Clinical trial Recruiting at 1 site Interventional Ages 16 and up

Improving mental health support for refugees through a psychological intervention

Official title: Boosting Refugee Integration Through Psychological Intervention

Run by University of Zurich · NCT06776523 · Data updated 2026-11-12

This study is testing a new way to help refugees and asylum seekers with their mental health by improving a support program that includes extra sessions and reminders to see if it makes a difference.

Quick facts

Study typeInterventional
Ages16 Years and up
SexAll
Enrollment1200 (estimated)
SponsorUniversity of Zurich
Academic / other
Locations1 site (Zurich)
StatusRecruiting
StartedJanuary 16, 2025
Main results expectedDecember 2026
Study endsSeptember 2027
Registry record updatedApril 27, 2026
Trial IDNCT06776523 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are refugees and asylum seekers aged 16 or older who are experiencing moderate to high levels of psychological distress.

Probably not a fit

Patients with significant cognitive or neurological impairments may not benefit from this intervention.

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

What this trial studies

This study focuses on enhancing the Problem Management Plus (PM+) intervention, a low-intensity psychological support program designed for refugees and asylum seekers facing mental health challenges. The intervention consists of five sessions that utilize evidence-based techniques such as problem-solving and stress management, delivered by trained non-professionals. The study aims to evaluate the effectiveness of PM+ while incorporating additional booster sessions and homework reminders to improve outcomes. It addresses the barriers refugees face in accessing mental health care, aiming to integrate this intervention into public health systems.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and psychosocial functioning of refugees and asylum seekers.

How similar studies have gone: Previous studies have shown that PM+ is effective in reducing mental health problems in crisis-affected populations, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
The inclusion criteria for participating in the study are:

* 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.

The exclusion criteria for participating in the study are:

* 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
    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

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.