{
  "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.\n\nMethods 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.\n\nEthics 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.\n\nTrial registration number: ClinicalTrials.gov , identifier: NCT07209306.",
  "abstract_shown": true,
  "affiliations": [
    "WHO 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",
    "Department of Public Health, University of Copenhagen",
    "Heidelberg Institute of Global Health, University Hospital and Faculty of Medicine, University of Heidelberg",
    "Faculty of Behavioural and Movement Sciences VU",
    "Department of Human Neurosciences, Sapienza University of Rome",
    "Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University",
    "Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London",
    "ESRC Centre for Society and Mental Health, King's College London",
    "German Center for Mental Health (DZPG), Partner Site Mannheim-Heidelberg-Ulm",
    "Mental Health Europe",
    "Department of Nursing Science, Faculty of Medicine, University of Turku",
    "Hong Kong Metropolitan University",
    "Center for Psychotraumatology, Institute of Psychology, Faculty of Philosophy, Vilnius University",
    "Centre for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva",
    "Swiss National Center of Competences in Research LIVES–Overcoming Vulnerability: Life Course Perspectives",
    "Faculty of Psychology and Educational Sciences, University of Geneva",
    "Center for Psychology at University of Porto (CPUP)",
    "Faculty of Psychology and Education Sciences – University of Porto",
    "Department of Clinical, Neuro and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam"
  ],
  "article_type": "methods article",
  "arxiv": null,
  "author_total": 30,
  "authors": [
    {
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        0
      ],
      "name": "Marianna Purgato"
    },
    {
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        0
      ],
      "name": "Federico Tedeschi"
    },
    {
      "affs": [
        0
      ],
      "name": "Eleonora Prina"
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    {
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        0
      ],
      "name": "Giulia Turrini"
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    {
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        0
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      "name": "Beatrice Compri"
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    {
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        0
      ],
      "name": "Andrea Chiccoli"
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    {
      "affs": [
        1
      ],
      "name": "Maria Marti-Castaner"
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    {
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        2
      ],
      "name": "Manuela De Allegri"
    },
    {
      "affs": [
        2
      ],
      "name": "Hoa Thi Nguyen"
    },
    {
      "affs": [
        3
      ],
      "name": "Sanne Feenstra"
    },
    {
      "affs": [
        4
      ],
      "name": "Sara Khalil"
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    {
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        5,
        6,
        7,
        8
      ],
      "name": "Ulrich Reininghaus"
    },
    {
      "affs": [
        5
      ],
      "name": "Leonie Fleck"
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    {
      "affs": [
        9
      ],
      "name": "Liuska Sanna"
    },
    {
      "affs": [
        10,
        11
      ],
      "name": "Maritta Välimäki"
    },
    {
      "affs": [
        10
      ],
      "name": "Maija Satamo"
    },
    {
      "affs": [
        12
      ],
      "name": "Evaldas Kazlauskas"
    },
    {
      "affs": [
        12
      ],
      "name": "Austeja Dumarkaite"
    },
    {
      "affs": [
        13,
        14,
        15
      ],
      "name": "Matthias Kliegel"
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    {
      "affs": [
        13,
        14
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      "name": "Chiara Scarampi"
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    {
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        13,
        14
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      "name": "Melanie Mack"
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    {
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        17
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      "name": "Cláudia de Freitas"
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    {
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      "name": "Joyce Anne Quinto"
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    {
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      "name": "Riccardo Serra"
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    {
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      "name": "Marit Sijbrandij"
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    {
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      "name": "Prasansa Subba"
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    {
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      "name": "Lorenzo Tarsitani"
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    {
      "affs": [
        1
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      "name": "Wietse Anton Tol"
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    {
      "affs": [
        0
      ],
      "name": "Michela Nosè"
    },
    {
      "affs": [
        0
      ],
      "name": "Corrado Barbui"
    }
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  "doi": "10.3389/fpubh.2026.1905759",
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  "pmcid": "PMC13730949",
  "pmid": "42984846",
  "published": "2026-10-21",
  "publisher": "Frontiers Media SA",
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      "origin": "openalex:3203|Migration, Health and Trauma",
      "subfield": "psychiatry"
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  ],
  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:21:14Z",
  "url": "https://research.draconitic.com/paper/eg6hbywqhynjh",
  "venue": "Frontiers in Public Health",
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