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

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In: BMJ Open, 9(2019), 5, S. e030259
Format: E-Artikel
Sprache: Englisch
veröffentlicht: BMJ
ISSN: 2044-6055
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finc.mega_collection BMJ (CrossRef)
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rft.atitle 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
rft.epage 0
rft.genre article
rft.issn 2044-6055
rft.issue 5
rft.jtitle BMJ Open
rft.tpages 0
rft.pages e030259
rft.pub BMJ
rft.date 2019-05-01
x.date 2019-05-01T00:00:00Z
rft.spage 0
rft.volume 9
abstract <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trials registration numbers</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT03571347" ext-link-type="clintrialgov">NCT03571347</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT03587896" ext-link-type="clintrialgov">NCT03587896</jats:ext-link>.</jats:p></jats:sec>
authors 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
doi 10.1136/bmjopen-2019-030259
languages eng
url http://dx.doi.org/10.1136/bmjopen-2019-030259
version 0.9
x.subjects General Medicine
x.type journal-article
x.oa 1