Assessing a psychological intervention for refugees and asylum seekers

Boosting Refugee Integration Through Psychological Intervention (BRIGHT) - a Pilot Randomised Controlled Trial

This study is testing a new mental health support program for refugees and asylum seekers to see if it helps them manage stress and feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of Zurich (other)
• Locations: 1 site (Zurich)
• Trial ID: NCT06397105 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include refugees and asylum seekers aged 16 or older who are experiencing moderate to high levels of psychological distress.

Not a fit: Patients with significant cognitive or neurological impairments may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve mental health outcomes for refugees and asylum seekers by providing accessible psychological support.

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

Eligibility criteria

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 this trial is running

Zurich

• 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.

Conditions: Psychological Distress, PTSD, Trauma, Psychological, Problem Management Plus, Mental Health Care, Refugees