Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trial.
Por:
Purgato M, Turrini G, Tedeschi F, Serra R, Tarsitani L, Compri B, Muriago G, Cadorin C, Ostuzzi G, Nicaise P, Lorant V, Sijbrandij M, Witteveen AB, Ayuso-Mateos JL, Mediavilla R, Haro JM, Félez M, Figueiredo N, Pollice G, David McDaid, Park AL, Kalisch R, Petri-Romão P, Underhill J, Bryant RA, Nosè M and Barbui C
Publicada:
25 ene 2023
Ahead of Print:
25 ene 2023
Categoría:
Public health, environmental and occupational health
Resumen:
INTRODUCTION: Migrant populations, including workers, undocumented migrants, asylum seekers, refugees, internationally displaced persons, and other populations on the move, are exposed to a variety of stressors and potentially traumatic events before, during, and after the migration process. In recent years, the COVID-19 pandemic has represented an additional stressor, especially for migrants on the move. As a consequence, migration may increase vulnerability of individuals toward a worsening of subjective wellbeing, quality of life, and mental health, which, in turn, may increase the risk of developing mental health conditions. Against this background, we designed a stepped-care programme consisting of two scalable psychological interventions developed by the World Health Organization and locally adapted for migrant populations. The effectiveness and cost-effectiveness of this stepped-care programme will be assessed in terms of mental health outcomes, resilience, wellbeing, and costs to healthcare systems. METHODS AND ANALYSIS: We present the study protocol for a pragmatic randomized study with a parallel-group design that will enroll participants with a migrant background and elevated level of psychological distress. Participants will be randomized to care as usual only or to care a usual plus a guided self-help stress management guide (Doing What Matters in Times of Stress, DWM) and a five-session cognitive behavioral intervention (Problem Management Plus, PM+). Participants will self-report all measures at baseline before random allocation, 2 weeks after DWM delivery, 1 week after PM+ delivery and 2 months after PM+ delivery. All participants will receive a single-session of a support intervention, namely Psychological First Aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire-Anxiety and Depression Scale summary score 2 months after PM+ delivery. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, resource utilization, cost, and cost-effectiveness. DISCUSSION: This study is the first randomized controlled trial that combines two World Health Organization psychological interventions tailored for migrant populations with an elevated level of psychological distress. The present study will make available DWM/PM+ packages adapted for remote delivery following a task-shifting approach, and will generate evidence to inform policy responses based on a more efficient use of resources for improving resilience, wellbeing and mental health. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT04993534.
Filiaciones:
Purgato M:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Turrini G:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Tedeschi F:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Serra R:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy
Tarsitani L:
Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy
Compri B:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Muriago G:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Cadorin C:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Ostuzzi G:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Nicaise P:
Institute of Health and Society (IRSS) - UCLouvain, Brussels, Belgium
Lorant V:
Institute of Health and Society (IRSS) - UCLouvain, Brussels, Belgium
Sijbrandij M:
Department of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, VU University, Amsterdam, Netherlands
Witteveen AB:
Department of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, VU University, Amsterdam, Netherlands
Ayuso-Mateos JL:
Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain
Department of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain
Department of Psychiatry, La Princesa University Hospital, Instituto de Investigación Sanitaria La Princesa (IIS-Princesa), Madrid, Spain
Mediavilla R:
Department of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain
Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain
Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain
Haro JM:
Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain
Research and Development Unit, Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Félez M:
Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain
Research and Development Unit, Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Figueiredo N:
Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, ERES, Paris, France
Pollice G:
Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, ERES, Paris, France
David McDaid:
Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom
Park AL:
Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom
Kalisch R:
Neuroimaging Center (NIC), Focus Program Translational Neuroscience (FTN), Johannes Gutenberg University Medical Center, Mainz, Germany
Leibniz Institute for Resilience Research, Mainz, Germany
Petri-Romão P:
Leibniz Institute for Resilience Research, Mainz, Germany
Underhill J:
Independent Research Consultant, Brighton, United Kingdom
Bryant RA:
School of Psychology, University of New South Wales, Sydney, NSW, Australia
Nosè M:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Barbui C:
Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy
Green Published, gold, Green Accepted
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