WHO psychological programs to support mental health in migrants resettled in Italy (ADVANCE)

Testing the Effectiveness and Implementability of WHO Psychological Intervention Strategies for Improving Mental Health Outcomes in Migrant Populations Resettled in Italy: the ADVANCE Randomized Controlled Trial

This project will see if WHO's Self-Help Plus (SH+) and Doing What Matters (DWM) programs reduce anxiety and depression in migrants living in Italy who have elevated psychological distress.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 237 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universita di Verona (other)
• Locations: 1 site (Verona, Italy)
• Trial ID: NCT07209306 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial compares WHO's Self-Help Plus (SH+) and its online version Doing What Matters (DWM) against a psychological placebo in migrants resettled in Italy who report elevated distress. Interventions are designed to be scalable and are delivered by trained non-professional helpers, with booster sessions and a guided digital option for DWM. The trial measures reductions in anxiety and depression symptoms (screening with K10 >15.9) and collects implementation outcomes to judge feasibility and scalability. Participants are adults living in Italy (including refugees, asylum seekers, and labor migrants) and are followed up to six months after randomization.

Who should consider this trial

Good fit: Adults (18+) living in Italy as migrants, refugees, or asylum seekers with elevated psychological distress (K10 >15.9) who can read and speak Italian or English are the ideal candidates.

Not a fit: People with imminent suicide risk, severe mental disorders (e.g., psychosis or substance dependence), severe cognitive impairment, acute medical conditions requiring hospitalization, or who plan to leave Italy before the six-month follow-up are unlikely to benefit in this trial.

Why it matters

Potential benefit: If successful, these low-cost, scalable interventions could reduce anxiety and depression symptoms and expand accessible mental health support for many migrants in Italy and similar settings.

How similar studies have performed: Earlier randomized trials of SH+ and DWM in refugee and migrant populations showed short-term reductions in distress, but medium- to long-term effects and large-scale implementability are still not well established.

Eligibility criteria

Inclusion Criteria:

* 18 years or older
* Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants;
* Having elevated levels of psychological distress (K10 \>15.9);
* Sufficient mastery (written and spoken) of one of the languages the SH+/DWM intervention is being delivered in (i.e., English and/or Italian);
* Oral and written informed consent before entering the study.

Exclusion Criteria:

* Planning to permanently move back to their home country before the last follow-up assessment (at six months after randomization);

  * Having acute medical conditions (requiring hospitalization);
  * Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up based on screening tool and clinical judgement;
  * Having a severe mental disorder (e.g., psychotic disorders, substance-dependence) based on clinical judgement;
  * Having severe cognitive impairment based on clinical judgement (e.g., severe intellectual disability or dementia);
  * Currently receiving specialized psychological treatment (e.g., Cognitive Behavioral treatment (CBT), Eye Movement Desensitizing and Reprocessing (EMDR));
  * In case of current psychotropic medication use: being on an unstable dose for at least two months.

Where this trial is running

Verona, Italy

• 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, Verona, Italy. — Verona, Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Corrado Barbui, MD, Full professor — Universita di Verona
• Study coordinator: Marianna Purgato, PhD, Associate professor

Conditions: Distress, Psychological, Distress, Emotional, Migrant populations, Psychological distress, Psychological wellbeing, WHO psychological interventions, Effectiveness, Implementation