Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials

Marianna Purgato, Kenneth Carswell, Ceren Acarturk, Teresa Au, Sena Akbai, Minna Anttila, Josef Baumgartner, Della Bailey, Massimo Biondi, Martha Bird, Rachel Churchill, Sevde Eskici, Louise Juul Hansen, Paul Heron, Zeynep Ilkkursun, Reinhold Kilian, Markus Koesters, Tella Lantta, Michela Nosè, Giovanni Ostuzzi, Davide Papola, Mariana Popa, Marit Sijbrandij, Lorenzo Tarsitani, Federico Tedeschi, Giulia Turrini, Ersin Uygun, Maritta Anneli Välimäki, Johannes Wancata, Ross White, Elisa Zanini, Pim Cuijpers, Corrado Barbui, Mark Van Ommeren, Marianna Purgato, Kenneth Carswell, Ceren Acarturk, Teresa Au, Sena Akbai, Minna Anttila, Josef Baumgartner, Della Bailey, Massimo Biondi, Martha Bird, Rachel Churchill, Sevde Eskici, Louise Juul Hansen, Paul Heron, Zeynep Ilkkursun, Reinhold Kilian, Markus Koesters, Tella Lantta, Michela Nosè, Giovanni Ostuzzi, Davide Papola, Mariana Popa, Marit Sijbrandij, Lorenzo Tarsitani, Federico Tedeschi, Giulia Turrini, Ersin Uygun, Maritta Anneli Välimäki, Johannes Wancata, Ross White, Elisa Zanini, Pim Cuijpers, Corrado Barbui, Mark Van Ommeren

Abstract

Introduction: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.

Methods and analysis: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.

Ethics and dissemination: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.

Trials registration numbers: NCT03571347, NCT03587896.

Keywords: asylum seekers; global mental health; psychosocial interventions; randomized controlled trials; refugees.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
RCT flow diagram. ETAU, enhanced treatment as usual; RCT, randomised controlled trial; SH+, Self-Help Plus.

References

    1. UNHCR. Global trends. Forced displacement in 2017. (Accessed 6 Mar 2019).
    1. UNHCR. Global trends. Forced displacement in 2015. (Accessed 6 Mar 2019).
    1. UNHCR. Global trends. Forced displacement in 2016. (Accessed 6 Mar 2019).
    1. Wells R, Steel Z, Abo-Hilal M, et al. . Psychosocial concerns reported by Syrian refugees living in Jordan: systematic review of unpublished needs assessments. Br J Psychiatry 2016;209:99–106. 10.1192/bjp.bp.115.165084
    1. Kirmayer LJ, Narasiah L, Munoz M, et al. . Common mental health problems in immigrants and refugees: general approach in primary care. CMAJ 2011;183:E959–67. 10.1503/cmaj.090292
    1. Miller KE, Rasmussen A. The mental health of civilians displaced by armed conflict: an ecological model of refugee distress. Epidemiol Psychiatr Sci 2017;26:129–38. 10.1017/S2045796016000172
    1. World Health Organization Regional Office for Europe. Mental health promotion and mental health care in refugees and migrants. Technical guidance. Copenhagen: WHO, 2018.
    1. Priebe S DG. Public health aspects of mental health among migrants and refugees: a review of the evidence on mental health care for refugees, asylum seekers and irregular migrants in the WHO European Region, 2016.
    1. Miller KE, Rasmussen A. War exposure, daily stressors, and mental health in conflict and post-conflict settings: bridging the divide between trauma-focused and psychosocial frameworks. Soc Sci Med 2010;70:7–16. 10.1016/j.socscimed.2009.09.029
    1. Alemi Q, Stempel C. Discrimination and distress among Afghan refugees in northern California: The moderating role of pre- and post-migration factors. PLoS One 2018;13:e0196822 10.1371/journal.pone.0196822
    1. Purgato M, Tol WA, Bass JK. An ecological model for refugee mental health: implications for research. Epidemiol Psychiatr Sci 2017;26:1–3. 10.1017/S204579601600069X
    1. Turrini G, Purgato M, Ballette F, et al. . Common mental disorders in asylum seekers and refugees: umbrella review of prevalence and intervention studies. Int J Ment Health Syst 2017;11:51 10.1186/s13033-017-0156-0
    1. Zhong BL, Liu TB, Chan SSM, et al. . Common mental health problems in rural-to-urban migrant workers in Shenzhen, China: prevalence and risk factors. Epidemiol Psychiatr Sci 2018;27:256–65. 10.1017/S2045796016001141
    1. Nosè M, Ballette F, Bighelli I, et al. . Psychosocial interventions for post-traumatic stress disorder in refugees and asylum seekers resettled in high-income countries: Systematic review and meta-analysis. PLoS One 2017;12:e0171030 10.1371/journal.pone.0171030
    1. Giacco D, Laxhman N, Priebe S. Prevalence of and risk factors for mental disorders in refugees. Semin Cell Dev Biol 2018;77:144–52. 10.1016/j.semcdb.2017.11.030
    1. Giacco D, Priebe S. Mental health care for adult refugees in high-income countries. Epidemiol Psychiatr Sci 2017:1–8.
    1. Turrini G, Purgato M, Acarturk C, et al. . Efficacy and acceptability of psychosocial interventions in asylum seekers and refugees: systematic review and meta-analysis. Epidemiol Psychiatr Sci 2019:1–13. 10.1017/S2045796019000027
    1. Epping-Jordan JE, Harris R, Brown FL, et al. . Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry 2016;15:295–6. 10.1002/wps.20355
    1. Tol WA, Augustinavicius J, Carswell K, et al. . Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda. Glob Ment Health 2018;5:e25 10.1017/gmh.2018.14
    1. Tol WA, Augustinavicius J, Carswell K, et al. . Feasibility of a guided self-help intervention to reduce psychological distress in South Sudanese refugee women in Uganda. World Psychiatry 2018;17:234–5. 10.1002/wps.20537
    1. Goldberg DP, Blackwell B. Psychiatric illness in general practice. A detailed study using a new method of case identification. Br Med J 1970;1:439–43. 10.1136/bmj.2.5707.439
    1. Sheehan DV, Lecrubier Y, Sheehan KH, et al. . The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):22–33.
    1. American Psychiatric Association. The Diagnostic and Statistical Manual of Mental Disorders. 5th edn; DSM–5 Washington DC: American Psychiatric Association, 2013.
    1. World Health Organization. The ICD-10 Classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: WHO, 1992.
    1. Begg C, Cho M, Eastwood S, et al. . Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637–9.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010;1:100–7. 10.4103/0976-500X.72352
    1. Cuijpers P, Muñoz RF, Clarke GN, et al. . Psychoeducational treatment and prevention of depression: the "Coping with Depression" course thirty years later. Clin Psychol Rev 2009;29:449–58. 10.1016/j.cpr.2009.04.005
    1. den Boer PC, Wiersma D, Van den Bosch RJ. Why is self-help neglected in the treatment of emotional disorders? A meta-analysis. Psychol Med 2004;34:959–71. 10.1017/S003329170300179X
    1. World Health Organization, Geneva. Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP). Geneva: WHO, 2010.
    1. Hayes SC, Levin ME, Plumb-Vilardaga J, et al. . Acceptance and commitment therapy and contextual behavioral science: examining the progress of a distinctive model of behavioral and cognitive therapy. Behav Ther 2013;44:180–98. 10.1016/j.beth.2009.08.002
    1. A-Tjak JG, Davis ML, Morina N, et al. . A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom 2015;84:30–6. 10.1159/000365764
    1. Fledderus M, Bohlmeijer ET, Pieterse ME, et al. . Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med 2012;42:485–95. 10.1017/S0033291711001206
    1. Ciwit BV. Castor Electronic Data Capture. Amsterdam, The Netherlands, 2018.
    1. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191–4. 10.1001/jama.2013.281053
    1. Cuijpers P, van Straten A, Smit F, et al. . Preventing the onset of depressive disorders: a meta-analytic review of psychological interventions. Am J Psychiatry 2008;165:1272–80. 10.1176/appi.ajp.2008.07091422
    1. van Zoonen K, Buntrock C, Ebert DD, et al. . Preventing the onset of major depressive disorder: a meta-analytic review of psychological interventions. Int J Epidemiol 2014;43:318–29. 10.1093/ije/dyt175
    1. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004;159:702–6. 10.1093/aje/kwh090
    1. Jme H. Item nonresponse: occurrence, causes, and imputation of missing answers to test items. DSWO Press: Leiden, 1999.
    1. Zellner A. An Efficient Method of Estimating Seemingly Unrelated Regressions and Tests for Aggregation Bias. Journal of the American Statistical Association 1962;57:348–68. 10.1080/01621459.1962.10480664
    1. Glick H. Economic evaluation in clinical trials (Reprinted.) Press OU, ed Handbooks in Health Economic Evaluation Series, 2010.
    1. Curtis L, Burns A. Unit Costs of Health and Social Care 2017, 2017.
    1. Brouwer WB, Koopmanschap MA. How to calculate indirect costs in economic evaluations. Pharmacoeconomics 1998;13(5 Pt 1):563–9. 10.2165/00019053-199813050-00008
    1. Knapp M. Making music out of noise – the cost function approach to evaluation∗. British Journal of Psychiatry 1998;173:7–11. 10.1192/S0007125000297997
    1. 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. 10.1002/hec.678
    1. Appleby J. Crossing the line: NICE’s value for money threshold. BMJ 2016;352:i1336 10.1136/bmj.i1336
    1. Robinson LA, Hammitt JK, Chang AY, et al. . Understanding and improving the one and three times GDP per capita cost-effectiveness thresholds. Health Policy Plan 2017;32:141–5. 10.1093/heapol/czw096
    1. Woods B, Revill P, Sculpher M, et al. . Country-Level Cost-Effectiveness Thresholds: Initial Estimates and the Need for Further Research. Value Health 2016;19:929–35. 10.1016/j.jval.2016.02.017
    1. Sijbrandij M, Acarturk C, Bird M, et al. . Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol 2017;8(sup2):1388102 10.1080/20008198.2017.1388102

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