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
Phase: NA
Conditions: Psychological Distress
Sponsor: Universita di Verona

 
 
This project has received funding from the European Union's Horizon 2020 Research and Innovation 
programme Societal Challenges under Grant Agreement No 733337. 
This project has received 
funding from the 
European Union’s Horizon 
2020 research and 
innovation programme 
Societal Challenges under 
Grant Agreement No 
101016127. 
 
 
 
 
RESPOND 
DRAFT 
RESEARCH 
PROTOCOL WP5 
- UNIVR 

 
 
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DRAFT RESEARCH PROTOCOL WP5 
 
 
 
 
Research Protocol WP5 – UNIVR – Version 1.3 (25/10/2021) 
RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and 
Psychosocial Concerns Resulting from the COVID-19 Pandemic 
Project Acronym: RESPOND 
Grant Agreement No 101016127 
 
Deliverable Information 
Project start date 
01/12/2020 
Duration of the project 
3 years (until 30/11/2023) 
Work package 
5 
Dissemination level 
CO 
Keywords 
Protocol, randomized trial, adaptation, DWM, PM+ 
Version 
0.1 General Draft from the team in VU 
0.2 Draft adapted by MP for the Italian context (29-04-
21) 
0.3 Draft revised by CB (29-04-21) and CB/MP (3-05-21) 
1.0 Final draft (14-05-21) 
1.1. Draft revised by FT, MP, and CB after comments 
from the CESC (19-07-21) 
1.2. Draft revised by FT, MP, and CB after comments 
from the CESC (03-08-21) 
1.3 Draft edited by GT in relation to the assessment tools 
and duration of PM+ sessions, and revised by MP (25-10-
21) 
 
 
 
 
 
 
 
The opinions expressed in this document reflect only the author’s view and in no way reflect the European Commission’s 
opinions. The European Commission is not responsible for any use that may be made of the information it contains. 

 
 
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PU=Public, CO=Confidential, only for members of the consortium (including the Commission Services), CI=Classified, as 
referred to in Commission Decision 2001/844/EC 

 
 
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Table of contents 
1. 
List of abbreviations and relevant definitions.............................................................................................................. 6 
2. 
Summary ...................................................................................................................................................................... 7 
3. 
Introduction and ratonale ............................................................................................................................................ 9 
4. 
Objectives................................................................................................................................................................... 12 
4.1. 
Primary objective .............................................................................................................................................. 12 
4.2. 
Secondary objective .......................................................................................................................................... 12 
5. 
Study design ............................................................................................................................................................... 13 
6. 
Study population ........................................................................................................................................................ 15 
6.1. 
Population ......................................................................................................................................................... 15 
6.2. 
Inclusion criteria ................................................................................................................................................ 15 
6.3. Exclusion criteria ..................................................................................................................................................... 15 
6.4. 
Sample size calculation ..................................................................................................................................... 15 
7. 
Treatment of subjects ................................................................................................................................................ 16 
7.1. 
Investigational product/treatment ................................................................................................................... 16 
7.2. 
Use of co-intervention (if applicable) ................................................................................................................ 19 
7.3. 
Escape medication (if applicable) ...................................................................................................................... 19 
8. 
Methods ..................................................................................................................................................................... 21 
8.1. 
Study parameters/endpoints ............................................................................................................................ 21 
8.1.1. 
Main study parameter/endpoint .............................................................................................................. 21 
8.1.2. 
Secondary study parameters/endpoints (if applicable) ........................................................................... 21 
8.1.3. 
Other study parameters ........................................................................................................................... 21 
8.2. 
Randomization, blinding and treatment allocation .......................................................................................... 22 
8.3. 
Study procedures .............................................................................................................................................. 21 
8.4. 
Withdrawal of individual subjects ..................................................................................................................... 28 
8.4.1. 
Specific criteria for withdrawal (if applicable) .......................................................................................... 29 
8.5. 
Replacement of individual subjects after withdrawal ....................................................................................... 29 
8.6. 
Follow-up of subjects withdrawn from treatment ............................................................................................ 29 
8.7. 
Premature termination of the study (if applicable) .......................................................................................... 29 
9. 
Safety reporting ......................................................................................................................................................... 21 
9.1. 
Temporary halt for reasons of subject safety ................................................................................................... 21 
9.2. 
AES and SAES ..................................................................................................................................................... 21 
9.2.1. 
Adverse events (AES) ................................................................................................................................ 21 
9.2.2. 
Serious Adverse Events (SAES) ................................................................................................................. 30 
9.3. 
Follow-up of adverse events ............................................................................................................................. 30 
9.4. 
Ethics and Data Advisory Board (EDAB) ............................................................................................................ 30 
10. 
Statistical analysis.............................................................................................................................................. 31 

 
 
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10.1. 
Primary outcome(s) ........................................................................................................................................... 21 
10.2. 
Secondary outcome(s)....................................................................................................................................... 32 
10.3. 
Other secondary parameters ............................................................................................................................ 32 
10.4. 
Interim analysis ................................................................................................................................................. 21 
11. 
Ethical considerations ....................................................................................................................................... 33 
11.1. 
Regulation statement ........................................................................................................................................ 33 
11.2. 
Recruitment and consent .................................................................................................................................. 21 
11.3. 
Objections by minors or incapacitated subjects ............................................................................................... 34 
11.4. 
Benefits and risk assessment, group relatedness ............................................................................................. 35 
11.5. 
Compensation injury ......................................................................................................................................... 35 
11.6. 
Incentives .......................................................................................................................................................... 21 
12. 
Administrative aspects, monitoring and publication ........................................................................................ 36 
12.1. 
Handling and storage of data and documents  ................................................................................................. 36 
12.2. 
Monitoring and quality assurance ..................................................................................................................... 21 
12.3. 
Amendments ..................................................................................................................................................... 37 
12.4. 
Annual progress report ..................................................................................................................................... 37 
13. 
References ............................................................................................................................................................. 38 
 
 
 
 

 
 
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1. List of abbreviations and relevant definitions 
ARM 
 
Asylum seekers, Refugees, Migrants 
CSQ 
 
Client Satisfaction Questionnaire 
CSRI  
 
Client Service Receipt Inventory 
DSM  
 
Diagnostic and Statistical Manual of Mental Disorders 
DWM 
 
Doing What Matters 
EQ-5D-5L 
EuroQol five dimension five level checklist for quality of life 
 
 
EU European Union 
GAD-7  
Generalized Anxiety Disorder checklist (consisting of 7 items) 
GCP  
 
Good Clinical Practice 
IC  
 
Informed Consent 
K10  
 
Kessler Psychological Distress Scale (ten item version) 
BTQ 
 
Brief Trauma Questionnaire 
MIMIS  
Mainz Inventory of MIcrostressorS 
PCL-5 
 
PTSD Checklist for DSM-5 (consisting of 20 items)  
PFA 
 
Psychological First Aid 
PM+  
 
Problem Management Plus 
PHQ-9  
Patient Health Questionnaire for depression scoring each of the 9 DSM-5 criteria 
PHQ-ADS 
Patient Health Questionnaire – Anxiety and Depression (sum score of PHQ-9 and GAD-7) 
PTSD  
 
Posttraumatic Stress Disorder 
RESPOND 
pREparednesS of health systems to reduce mental health and Psychosocial   concerns resulting from 
 
 
the COVID-19 paNDemic 
RCT  
 
Randomized Controlled Trial 
WHO  
 
World Health Organization 
 
 

 
 
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2. SUMMARY 
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 (if applicable): 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, in-
person 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 (EQ-5D-5L), 
and cost of care (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 

 
 
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feasibility of scaling-up the implementation on the stepped-care DWM/PM+ intervention within asylum seekers, 
refugees, and migrants in Italy.  
 
 

 
 
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3. INTRODUCTION AND RATONALE 
Impact of pandemic and containment measures 
The ongoing COVID-19 pandemic has a major and potentially long-lasting effect on mental health and wellbeing across 
populations in Europe and worldwide. The pandemic has affected every country in the world, with some of the most 
deeply affected countries in Europe, including Italy (John Hopkins University and Medicine, 2020). Early reports 
regarding the levels of psychological distress associated with the COVID-19 crisis are highly concerning (McGinty, 
Presskreischer, Han & Barry, 2020) and led to the UN releasing a policy briefing on the mental health impacts of COVID-
19 warning that a ‘long-term upsurge in the number and severity of mental health problems is likely’ (United Nations, 
2020). 
European governments installed epidemic control measures to contain the spreading of the virus, which include 
lockdown restrictions and closures (amongst others) that have created a great impact on society (Blavantnik School of 
Government, University of Oxford, 2020). Physical distancing and staying at home orders have led to elevated 
loneliness in many people, which is in turn associated with depression and suicidal ideation (Stickley & Koyanagi, 2016). 
Despite social protection programs, many individuals have directly been impacted financially by the economic 
consequences of the containment measures, and have seen their income decline, especially people with short-term or 
part-time contracts, or those being self-employed. Economic estimates show that the lockdown will directly affect 
sectors amounting to up to a loss of 2 percentage points in annual GDP growth for each month of containment (OECD, 
2020). Following economic recession, mental health problems have been shown to increase (Garcy & Vagero, 2013).  
 
Focus on vulnerable groups 
Although the COVID-19 pandemic has affected the whole population, consequences are not distributed equally. COVID-
19 has had a larger effect on people living under fragile circumstances, and on socio-economically disadvantaged and 
minority populations across Europe. The risk of dying from COVID-19 is higher among people in socio-economically 
deprived areas than among people in the least deprived areas (Public Health England, 2020). Furthermore, historically, 
following recession higher increases in mental health symptoms of younger working-age people have been found 
(Thomson & Katikireddi, 2018). Thus, the COVID-19 pandemic and the associated containment measures are expected 
to lead to an exacerbation of health inequalities in Europe and beyond. In May 2020, the WHO already stated that 
particular attention should be given to vulnerable groups, including asylum seekers, refugees, and migrants 
(ARM)(WHO, 2020b). 
 
ARM resettled in high-income countries are exposed to multiple health-related risks and vulnerabilities than the 
general population, due to their exposure to complex traumatic events before and during transition, and to additional 
traumatic events once resettled in a hosting country (Turrini et al, 2017). In particular, in the COVID-19 pandemic ARM 
may lack biosecurity measures as basic protection equipment due to insufficient information. They are also at high risk 
of infection because of proximity, lack of sanitation, and poor living conditions. There is evidence of discrimination and 
social exclusion amongst resettled ARM living in areas associated with COVID-19 (IASC, 2019; WHO, 2020). These 
reports are in line with previous evidence indicating that discrimination has been a key concern even in the general 
population in relation to other viral outbreaks and epidemics (Person et al, 20014). In addition, asylum seekers, 
refugees, and migrants are often left out of disaster preparedness planning, and may experience lack of access to 
information delivered in a culturally appropriate way, with problems in adapting their behaviors to protection measures 
and social rules such as social distancing. 
The Box 1 below reports the definitions of asylum seekers, refugees, and migrants (ARM) according to the UNHCR 
(UNHCR, 2018). 
Asylum seekers  
Asylum seekers are persons fleeing armed conflict or persecution, but whose request for 
sanctuary has yet to be processed. 
Refugees 
Refugees are persons fleeing armed conflict or persecution. Their situation is often so perilous 
and intolerable that they cross national borders to seek safety in nearby countries, and thus 
become internationally recognized as "refugees" with access to assistance from States, UNHCR, 
and other organizations. They are so recognized precisely because it is too dangerous for them 

 
 
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to return home, and they need sanctuary elsewhere. These are people for whom denial of 
asylum has potentially deadly consequences. 
Migrants 
(economic) 
Migrants choose to move not because of a direct threat of persecution or death, but mainly to 
improve their lives by finding work, or in some cases for education, family reunion, or other 
reasons. Unlike refugees who cannot safely return home, migrants face no such impediment to 
return. If they choose to return home, they will continue to receive the protection of their 
government. 
 
 
Scalable psychological interventions to improve resilience, mental health and wellbeing  
There is a high need of psychosocial interventions for at-risk groups, such as ARM, affected by traumatic events and 
additionally by the COVID-19 pandemic to address the most prevalent mental health problems, most notably symptoms 
of distress, anxiety, depression, and posttraumatic stress disorder (PTSD). Telehealth has proven to be effective for 
delivery of individual or group-based mental health and psychosocial support interventions (Banbury, Nancarrow, Dart, 
Gray & Parkinson, 2018), and has great advantages over regular mental health care delivery in terms of its feasibility 
under lockdown restrictions, scalability, and reducing costs. This can be particularly useful for ARM resettled in Italy 
who experience various barriers to (mental) health care. However, it is yet unclear whether it has met the needs of 
more vulnerable people with specific needs, who are illiterate, older, or people without internet access (EuroHealthNet, 
2020). 
The World Health Organization (WHO) has developed a number of scalable psychological interventions for populations 
affected by adversity (WHO, 2017). They include -amongst others- Doing What Matters in Times of Stress (DWM) and 
Problem Management Plus (PM+). A core feature of all WHO scalable interventions is that they can be trained to and 
delivered by non-professional helpers, such as a trained peer, or helper at the workplace, or a psychosocial worker 
(task-shifting) (WHO, 2017; Epping-Jordan et al., 2016). They have also been designed to be widely applicable to a 
variety of mental health problems (depression, anxiety and PTSD) and easily adaptable to different populations, 
cultures and languages. Finally, the interventions and their implementation materials are freely available on the WHO 
website. 
DWM was originally designed for flexible implementation either in a group or individual format including an online 
format. People participating in DWM also receive support from a briefly trained helper. DWM is based on acceptance 
and commitment therapy (ACT), a modern form of cognitive-behavioral therapy with a strong focus on mindfulness 
practices and includes exercises which aim to enhance stress reduction and build social support, adaptive coping and 
resilience (Epping-Jordan et al., 2016). It has been implemented with different populations of asylum seekers and 
refugees in Europe, Turkey (Purgato et al., 2019) and Northern Uganda (Tol et al., 2020). In RESPOND, the DWM pre-
recorded audios and an illustrated stress management guide called “Doing What Matters in Times of Stress: an 
illustrated guide” (WHO, 2020a), has been culturally adapted to an online application tool. This way, people can use the 
self-help intervention in their own time. The five weekly sessions of the intervention will follow the five chapters of the 
book (grounding, unhooking, acting on your values, being kind and making room). Participants will receive a weekly call 
from a so-called “helper” to support them accessing the intervention sessions, and to shortly revise the contents of 
each session. 
PM+ is a transdiagnostic intervention (Banbury et al., 2018) for reducing symptoms of depression, anxiety, PTSD, and 
related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group 
delivery formats for face-to-face or online delivery. PM+ comprises five weekly sessions using evidence-based 
techniques: of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. 
PM+ has been successfully implemented in Kenya (Bryant et al., 2017) and Pakistan (Rahman et al., 2016b). Both DWM 
and PM+ have been implemented through two large EU H2020 funded projects, STRENGTHS (733337) and RE-DEFINE 
(779255). For this study, we adapted both the DWM and the PM+ intervention to the COVID-19 pandemic and to the 
context and culture of the target population, i.e. we adapted examples and pictures used in the intervention. 
 
RESPOND Project 
This study is embedded in the larger, EU H2020 CORONAVIRUS-funded RESPOND (PREparednesS of health systems to 
reduce mental health and Psychosocial concerns resulting from the COVID-19 paNDemic) project. The RESPOND project 

 
 
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aims to improve the preparedness of the European mental health care system in the face of future pandemics. In order 
to do that a consortium of eight countries (BE, DE, ES, FR, NL, IT, SWE, UK) will collaborate in: 
1) Identifying risk groups for poor wellbeing and mental health related to the COVID-19 pandemic by analyzing 
longitudinal epidemiological data and identifying resilience factors related to the COVID-19 pandemic;  
2) Examining the impact of the COVID-19 pandemic on long-term health and mental health services use, and the 
associations between health and mental health care use and socio-economic factors across European 
countries with different control measures and pandemic course (Sweden, Italy and Spain);  
3) Performing rapid and recurring holistic assessments of policies and measures across Europe that have and will 
address different phases of the COVID-19 pandemic to protect the mental health and wellbeing of groups at 
high-risk for COVID-19 related mental health issues 
4) Examining the necessary health system and wider contextual and policy conditions for successful 
implementation and scaling-up of remote-delivered stepped-care using existing, scalable World Health 
Organization (WHO) programs to improve resilience, wellbeing, overall functioning and mental health, across 
frontline workers and other high-risk groups for COVID-19 related poor mental health, including ARM. 
5) Providing regional and national health care authorities, including relevant public health and long-term care 
authorities, with transferable evidence-based practices, methodologies and guidance for scaling up mental 
health and broader social and economic support measures for frontline workers and other risk groups for 
COVID-19 related mental health symptoms, including ARM. 
 
This study(-protocol) contributes to aim number 4; examining the feasibility and cost-effectiveness of remote-delivered 
scalable interventions for targeting COVID-19-related psychological distress and mental health issues. Both DWM and 
PM+ have been found to be effective (Purgato et al., 2019; Tol et al., 2020; Bryant et al., 2017; Rahman et al., 2016b), 
but it is unknown if they are also effective when combined as a stepped-care program compared to care-as-usual. 
Within Italy, the targeted vulnerable group to examine the effectiveness of the stepped-care intervention, will be 
asylum seekers, refugees, and migrants. The treatment group will be compared to an enhanced care-as-usual (CAU) 
group in terms of a number of health and implementation outcome variables. 
 
 

 
 
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4. OBJECTIVES 
4.1. PRIMARY OBJECTIVE 
To evaluate the (cost-)effectiveness, feasibility, and acceptability of the culturally and contextually adapted DWM/PM+ 
stepped-care program among ARM resettled in Italy during the COVID-19 pandemic in terms of mental health 
outcomes, resilience, wellbeing, health inequalities, and costs to health systems.  
4.2. SECONDARY OBJECTIVE 
To identify barriers and facilitators to treatment engagement and adherence and opportunities for scaling up among 
the target population in Italy (qualitative part of the study). 
 
 

 
 
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5. STUDY DESIGN 
The study consists of a single-blind randomized controlled trial (RCT), that will include a qualitative analysis in its final 
phase. As a preliminary work, we conducted a qualitative study to assess the needs of ARM resettled in Italy and to 
inform the adaptation of the DWM/PM+ interventions. The preliminary phase has been completed and was described 
in a separate protocol for which ethical approval was granted by the Comitato di Approvazione della Ricerca sulla 
Persona – CARP – of the University of Verona. 
Randomized controlled trial (stepped-care DWM/PM+ intervention with Psychological First Aid and care-as-
usual vs. Psychological First Aid and care-as-usual alone). 
The final phase of the RCT will include a process evaluation with qualitative interviews and focus groups to 
assess barriers and facilitators of engagement and adherence to the stepped-care intervention and 
opportunities for scaling up the implementation of the intervention. 
Box 2. Summary of the present research. 
 
Randomized controlled trial: the DWM/PM+ programs will be evaluated in a RCT. Participants will be screened for 
elevated distress (K10; see Figure 1). We will conduct a RCT in ARM with increased psychological distress to determine 
whether the stepped care intervention (i.e. DWM/PM+) leads to stronger decreases in mental health outcomes, and 
increase in wellbeing among compared to care-as-usual (CAU). This phase is designed as a randomized, single-blind 
parallel-group trial with one treatment group (n=105) and one comparison group (n=105). All participants in both the 
treatment and the comparison group will receive Psychological Frist Aid (PFA) and CAU. In addition to PFA and CAU, 
participants randomized into the treatment group will receive the DWM/PM+ stepped-care intervention, while 
participants randomized in the comparison group will receive PFA and CAU only.  
All participants in the treatment group (i.e. those who receive DWM and PM+ and those who only receive DWM 
because symptoms subside) will be followed for a period of 2 months after the end of the PM+ session (see Figure 1 for 
assessment points). 
The final part of the RCT will include a qualitative study, consisting of interviews and/or focus group discussions among 
key stakeholders (identified as reported below) to evaluate barriers and facilitators to treatment engagement and 
adherence to the DWM/PM+ stepped-care intervention, as well as opportunities for scaling up the implementation of 
the intervention within the existing healthcare system in Italy. This will inform partners in RESPOND of the synthesis 
and dissemination of the DWM/PM+ stepped-care intervention for vulnerable groups during a pandemic. 
The qualitative study will include the following key stakeholders (a) participants in the RCT who completed DWM 
(n=2/4; improved and not improved), who completed PM+ (n=2/4; improved and not improved), 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).  

 
 
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Figure 1. Flowchart of randomized controlled trial 
 
 

 
 
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6. STUDY POPULATION 
6.1. POPULATION 
Participants for the RCT will be ARM resettled in Italy. Participants will be recruited through (a) targeted social media 
recruitment, (b) key stakeholders as NGOs located in Italy, and (c) other community-based organizations offering legal 
and/or social and/or psychosocial support for this vulnerable group. 
Participants for the qualitative process evaluation will be key informants, such as participants who took part in the RCT; 
DWM/PM+ facilitators (helpers and supervisors); local stakeholders (recruited through participating centers in the RCT 
phase). For participants who took part in the RCT, we aim to include both those who took part only in DWM and those 
who took part in PM+ as well. Also drop-outs from both the DWM and PM+ intervention will be asked to participate in 
the qualitative process evaluation. 
6.2. INCLUSION CRITERIA 
Participants will be eligible to participate in the study if they meet all of the following criteria:  
 
18 years or older;  
 
Living in Italy as asylum seeker, refugee, or migrant 
 
Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).   
 
Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered 
in (e.g. English, Italian). 
 
Oral and written informed consent before entering the study.  
6.3. EXCLUSION CRITERIA 
Potential participants who meet the inclusion criteria will be excluded from participation in this study if they meet any 
of the following criteria: 
 
Planning to permanently move back to their home country before the last quantitative assessment at 2 
months after PM+; 
 
Having acute medical conditions (requiring hospitalization); 
 
Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up; 
 
Having a severe mental disorder (e.g. psychotic disorders, substance-dependence);  
 
Having severe cognitive impairment (e.g. severe intellectual disability or dementia); 
 
Currently receiving specialized psychological treatment (e.g. EMDR, CBT); 
 
In case of current psychotropic medication use: being on an unstable dose for at least 2 months. 
6.4. SAMPLE SIZE CALCULATION 
A total number of 212 participants will be included. Based on prior studies on a PM+ intervention (Bryant et al., 2017; 
Rahman et al., 2016b), we aim to detect a small to medium effect size Delta (defined as as the square root of the ratio 
of the variance of the tested effect to the comparison error variance) of 0.3 in the PM+ group at 2 months post-
treatment based on the primary composite outcome PHQ-ADS (Kroenke et al., 2016; 2019). The PHQ-ADS is the 
combined sum score of depression and anxiety symptoms of the PHQ-9 and GAD-7, respectively and has shown good 
internal consistency (α = .88 to .92) (Kroenke et al., 2016; 2019). A power calculation for an ANOVA repeated 

 
 
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measurement design with two time-periods to identify the effect of treatment at the last endpoint suggests a minimum 
sample size of N=74 per group (power=0.95, alpha=0.05, two-sided, rho=0.9). Taking into account 30% attrition, we aim 
to include a total number of 212 participants (106 in the stepped-care DWM/PM+ treatment group - with PFA and CAU 
- and 106 in the PFA and CAU comparison group). 
 
7. TREATMENT OF SUBJECTS 
Psychological First Aid (PFA) 
All participants, both in the treatment and the comparison group, will be offered individual Psychological First Aid (PFA) 
through a face-to-face or teleconferencing meeting. PFA is a WHO developed support strategy that involves humane, 
supportive and practical help for individuals suffering from serious humanitarian crises. PFA does not necessarily 
involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to 
promote in the aftermath of crises, i.e. a sense of safety, calm, self- and community efficacy, connectedness, and hope 
(Hobfoll et al., 2007). PFA consists of a (telephone) conversation (approximately 30-45 minutes) that a helper has with a 
participant. PFA has various themes; in PFA, the helper provides non-intruding practical care and support, assesses 
needs and concerns, helps people to address basic needs (e.g. information), listens to people without pressuring them 
to talk, comforts people and helps them to feel calm, helps people to connect to information, services, and social 
support, and protects people from further harm (WHO, 2011).   
 
Care-as-usual (CAU)  
In addition to PFA, both the treatment and the comparison group will receive care-as-usual (CAU); they will be allowed 
to receive any usual care. CAU may include community care, social/legal support, and psychoeducation. 
Because ARM may have a lack of knowledge of the Italian health care system and therefore may not utilize health care 
(Aanjaagteam Bescherming Arbeidsmigranten, 2020), we will inform them on the Italian health care system as well. 
Additionally, participants will receive information about locally available referral options. We will record for all 
participants whether they have a general practitioner (when they consent to having this recorded). In case the 
participant gives approval, we will record name and contact details. 
7.1. INVESTIGATIONAL PRODUCT/TREATMENT 
Treatment group: Stepped-care Doing What Matters/Problem Management Plus (DWM/PM+)  
Stepped-care models assume to provide health care in the most efficient and cost-effective way: the first step of care is 
readily available for all those in need and more costly treatments are reserved only for those not improving. Evidence 
suggest that stepped-care models are modestly effective (van Straten, Hill, Richards & Cuijpers, 2014; Ho, Yeung, Ng & 
Chan, 2016) although there is a high heterogeneity of such models (number of steps, duration of steps, rules about 
stepping up) and their effects. Interestingly, research in clinical practice has shown that results improve when care 
providers switch from a matched care to a stepped-care approach (Boyd, Baker & Reilly, 2019). 
The treatment group will receive the stepped-care program consisting of Doing What Matters in Times of Stress (DWM) 
(step 1) and Problem Management Plus (PM+) (step 2) in addition to Psychological First Aid (PFA) and care-as-usual 
(CAU) (for details of CAU, see: ‘Care-as-usual (CAU)’ below). Step 2 will only be provided if the participant still has 
elevated levels of psychological distress (K10 > 15.9) at 2 weeks after DWM, i.e. during the second quantitative 
assessment.  
 
Step 1: Doing What Matters in Times of Stress (DWM) 
The DWM program has been developed by WHO and collaborators working in the humanitarian field. DWM was 
designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, easily 
adaptable to different cultures and languages, and both meaningful and safe for people with and without mental 
disorders. DWM is based on acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, with 

 
 
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distinct features (Hayes, Levin, Plumb-Vilardaga, Villatte & Pistorello, 2013). ACT is based on the concept that ongoing 
attempts to suppress unwanted thoughts and feelings can make these problems worse, so instead it emphasizes on 
learning new ways to accommodate these thoughts and feelings without letting them dominate. ACT has been shown 
to be useful for a range of mental health issues (Tjak et al., 2015) and has been used successfully in a guided self-help 
format (Hayes et al., 2013). 
  
The DWM program consists of a self-help guide that is complemented with pre-recorded audio exercises. The 
audio material imparts key information about stress management and guides participants through individual exercises. 
Additionally, participants are guided by a briefly trained helper. 
 
DWM includes five sections (or modules), each of which focuses on a specific skill: 
 
Section 1: Grounding: Bringing attention back to the present moment when caught up in distressing emotions. 
 
Section 2: Unhooking: Noticing difficult thoughts and feelings, naming difficult thoughts and feelings, and 
refocusing on what you are doing.   
 
Section 3: Acting on your values: Identifying personal values and then taking small or big actions to live in line 
with these values.  
 
Section 4: Being kind: Enhancing and encouraging kindness towards oneself and towards others. 
 
Section 5: Making room: Learning how to tolerate stress while still acting consistently with values. 
In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios 
and the self-help guide, have been adapted for use on a smartphone or other device with internet access. The format of 
DWM is innovative in that it seeks to ensure that key intervention components are delivered as intended through the 
use of pre-recorded audio, without the burden of extensive training and supervision. In the online application tool a 
new module (i.e. section) is released every week so participants will be asked to go through the entire DWM 
intervention within five weeks with weekly guidance from a helper. Due to its format, the DWM program does not 
require much time from experts for implementation. The delivery mode for the support from the helper will be flexible 
and in line with COVID-19 regulations. The potential of using a psycho-educational course to access hard-to-reach 
populations has been demonstrated previously (Cuijpers, Munoz, Clarke & Lewinsohn, 2009). Additionally, research has 
found that guided self-help programs produce much better results than “pure” (unguided) self-help, and the effects 
produced by guided self-help are surprisingly similar to face-to-face psychological treatment (Fledderus, Bohlmeijer, 
Pieterse & Schreurs, 2012).  
 
Protocol adherence 
We will assess DWM protocol adherence at post-intervention based on meta-data collected during the intervention (i.e. 
by tracking participants usage of the DWM app such as who accesses what page, how often, how much time 
participants spend on the app etc.).  We will only use this meta-data during the intervention to remind each participant 
(e.g. through e-mail) after finishing each module to let them know that they should start a new module. Additionally, 
participants receive a weekly phone call from a helper to see how they are doing and to check on their progress.  
 
Step 2: Problem Management Plus (PM+) 
PM+ is a new, brief, psychological intervention program based on cognitive behavioral therapy (CBT) techniques that 
are empirically supported and formally recommended by the WHO (Dua et al., 2011). The manual involves the following 
empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and 
accessing social support. Figure 2 shows a brief outline of the five sessions. In these 60-minute sessions participants 
may talk to trained non-professional helpers (who are supervised by registered (clinical) psychologists). We will follow 
this outline, except that we excluded all assessment instruments from the manual, since they are administered at the 
assessments instead of at the intervention sessions. PM+ has four core features: it is brief (five sessions); delivered by 
para-professionals; transdiagnostic thereby addressing depression, anxiety, PTSD, stress and problems as defined by 
people themselves; originally designed for people in low-income country communities but easily adaptable to different 
(vulnerable) populations, cultures and languages.  
In this study, the delivery mode of the PM+ intervention will be flexible, with remote delivery in phases of the pandemic 
when physical distancing rules apply. The PM+ intervention has been culturally and contextually adapted. This is a 
future-oriented attempt towards a more holistic mental health care system that can flexibly switch between modes of 
delivery (e.g. remotely (e.g. Zoom) or face-to-face), depending on the needs and the specific containment measures 

 
 
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that apply, and the specific preferences and needs of the participant.  
 
Protocol adherence  
Protocol adherence will be ensured by weekly supervisions provided by the PM+ trainers/supervisors as well as the 
fidelity checklist (Dawson et al., 2016). In addition to these, audio records of the sessions will be used for fidelity checks. 
The sessions will be audio recorded with professional equipment only if the participant gives consent to be recorded.  
 
 
Figure 2. Outline of five PM+ sessions (figure from PM+ Manual, WHO, 2016). We will follow this outline, apart from the 
PSYCHLOPS assessment which is excluded. 
Helpers in PFA, DWM and PM+ interventions 
In general, helpers selected to provide support to users should have at least primary school level literacy as well as 
good knowledge and skills in providing psychosocial support. Delivering PFA, DWM or PM+ can be learned by both 
professionals and non-professionals who are in a position to help people impacted by (very) distressing events. Helpers 
should speak the same language as the participant (as well as being able to communicate in English). It is not necessary 
for helpers to have a psychosocial or mental health background in order to be able to offer these interventions. 
Necessary skills include foundational helping skills, such as effective community and rapport-building skills, and 
experience supporting people in distress. For DWM but particularly PM+ helpers, it is also recommended that helpers 
experience receiving support using the stress management guide (i.e., practice using the stress management guide as a 
user with a colleague acting as the helper). If support is provided remotely, it is preferable that helpers have experience 
with remote support and receive training in this approach (e.g., EQUIP REMOTE). Practice sessions (e.g., providing 
support to other helpers, practice supporting persons with impairments) can help identify issues that may arise prior to 
working with users and build helper capacity. Helpers need to sign a confidentiality agreement and need to show a 

 
 
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certificate of conduct. Helpers may deliver either PFA, DWM and/or PM+, if they are trained (and supervised) in each 
intervention delivered.  
 
Training PFA helpers 
Before providing PFA, helpers will receive training to enhance knowledge and gain better understanding of appropriate 
psychosocial responses and skills in providing support to individuals exposed to adversity (Sijbrandij et al., 2020). This 
half- or one-day training (WHO, 2013) will include explanations of the basic concepts and PFA principles, how to 
support (very) distressed people, and how not to cause further harm by using participatory learning (i.e. role-play).  
   
Training DWM helpers 
Similar to PFA-helpers, the role of the coach in DWM is to provide brief motivational support to the participants; not 
provide specialized mental health services. Helpers should be empathetic and motivated to do this. Before working as a 
helper, helpers will receive a short training by academics and/or mental health-care professionals. Helpers will be 
trained in providing support using the stress management guide (i.e., practice using the stress management in role-
plays with other helpers) and practice to deliver support remotely (i.e. practice providing support in role-play settings). 
Helpers will receive a written manual as a guide for the brief support sessions.  
 
Training PM+ helpers  
PM+ helpers will receive eight days of training, followed by three practice cases, on-the-job training, and close 
supervision during the whole trial by the PM+ trainers/supervisors. Audio records of PM+ sessions will also be used for 
supervision. The training program comprises of education about common mental disorders, basic counseling skills, 
delivery of intervention strategies and self-care (Rahman et al., 2016a). The additional criteria for PM+ providers 
include having completed a high-school education and complete the EQUIP ‘Delivering Remote Services’ training.   
 
Trainers/supervisors  
All DWM/PM+ helpers will be actively trained and supervised by registered (clinical) psychologists and will be continued 
to be monitored throughout the process. These clinicians will also independently assess and monitor treatment 
sessions at-random in order to ensure treatment adherence and fidelity. Furthermore, these expert clinicians will 
supervise the entire assessment and therapeutic process to reduce the burden on and risks for participants. 
 DWM/PM+ trainers/supervisors will be approximately five licensed mental health care professionals such as health-
care psychologists or psychiatrists. They will be trained by a Master Trainer via a training-of-trainers (TOT) program, 
consisting of the same elements as the training for helpers, but also of training and supervision skills (Rahman et al., 
2016a). The PM+ trainers/supervisors will be responsible for close supervision of the PM+ helpers. Therefore, as a next 
step, they will train DWM/PM+ helpers. Figure 3 shows how the TOT of PM+ is planned. Such training with continued 
supervision by professionals has been successfully used for (lay-)counselors before (Murray et al., 2011).  
The research team at UNIVERSITY OF VERONA will be responsible for arranging the trainings and supervision for the lay 
helpers. Supervision of the helpers by the trainers/supervisors will take place on a weekly basis (Dawson et al., 2016). 
This will be done remotely or face-to-face, depending on the preference of the trainers/supervisors and accounting for 
COVID-19 regulations. The trainers/supervisors will also receive supervision by the Master trainer when necessary. 

 
 
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Figure 3. Training of Trainers/Supervisors and DWM/PM+ Helpers 
7.2. USE OF CO-INTERVENTION (IF APPLICABLE) 
Not applicable 
7.3. ESCAPE MEDICATION (IF APPLICABLE) 
Not applicable 
 
 
 
 Master trainer 
 
TASKS: 
- TOT for trainers/supervisors 
- Supervision of trainers/supervisors 
when there is a need 
 Trainers/supervisors 
 
TASKS: 
- Training of lay helpers 
- Weekly supervision of DWM/PM+ providers 
 
DWM/PM+ 
providers  
(lay helpers) 
 
TASKs: 
- Provision of DWM/PM+ to 
participants in the treatment 
group 

 
 
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8. METHODS 
8.1. STUDY PARAMETERS/ENDPOINTS 
All participants will have five assessments (T0-T4), mostly by filling out online questionnaires. The five assessments take 
place at the following time-points (see also Figure 1): 
  
T0: Screening for eligibility including psychological distress  
  
T1: Baseline assessment  
  
T2: 2 weeks post DWM intervention assessment 
  
T3: 1-week post PM+ intervention assessment 
  
T4: 2-months post PM+ intervention assessment 
8.1.1. Main study parameter/endpoint 
The primary endpoint will be the decrease in symptoms of depression and anxiety from baseline to two-month follow-
up after the PM+ intervention ended, measured through the combined sum score of the Patient Health Questionnaire-
9 (PHQ-9) and Generalized Anxiety Disorder (GAD-7) previously validated as the PHQ-ADS (Kroenke et al., 2016; 2019). 
A description of the measure(s) can be found under ‘Study Procedures’. Based on prior studies on PM+ in Pakistan and 
Kenya (Rahman et al., 2016b; Bryant et al., 2017) where PM+ was administered as a standard treatment, we expect to 
detect a Cohen’s d effect size of 0.3 in the PM+ group at 2 months post-treatment. 
8.1.2. Secondary study parameters/endpoints (if applicable) 
1. Level of depression (PHQ-9) 
2. Level of anxiety (GAD-7) 
3. Severity of posttraumatic stress disorder (PCL-5) 
4. Resilience based on exposure to stressful (general- and COVID-19 related-) events (MIMIS) 
5. Quality of life (EQ-5D-5L) 
6. Cost of care: impact on use of health system, other services, time out of employment and other usual activities and 
need for informal care (CSRI schedule) 
 
The measurement instruments are described under ‘Study procedures’. 
8.1.3. Other study parameters 
The measurement instruments are described under ‘Study procedures’. 
1. Demographic data  
2. Exposure to adverse life-events (BTQ) 
3. Treatment fidelity (DWM: tracking app usage based on meta-data, PM+: audio records, checklists) 
4. Level of self-identified complaints during PM+ (“Psychological Outcomes Profiles” (PSYCHLOPS)) 
5. Satisfaction (qualitative assessment in study phase 3)  

 
 
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6. Acceptability of the program (qualitative assessment in study phase 3) 
7. Implementation indicators: reach, dose, resource use, costs of recruiting, training and retaining staff delivering the 
stepped-care program, program costs, adaptation, the process, quality. 
 
 
8.2. RANDOMIZATION, BLINDING AND TREATMENT ALLOCATION 
After the screening and the baseline assessment, participants will be randomized to either the treatment group (n=105) 
or the comparison group (n=105), with an equal probability of assignment to each group (allocation ratio 1:1). The trial 
is a single-blind RCT (i.e. outcome assessors are blind to treatment allocation). Randomization will be carried out 
through computerized software (e.g. Castor) using limited block size (e.g. 6-12 participants per block) and will be 
performed by an independent person who is not involved in the assessment of participants. If participants are 
randomized into the treatment group, they will be allocated to a DWM helper. This is also done blind by an 
independent person who is not involved in the assessment. The allocated helper will send an e-mail to the participant 
to set up a time and date for a first acquaintance telephone call before the intervention starts. During this call, the 
weekly support calls of the DWM helper will be discussed and planned. If participants still meet the inclusion criteria 2 
weeks after the DWM program ended, they will be contacted by the PM+ helper (might be the same helper as for 
DWM) to plan five consecutive (tele-conferencing) meetings of 60 minutes with the participant. The first session will be 
scheduled within a few days and not longer than one week after the pre-intervention assessment. 
8.3. STUDY PROCEDURES 
 
Screening (T0) 
Following informed consent (see TEMPLATE TO BE PREPARED), participants will be invited to complete step 1 of the 
first assessment: screening. Screening consists of using several (self-administered) measurement instruments to see if 
people meet the inclusion criteria (6.2 Inclusion criteria). Also, specific questions are asked to check whether 
participants should be excluded because of fulfilling exclusion criteria.  
● 
Screening for inclusion criteria 
In order to be included in the study, participants need to score above 15.9 on the Kessler Psychological 
Distress Scale (K10), a 10-item screening questionnaire for common mental disorders (Kessler et al., 2002). 
This instrument will be self-administered and this way literacy (as inclusion criterion) is immediately accounted 
for. Because DWM consists of online materials with text, it is important that people are able to read. If 
indicated, they will be referred to external specialists for potential follow-up. More detailed explanations of all 
measures are described under ‘Measurement Instruments’. 
 
● 
Screening for exclusion criteria 
If individuals meet inclusion criteria, they will be screened for exclusion criteria (6.3 Exclusion criteria). If they 
meet one or more exclusion criteria they will be excluded and referred for appropriate treatment and support. 
We will assess whether individuals: (a) plan to permanently move back to their home country within the next 6 
months; (b) have plans to end their life or are in acute need of protection (see Measurement Instruments); c) 
currently use psychotropic medication of which the dose has been changed in the past 2 months or currently 
receive specialized psychological treatment and d) suffer from a severe mental disorder (e.g., psychotic 
disorders, substance-dependence) or severe cognitive impairment (e.g., severe intellectual disability or 
dementia) (see Measurement Instruments for questions/observations in either a face-to-face, telephone or 
tele-conferencing contact during screening) (WHO, 2016, pp. 87).   

 
 
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● 
When participants are not selected for the trial because they score below the cut-off scores for the K10 or 
when they meet the exclusion criteria as described in Exclusion Criteria, they will immediately be provided 
feedback e.g. on the screening outcomes (including K10 score) and an explanation why they are not eligible for 
the study (p. 86 of the PM+ intervention manual; WHO, 2016). When participants are excluded because of an 
imminent suicide risk, expressed acute needs/protection risks (for example, a young woman who expresses 
that she is at acute risk of being assaulted or killed) or observed (suspicion of) severe mental disorders or 
severe cognitive impairment they will be referred for appropriate treatment and support such as their general 
practitioner, and/or a mental health specialized support or to local social service provision, depending upon 
their clinical characteristics and needs. If the patients agree to be referred, the assessment results will be 
provided to their general practitioner or the treating mental health professional with permission of the 
participant. 
Baseline assessment (T1) 
If participants meet the eligibility criteria and score above the cut-off of the K10, they will continue with the baseline 
assessment. This step includes administration of questionnaires about socio-demographic characteristics and; PTSD 
Checklist for DSM-5 (PCL-5), the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorders-7 (GAD-7), the 
Mainz Inventory of MIcrostressorS (MIMIS), Checklist for Quality of life (EQ-5D-5L), and the Client Service Receipt 
Inventory (CSRI). 
Post-intervention and follow-up assessment (T2, T3, T4) 
Quantitative assessments will take place four times: at screening (T0) and baseline (T1: before the intervention), at 2 
weeks after DWM (T2) and at 1 week (T3) and at 2 months after finishing PM+ (T4). All instruments used in the baseline 
assessment (T1) will be used for each of the post-intervention and follow-up assessments, see Table 1. The screening 
instrument K10 (T0) will be re-assessed at T2 only.  
In case participants do not respond to a scheduled assessment, they will be called a maximum of five times (on 
different days) for scheduling a new appointment.  
 
Assessors 
Assessments T1 to T4 will be conducted online (collective program CASTOR). Additionally, assessment of suicide risk, 
mental, neurological or substance use disorders, and the CSRI will be conducted by an assessor, in person or through 
video/telephone calls.  
 
Assessment of treatment fidelity 
DWM: Participants’ access to the DWM intervention will be tracked, such as who accesses what page, how often, how 
much time participants spend on the intervention, etc. This way, we can track protocol adherence to the DWM 
afterwards, once they finished the intervention. During the intervention, we will only use meta-data to track 
participants’ progress in the sense that participants will receive an e-mail that the next module has been unlocked and 
is accessible for them to use one week after they finished the previous module. Additionally, participants receive a 
weekly phone call from a helper to see how they are doing and check on their progress. The metadata of participants’ 
tracked intervention access behavior will not be shared with the DWM helpers.  
PM+: Audio tapes of the treatment sessions will be recorded to monitor treatment fidelity. The audio tapes can be used 
for supervision by the trainers/supervisors and will be used to rate treatment fidelity by UNIVERSITY OF VERONA 
research assistants. 
 
Measurement instruments 
The measurement instruments that will be used for the four quantitative assessments, i.e. at screening (T0) and 
baseline (T1), post-intervention 1 (T2), and post-intervention 2 (T3), and follow-up (T4), as well as during the 
DWM/PM+ intervention are depicted in Table 1. All instruments (as well as the intervention) will be administered in 
English or in Italian, or in the native language of the participants according to their availability.  
 
[PLEASE FIND TABLE 1 below with Overview of the concepts, their measures, the type of study parameter in the 
study, and the moment of measuring during study phase 2]

 
 
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Concept 
Measures 
Type of 
study 
parameter 
Moment of measuring 
 
 
Screening 
(T0) 
Baseline 
(T1) 
DWM 
 
 
Post-
assessment 1 
(T2) 
PM+ 
Post-
assessment 2 
(T3) 
Follow-up 
assessment 
(T4) 
Psychological distress 
K10 
Screener 
x 
 
 
x 
 
 
 
Suicide risk: 
 
 
 
 
 
 
 
  
  
- 
Face-to-face or 
PM+ tool 
Screener 
x 
 
 
x 
x 
 
 
- 
Self-administered 
Step-by-step 
question 
Screener 
x 
 
 
x 
 
x 
x 
Mental, neurological or 
substance use disorders 
PM+ tool 
Screener 
x 
 
 
 
 
 
 
Depression and Anxiety: 
PHQ-ADS 
Primary 
 
 
 
 
 
 
 
   Subscale depression 
PHQ-9 
Secondary 
 
x 
 
x 
 
x 
x 
   Subscale anxiety 
GAD-7 
Secondary 
 
x 
 
x 
 
x 
x 
Posttraumatic stress 
reactions 
PCL-5 
Secondary 
 
x 
 
x 
 
x 
x 
Self-identified problems 
PSYCHLOPS 
Secondary 
 
x 
 
x 
 
x 
x 
Resilience 
MIMIS 
Secondary 
 
x 
 
x 
 
x 
x 
Resilience factors 
PASSc 
Secondary 
 
x 
 
x 
 
x 
x 
Quality of life 
EQ-5D-5L 
Secondary 
 
x 
 
x 
 
x 
x 
Impact on resource 
use/costs  
CSRI  
Secondary 
 
x 
 
x 
 
x 
x 
Socio-demographics 
 
Other 
 
x 
 
 
 
 
 
COVID-19 exposure 
Questionnaire 
Other 
 
x 
 
x 
 
x 
x 
Exposure to life events 
BTQ 
Other 
 
x 
 
 
 
x 
 
Treatment fidelity: 
- 
DWM 
Metadata 
Other 
 
 
x 
 
 
 
 
- 
PM+ 
Audio records 
Other 
 
 
 
 
x 
 
 
Satisfaction DWM 
CSQ Interview 
Other 
 
 
 
x 
 
 
 
Satisfaction PM+ 
CSQ Interview 
Other 
 
 
 
 
 
x 
 

 
 
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Screeners 
Screening instruments  
K10: psychological distress 
Psychological distress will be measures using the Kessler-10 Psychological Distress Scale (Kessler et al., 2002). The K10 is 
a ten-item self-report questionnaire to screen broadly for psychological distress (e.g. anxiety and depression related 
distress) experienced in the past 30 days. Items are rated on a five-point Likert scale ranging from none of the time to 
all of the time. The sum of the ten items gives a total score ranging from 10 to 50. Higher scores represent higher levels 
of distress. The K10 has strong psychometric properties and has strong discriminatory power to distinguish DSM-IV 
cases from non-cases (Kessler et al., 2002). The K10 has been validated in various population samples and is a useful 
instrument in both primary care (Kessler et al., 2002) and general population samples (Furukawa, Kessler, Slade & 
Andrews, 2003; Kessler et al., 2005). Moreover, the K10 has been found to not have any substantial bias in regards to 
education level and gender, thus making it useful for research (Baillie, 2005). The K10 exists in various languages, 
among which are English and Italian.  
There is no standard cut-off score for the K10 present. In addition to a cut-off score of 20, also lower cut-off scores have 
been found, e.g. a cut-off score of 12 (Lace et al., 2019) or a cut-off score of 14 (Baggaley et al., 2007). When 
determining the appropriate cut-off point, it is important to take into account the context in which the measurement 
instrument is used. In order to not miss potential participants, in research a low cut-off score with a low rate of false 
negatives and a high sensitivity is favored (Smits, Smit, Cuijpers & De Graaf, 2007). In STRENGHTS, a similar study to the 
RESPOND project, among Syrian refugees in the Netherlands, a cut-off point of 15 was used to indicate moderate to 
high levels of psychological distress (de Graaff et al., 2020). This was based on a study among Afghan and Kurdish 
refugees asylum seekers in New Zealand and Australia where they used the following cut-off scores: 10–15.9 (low risk 
of psychological distress), 16–21.9 (moderate levels of distress consistent with a diagnosis of moderate depression 
and/or anxiety disorder), 22–29.9 (high level of distress) and 30 or more (possibility of very high or severe levels of 
distress) (Sulaiman-Hill & Thompson, 2010). As the RESPOND project is conducted in various European countries with 
various (vulnerable) populations (e.g. health care workers in Spain and migrants in Italy), we will use a cut-off score of 
15.9 which we believe is appropriate for this varying target populations.  
Screening instruments for exclusion criteria 
Suicidal ideation 
Suicidality will be explored at several time-points (at T0, at T1, during PM+ and at follow-up assessments) with either 
the ‘assessment of thoughts of suicide’ risk tool (from PM+; WHO, 2016, pp. 86) when assessed in face-to-face contact 
(e.g. in person or remotely through teleconferencing or telephone) or with the self-administered step-by-step 
suicidality question (Van ‘t Hof et al., 2021) when assessed with an online questionnaire. People who have plans to end 
their life (as indicated by an answer of “yes” on the screening question - “In the past week/month, have you had serious 
thoughts or a plan to end your life?”) will be excluded from the study. Participants who answer “yes” to this additional 
screening question will be considered at imminent risk of suicide (Van ‘t Hof et al., 2021). In case of imminent suicidal 
risk, people are excluded from participation. They will be explained (on-screen or by telephone/teleconferencing or in 
person) that they cannot participate but that they may need additional mental health support with advice to go to an 
emergency room or to a local psychiatric center (all the details on the available local mental health services will be 
provided). They will also be presented with suggestions for steps to follow in order to receive mental health care (e.g. 
contact general practitioner), encouraged to seek help, and provided with additional self-care tips. 
 
Severe mental disorder 
(Suspicion of) a severe mental disorder will be assessed by the PM+ tool ‘Impairments possibly due to severe mental, 
neurological or substance use disorders’. This is a tool which is to be filled in by the assessor based on their 
observations and judgment of the client’s behaviors. No questions are asked to the participant. The tool asks 4 
questions related to the participant’s behavior: 1) does the client understand you (even though they speak the same 
language or dialect)?; 2) Is the client able to follow what is happening in the assessment to a reasonable extent?; 3) Are 
the client’s responses bizarre and/or highly unusual?; 4) From the client’s responses and behaviors, does it appear that 
they are not in touch with reality or what is happening in the assessment? If the answer is no to question 1 or 2, or yes 

 
 
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to question 3 or 4, the participant will be excluded. 
 
Primary outcome measure 
The PHQ-ADS is the sum of the PHQ-9 and GAD-7 scores (details of both instruments summarized below) and thus can 
range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology. Two 
validation studies of the PHQ-ADS in trial data-sets of patients with chronic (musculoskeletal) pain and oncologic 
diseases have been published (Kroenke et al., 2016; Kroenke et al., 2019). Evidence shows high internal reliability 
(Cronbach's alpha of 0.8 to 0.9), strong convergent and construct validity, sufficient unidimensionality and evidence for 
sensitivity to change (i.e. differentiating between individuals classified as worse, stable, or improved by a reference 
measure at three months post-intervention). 
 
Secondary outcome measures 
PHQ-9: depression (PHQ-9; subscale of PHQ-ADS) 
Depressive symptoms during the past two weeks will be measured using the Patient Health Questionnaire depressive 
module. It asks how often someone was bothered by each of the nine DSM-5 criteria and scores answers on a four-
point Likert scale ranging from 0 (not at all) to 3 (nearly every day) (Kroenke, Spitzer, & Williams, 2001). In addition to 
the nine items, the PHQ-9 asks: “If you checked off any problems, how difficult have these problems made it for you to 
do your work, take care of things at home, or get along with other people?”, which is to be answered with “Not difficult 
at all”, “Somewhat difficult”, “Very difficult”, or “Extremely difficult”. For the current study, we will examine changes in 
caseness in depression. We will use a cut-off score of 10, which has been found to be a valid cut-off point for diagnosis 
(Manea, Gilbody & McMillan, 2021). 
 The PHQ-9 has been translated to and is available in many languages (see https://www.phqscreeners.com/), amongst 
which are English and Italian. The PHQ-9 has been found to be a reliable and valid instrument to measure depressive 
severity. Furthermore, due to its brevity, PHQ-9 is a useful instrument for usage in a clinical or research setting 
(Kroenke et al., 2001).  
GAD-7: anxiety symptoms (GAD-7; subscale of PHQ-ADS) 
The Generalized Anxiety Disorder (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire which 
assesses the degree to which the patient has been bothered by feeling nervous, anxious or on edge over the last two 
weeks. Items also include other generalized anxiety symptoms such as being unable to stop worrying about multiple 
things, having trouble relaxing or sitting still, feeling irritable and being afraid of something bad happening at all times 
(Spitzer et al., 2006). Items are scored from 0 to 3, respectively for experiencing symptoms ‘not at all’, for ‘several days’, 
for ‘more than half the days’ and for ‘nearly every day’. The total score ranges from 0 to 21. Cut-off points for mild, 
moderate and severe anxiety, are scores of 5, 10 and 15, respectively (Spitzer et al., 2006). A score of 10 has been 
identified as the optimal cut-off score to balance specificity and sensitivity (Spitzer et al., 2006).  
 The GAD-7 has been translated to and is available in many languages (see https://www.phqscreeners.com/), amongst 
which are English and Italian. The GAD-7 has been found to be a valid and reliable instrument in both the psychiatric 
(Kertz, Bigda‐Peyton & Bjorgvinsson, 2013; Rutter & Brown, 2017) and the general population (Löwe et al., 2008; Hinz 
et al., 2017).  
 
PCL-5: PTSD Symptoms 
Posttraumatic stress disorder (PTSD) symptoms during the past week according to the DSM-5 PTSD diagnosis will be 
measured using the PTSD Checklist for DSM-5 (PCL-5) (Weathers et al., 2013). A shortened 8-item version of the original 
PCL-5 (a 20-item checklist which correspond with the 20 DSM-5 PTSD symptoms) will be used. Items are rated on a 0-4 
scale. Added up, the maximum severity score is 32. Higher scores indicate higher symptomatology. The original 20-item 
PCL-5 exists amongst others, in English (Weathers et al., 2013). 
Since populations in the trials might not all be severely traumatized, we will use the abbreviated 8-item version. In a 
comparison of two abbreviated version, i.e., the 4-item and 8-item versions of the PCL-5, the PCL-5 8 item version 
showed a strong correlation with the total scale, greater internal consistency, and allowed for sufficient variability in 
patient response. Internal consistency of the 8-item version was α 0.90 (comparable to total PCL-5 20-item version) and 

 
 
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accounted for 94.1% (R = 0.97) of the variance in the total PCL-5. There were no significant differences in the sensitivity 
and specificity between the total 20-item PCL-5 scale and the 8-item scale (Price et al., 2016).  
 
MIMIS: resilience 
The Mainz Inventory of Microstressors (MIMIS) was recently developed to measure objective microstressors of modern 
life in the past 7 days (Chmitorz et al., 2020). In the Dynacore-C study (Veer et al., 2021) this was changed into a period 
of 2 weeks. The MIMIS uses a definition of resilience as a trade-off between the outcome of mental health and 
exposure to adversity. Outcome-based resilience will be assessed by relating self-reported changes in mental health 
problems (i.e. anxiety and depression) over the past 2 weeks (assessed with the PHQ-ADS) to the self-reported 
exposure to stressors. The MIMIS was adapted in three ways: firstly, it was shortened to reduce the burden on 
participants, secondly, new items were generated to capture exposure to pandemic-related stressors, and thirdly, the 
question was changed to cover the past 14 days (rather than 7 previously). With the adapted instrument, stressor 
exposure is thus measured in RESPOND by a combined list of general stressors (6 items), COVID-19-specific stressors (5 
items), general life events (n=3), and population-specific stressors (n=8). Daily stressor items (general, COVID-19, 
population-specific) are rated on a four-point Likert scale in which participants can indicate the frequency at which a 
stressor occurred, ranging from 0 (did not happen/almost never) to 3 ((nearly) every day).  Life events are rated on a 
five-point Likert scale to indicate the impact of this event, ranging from 0 (this situation did not happen) to 4 (severe 
impact). 
A high correlation has been found between the ecological momentary assessment (EMA), end-of-day, and end-of-week 
versions of the MIMIS regarding the occurrence and severity of microstressors, thereby indicating ecological validity of 
the MIMIS questionnaire (Chmitorz et al., 2020). 
EQ-5D-5L: quality of life 
The EQ-5D-5L measures quality of life and consists of two parts, the EQ-5D and the EQ VAS. Part 1, the EQ-5D, rates the 
level of impairment across five dimensions: mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems 
and extreme problems. The EQ‐5D‐5L is an adapted version of the EQ‐5D(-3L), which only had three response options 
for each dimensions and was therefore thought to not sufficiently capture milder health issues and small changes 
between different states of health (Herdman et al., 2011). The EQ-5D-5L has been used widely and is available in over 
150 languages, also for laptop, tablet or Castor EDC (https://euroqol.org/eq-5d-instruments/eq-5d-5l-available-modes-
of-administration/self-complete-for-use-in-castor-edc/). Country specific utility weights will be attached to data from 
the EQ-5D-5L and changes in participant quality of life years gained between intervention and control groups will be 
determined. Part 2, the EQ VAS, is a visual, vertical, analogue scale. The endpoints of the scale are called ‘The best 
health you can imagine’ and ‘The worst health you can imagine’ and the current health status of that day needs to be 
indicated, after which the number checked on the scale also needs to be written down. 
 
PSYCHLOPS: self-identified problems  
The Psychological Outcomes Profiles (PSYCHLOPS) scale is a patient-generated outcome measure as an indicator of 
change after therapy (Ashworth et al., 2004). PSYCHLOPS consists of four questions. It contains three domains: 
problems (2 questions), function (1 question), and wellbeing (1 question). Participants are asked to give free text 
responses to the problem and function domains. Responses are scored on an ordinal six-point scale producing a 
maximum score of 18 (six points per domain). PSYCHLOPS has been validated in primary care populations across several 
countries (Czachowski, Seed, Schofield, & Ashworth, 2011; Héðinsson, Kristjánsdóttir, Ólason, & Sigurðsson, 2013). 
 
CSRI schedule: cost of care  
The Client Service Receipt Inventory (CSRI) was developed for the collection of data on service utilization (e.g. use of 
health system, other services, time out of employment and other usual activities, need for informal care) and related 
characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-
effectiveness research. It has been used cross-culturally and is available for Italy (Chisholm et al., 2000).  
Other measures 
Socio-demographic information 

 
 
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Socio-demographic information will be collected with predefined items based on the REDEFINE and STRENGTHS studies 
(i.e. age, gender, nationality, years of education, relationship status, and main work-status and additional questions 
regarding country of birth, household population (incl. children < 18 and elderly people), household income on average, 
occupational area working, mental health condition and overall current health status and housing (square meters of the 
house, outdoor space available).  
Impact of COVID-19 questionnaire 
The COVID-19 questionnaire includes 11 questions related to the impact of COVID-19. The questionnaire is based on 
other COVID-19 questionnaires (Conway, Woodward & Zubrod, 2020). It may be backward translated from English to 
other languages and will be administered at each time-point. 
 
Resilience factor(s): positive appraisal style 
Resilience factors (i.e. underlying factors that lead to resilience) may also be measured by assessing factors like 
optimism, positive appraisal style, perceived social support  (in general and related to COVID-19), perceived self-efficacy 
and behavioral coping style. In RESPOND, we will assess positive appraisal style with the “Positive Appraisal Style Scale 
– content focused” (PASSc). The PASSc is based on positive appraisal style theory of resilience (PASTOR; Kalisch et al, 
2015; Kalisch et al, 2021). The PASTOR theory conceptualises resilience as an outcome: the maintenance of mental 
health after stressor exposure. Positive appraisal style would therefore not be a measure of resilience, but a resilience 
factor. It intends to capture the underlying mechanism which leads to resilience. The PASSc is currently used in a 
number of longitudinal studies (Mainz Resilience Study (MARP); Longitudinal Resilience Assessment study (LORA)and 
several studies of the DynaMORE project). The PASSc was originally developed as a 29 items questionnaire featuring 
generalized positive appraisals of and attitudes towards difficulties, covering specifically the 3 main dimensions of 
stressor/threat appraisal - appraisal of threat magnitude/cost (relating to catastrophizing vs. trivialization), of threat 
probability (relating to pessimism vs. optimism), and of one’s coping potential (relating to helplessness vs. 
overconfidence). Internal validity testing and a factor analysis resulted in a reduced list of 12 items, which is the Positive 
Appraisal Style Scale (PASSc). A paper (R. Kalish and P. Petri-Ramao) currently being prepared shows internal 
consistency α = .87 and reliability Cronbach’s α = .84. The PASSc shows convergent validity with other underlying 
resilience factors as it correlates with optimism .52 (SOP-2), with stress recovery (BRS): .50, with well-being (WHO-5): 
.42, with trait anxiety (STAI-Y2): -.51 , with neuroticism (from BFI-10): -.49.  Discriminant validity is shown in low 
correlation with I-8 impulsivity subscales urgency, intention <=.13; with openness (from BFI-10): .17, with 
conscientiousness (from BFI-10): .19. 
 
Brief Trauma Questionnaire  
The BTQ is a brief self- report questionnaire that is derived from the Brief Trauma Interview (Schnurr et al., 1995). 
(Information about the reliability and validity of the BTI is provided in Schnurr et al., 2002). The BTQ was originally 
designed to assess traumatic exposure according to DSM‐IV but specifically asked only about Criterion A.1 (life 
threat/serious injury) because of the difficulty of accurately assessing A.2 (subjective response) in a brief self- report 
format. Criterion A.2 has been eliminated from the PTSD diagnostic criteria in DSM- 5, so the BTQ provides a complete 
assessment of Criterion A. The questionnaire may be used to determine whether an individual has had an event that 
meets the A Criterion, or to determine the different types of Criterion A events an individual has experienced. 
 
Treatment fidelity 
Process monitoring of the full stepped-care intervention includes review of helpers’ records of DWM phone calls and 
PM+ sessions with clients; helpers’ supervision records including intervention fidelity monitoring, and supervision of 
supervisors by intervention trainers. Tracked intervention access information of the DWM app and audio records of the 
PM+ sessions will be analyzed by UNIVERSITY OF VERONA research assistants and used for treatment fidelity analysis. 
The data will be collected throughout the intervention delivery (see Table 1) and reviewed as it is collected, leading to 
an iterative process of intervention monitoring informing intervention delivery. 
To monitor treatment fidelity of DWM, participants’ usage of the DWM intervention will be tracked (see study 
procedures - Assessment of treatment fidelity). To monitor treatment fidelity of PM+, treatment sessions will be audio-
recorded. If participants are randomized into the treatment group, they will be asked to record the sessions. Giving 
consent to the audio recording is no requirement to receive the PM+ program. Audio records will be coded by research 

 
 
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assistants at UNIVERSITY OF VERONA and used for treatment fidelity analysis. In order to determine whether the 
intervention-as-implemented does not differ from the intervention-as-designed, fidelity checklists filled out by 
UNIVERSITY OF VERONA research assistants are completed for a random sample, stratified on helpers, of sessions / 
participants. The data will be collected throughout the intervention delivery and reviewed as it is collected, leading to 
an iterative process of intervention monitoring informing intervention delivery. Treatment fidelity will be analyzed as 
manipulation check. 
 
Satisfaction and acceptability 
Satisfaction and acceptability of the stepped-care DWM/PM+ intervention is measured through qualitative process 
evaluation (see Study Phase 3). Additionally, at the first assessment after DWM (T2) and after PM+ (T3), participants 
will also fill out a questionnaire to measure their satisfaction with the intervention. The CSQ-I for the web-based 
intervention DWM (Boss et al., 2016) and the CSQ-8 for PM+ Client Satisfaction Questionnaire (CSQ-8; Attkisson & 
Zwick, 1982). 
 
Implementation indicators 
After the intervention has finished, various implementation indicators will be assessed, such as reach, dose, resource 
use, costs of recruiting, training and retaining staff delivering the stepped-care program, program costs, adaptation, the 
process and quality of the stepped-care DWM/PM+ intervention.  
Additionally part of the cost-effectiveness analysis, we will estimate the incremental cost per change in the primary 
outcome, as well as quality of life. To do this, estimates of the resource use and costs of implementation are needed, 
making use of data from implementation indicators. This will involve analysis of records on resources and costs for 
initial training, as well as use of process and fidelity data on resources used for receipt of interventions, such as the 
number of PM+ sessions attended and input and support from supervisors.  
Qualitative evaluation at the end of the RCT 
The aim of this qualitative evaluation is to explore the feasibility, i.e. identifying barriers and facilitators specific to the 
target population, of scaling-up the implementation on the stepped-care DWM/PM+ intervention within Italy. This will 
be done by conducting interviews and/or focus group discussions (FGDs) with key informants. In these interviews, 
participants’ satisfaction and acceptability of the program will also be explored.  
 Key informants will include participants in the treatment group who completed the DWM intervention (n=2/4) or the 
PM+ intervention (n=2/4), who dropped-out during DWM (n=2/4) or during PM+ (n=2/4). Participants will be asked 
questions concerning the satisfaction and acceptability of the intervention, barriers and facilitators to adherence, and 
to what extent they think that the stepped-care program has actually contributed to improving participants’ 
functioning. Recruitment for participants of the treatment group will start at 3 months post-PM+.  
 Additionally, we will interview local stakeholders of the participating centers, e.g. mental health professionals, Non-
Governmental Organizations (NGOs) workers, cultural and linguistic mediators and local policy makers with knowledge 
on mental health care (10/15participants in total). Policy decision makers will be interviewed to obtain their 
perceptions of the benefits and challenges of integrating the stepped-care DWM/PM+ intervention into routine service 
provision. Health care professionals will be interviewed to explore their views on the potential for scaling-up the 
stepped-care DWM/PM+ intervention and integrating the program into the health system in Italy. Furthermore, we will 
conduct focus group discussions (FGD) with facilitators (n=2/4) of the DWM/PM+ intervention. Facilitators will include 
both helpers and trainers/supervisors. Facilitators will be interviewed on their experience in providing the DWM/PM+ 
intervention and to obtain their ideas in implementing this intervention in Italy. 
Interviews and FGDs will be conducted online or in person, depending on the preferences of the participant and will in 
accordance with COVID-19 regulations. Key informant interviews and FGDs will be audio-recorded, transcribed and 
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8.4. WITHDRAWAL OF INDIVIDUAL SUBJECTS 
Participants can leave the study at any time for any reason if they wish to do so without any consequences. The 
investigator can decide to withdraw a participant from the study for urgent medical reasons, e.g. imminent suicide risk. 
Since only individuals with imminent suicide risk will be excluded, those with suicidal thoughts at inclusion/screening  
will be followed up by the helpers. When during calls with DWM/PM+ helpers, participants show deterioration with 
imminent suicidal plans than the helper will discuss this immediately with one of the DWM/PM+ supervising mental 
health specialists. Also, when there is clear suspicion of worsening of (severe) mental health problems, participants will 
be asked to withdraw from the study and contact their general practitioner for a referral to specialized mental health 
treatment. 
 
8.4.1. Specific criteria for withdrawal (if applicable) 
Not applicable for this study. 
8.5. REPLACEMENT OF INDIVIDUAL SUBJECTS AFTER WITHDRAWAL 
No new subjects will be included for each withdrawn subject. In our power calculation for the sample size, we have 
taken into account 30% attrition. 
8.6. FOLLOW-UP OF SUBJECTS WITHDRAWN FROM TREATMENT 
If a subject decides to withdraw from the study, the investigator will ask for the reason. It will be enquired whether the 
subject wishes to withdraw from the study or from a specific time point only and so whether the subject can be re-
contacted at a later time. Withdrawal from the study will have no effect on the regular treatment. Subjects who leave 
the study for medical reasons will be followed until the interfering condition has resolved or reached a stable state.  
8.7. PREMATURE TERMINATION OF THE STUDY (IF APPLICABLE) 
Not applicable. 
 
    9. SAFETY REPORTING 
9.1 TEMPORARY HALT FOR REASONS OF SUBJECT SAFETY 
The study sponsor (UNIVR) will suspend the study if there is sufficient ground that continuation of the study will 
jeopardize subject health or safety. The sponsor will notify the Ethics Committee without undue delay of a temporary 
halt including the reason for such an action. The study will be suspended pending a further positive decision by the 
Ethics Committee. The investigator will take care that all subjects are kept informed.  
9.2 AES AND SAES 

 
 
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9.2.1 ADVERSE EVENTS (AES) 
Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not 
considered related to the trial procedure or the stepped-care DWM/PM+ intervention. All adverse events reported 
spontaneously by the subject or observed by the investigator or his staff will be recorded. 
 
9.2.2 SERIOUS ADVERSE EVENTS (SAES) 
A serious adverse event is any untoward medical occurrence or effect that  
-      results in death; 
-      is life threatening (at the time of the event); 
-      requires hospitalization or prolongation of existing inpatients’ hospitalization; 
-      results in persistent or significant disability or incapacity; 
-      is a congenital anomaly or birth defect; or 
-      any other important medical event that did not result in any of the outcomes listed above due to medical or 
surgical intervention but could have been based upon appropriate judgement by the investigator. 
An elective hospital admission will not be considered as a serious adverse event. 
The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events. 
9.3 FOLLOW-UP OF ADVERSE EVENTS 
All AEs will be followed until they have abated, or until a stable situation has been reached. 
Depending on the event, follow-up may require additional tests or medical procedures as indicated, and/or referral to 
the general physician or a medical specialist. SAEs need to be reported till end of study. The DWM and PM+ helpers will 
be supervised and receive weekly supervision by experienced mental health care professionals. If, during the course of 
the study, participants in the treatment group (PM+/DWM/CAU) or comparison group (CAU only) show severe 
psychiatric symptoms (e.g., psychosis, imminent suicide risk, etc.), or any other symptoms occur that require immediate 
specialist treatment and follow-up, they will be referred to specialist staff (e.g. psychiatrists) for immediate follow-up. 
The researcher from UNIVERSITY OF VERONA will be responsible to monitor this process and make sure the 
appointment has been made. 
9.4 ETHICS AND DATA ADVISORY BOARD (EDAB) 
The RESPOND’ Ethics and Data Advisory Board (EDAB) will monitor and provide expert advice on data management and 
all ethical, legal and societal issues that arise within the project, promoting integrity and a better alignment of 
RESPOND with social needs and expectations that may arise within or as a result of RESPOND. This includes monitoring 

 
 
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the safety, rights, and wellbeing of study participants, and providing input for ethics reports. In addition, the EDAB will 
provide advice on FAIR data management, including data privacy and adherence to the GDPR. The EDAB will ensure 
that the trial and data collection in RESPOND are conducted in accordance with the International Conference on 
Harmonisation (ICH), the WHO Good Clinical Practice standards (GCP), Declaration of Helsinki (64th WMA General 
Assembly, Fortaleza, Brazil, October 2013), and (inter)national laws (e.g, Medical Research Involving Human Subjects 
Act (WMO)). In addition, the ethical, legal of the participants and research staff members will be reviewed and interim 
analyses will be considered in case safety issues are (suspected to be) violated. Incidental findings within RESPOND 
refer to an extreme score on study instruments (questionnaires or interviews) that need additional follow-up. Other 
issues that will be considered include privacy and intellectual property rights. Relevant issues will be discussed in an 
annual meeting, but if issues arise between these meetings, the EDAB will be requested to plan an additional meeting. 
Additional meetings will be held before submission of ethics documents for formal approval as well as before 
submission of ethics reports. The EDAB compromises of independent members having no conflict of interest with the 
sponsor of the study, i.e. dr. Christopher Dowrick, dr. Victor Perez, and dr. Sonja Rutten, member of the Ethics Review 
Committee Board member (VUA). For RESPOND principal investigator Prof. dr. Marit Sijbrandij will join the EDAB 
meetings together with assistant professor Dr. Anke Witteveen. Tom Paffen LL.M (VU) will join for matters of data 
protection and privacy.  
The management team and EDAB will ensure that all necessary actions will be undertaken to minimize risks and suggest 
necessary measures to counter these risks. Through efficient communication between the EDAB, overall management 
(Work Package 1), and leader of individual Work Packages, the consortium will ensure that mitigation measures will be 
undertaken in a timely and effective manner.  
The advice(s) of the EDAB will only be sent to the sponsor of the study. Should the sponsor decide not to fully 
implement the advice of the EDAB, the sponsor will send the advice to the reviewing Ethics Committee, including a note 
to substantiate why (part of) the advice of the EDAB will not be followed. The EDAB should conclude each review with 
their recommendations to RESPOND as to whether the study should continue without change, be modified, or be 
terminated. Recommendations regarding modification of the design and conduct of the study could include: 
modifications of the study protocol based upon the review of the safety data; suspension or early termination of the 
study or of one or more study arms because of serious concerns about subjects’ safety, inadequate performance, or 
rate of enrolment; suspension or early termination of the study or of one or more study arms because study objectives 
have been obtained according to pre-established statistical guidelines. 
10. STATISTICAL ANALYSIS 
The statistical analyses for the Randomized Controlled Trial are described under section below. 
 
10.1 PRIMARY OUTCOME(S) 
The statistical analysis of the RCT will estimate effectiveness of the stepped-care DWM/PM+ with PFA and CAU 
intervention compared to PFA and enhanced CAU alone, with PHQ-ADS score as the primary study outcome.  
 
The primary outcome will be summarized using number of subjects (n), minimum and maximum; and means, standard 
deviations (SD) for normally distributed data, or medians and inter-quartile ranges for non-normally distributed data. 
To measure comparisons at baseline between the two treatment groups t-tests (continuous variables) or chi-squared 
test (categorical variables) will be conducted for normally distributed data; Mann-Whitney tests will be conducted for 
continuous non-normally distributed data.  
Both intention-to-treat (ITT) analysis, including all randomized participants (n=212), and completers’ (per protocol - PP) 
analysis will be carried out. The main conclusion of the trial will be based on the ITT analysis of the primary outcome. A 
secondary analysis of the primary outcome will also be presented using the PP population.  

 
 
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The statistical analysis will be masked, i.e. the trial statistician will be blinded to the treatment groups until the analysis 
has been completed. Moreover, the trial statistician will not be involved in determining participants’ eligibility, in 
administering the intervention, in measuring the outcomes or in entering data. 
To estimate the treatment effect, a linear mixed model will be employed for the primary endpoint analysis, which will 
have treatment as fixed effects, baseline measurement of primary endpoint as covariate, and subject as random 
effects. The mean difference between two treatment arms at each visit/time together with its 95% confidence interval 
will be derived from the mixed model. Covariate-adjusted mixed model of primary endpoint will also be performed by 
adding pre-specified covariates at baseline (gender, age, education, prior trauma, COVID-19 related events and stressor 
list) into the above model. 
Missing data 
Missing data will be treated as missing at random (MAR). No imputations of missing values will be made, as multilevel 
models can deal with missing data (Singer, Willett & Willett, 2003). 
 
10.2 SECONDARY OUTCOME(S) 
 
Economic outcomes 
Health economic analysis will be conducted to determine the difference in costs and outcomes in the intervention arm 
as compared to the care as usual group at each time-point. Primary analysis will be the total costs over the 2-month 
follow-up treatment period. Between-group comparison of mean costs will be completed using standard t-test with 
ordinary least squares regression used for adjusted analysis, with the validity of results confirmed using bootstrapping. 
Pseudonymised data will be sent to the London School of Economics and Political Science, partner in RESPOND under 
Work Package 3, for the health economics analysis of the CSRI. 
Analysis of secondary outcomes with repeated measurements 
Additionally, a linear mixed model as mentioned for the primary outcome analysis (PHQ-ADS) will be carried out for 
analyzing the following clinical outcomes measured at baseline, at 2 weeks after DWM, at 1 week and at 2 months after 
finishing PM+: posttraumatic stress reactions (PCL-5), depressive symptoms (PHQ-9), generalized anxiety (GAD-7), 
resilience (MIMIS) and quality of life (EQ-5D-5L). 
Analysis of other secondary outcomes  
Changes in caseness of the composite measure anxiety and depression will be calculated using the recommended cut-
off of >20 for moderate severity on the PHQ-ADS questionnaire (Kroenke et al., 2016; Kroenke et al., 2019) and will be 
analyzed using a hierarchical logistic model with the same fixed and random effects as the hierarchical linear models 
above, from which odds ratio of having a depression together with 95% CI at each time point will be derived.   
Corrections for multiple testing 
Models will be tested on α = .05; to deal with problems associated with multiple testing, for each time point T2-T4 the 
hypothesis that the experimental intervention has no effect on secondary outcome scores will be tested by performing 
the Seemingly Unrelated Regression equations model (Zellner, 1962), controlling for baseline values.  
 

 
 
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10.3 OTHER STUDY PARAMETER(S) 
The final phase of this RCT will include qualitative interviews and/or focus group discussions among key stakeholders to 
evaluate possible barriers and facilitators to treatment engagement and adherence to the PM+/DWMS program. The 
outcomes of these assessments will be used to make informed-decisions for potential mediators or moderators of 
PM+/DWMS treatment effectiveness.  
Treatment fidelity:  
In order to determine whether the intervention-as-implemented does not differ from the intervention-as-designed, 
fidelity checklists filled out by UNIVERSITY OF VERONA research assistants are completed for a random sample of 10% 
of all recordings, stratified on peer-refugee PM+ providers, of sessions/participants. Treatment fidelity will be analyzed 
as manipulation check.  
 
Analyses of qualitative interviews and focus group discussions  
Interviews and focus group discussions will be audio-recorded. These recordings will not include any identification of 
participants by name and will be labelled with an anonymized key only known to the researchers. The information 
recorded is confidential, and no one else except the members of the research team will have access to it. Once the 
interview is finished, the recording will be transcribed. The transcribed data will be coded and analyzed through 
thematic analysis. Once all data is processed, audio-recordings will be deleted.  
 
10.4 INTERIM ANALYSIS 
Interim analyses will be considered in case safety issues are (suspected to be) violated. See ‘Safety committee’. 
 
 
11. ETHICAL CONSIDERATIONS 
11.1 REGULATION STATEMENT 
This study will fully comply with relevant European and national regulations concerning data protection, 
privacy regulations, and the procedures for obtaining informed consent. All these procedures will be 
conducted according to the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 
2013), in accordance with, the EU Good Clinical Practice Directive (2001/20/EC), the International 
Conference on Harmonization (ICH), the WHO Good Clinical Practice Standards (GCP), and the Medical 
Research Involving Human Subjects Act (WMO).  
 
11.2 RECRUITMENT AND CONSENT 

 
 
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Recruitment 
Eligible trial participants will be adult (18 years or above) asylum seekers, refugees or migrants without acute 
medical conditions (see inclusion and exclusion criteria in paragraph 4.2 and 4.3). The recruitment strategy 
for the RCT will be pragmatic and will mainly involve relationships with community organizations and local 
institutions that implement services/projects for ARM in Italy (e.g. municipalities, NGOs, health care 
providers, and/or language courses). If necessary, participants will also be recruited through targeted (social) 
media strategies and snowballing. The qualitative evaluation will include a purposive sampling method 
called, maximum variation sampling. In this sampling method, the sample is selected based on variations of 
some key characteristics (Suri, 2011). For the treatment group participants relevant variables will include 
gender, age, country of origin, and status of completing the intervention program (drop-out or completed). 
Selection of DWM and PM+ helpers will also be based on maximum variation and the relevant variables will 
include gender, age, country of origin, and the type of intervention (DWM and/or PM+) provided. Mental 
health specialists/supervisors involved in the trial will be directly approached if they want to participate in 
the interviews. Decision makers from the key stakeholders will be approached through available professional 
contacts. 
Informed consent procedure 
Before being enrolled in the study, participants will be informed about the nature and scope of the study in a 
form understandable to them. Participation will be completely voluntary to prevent biased responding – 
either exaggerating or minimizing problems in the belief that this may help participants obtaining secondary 
advantages. If a potential participant wants to participate, a research assistant will meet with the potential 
participant (in person or through video-calling). The research assistant will explain the research to the 
potential study participant and will provide the information document to the participant.  
  
 Persons who decide to participate in the trial will be asked to complete a written consent form to check 
for eligibility (after a minimum consideration time of one week). If participants meet the eligibility criteria 
(K10 >15.9 and not meet any exclusion criteria), they can participate in the trial. We will inform participants 
of the reason why they can or cannot participate in the RCT. In order to participate in the trial, participants 
will sign a second informed consent form, covering the optional recording of PM+ sessions in case of PM+ 
administration and the qualitative interviews. Giving consent for the audio recordings and/or for the 
qualitative interviews is not a condition for participating in the study. Audio recordings will only be used for 
fidelity assessments and supervisions.  
The research assistant will explain the research to the potential participant via telephone or video 
conference.  
  
Participants are allowed to withdraw from the study at any time after they have given their written 
consent. If people are eligible for participation in the RCT, we will inform their general practitioner of this. 
 
11.3 OBJECTION BY MINORS OR INCAPACITATED SUBJECTS 
Not applicable. 

 
 
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11.4 BENEFITS AND RISKS ASSESSMENT, GROUP RELATEDNESS 
Participants randomized into the DWM/PM+ treatment group may benefit from their participation in terms 
of expected reductions in psychological distress. The risks associated with participation are estimated to be 
minimal, since DWM and PM+ have shown to reduce psychological distress in previous studies (Purgato et 
al., 2019; Tol et al., 2020; Bryant et al., 2017; Rahman et al., 2016b). Participants in both the treatment and 
comparison group will not be withheld care as usual (note: the treatment group receives CAU along with 
stepped-care DWM/PM+ and psychological first aid (PFA), the comparison group will receive enhanced CAU 
and PFA only).  
  
It is possible that participants experience (increased) stress/depressive feelings during the PM+ 
sessions (e.g. by speaking of stressful events happening at work or speaking of their personal (living) 
situation). The intervention will be supervised and strictly monitored by experienced clinical psychologists. If 
a participant deteriorates during the intervention period, or has elevated symptoms at follow-up 
assessments, (s)he will be advised to contact his/her general practitioner (part of the CAU), who may refer 
the participant for continued or high-intensity treatment, e.g. referral to an external specialist (licensed 
psychologist or psychiatrist). Whether referral has taken place, will be actively followed up by the 
researchers.   
 
Participants may also experience some distress during the assessments, as they may think of their 
situation. These assessments will be conducted online through self-reporting, and/or through video-calling.  
The interviewer-administered assessments will be administered by assessors who are trained and closely 
monitored by the University of Verona research team. Administering the instruments is crucial to draw 
conclusions about the feasibility and credibility of the intervention. In case of an undesirable emotional 
reaction both during the intervention as well as during the follow-up assessments the researcher or a 
clinician will be available to provide support if necessary or desirable.  
 
 
11.5 COMPENSATION FOR INJURY 
Participation in the study only carries negligible risks for the research subjects; therefore, the present study 
is relieved from an insurance that provides cover for damage to research subjects. 
 
11.6 INCENTIVES 
If applicable, study participants will receive reimbursements during the study. Participants will receive a 
reimbursement ranging from 25 to 75 euros (monetary or in their bank account). The amount will vary 
depending on their involvement in the study (n. of sessions to attend, n. of assessments, etc).   
 
 

 
 
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12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
12.1 HANDLING AND STORAGE OF DATA AND DOCUMENTS 
All data will be handled confidentially and will be coded by a code known only by the research team. Processing of 
personal data will comply to the General Data Regulation (“GDPR”) on the protection of individuals regarding the 
processing of personal data and the free movement of such data.  
  
Data including personal information will be stored in a locked record at the University of Verona to ensure the 
confidentiality of the study participants. Only authorized research personnel would have access to this data. According 
to the data management rules of RESPOND, all partners acknowledge and agree that no personal data, as defined in 
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural 
persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 
95/46/EC (General Data Protection Regulation) (“GDPR”), will be exchanged between the Parties. Moreover, all 
partners in RESPOND acknowledge and agree that each partner is considered independent controller, as defined in 
GDPR, for its processing of personal data and will act in accordance with applicable data protection laws (including but 
not limited to GDPR).  
Qualitative data collection 
Before commencing a qualitative interview, the date of the interview or of the PM+ session and the participant number 
will be recorded on a professional audio recording device. No identifying information will be collected during the 
qualitative interviews, with all data de-identified. Audio files (mp3) will be encrypted and stored in a password 
protected server at the University of Verona, that can only be accessed by the members of the University of Verona 
research team. The audio files will be saved separately from their identifiers. The audio files for Study Phase 3 
(interviews) will be transcribed in the Microsoft word program (secured with a password known to the research team 
only) and safely stored at the office of the principal investigator who coordinates the research at the University of 
Verona. After the completion of the project, the mp3 files will be destroyed.  
 
Quantitative data collection 
Quantitative data will be coded and the identifying key (a list connecting names to numbers) will be kept in a separate, 
secure locked location in the coordinating researcher’s office (prof. dr. Corrado Barbui). The data will be entered into a 
data-analytic computer program (e.g., SPSS), without the identifying key. All data will be stored pseudonymous, and 
they will be available only to the University of Verona research team members. All pseudonymous data to be stored at 
the University of Verona will be stored in a data repository. The team will identify an online platform that can be used 
to share and publish research data in a (semi-)open environment. The University of Verona research group will analyze 
the data, and both positive and negative trial results will be disclosed. No attributable data will be used in publications. 
Results will be submitted for publication to peer-reviewed scientific journals. After the completion of RESPOND, the list 
of participants will be stored in DarkStor, an offline research data archive for sensitive data. Data of the trial are only 
accessible by authorized persons (principal investigator prof. dr. Corrado Barbui).   
 
12.2 MONITORING AND QUALITY ASSURANCE 

 
 
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Process monitoring is a part of the RCT and more detailly explained under ‘Study Procedures’.  
Monitoring includes review of Helpers’ records of PM+, supervision records including intervention fidelity monitoring 
and supervision of supervisors by the Master trainers. The supervision of Helpers will be scheduled weekly. The 
supervision will be given by expert psychologists. The supervising psychologists will also receive supervision from the 
Master trainers and these supervisions will be scheduled monthly.  
This is similar to the procedure used by Rahman and colleagues (2016) for the PM+ trial in Pakistan.  
One of the outcome measures of this study is the treatment fidelity. Audio records will be coded by University of 
Verona research assistants. The data will be collected throughout the intervention delivery (see Table 1). Monitoring of 
the assessments will be the responsibility of the main investigator of the qualitative assessment.  
In case of any concerns about the capacity of the assessors to carry out their roles, psychologists will conduct full 
assessments to ensure quality. This oversight will help ensure that any potential concerns about the capacity of 
assessors to carry out their roles is picked up and responded to. 
12.3 AMENDMENTS 
Amendments are changes made to the research after a favorable opinion by the accredited Ethics Committee has been 
given. All amendments will be submitted to the Ethics Committee.  
 
12.4 ANNUAL PROGRESS REPORT 
The University of Verona research team will submit a summary of the progress of the trial to the accredited Ethics 
Committee once a year. Information will be provided on the date of inclusion of the first subject, numbers of subjects 
included and numbers of subjects that have completed the trial, serious adverse events, other problems, and 
amendments.  
 
12.5 TEMPORARY HALT AND (PREMATURELY) END OF STUDY REPORT 
The investigator/sponsor (University of Verona) will notify the accredited Ethics Committee of the end of the study 
within a period of 8 weeks. The end of the study is defined as the last finished follow-up assessment (T4) of the last 
participant who joined the RCT. The sponsor will notify the Ethics Committee immediately of a temporary halt of the 
study, including the reason of such an action. In case the study is ended prematurely, the sponsor will notify the 
accredited Ethics Committee within 15 days, including the reasons for the premature termination. Within one year after 
the end of the study, the investigator/sponsor will submit a final study report with the results of the study, including 
any publications/abstracts of the study, to the Ethics Committee.  
 
12.6 PUBLIC DISCLOSURE AND PUBLICATION POLICY 
The trial will be registered in a public trial registry before the first patient is recruited. For the RESPOND project, a 
Communication and Dissemination Plan has been written. This study will lead to publications in international, peer-
reviewed journals. Additionally, findings will be shared/presented on the project website, through newsletters, through 

 
 
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regular and social media, at high level dissemination events, through policy briefs, etc. In addition, results will be 
disseminated through channels of the WHO and through events within the EU. The publication policy of the planned 
research will be carried out in line with the CCMO statement publication policy (March 2002). 
 
 
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