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 & 14 others 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

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number030259
JournalBMJ Open
Volume9
Issue number5
DOIs
Publication statusPublished - 1 May 2019

Fingerprint

Refugees
Turkey
Mental Disorders
Cost-Benefit Analysis
Randomized Controlled Trials
Ethics Committees
Psychology
Symptom Assessment
Self-Help Groups
Incidence
Informed Consent
Ethics
Publications
Interviews
Health
Therapeutics

Keywords

  • Asylum seekers
  • Global mental health
  • Psychosocial interventions
  • Randomized controlled trials
  • Refugees

Cite this

Purgato, Marianna ; Carswell, Kenneth ; Acarturk, Ceren ; Au, Teresa ; Akbai, Sena ; Anttila, Minna ; Baumgartner, Josef ; Bailey, Della ; Biondi, Massimo ; Bird, Martha ; Churchill, Rachel ; Eskici, Sevde ; Hansen, Louise Juul ; Heron, Paul ; Ilkkursun, Zeynep ; Kilian, Reinhold ; Koesters, Markus ; Lantta, Tella ; Nosè, Michela ; Ostuzzi, Giovanni ; Papola, Davide ; Popa, Mariana ; Sijbrandij, Marit ; Tarsitani, Lorenzo ; Tedeschi, Federico ; Turrini, Giulia ; Uygun, Ersin ; Välimäki, Maritta Anneli ; Wancata, Johannes ; White, Ross ; Zanini, Elisa ; Cuijpers, Pim ; Barbui, Corrado ; Van Ommeren, Mark. / 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. In: BMJ Open. 2019 ; Vol. 9, No. 5.
@article{5633a2e891674593aef7187244b46414,
title = "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",
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",
author = "Marianna Purgato and Kenneth Carswell and Ceren Acarturk and Teresa Au and Sena Akbai and Minna Anttila and Josef Baumgartner and Della Bailey and Massimo Biondi and Martha Bird and Rachel Churchill and Sevde Eskici and Hansen, {Louise Juul} and Paul Heron and Zeynep Ilkkursun and Reinhold Kilian and Markus Koesters and Tella Lantta and Michela Nos{\`e} and Giovanni Ostuzzi and Davide Papola and Mariana Popa and Marit Sijbrandij and Lorenzo Tarsitani and Federico Tedeschi and Giulia Turrini and Ersin Uygun and V{\"a}lim{\"a}ki, {Maritta Anneli} and Johannes Wancata and Ross White and Elisa Zanini and Pim Cuijpers and Corrado Barbui and {Van Ommeren}, Mark",
year = "2019",
month = "5",
day = "1",
doi = "10.1136/bmjopen-2019-030259",
language = "English",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "5",

}

Purgato, M, Carswell, K, Acarturk, C, Au, T, Akbai, S, Anttila, M, Baumgartner, J, Bailey, D, Biondi, M, Bird, M, Churchill, R, Eskici, S, Hansen, LJ, Heron, P, Ilkkursun, Z, Kilian, R, Koesters, M, Lantta, T, Nosè, M, Ostuzzi, G, Papola, D, Popa, M, Sijbrandij, M, Tarsitani, L, Tedeschi, F, Turrini, G, Uygun, E, Välimäki, MA, Wancata, J, White, R, Zanini, E, Cuijpers, P, Barbui, C & Van Ommeren, M 2019, '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' BMJ Open, vol. 9, no. 5, 030259. https://doi.org/10.1136/bmjopen-2019-030259

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

In: BMJ Open, Vol. 9, No. 5, 030259, 01.05.2019.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - Effectiveness and cost-effectiveness of self-help plus (sh+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey

T2 - Study protocols for two randomised controlled trials

AU - Purgato, Marianna

AU - Carswell, Kenneth

AU - Acarturk, Ceren

AU - Au, Teresa

AU - Akbai, Sena

AU - Anttila, Minna

AU - Baumgartner, Josef

AU - Bailey, Della

AU - Biondi, Massimo

AU - Bird, Martha

AU - Churchill, Rachel

AU - Eskici, Sevde

AU - Hansen, Louise Juul

AU - Heron, Paul

AU - Ilkkursun, Zeynep

AU - Kilian, Reinhold

AU - Koesters, Markus

AU - Lantta, Tella

AU - Nosè, Michela

AU - Ostuzzi, Giovanni

AU - Papola, Davide

AU - Popa, Mariana

AU - Sijbrandij, Marit

AU - Tarsitani, Lorenzo

AU - Tedeschi, Federico

AU - Turrini, Giulia

AU - Uygun, Ersin

AU - Välimäki, Maritta Anneli

AU - Wancata, Johannes

AU - White, Ross

AU - Zanini, Elisa

AU - Cuijpers, Pim

AU - Barbui, Corrado

AU - Van Ommeren, Mark

PY - 2019/5/1

Y1 - 2019/5/1

N2 - 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.

AB - 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.

KW - Asylum seekers

KW - Global mental health

KW - Psychosocial interventions

KW - Randomized controlled trials

KW - Refugees

UR - http://www.scopus.com/inward/record.url?scp=85065927898&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85065927898&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-030259

DO - 10.1136/bmjopen-2019-030259

M3 - Article

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 5

M1 - 030259

ER -