NCT07209306 WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial
| NCT ID | NCT07209306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Distress, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 237 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 237 participants in total. It began in 2025-04-09 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 elevated psychological distress. Additionally, it seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions. Study design: We will conduct a hybrid three-arm efficacy-implementation randomized controlled trial. Study population Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 \>15.9) (n=237). Intervention : All participants (in the three comparison groups) will receive Psychological First Aid (PFA) and enhanced care as usual (ECAU). In addition to PFA and ECAU, the intervention group 1 will receive SH+ complemented with an online booster session (delivered 4 weeks after SH+), the intervention group 2 will receive DWM complemented with an online booster session (delivered 4 weeks after DWM), and the intervention group 3 will receive psychological placebo (PsychP) complemented with an online session with neutral contents of the same duration of groups 1 and 2 (delivered 4 weeks after PsychP). Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, in-person or through (video) calls. For all participants, online assessments will take place at baseline, at 4/6 weeks after having received DWM (which corresponds to 1 week after the booster session, and 3 months after randomization), and at 6 months after randomization. The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to three-month after randomization, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen's d effect size of 0.3 in the SH+ and DWM groups at 3 months after randomization. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), functional impairment (WHODAS), wellbeing (WHO-5), quality of life (EQ-5D-5L), and cost of care (CSRI). Implementation outcomes will be measured with the Adoption of Information, Technology measure, Measure of Disseminability and Levels of Institutionalization tool, adverse events, and WHO fidelity forms. Additional study parameters include demographic data and dropouts.
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.
Contact & Investigator
Corrado Barbui, MD, Full professor
PRINCIPAL INVESTIGATOR
Universita di Verona
Frequently Asked Questions
Who can join the NCT07209306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distress, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07209306 currently recruiting?
Yes, NCT07209306 is actively recruiting participants. Contact the research team at marianna.purgato@univr.it for enrollment information.
Where is the NCT07209306 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT07209306 clinical trial?
NCT07209306 is sponsored by Universita di Verona. The principal investigator is Corrado Barbui, MD, Full professor at Universita di Verona. The trial plans to enroll 237 participants.