Effectiveness, cost-effectiveness and implementation of WHO psychological interventions for migrant populations resettled in Italy: study protocol for the ADVANCE hybrid type-I randomized controlled trial
19 affiliations
- 1WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
- 2Department of Public Health, University of Copenhagen
- 3Heidelberg Institute of Global Health, University Hospital and Faculty of Medicine, University of Heidelberg
- 4Faculty of Behavioural and Movement Sciences VU
- 5Department of Human Neurosciences, Sapienza University of Rome
- 6Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University
- 7Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London
- 8ESRC Centre for Society and Mental Health, King's College London
- 9German Center for Mental Health (DZPG), Partner Site Mannheim-Heidelberg-Ulm
- 10Mental Health Europe
- 11Department of Nursing Science, Faculty of Medicine, University of Turku
- 12Hong Kong Metropolitan University
- 13Center for Psychotraumatology, Institute of Psychology, Faculty of Philosophy, Vilnius University
- 14Centre for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva
- 15Swiss National Center of Competences in Research LIVES–Overcoming Vulnerability: Life Course Perspectives
- 16Faculty of Psychology and Educational Sciences, University of Geneva
- 17Center for Psychology at University of Porto (CPUP)
- 18Faculty of Psychology and Education Sciences – University of Porto
- 19Department of Clinical, Neuro and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam
Abstract
Introduction: Migrant populations are exposed to multiple psychosocial stressors throughout the migration process, increasing their risk for common mental health conditions. There is increasing evidence for psychological interventions amongst migrants, although intervention effects tend to attenuate over time and efficacy against placebo is unknown. At the same time, implementation science questions are becoming critical, such as the benefits of in-person and online psychological interventions.
Methods and analysis: We present a study protocol for a randomized hybrid type-I effectiveness-implementation study that will enroll adult migrants resettled in Italy who experience elevated psychological distress. Participants ( n = 237) will be randomized to receive either in-person Self-Help Plus (SH+) or online Doing What Matters in Times of Stress (DWM). We will assess the performance of both SH + and DWM with an additional booster session, and will compare them against a psychological placebo without active intervention ingredients. An intention-to-treat analysis using linear mixed models will be conducted to explore interventions’ effects on depressive and anxiety symptoms at 3 months following randomization as measured by the Patient Health Questionnaire-Anxiety and Depression Scale, and to explore a set of implementation outcomes. We will also measure depressive symptoms, anxiety symptoms, mental health status, functioning, wellbeing, cost associated with care, quality of life, and self-stigma as secondary outcomes.
Ethics and dissemination: The study protocol, informed consent procedures, and data protection measures were approved by the Comitato Etico Territoriale (CET) Area Sud Ovest Veneto (Approval ID n. 68505). The results of the present trial will be disseminated through the ADVANCE policy and scaling up strategy, in peer-reviewed journals, and at international and national scientific meetings.
Trial registration number: ClinicalTrials.gov , identifier: NCT07209306.
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BibTeX
@article{purgato2026effectiveness,
title = {{Effectiveness, cost-effectiveness and implementation of WHO psychological interventions for migrant populations resettled in Italy: study protocol for the ADVANCE hybrid type-I randomized controlled trial}},
author = {Marianna Purgato and Federico Tedeschi and Eleonora Prina and Giulia Turrini and Beatrice Compri and Andrea Chiccoli and Maria Marti-Castaner and Manuela De Allegri and Hoa Thi Nguyen and Sanne Feenstra and Sara Khalil and Ulrich Reininghaus and Leonie Fleck and Liuska Sanna and Maritta Välimäki and Maija Satamo and Evaldas Kazlauskas and Austeja Dumarkaite and Matthias Kliegel and Chiara Scarampi and Melanie Mack and Cláudia de Freitas and Joyce Anne Quinto and Riccardo Serra and Marit Sijbrandij and Prasansa Subba and Lorenzo Tarsitani and Wietse Anton Tol and Michela Nosè and Corrado Barbui},
journal = {Frontiers in Public Health},
year = {2026},
month = oct,
doi = {10.3389/fpubh.2026.1905759},
url = {https://www.frontiersin.org/articles/10.3389/fpubh.2026.1905759/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Effectiveness, cost-effectiveness and implementation of WHO psychological interventions for migrant populations resettled in Italy: study protocol for the ADVANCE hybrid type-I randomized controlled trial
AU - Marianna Purgato
AU - Federico Tedeschi
AU - Eleonora Prina
AU - Giulia Turrini
AU - Beatrice Compri
AU - Andrea Chiccoli
AU - Maria Marti-Castaner
AU - Manuela De Allegri
AU - Hoa Thi Nguyen
AU - Sanne Feenstra
AU - Sara Khalil
AU - Ulrich Reininghaus
AU - Leonie Fleck
AU - Liuska Sanna
AU - Maritta Välimäki
AU - Maija Satamo
AU - Evaldas Kazlauskas
AU - Austeja Dumarkaite
AU - Matthias Kliegel
AU - Chiara Scarampi
AU - Melanie Mack
AU - Cláudia de Freitas
AU - Joyce Anne Quinto
AU - Riccardo Serra
AU - Marit Sijbrandij
AU - Prasansa Subba
AU - Lorenzo Tarsitani
AU - Wietse Anton Tol
AU - Michela Nosè
AU - Corrado Barbui
PY - 2026
DA - 2026/10/21
JO - Frontiers in Public Health
DO - 10.3389/fpubh.2026.1905759
UR - https://www.frontiersin.org/articles/10.3389/fpubh.2026.1905759/full
AB - Introduction: Migrant populations are exposed to multiple psychosocial stressors throughout the migration process, increasing their risk for common mental health conditions. There is increasing evidence for psychological interventions amongst migrants, although intervention effects tend to attenuate over time and efficacy against placebo is unknown. At the same time, implementation science questions are becoming critical, such as the benefits of in-person and online psychological interventions. Methods and analysis: We present a study protocol for a randomized hybrid type-I effectiveness-implementation study that will enroll adult migrants resettled in Italy who experience elevated psychological distress. Participants ( n = 237) will be randomized to receive either in-person Self-Help Plus (SH+) or online Doing What Matters in Times of Stress (DWM). We will assess the performance of both SH + and DWM with an additional booster session, and will compare them against a psychological placebo without active intervention ingredients. An intention-to-treat analysis using linear mixed models will be conducted to explore interventions’ effects on depressive and anxiety symptoms at 3 months following randomization as measured by the Patient Health Questionnaire-Anxiety and Depression Scale, and to explore a set of implementation outcomes. We will also measure depressive symptoms, anxiety symptoms, mental health status, functioning, wellbeing, cost associated with care, quality of life, and self-stigma as secondary outcomes. Ethics and dissemination: The study protocol, informed consent procedures, and data protection measures were approved by the Comitato Etico Territoriale (CET) Area Sud Ovest Veneto (Approval ID n. 68505). The results of the present trial will be disseminated through the ADVANCE policy and scaling up strategy, in peer-reviewed journals, and at international and national scientific meetings. Trial registration number: ClinicalTrials.gov , identifier: NCT07209306.
SN - 2296-2565
ER -