TY - JOUR
T1 - Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy
T2 - Study protocol for the RESPOND randomized controlled trial
AU - Purgato, Marianna
AU - Turrini, Giulia
AU - Tedeschi, Federico
AU - Serra, Riccardo
AU - Tarsitani, Lorenzo
AU - Compri, Beatrice
AU - Muriago, Giulia
AU - Cadorin, Camilla
AU - Ostuzzi, Giovanni
AU - Nicaise, Pablo
AU - Lorant, Vincent
AU - Sijbrandij, Marit
AU - Witteveen, Anke B.
AU - Ayuso-Mateos, José Luis
AU - Mediavilla, Roberto
AU - Haro, Josep Maria
AU - Felez-Nobrega, Mireia
AU - Figueiredo, Natasha
AU - Pollice, Giulia
AU - McDaid, David
AU - Park, A. La
AU - Kalisch, Raffael
AU - Petri-Romão, Papoula
AU - Underhill, James
AU - The RESPOND Consortium
AU - Bryant, Richard A.
AU - Nosè, Michela
AU - Barbui, Corrado
N1 - Funding Information: The RESPOND project is funded under Horizon 2020—the Framework Programme for Research and Innovation (2014–2020) (Grant number: 101016127—RESPOND). The content of this article reflects only the authors' views and the European Community is not liable for any use that may be made of the information contained therein. Publisher Copyright: Copyright © 2023 Purgato, Turrini, Tedeschi, Serra, Tarsitani, Compri, Muriago, Cadorin, Ostuzzi, Nicaise, Lorant, Sijbrandij, Witteveen, Ayuso-Mateos, Mediavilla, Haro, Felez-Nobrega, Figueiredo, Pollice, McDaid, Park, Kalisch, Petri-Romão, Underhill, Bryant, Nosè and Barbui.
PY - 2023/1/25
Y1 - 2023/1/25
N2 - 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.
AB - 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.
KW - COVID-19
KW - asylum seeker
KW - migrants
KW - psychological distress
KW - refugee
KW - resilience
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U2 - https://doi.org/10.3389/fpubh.2023.1100546
DO - https://doi.org/10.3389/fpubh.2023.1100546
M3 - Article
C2 - 36761135
SN - 2296-2565
VL - 11
SP - 1
EP - 10
JO - Frontiers in Public Health
JF - Frontiers in Public Health
M1 - 1100546
ER -