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WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial

RecruitingNAAges 18 Years - anyAllUniversita di Verona
NCT07209306 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their lives during and after migration. The World Health Organization has developed scalable psychological interventions, including Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM), which are designed for delivery by non-professional helpers and adaptable to various cultures and mental health issues. While initial randomized controlled trials (RCTs) show these interventions are effective, their medium to long-term efficacy, implementability and scalability have not been thoroughly evaluated. Objectives: This study aims to examine the efficacy of SH+ and DWM versus a psychological placebo in reducing anxiety and depression symptoms among migrants experiencing el

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📋 Eligibility rules (as published)
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.
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What it tests

  • Experimental: Self-Help Plus and booster session
  • Doing What Matters in Times of Stress and booster session
  • Psychological Placebo
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Where

1 site
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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