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.