Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trial Article Swipe
Marianna Purgato
,
Giulia Turrini
,
Federico Tedeschi
,
Riccardo Serra
,
Lorenzo Tarsitani
,
Beatrice Compri
,
Giulia Muriago
,
Camilla Cadorin
,
Giovanni Ostuzzi
,
Pablo Nicaise
,
Vincent Lorant
,
Marit Sijbrandij
,
Anke B. Witteveen
,
José Luís Ayuso‐Mateos
,
Roberto Mediavilla
,
Josep María Haro
,
Mireia Félez-Nóbrega
,
Natasha Figueiredo
,
Giulia Pollice
,
David McDaid
,
A‐La Park
,
Raffaël Kalisch
,
Papoula Petri‐Romão
,
James Underhill
,
Richard A. Bryant
,
Michela Nosè
,
Corrado Barbui
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3389/fpubh.2023.1100546
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3389/fpubh.2023.1100546
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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3389/fpubh.2023.1100546
- https://www.frontiersin.org/articles/10.3389/fpubh.2023.1100546/pdf
- OA Status
- gold
- Cited By
- 20
- References
- 45
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4317932311
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4317932311Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3389/fpubh.2023.1100546Digital Object Identifier
- Title
-
Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-01-25Full publication date if available
- Authors
-
Marianna Purgato, Giulia Turrini, Federico Tedeschi, Riccardo Serra, Lorenzo Tarsitani, Beatrice Compri, Giulia Muriago, Camilla Cadorin, Giovanni Ostuzzi, Pablo Nicaise, Vincent Lorant, Marit Sijbrandij, Anke B. Witteveen, José Luís Ayuso‐Mateos, Roberto Mediavilla, Josep María Haro, Mireia Félez-Nóbrega, Natasha Figueiredo, Giulia Pollice, David McDaid, A‐La Park, Raffaël Kalisch, Papoula Petri‐Romão, James Underhill, Richard A. Bryant, Michela Nosè, Corrado BarbuiList of authors in order
- Landing page
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https://doi.org/10.3389/fpubh.2023.1100546Publisher landing page
- PDF URL
-
https://www.frontiersin.org/articles/10.3389/fpubh.2023.1100546/pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://www.frontiersin.org/articles/10.3389/fpubh.2023.1100546/pdfDirect OA link when available
- Concepts
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Protocol (science), Psychological intervention, Randomized controlled trial, Medicine, Environmental health, Family medicine, Alternative medicine, Psychiatry, Psychology, Gerontology, Surgery, PathologyTop concepts (fields/topics) attached by OpenAlex
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20Total citation count in OpenAlex
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2025: 8, 2024: 8, 2023: 4Per-year citation counts (last 5 years)
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45Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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