Status:
RECRUITING
WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial
Lead Sponsor:
Universita di Verona
Collaborating Sponsors:
University of Roma La Sapienza
Conditions:
Distress, Psychological
Distress, Emotional
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their liv...
Detailed Description
The World Health Organization (WHO) has developed a number of scalable psychological interventions for populations affected by adversity. These include Self Help Plus (SH+) and its online version Doin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT07209306
Start Date
April 9 2025
End Date
April 30 2027
Last Update
October 6 2025
Active Locations (1)
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1
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, 37135