RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic. A Randomized Controlled Trial in Italy

Rationale: The ongoing COVID-19 pandemic has a major and potentially long-lasting effect on mental health and wellbeing across populations worldwide. Vulnerable groups, such as asylum seekers, refugees and migrants, are disproportionally affected by the COVID-19 pandemic. There is a high need for psychosocial interventions that can target the most prevalent mental health problems as a result of the COVID-19 pandemic, addressing the needs of many people in a way that maximizes the use of resources. The World Health Organization (WHO) has developed two scalable, low-intensity psychological interventions: Doing What Matters in times of stress (DWM; a self-help intervention) and Problem Management Plus (PM+; a face-to-face intervention). DWM and PM+ can be delivered by paraprofessionals, are applicable to a variety of mental health problems (depression, anxiety and PTSD), and can be adapted to different populations, cultures and languages. Both DWM and PM+ have been proven to be effective on their own. In this study, DWM and PM+ will be combined into a stepped-care intervention. This study is part of the larger EU H2020-RESPOND project, which aims to improve the preparedness of the European mental health care system in the face of future pandemics.

Objective: The main objective is to evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted DWM/PM+ stepped-care programs amongst asylum seekers, refugees, and/or migrants living in Italy during the COVID-19 pandemic in terms of mental health outcomes, resilience, wellbeing, health inequalities, and costs to health systems. The main hypothesis is that the stepped-care DWM/PM+ intervention together with psychological first aid (PFA) in addition to care-as-usual (CAU) will be more effective in decreasing psychological distress and symptoms of mental health problems than PFA and CAU alone. We aim to conduct a randomized controlled trial (RCT) to assess the (cost-)effectiveness of the stepped-care DWM/PM+ intervention, and to identify (a) barriers and facilitators to treatment engagement and adherence and (b) opportunities for scaling up the implementation of the DWM/PM+ intervention within the existing health care system in Italy.

Study design: pragmatic implementation trial with a single-blinded, randomized, parallel-group design. The final phase of the trial will consist of a qualitative process evaluation with individual interviews and focus group discussions (FGDs).

The qualitative phase will include some participants in the randomized trial who completed DWM (n=2/4;), who completed PM+ (n=2/4), who dropped-out during DWM (n=2/4), and who dropped-out during PM+ (n=2/4); (b) local stakeholders (n=10/15) (c) facilitators of the DWM and PM+ intervention (both helpers and trainers/supervisors).

Study population: Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 >15.9) (n=212).