Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan 25:11:1100546.
doi: 10.3389/fpubh.2023.1100546. eCollection 2023.

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  1 , Giulia Turrini  1 , Federico Tedeschi  1 , Riccardo Serra  1   2 , Lorenzo Tarsitani  2 , Beatrice Compri  1 , Giulia Muriago  1 , Camilla Cadorin  1 , Giovanni Ostuzzi  1 , Pablo Nicaise  3 , Vincent Lorant  3 , Marit Sijbrandij  4 , Anke B Witteveen  4 , José Luis Ayuso-Mateos  5   6   7 , Roberto Mediavilla  5   6   8 , Josep Maria Haro  6   9 , Mireia Felez-Nobrega  6   9 , Natasha Figueiredo  10 , Giulia Pollice  10 , David McDaid  11 , A-La Park  11 , Raffael Kalisch  12   13 , Papoula Petri-Romão  13 , James Underhill  14 , Richard A Bryant  15 , Michela Nosè  1 , Corrado Barbui  1
Affiliations

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 et al. Front Public Health. .

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.

Keywords: COVID-19; asylum seeker; migrants; psychological distress; refugee; resilience.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bhugra D, Gupta S, Schouler-Ocak M, Graeff-Calliess I, Deakin NA, Qureshi A, et al. . EPA guidance mental health care of migrants. Eur Psychiatry. (2014) 29:107–15. 10.1016/j.eurpsy.2014.01.003 - DOI - PubMed
    1. Abubakar I, Aldridge RW, Devakumar D, Orcutt M, Burns R, Barreto ML, et al. . The UCL-lancet commission on migration and health: the health of a world on the move. Lancet. (2018) 392:2606–54. 10.1016/S0140-6736(18)32114-7 - DOI - PMC - PubMed
    1. Bhugra D, Gupta S, Bhui K, Craig T, Dogra N, Ingleby JD, et al. . WPA guidance on mental health and mental health care in migrants. World Psychiatry. (2011) 10:2–10. 10.1002/j.2051-5545.2011.tb00002.x - DOI - PMC - PubMed
    1. Statista. Migration to Italy—Statistics and Facts. Hamburg: Statista (2021). Available online at: https://www.statista.com/topics/5899/migration-to-italy/#topicHeader__wr... (accessed December 15, 2022).
    1. UNHCR. Refugee Data Finder. Washington, DC: UNHCR (2022). Available online at: https://www.unhcr.org/refugee-statistics/ (accessed December 15, 2022).

Publication types

Associated data