s00520-018-4436-2
    1. Wolf A, Fors A, Ulin K, et al. . An eHealth diary and Symptom-Tracking tool combined with Person-Centered care for improving self-efficacy after a diagnosis of acute coronary syndrome: a substudy of a randomized controlled trial. J Med Internet Res 2016;18:e40. 10.2196/jmir.4890
    1. Heckemann B, Wolf A, Ali L, et al. . Discovering untapped relationship potential with patients in telehealth: a qualitative interview study. BMJ Open 2016;6:e009750. 10.1136/bmjopen-2015-009750
    1. Eysenbach G. What is e-health? J Med Internet Res 2001;3:e20. 10.2196/jmir.3.2.e20
    1. Andersson G. Internet-Delivered psychological treatments. Annu Rev Clin Psychol 2016;12:157–79. 10.1146/annurev-clinpsy-021815-093006
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191–4. 10.1016/S0140-6736(00)04337-3
    1. Husereau D, Drummond M, Petrou S, et al. . Consolidated health economic evaluation reporting standards (cheers) statement. BMJ 2013;346:f1049 10.1136/bmj.f1049
    1. Pinnock H, Barwick M, Carpenter CR, et al. . Standards for reporting implementation studies (STARI): explanation and elaboration document. BMJ Open 2017;7:e013318. 10.1136/bmjopen-2016-013318
    1. Sanders EB-N, Stappers PJ. Co-Creation and the new landscapes of design. CoDesign 2008;4:5–18. 10.1080/15710880701875068
    1. Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail 2001;7:176–82. 10.1054/jcaf.2001.25652
    1. Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale : Johnston M, Wright S, Weinman J, Measures in health psychology: A user’s portfolio. Windsor: UK: NFER-NELSON, 1995: 35–7.
    1. Löve J, Moore CD, Hensing G. Validation of the Swedish translation of the general self-efficacy scale. Qual Life Res 2012;21:1249–53. 10.1007/s11136-011-0030-5
    1. Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53–72. 10.1016/0168-8510(96)00822-6
    1. Lundgren-Nilsson Åsa, Jonsdottir IH, Pallant J, et al. . Internal construct validity of the Shirom-Melamed burnout questionnaire (SMBQ). BMC Public Health 2012;12:1. 10.1186/1471-2458-12-1
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385–96. 10.2307/2136404
    1. Glise K, Hadzibajramovic E, Jonsdottir IH, et al. . Self-Reported exhaustion: a possible indicator of reduced work ability and increased risk of sickness absence among human service workers. Int Arch Occup Environ Health 2010;83:511–20. 10.1007/s00420-009-0490-x
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Smets EM, Garssen B, Bonke B, et al. . The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995;39:315–25. 10.1016/0022-3999(94)00125-O
    1. Lorig KR, Sobel DS, Ritter PL, et al. . Effect of a self-management program on patients with chronic disease. Eff Clin Pract 2001;4:256–62.
    1. Leon AC, Olfson M, Portera L, et al. . Assessing psychiatric impairment in primary care with the Sheehan disability scale. Int J Psychiatry Med 1997;27:93–105. 10.2190/T8EM-C8YH-373N-1UWD
    1. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med 2000;19:3219–36. 10.1002/1097-0258(20001215)19:23<3219::AID-SIM623>;2-P
    1. Burström K, Sun S, Gerdtham U-G, et al. . Swedish experience-based value sets for EQ-5D health states. Qual Life Res 2014;23:431–42. 10.1007/s11136-013-0496-4
    1. Dolan P, Gudex C, Kind P, et al. . A social tariff for EuroQol: results from a UK general population survey 1995.
    1. Krol M, Brouwer W, Rutten F. Productivity costs in economic evaluations: past, present, future. Pharmacoeconomics 2013;31:537–49. 10.1007/s40273-013-0056-3
    1. Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: medical Research Council guidance. BMJ 2015;350:h1258. 10.1136/bmj.h1258
    1. McCormack B, McCance T. Person-centred practice in nursing and health care : theory and practice. Second edition Chichester: Wiley Blackwell, 2017.
    1. Hawe P, Shiell A, Riley T. Complex interventions: how "out of control" can a randomised controlled trial be? BMJ 2004;328:1561–3. 10.1136/bmj.328.7455.1561
    1. Hasselberg K, Jonsdottir IH, Ellbin S, et al. . Self-Reported stressors among patients with exhaustion disorder: an exploratory study of patient records. BMC Psychiatry 2014;14:66. 10.1186/1471-244X-14-66
    1. Karasek R, Theorell T. Healthy work : stress, productivity, and the reconstruction of working life. New York: Basic Books, 1990.
    1. Beatty L, Binnion C. A systematic review of predictors of, and reasons for, adherence to online psychological interventions. Int J Behav Med 2016;23:776–94. 10.1007/s12529-016-9556-9

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir