Boosting refugee mental health and integration through a low-intensity intervention: study protocol for a pragmatic randomized controlled trial

Background Forcibly displaced people (FDP) are frequently exposed to multiple stressors and adversities, increasing their risk of developing mental health problems. However, they often face significant barriers to accessing adequate mental health care. To improve access to evidence-based psychological support, the World Health Organization developed Problem Management Plus (PM+), a brief, low-intensity psychological intervention delivered by trained non-specialists, aimed to alleviate common mental disorders among individuals affected by adversity. The outlined study will evaluate the effectiveness of PM+ augmented with additional homework reminders and three booster sessions when delivered in a real-world setting. Methods A pragmatic randomized controlled trial (RCT) will be conducted with 1,000 FDP in the canton of Zurich, Switzerland. Adult FDP with elevated psychological distress (≥ 20 on the Kessler-10 Psychological Distress Scale) will be randomly assigned to either the augmented PM+ intervention group ( n = 667) or care as usual group ( n = 333). Outcome assessments will be conducted at 3, 6, and 12 months after baseline assessment. The primary outcome is psychological distress at 3-month follow-up, measured by the Hopkins Symptom Checklist-25. Secondary outcomes include post-traumatic stress symptoms, general psychological distress, somatic symptoms, post-migration stressors, level of social integration, suicidal ideation, at 3, 6, and 12-months. Discussion This trial will provide evidence on the effectiveness of augmented PM + and its feasibility for integration into the Swiss health care system. If effective, the intervention will be adapted and tested in other regions and settings in Switzerland, with the goal of establishing a sustainable implementation strategy within national mental health services. Trial registration ClinicalClinicalTrials.gov: NCT06776523. Prospectively registered on 09 January 2025.