Evidence map›Paper›PMID 36761135›Full record

ArticleFrontiers in public health2023

Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trial.

Marianna Purgato, Giulia Turrini, Federico Tedeschi, Riccardo Serra, Lorenzo Tarsitani, Beatrice Compri, Giulia Muriago, Camilla Cadorin, Giovanni Ostuzzi, Pablo Nicaise and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04993534 (RESPOND), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04993534 naunknown statusnot on this map

RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic. A Randomized Controlled Trial in Italy

TypeinterventionalSponsorUniversita di VeronaRan2021 to 2023Enrolled212ConditionsPsychological DistressArmsStepped-care DWM/PM+, Psychological First Aid + usual care (CAU)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 12 institutions in 7 countries.

Marianna PurgatoDepartment 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.
Giulia TurriniDepartment 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.
Federico TedeschiDepartment 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.
Riccardo SerraDepartment 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.
Lorenzo TarsitaniDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Beatrice CompriDepartment 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.
Giulia MuriagoDepartment 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.
Camilla CadorinDepartment 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.
Giovanni OstuzziDepartment 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.
Pablo NicaiseInstitute of Health and Society (IRSS) - UCLouvain, Brussels, Belgium.
Vincent LorantInstitute of Health and Society (IRSS) - UCLouvain, Brussels, Belgium.
Marit SijbrandijDepartment of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, VU University, Amsterdam, Netherlands.
Anke B WitteveenDepartment of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, VU University, Amsterdam, Netherlands.
José Luis Ayuso-MateosDepartment of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Roberto MediavillaDepartment of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Josep Maria HaroCentro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain.
Mireia Felez-NobregaCentro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain.
Natasha FigueiredoSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, ERES, Paris, France.
Giulia PolliceSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, ERES, Paris, France.
David McDaidCare Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
A-La ParkCare Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
Raffael KalischNeuroimaging Center (NIC), Focus Program Translational Neuroscience (FTN), Johannes Gutenberg University Medical Center, Mainz, Germany.
Papoula Petri-RomãoLeibniz Institute for Resilience Research, Mainz, Germany.
James UnderhillIndependent Research Consultant, Brighton, United Kingdom.
Richard A BryantSchool of Psychology, University of New South Wales, Sydney, NSW, Australia.
Michela NosèDepartment 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.
Corrado BarbuiDepartment 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.
University of Verona · ITCentro de Investigación Biomédica en Red de Salud Mental · ESInstitut Scientifique de Santé Publique · BELondon School of Economics and Political Science · GBHospital Universitario La Paz · ESInstituto de Salud Carlos III · ESInstitut Pierre Louis d‘Épidémiologie et de Santé Publique · FRJohannes Gutenberg University Mainz · DELeibniz Institute for Resilience Research · DESapienza University of Rome · ITSorbonne Université · FRUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

COVID-19Transients and MigrantsHumansPandemicsPragmatic Clinical Trials as TopicPsychosocial InterventionQuality of LifeRandomized Controlled Trials as Topicasylum seekerCOVID-19migrantspsychological distressrefugeeresilience

Identifiers

PMID36761135
PMCPMC9905848
OpenAlexW4317932311

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.