RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic

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).

Intervention: All participants (in both the treatment and the comparison group) will
receive Psychological First Aid (PFA) and CAU. In addition to PFA and CAU, the treatment
group will receive the stepped-care intervention (DWM with or without PM+). The
stepped-care intervention consists of DWM (step 1), and conditionally PM+ (step 2) if
participants still meet criteria for psychological distress (K10 >15.9) 2 weeks after
having received DWM.

DWM, i.e. a self-help book with pre-recorded audios, has been adapted as an online
intervention (phase 1). PM+ consists of five sessions and will be delivered by trained
peer-support helpers in person or via teleconferencing in individual or group format. In
addition to PFA, the comparison group will receive CAU which ranges from community care
to specialized psychological treatments, according to the needs and clinical
characteristics of participants.

Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be
interviewer-administered, inperson or through (video) calls. For all participants, online
assessments will take place at baseline, at 2 weeks after having received DWM, at 1 week
and at 2 months after having received PM+. The primary outcome will be the decrease in
symptoms of anxiety and depression from baseline to two-month follow-up, measured through
the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7
(GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a
Cohen's d effect size of 0.3 in the DWM/PM+ group at 2 months post-treatment. Additional
health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), symptoms of
posttraumatic stress disorder (PCL-5), resilience (Mainz Inventory of Microstressors,
MIMIS), quality of life (5-level EQ-5D version, EQ-5D-5L), and cost of care (Client
Service Receipt Inventory, CSRI). Additional study parameters will include demographic
data, COVID-19 related (exposure) variables, treatment fidelity, satisfaction and
acceptability of the intervention program, and implementation indicators (such as reach,
dose, resource use, intervention-related costs). Through FGDs and interviews at the end
of the trial, the feasibility of scaling-up the implementation on the stepped-care
DWM/PM+ intervention within asylum seekers, refugees, and migrants in Italy.