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.

Adult Cognitive Behavioral Therapy / economics Community Mental Health Services / economics Cost-Benefit Analysis Delivery of Health Care / economics Europe / epidemiology Female Health Behavior Health Services Needs and Demand Humans Male Mental Disorders / diagnosis Prospective Studies Randomized Controlled Trials as Topic Refugees / psychology Turkey / epidemiology

asylum seekers global mental health psychosocial interventions randomized controlled trials refugees

Journal

BMJ open

ISSN: 2044-6055

Titre abrégé: BMJ Open

Pays: England

ID NLM: 101552874

Informations de publication

Date de publication:
14 05 2019

Historique:

entrez: 17 5 2019

pubmed: 17 5 2019

medline: 23 5 2020

Statut: epublish

Résumé

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. 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. 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. NCT03571347, NCT03587896.

Identifiants

DOI: 10.1136/bmjopen-2019-030259 PMID: 31092670 PMC: PMC6530324

pubmed: 31092670

pii: bmjopen-2019-030259

doi: 10.1136/bmjopen-2019-030259

pmc: PMC6530324

doi:

Banques de données

ClinicalTrials.gov

['NCT03571347', 'NCT03587896']

Types de publication

Clinical Trial Protocol Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

e030259

Subventions

Organisme : World Health Organization

ID : 001

Pays : International

Informations de copyright

Déclaration de conflit d'intérêts

Competing interests: None declared.

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