The World Health Organization (WHO), in collaboration with Italian universities, has embarked on a critical clinical trial to evaluate psychological interventions for addressing mental health challenges among migrants resettled in Italy. This study, titled the ADVANCE Trial, responds to the growing need for effective psychological solutions following migration-related stressors.
In this article:
- What changed?
- Who is affected?
- How were the interventions structured?
- Frequently Asked Questions
- Implications of the findings
- Disclaimer
- Announcement link
What changed?
The ADVANCE Trial is currently recruiting participants as of October 2025. The study aims to assess the efficacy of three intervention approaches on migrants experiencing emotional and psychological distress. These include:
- Self-Help Plus: An experimental structured program designed to promote emotional resilience.
- Doing What Matters in Times of Stress: Guided sessions that provide practical tools for managing stress effectively.
- Psychological Placebo: A control method ensuring reliable comparison across participants.
The trial represents an innovative step toward understanding mental health strategies applicable to unique societal contexts.
Who is affected?
Migrants resettled in Italy, many of whom endure significant psychological and emotional distress due to migration and resettlement challenges, form the target population for this study. Distress caused by displacement, discrimination, and integration difficulties are commonly observed.
This trial provides actionable options for healthcare organizations, policymakers, and clinical teams to refine mental health support for vulnerable groups.
How were the interventions structured?
The ADVANCE Trial uses distinct intervention models:
Self-Help Plus and Booster Session
This experimental program includes guided self-help methods. Participants also receive booster sessions to sustain the benefits over time.
Doing What Matters in Times of Stress
These sessions are derived from WHO recommendations and focus on cognitive behavioral techniques to manage stress effectively.
Psychological Placebo
A placebo intervention is used to compare efficacy across experimental methods. Ethical oversight ensures all participants receive appropriate care.
Supported by Università di Verona and University of Roma La Sapienza, researchers have committed to adhering to rigorous clinical and ethical standards.
Frequently Asked Questions
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What is the ADVANCE Trial?
The ADVANCE Trial is a study evaluating WHO-designed psychological interventions in Italian migrant populations.
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Why focus on migrants resettled in Italy?
Migrant populations often face unique mental health challenges linked to displacement and integration processes.
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What are the interventions tested?
The trial includes Self-Help Plus, Doing What Matters in Times of Stress, and Psychological Placebo models.
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How do participants benefit?
Participants gain tools for stress management and emotional resilience while contributing data valuable for healthcare advancements.
Implications of the findings
The ADVANCE Trial is expected to shape global healthcare approaches for migrant populations. Clinical teams should observe trial outcomes to integrate effective techniques into patient care workflows. Policy teams may leverage insights to design inclusive mental health programs.
Universities and professional organizations should explore ways to incorporate intervention results into broader education and clinical practice frameworks.
Disclaimer
This article is informational and intended for clinical, quality, regulatory, and related professionals. It does not constitute legal advice or clinical recommendations. Refer to official trial documentation for definitive details.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07209306?term=medical+device