Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT07209306
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07209306
Study Brief:
Protocol Section:
NCT07209306