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New treatment option for Distress, Psychological
Official title WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial
ClinicalTrials.gov ID: NCT07209306
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Verona, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.