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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT04993534
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older;
* Living in Italy as asylum seeker, refugee, or migrant
* Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) \>15.9).
* Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. English, Italian).
* Oral and written informed consent before entering the study.
Exclusion Criteria:
* Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+;
* Having acute medical conditions (requiring hospitalization);
* Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up;
* Having a severe mental disorder (e.g. psychotic disorders, substance-dependence);
* Having severe cognitive impairment (e.g. severe intellectual disability or dementia);
* Currently receiving specialized psychological treatment (e.g. Eye Movement Desensitization and Reprocessing - EMDR; Cognitive behavioural therapy - CBT);
* In case of current psychotropic medication use: being on an unstable dose for at least 2 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04993534
Study Brief:
Protocol Section:
NCT04993534