Assessing a psychological intervention for refugees and asylum seekers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the feasibility and acceptability of an adapted version of the Problem Management Plus (PM+) intervention for refugees and asylum seekers facing psychological distress. PM+ is a brief, low-intensity psychological intervention designed to be delivered by non-professionals, focusing on problem-solving, stress management, behavioral activation, and social support. The study aims to enhance access to mental health care for this vulnerable population by providing additional booster sessions and a digital support program. The findings will inform the design of a larger definitive randomized controlled trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* refugees and asylum seekers (RAS) aged 16 or older;
* residing in one of the participating local sites (Swiss municipalities, namely, Gemeinden, and transitional asylum centers, namely, Durchgangszentren) where PM+ is offered and which gave their consent for participation in the RCT;
* speaking at least one of the following 12 languages: German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil, and Pashto;
* obtaining a score of 20 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a brief clinically validated screening questionnaire that assesses general psychological distress in the past 30 days. A score equal to or higher than 20 is used as an indication of moderate to high levels of psychological distress.

Exclusion Criteria:

* significant cognitive or neurological impairment measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
* acute medical conditions or severe mental disorders (e.g., psychotic or substance-abuse disorders) measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
* acute risk of suicide as measured by the Suicidal Ideation Attribution Scale (SIDAS; van Spijker et al., 2014) and the Thoughts of Suicide Questionnaire (World Health Organization WHO, 2016).

Where it's running

• Klinik für Konsiliarpsychiatrie und Psychosomatik, Universitätsspital Zürich
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Naser Morina, PD Dr. — Klinik für Konsiliarpsychiatrie und Psychosomatik
• Study coordinator: Naser Morina, PD Dr.
• Email: naser.morina@usz.ch
• Phone: +41 44 255 5280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.