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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: marianna.purgato@univr.it
• Phone: +390458124884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.