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Effectiveness of a scalable, remotely delivered stepped-care intervention to reduce symptoms of psychological distress among Polish migrant workers in the Netherlands: study protocol for the RESPOND randomised controlled trial

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Background The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. Methods The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders’ views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. Discussion To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. Trial registration Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052
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Roosetal. BMC Psychiatry (2023) 23:801
https://doi.org/10.1186/s12888-023-05288-5
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BMC Psychiatry
Eectiveness ofascalable, remotely
delivered stepped-care intervention
toreduce symptoms ofpsychological
distress amongPolish migrant workers
intheNetherlands: study protocol
fortheRESPOND randomised controlled trial
Rinske Roos1*, Anke B. Witteveen1, José Luis Ayuso‑Mateos2,3,4, Corrado Barbui5, Richard A. Bryant6,
Mireia Felez‑Nobrega4,7, Natasha Figueiredo8, Raffael Kalisch9,10, Josep Maria Haro4,7, David McDaid11,
Roberto Mediavilla2,3,4, Maria Melchior8, Pablo Nicaise12, A‑La Park11, Papoula Petri‑Romão9, Marianna Purgato5,
Annemieke van Straten1, Federico Tedeschi5, James Underhill13 and Marit Sijbrandij1 on behalf of the
RESPOND Consortium
Abstract
Background The COVID‑19 pandemic has negatively affected the mental health of international migrant workers
(IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed
by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters
in times of stress (DWM), a guided self‑help web application, and Problem Management Plus (PM +), a brief facilitator‑
led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped‑
care programme (DWM/PM +) is effective and cost‑effective in reducing psychological distress, among Polish migrant
workers with psychological distress living in the Netherlands.
Methods The stepped‑care DWM/PM + intervention will be tested in a two‑arm, parallel‑group, randomized con‑
trolled trial (RCT) among adult Polish migrant workers with self‑reported psychological distress (Kessler Psychological
Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives
DWM/PM + with psychological first aid (PFA) and care‑as‑usual (enhanced care‑as‑usual or eCAU), or into the con‑
trol group that receives PFA and eCAU‑only (1:1 allocation ratio). Baseline, 1‑week post‑DWM (week 7), 1‑week
post‑PM + (week 13), and follow‑up (week 21) self‑reported assessments will be conducted. The primary outcome
is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ‑ADS).
Secondary outcomes are self‑reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD),
*Correspondence:
Rinske Roos
r.roos@vu.nl
Full list of author information is available at the end of the article
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Page 2 of 14
Roosetal. BMC Psychiatry (2023) 23:801
resilience, quality of life, and cost‑effectiveness. In a process evaluation, stakeholders’ views on barriers and facilitators
to the implementation of DWM/PM + will be evaluated.
Discussion To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interven‑
tions into a stepped‑care programme for migrant populations. If proven to be effective, this may bridge the mental
health treatment gap IMWs experience.
Trial registration Dutch trial register NL9630, 20/07/2021, https:// www. onder zoekm etmen sen. nl/ en/ trial/ 27052
Keywords International migrant workers, Randomized controlled trial, Scalable interventions, Non‑specialist
healthcare workers, Stepped‑care, Common mental health disorders, Digital biomarkers, Hair steroid hormone
concentrations
Introduction
Large-scale epidemics of infectious diseases have been
associated with a substantial burden on the mental health
of the population [1]. Although recent studies have not
found convincing evidence for substantial increases in
mental health symptoms during the COVID-19 pan-
demic compared to the pre-pandemic period [2], trajec-
tory studies show that the mental health of vulnerable
groups such as women, young people, people with pre-
existing physical ill-health, or those experiencing socio-
economic difficulties deteriorated more than the general
population during the COVID-19 pandemic [3, 4].
International migrant workers (IMWs) can be viewed
as another group vulnerable to the consequences of the
COVID-19 pandemic. IMWs are migrants of working
age, who at some point were part of the labour force
of the country they migrated to [5]. Globally, there are
169 million IMWs, of which two-thirds reside in high-
income countries [5]. In the Netherlands, there are
about one million IMWs, with over half of them com-
ing from the European Union, primarily from Poland
(CBS, 2022). IMWs often have a vulnerable position in
society, working in so-called 3-D jobs: dirty, danger-
ous, and demanding (or demeaning or degrading) jobs
[6]. Compared to non-migrant workers, IMWs are more
likely to work in essential, low-skilled occupations, have
temporary contracts, work longer hours for lower wages,
are willing to take on greater risks and have jobs that
are not suitable for remote working [6, 7]. Most often,
they work in the service sector (e.g. wholesale and retail,
transportation and storage), followed by industry and
agriculture [5]. During the pandemic, additional chal-
lenges for IMWs were, amongst others, limited social
protection, high risk of exposure to and transmission of
COVID-19, and impending job loss, in turn, leading to
economic hardship and loss of housing (often provided
by the employer) [8].
Prior to the COVID-19 pandemic, mental health prob-
lems were already one of the most commonly reported
work-related health problems among IMWs [9, 10]. IMWs
have been found to develop more symptoms of anxiety
and depression than non-migrant workers [11]. ese
common mental health problems have been exacerbated
by the ongoing COVID-19 pandemic [12]. Despite this
mental health burden, access to specialist health care is
limited [10, 13]. IMWs can face various barriers related
to seeking mental health services (e.g. lack of awareness
of services, stigma) and to accessing the existing services
(e.g. language differences, lack of culturally appropriate
services) [14, 15]. In light of the COVID-19 pandemic,
there is thus an even higher need for psychosocial inter-
ventions for IMWs targeting the most notable symptoms
of psychological distress, such as anxiety, depression, and
posttraumatic stress disorder (PTSD) [16, 17].
Scalable strategies and interventions such as those
developed by the World Health Organization (WHO)
may bridge the mental health treatment gap in vulner-
able populations such as IMWs. ese interventions are
scalable because they are simplified and short versions
of evidence-based psychological interventions for com-
mon mental disorders and can be delivered as (guided)
self-help interventions (e.g. a book or online format)
and/or by trained and supervised non-specialist men-
tal health care workers [18, 19]. Since the onset of the
COVID-19 pandemic, there has been growing shift
to the remote delivery of mental health services due to
physical distancing and lockdowns [4]. Human-guided
digital interventions seem to be equally effective to face-
to-face psychotherapy for the treatment of common
mental health symptoms such as anxiety and depres-
sion [20]. Policy makers, mental health professionals and
service users have expressed interest in continuing with
this remote delivery in the absence of pandemic-related
measures [21].
For this study, two WHO scalable interventions have
been combined to be delivered remotely as a stepped-
care intervention. In stepped-care interventions, indi-
viduals first receive an evidence-based, low-intensity
treatment, i.e. a treatment requiring less of the individu-
al’s and the professional’s time and which is less expensive
[22]. As patients’ progress is monitored, those not (signif-
icantly) responding to treatment step up to a treatment of
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Roosetal. BMC Psychiatry (2023) 23:801
higher intensity [22]. In this way, stepped-care interven-
tions have the potential to reach more people at the cost
of fewer resources. Often, (guided) self-help treatments
are used as a first step in stepped-care interventions,
showing comparable effectiveness to face-to-face inter-
ventions [23].
In this RCT of IMWs in the Netherlands, partici-
pants in the intervention group are offered a two-step,
stepped-care intervention. e first step is a digitalized
guided self-help web application (web app) of Doing
What Matters in times of stress (DWM), an illustrated
self-help book that is part of Self-Help Plus (SH +) [24].
SH + is a guided self-help intervention based on accept-
ance and commitment therapy (ACT) that is delivered
in five 2-h sessions to groups of 20–30 people. So far,
SH + has been evaluated among refugee populations,
showing overall beneficial effects in improving self-
identified problems and well-being [25]. For this project,
DWM has been adapted for delivery in a digital smart-
phone-based format [26]. e second step is Problem
Management Plus (PM +), a transdiagnostic psychologi-
cal intervention based on cognitive behavioural therapy
(CBT) that addresses common mental health problems
(e.g. depression, anxiety, stress) and self-identified prac-
tical problems (e.g. unemployment). Over five weekly
face-to-face remotely delivered videoconferencing ses-
sions, PM + teaches strategies to manage psychosocial
problems [27]. In previous randomized controlled trials
(RCTs), PM + has been found to be effective in reducing
psychological distress in low-income settings [28, 29] and
Syrian refugees in the Netherlands [30, 31]. In addition to
DWM and PM + , all participants, i.e. participants in both
the intervention and control group, receive psychologi-
cal first aid (PFA). PFA consists of humane, supportive,
and practical help for individuals who have experienced
a traumatic event [32]. is stepped-care programme has
also been found to be effective among healthcare work-
ers experiencing psychological distress in the initial pan-
demic hotspots [33].
Recent advances have been made in examining both
digital markers and biomarkers either as correlates or
as secondary treatment outcomes. Traditional assess-
ment of psychological well-being and distress in IMWs
through (online) questionnaires can be burdensome
and time-consuming, while recently developed non-
invasive, low-burden digital phenotyping measures that
integrate voice, speech, movement and facial expres-
sion data from smart devices (e.g. smartphones) may be
a promising and scalable way for assessing psychologi-
cal wellbeing (e.g. depression, PTSD) [3436]. Notably,
altered speech and vocality, reduced facial expressiv-
ity and movement have been found in major depressive
disorder and psychopharmacological treatment has dem-
onstrated restored levels of digital markers (e.g. increased
head movement) and a decrease in anger and fear facial
expressions [37, 38]. Similarly, neuroendocrine correlates
such as cortisol can be used as a non-invasive biomarker
of physiological responses to chronic stressors. Hair cor-
tisol concentrations (HCC) reflect hormone release over
longer time intervals, as they indicate hormone secretion
over several months [39]. Studies have found that HCC
is related to PTSD, depression and anxiety disorders [40,
41] or with perceived job insecurity and work stress [42,
43]. In recent years, HCC has also been used as a second-
ary outcome of psychological interventions [44, 45].
is paper presents the study protocol for a ran-
domised controlled trial in the Netherlands to exam-
ine the (cost-)effectiveness of the remotely delivered
stepped-care DWM/PM + programme adapted for dis-
tressed IMWs living in the Netherlands. e final stage
will consist of a process evaluation to assess the feasibility
and acceptability of the intervention.
Methods
Study aim anddesign
is study is part of the EU Horizon2020 RESPOND pro-
ject, which aims to improve the preparedness of Euro-
pean mental health care systems in the face of future
pandemics. e primary objective of the current study is
to evaluate the (cost-)effectiveness, feasibility, and accept-
ability of the culturally and contextually adapted DWM/
PM + stepped-care program among Polish migrant work-
ers living in the Netherlands throughout the COVID-19
pandemic in terms of mental health outcomes, resilience,
wellbeing, and costs to health systems and society. is
will be done by conducting a single-blind, two-arm, par-
allel-group, superiority RCT with a 1:1 allocation ratio
in which a remotely delivered stepped-care programme
with PFA and care-as-usual (enhanced care-as-usual or
eCAU) will be compared to PFA with CAU (eCAU) only.
e primary endpoint is a composite measure of depres-
sion and anxiety at 21 weeks from baseline assessment
(t4). Figure1 shows a flowchart of the study design. In
addition, we will explore barriers and facilitators to treat-
ment engagement and adherence and opportunities for
scaling up among IMWs in the Netherlands, as well as
the implementation outcomes of the stepped-care pro-
gramme. is will be done by a mixed-methods process
evaluation following the RCT.
Study setting
is study takes place in the Netherlands and is con-
ducted by VU University Amsterdam in collaboration
with a local mental health care organisation specialized
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Roosetal. BMC Psychiatry (2023) 23:801
in the delivery of mental health care to Polish people
[GGZ Keizersgracht]. e DWM/PM + programme is
delivered fully remotely in the participants’ language (i.e.
Polish); both participants and those delivering the inter-
vention join the programme from their own (private or
work) environments.
Fig. 1 Flowchart of the randomized controlled trial
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Roosetal. BMC Psychiatry (2023) 23:801
Participants
Inclusion criteria
age 18 years or older;
currently living in the Netherlands (no duration
of stay required; they may have arrived after most
pandemic restrictions had been lifted);
having psychological distress, as indicated by the
Kessler Psychological Distress Scale (K10) with a
score of > 15.9 (s ee screening measure);
having sufficient mastery (written and spoken) of
the language in which the programme is delivered
(i.e. Polish);
having access to an electronic device with Internet
access to follow the programme.
Exclusion criteria
planning to permanently move abroad within the
next 6 months, i.e. before the last quantitative
assessment;
having acute medical conditions (requiring hospi-
talization);
imminent suicide risk, or expressed acute needs or
protection risks requiring immediate follow-up;
having a severe mental disorder (e.g. psychotic dis-
order, substance dependence);
having a severe cognitive impairment (e.g. severe
intellectual disability, dementia);
receiving specialist psychological treatment (e.g.
eye movement desensitization and reprocessing,
CBT);
using psychotropic medication for less than 2 months
or change in dosage in the past 2 months.
Procedure
Recruitment
Participants will be recruited in various ways, e.g.
through NGOs, general practitioners, municipalities,
Polish churches, Polish supermarkets, and social media
(e.g. Facebook, Instagram). To avoid potential coer-
cion, people interested in participating in the project
are invited to reach out to the research team themselves
(i.e. by e-mail, telephone, or through social media). Once
they reached out, the research team contacts all potential
participants by phone. If they are interested, both a digi-
tal and paper informed consent form (ICF) will be sent.
Permission to record DWM phone calls and/or PM + ses-
sions for fidelity checks and digital marker analysis, and/
or to provide a hair sample (see other measures), are all
optional.
Once the participant has given informed consent, an
online screening session is scheduled. All participants
that indicate on the ICF that they are willing to give a hair
sample will receive a hair sample kit consisting of instruc-
tions on how to take the hair sample, a (paper) hair ques-
tionnaire, and a prepaid envelope to return it.
Screening
Screening (t0) will be conducted through a video call (MS
Teams, 20–30 min) with a Polish speaking research assis-
tant. Screening consists of an online self-report question-
naire (sociodemographic questions and K10) followed by
exclusion questions that are asked directly to the partici-
pant (e.g., “did you receive any mental health diagnosis?”)
or answered by the research assistant (e.g., “does the par-
ticipant follow the conversation?”). Screening is ended as
soon as a participant screens out based on any inclusion
or exclusion criterion. Participants who indicated on the
ICF that they were willing to give a hair sample but score
too low on the K10 are still asked to give a hair sample at
baseline and to complete the baseline assessment (t1).
Assessments
After screening, data is collected through self-report
assessments at four time points: t1 (baseline, week 1 –
sent at the end of screening), t2 (post-DWM, week 7), t3
(post-PM + , week 13), and t4 (follow-up, week 21) with
the online programme Castor Electronic Data Cap-
ture (EDC) [46]. Each digital assessment with question-
naires will be sent to participants via e-mail and can
be completed through any device with Internet access
(e.g. smartphone, laptop, tablet). Total completion time
of each digital assessment is about 30 min (see ‘Study
measures’).
Participants have 14 days to complete the question-
naire When an assessment remains incomplete, partici-
pants will receive a maximum of 3 reminders on days 2,
5, and 10 through different communication channels to
promote participant retention. Hair samples and (paper)
questionnaires are collected at t1 and t4 through regular
mail. Once the research team receives the hair sample
and the hair questionnaire, answers are entered in Castor
EDC as well. Participants receive a 10-euro gift voucher
for each completed assessment with a maximum of 4
vouchers (t1-t4), regardless of whether they send a hair
sample.
Assessors
e consent and screening procedure will be carried
out by trained research assistants who are fluent in Pol-
ish. Research assistants will be blinded to participant
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Roosetal. BMC Psychiatry (2023) 23:801
allocation to the intervention or control group, by
restricting their user rights in Castor EDC. is way, they
can assist participants during the assessments if needed.
Blinding may be revealed in case of suicidal ideation (see
screening measures).
Randomization
Participants (N = 212) will be randomized into the PFA/
DWM/PM + CAU (intervention) (n = 106) or PFA/CAU
only (control) (n = 106) group using a four and six block
design via Castor EDC.
Trial status
is RCT started enrolling on 03 June 2022. Currently,
138 participants have been enrolled.
Process evaluation
After the RCT, participants who gave permission for
follow-up research will be approached to participate in
the process evaluation. A qualitative process evaluation
will be conducted to assess the satisfaction and accept-
ability of the DWM/PM + programme and to identify
barriers and facilitators to treatment engagement and
adherence. Additionally, this evaluation aims to explore
opportunities for scaling up the implementation of the
DWM/PM + programme for IMWs within the existing
healthcare system. is evaluation will be conducted
through semi-structured interviews with key inform-
ants, including DWM/PM + participants (n = 20), fam-
ily members/close persons of participants (n = 12), and
stakeholders (e.g. (mental) health practitioners, policy
makers). DWM/PM + participants will consist of partici-
pants who completed DWM and improved, who com-
pleted PM + and improved, who completed PM + and
did not improve, who dropped out during DWM, and
who dropped-out during PM + . Additionally, a focus
group discussion (FGD) will be conducted with help-
ers and trainers/supervisors (n = 6–8) (see Stepped-care
programme). Participants from the RCT and their fam-
ily members/close friends will each receive a 20 euro gift
voucher per interview.
Study measures
Table1 provides an overview of all study measures. Par-
ticipants need to complete the items of the K10, the pri-
mary outcome (PHQ-ADS), and the suicide screening, in
order to continue the assessment. e rest of the ques-
tionnaires are non-mandartory and participants can skip
items and sections.
Screening measures
Psychological distress will be measured with the K10
[47]. e K10 consists of ten items that focus on anxiety
and depression-related distress over the past 30 days.
Items are scored on a five-point Likert scale (1–5), giv-
ing a total score of 10–50 with higher scores representing
higher levels of distress. In line with previous research
[48, 49] a cut-off score of > 15.9 is used, which indicates
psychological distress [50]. e K10 is validated in vari-
ous languages (e.g. Dutch) [51].
Suicidal ideation will be assessed with the suicidal
thoughts interview from the PM + manual (t0, screening)
[52] or with a screening question used in a previous trial
testing an e-health intervention (t2-t4) [53]. If a partici-
pant answers positively to this screening question (t2-t4),
a message will appear with information on where to get
help and stating that a member of the research team will
reach out to the participant. Once a phone call has been
scheduled with the participant, an assessor will adminis-
ter the suicidality module of the Mini-International Neu-
ropsychiatric Interview (MINI) [54]. Suicidal ideation is
not assessed during t1 as this directly follows screening.
Cognitive impairment will be assessed with the observa-
tion checklist from the PM + manual.
Primary outcome measure
e primary outcome and endpoint is a combined
measure of depression and anxiety at week 21 (t4,
2-month follow-up) as indicated by the Patient Health
Questionnaire Anxiety and Depression Scale (PHQ-
ADS). e PHQ-ADS is a validated measure of the com-
bined sum score of the Patient Health Questionnaire
depression module (PHQ-9) [55] and Generalized Anxi-
ety Disorder (GAD-7) [56] questionnaire (see second-
ary outcomes). Answer options for both the PHQ-9 and
GAD-7 are ‘not at all’ (0), ‘several days’ (1), ‘more than
half the days’ (2), and ‘nearly every day’ (3) with a sum
score of 0–48.
Secondary outcome measures
Symptoms of depression and anxiety during the pre-
ceding two weeks will be measured by the nine-item
PHQ-9 [55] and the seven-item GAD-7 [56] respectively.
Answers on both questionnaires are scored on a 0–3 Lik-
ert scale (PHQ-9: range 0–27; GAD-7: range 0–21) with
higher scores indicating higher symptomatology. For
both questionnaires, a cut-off score of 10 will be used
[56, 57]. 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
answered on a four-point Likert scale ranging from ‘not
difficult at all’ to ‘extremely difficult’. e Polish version
of the PHQ-9 has been validated [58]. e Polish version
of the GAD-7 has not been validated yet but has recently
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Roosetal. BMC Psychiatry (2023) 23:801
been used in various studies to assess anxiety during the
COVID-19 pandemic in Poland and shown high internal
consistency [5961].
Symptoms of PTSD during the past month will be
measured by the 8-item PCL-5 [62], which is a short-
ened version of the 20-item PTSD Checklist for DSM-5
(PCL-C) [63]. Items are rated on a 0–4 scale (0–32), with
higher scores indicating higher levels of symptoms. e
Polish version of the 20-item PCL-5 has been found to
have good psychometric properties [64].
Outcome-based resilience will be operationalised as
an individual’s deviation from the sample-normalised
Table 1 Schedule of enrolment, interventions and assessments
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Roosetal. BMC Psychiatry (2023) 23:801
stressor reactivity (SR) line. To this end, a measure of
stressor exposure has been developed based on the Mainz
Inventory of Microstressors (MIMIS) [65] and similar
measures [66]. e stressor lists were further adapted
to fit the target population and shortened to minimize
burden of participants. e questionnaire consists of 22
items measuring life events (three items), and general
(six items), COVID-related (five items) and migrant spe-
cific (eight items) stressors. Life events are measured on
a five-point Likert scale (0–4) rating severity and stress-
ors are measured on a four-point Likert scale (0–3) rating
how often something occurred. e sample’s norma-
tive stressor reactivity will be calculated by regressing
stressor exposure (E; as measured by the stressor lists)
against mental health symptoms (P; as measured by
PHQ-ADS, PHQ-9, GAD-7). For the purpose of building
the SR score, the E score that explains the most variance
of mental health symptoms will be used. e best fitting
regression model will be taken as the sample’s E-P line.
Individual SR scores are then calculated as the residuals
to the E-P line, where a positive deviation denotes less
resilient outcomes and negative scores more resilient
outcomes, respectively.
Positive appraisal style, a factor leading to resilience,
will be measured with the Positive Appraisal Style Scale,
content-focused (PASS-content) [67]. It consists of 12
items focusing on how participants usually act, feel, and
think in stressful situations. Scores range from 1 (never)
to 4 (almost always; total range 12–48).
Quality of life will be measured by the EuroQol
5-dimensional descriptive system—5-level version
(EQ-5D-5L) which consists of the EQ-5D (part 1) and
EQ-VAS (part 2) [68]. e EQ-5D consists of five items
rating the level of impairment across the dimensions
of 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. e EQ-VAS consists
of a visual, analogue scale with as endpoints ‘the best’
[1] and ‘the worst’ [5] health you can imagine. e EQ-
5D-5L has been used widely and is available in over 150
languages, including Polish, also for collection by laptop,
tablet or Castor EDC [69].
To examine cost-effectiveness, health service utiliza-
tion and the effect of ill-health on participants’ and their
family/friends’ employment over the past 2 (t2, t3, t4) or
3 (t1) months will be measured with an adapted version
of the Client Service Receipt Inventory (CSRI) [70]. e
CSRI has been further adapted to fit the target popula-
tion of this study. Health service utilization focuses on
12 types of health care providers, as well as in- and out-
patient hospital services. If utilization of a health service
is indicated, follow-up questions will be asked regarding
the contact, e.g. number of visits, type (in-person/online)
and duration of contact, location (Netherlands/Poland),
travel and waiting time, and travel costs. Additionally,
trial costs (e.g. training, supervision, intervention facilita-
tor time) are collected.
Other measures
Sociodemographic information is collected at all time-
points. During the screening, basic information (e.g.
gender, age, education), information regarding migration
(e.g. time spent in the Netherlands), and work (e.g. sec-
tor, working hours, income source, contract type) are col-
lected. At baseline, further information is collected (e.g.
relationship status, living situation). Potentially fluctuat-
ing sociodemographic information is recollected at fol-
low-up assessments.
Exposure to potentially traumatic events will be
assessed using a shortened version of the Brief Trauma
Questionnaire (BTQ) [71]. e BTQ comprises 10 items,
each corresponding to an event that can be indicated as
either having occurred or not. To accommodate follow-
up, minor adaptations were made to the BTQ.
Impacts of COVID-19 will be assessed with a question-
naire based on other COVID-19 questionnaires [72]. It
consists of 16 items focusing on various aspects of the
COVID-19 pandemic (e.g. COVID-19 infection, adher-
ence to and consequences of COVID-19 regulations)
and an additional item on vaccination status at baseline
assessment.
After the trial, various implementation indicators,
e.g. reach, dose, resource use, and costs (training, staff,
recruitment etc.), will be assessed. Furthermore, based
on the implementation indicators and fidelity data the
incremental costs per change in the primary outcome
and quality of life will be estimated.
Hair cortisol concentrations (HCC), cortisone, dehy-
droepiandrosterone (sulphate) (DHEA(S)), testosterone,
and progesterone levels will be analysed through hair
samples. In about 100 hair strands, cut as close as pos-
sible from the scalp at the vertex posterior, the 3cm hair
from the scalp will be analysed for cumulative HCC, cor-
tisone, and DHEA(S) levels [39]. Based on an average hair
growth rate of 1 cm/month [73], this will give an indi-
cation of physiological stress levels over 3 months. Par-
ticipants will be instructed to obtain a hair sample with
the assistance of another person. As support, an instruc-
tion video has been created. In addition, participants are
asked to complete a hair questionnaire to assess several
relevant hair-specific characteristics (e.g. on hair wash-
ing, hair treatments and on substance or medication use
such as corticosteroids).
Video records of PM + sessions will be analysed for dig-
ital markers of facial activity (e.g. happiness, sadness, and
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Page 9 of 14
Roosetal. BMC Psychiatry (2023) 23:801
fear), voice (e.g. speech prevalence), and movement (e.g.
head pitch). is will be done using open-source tools
based on the analysis by Galatzer-Levy etal. [74].
Translation andadaptation ofthestudy measures
When available, instruments translated and/or validated
in Polish were selected. In line with WHO guidelines on
the translation and adaptation of research instruments
[75], instruments without existing Polish translations
were translated and back-translated. In case of discrepan-
cies in translation, items were discussed by the transla-
tors to reach consensus.
Interventions
Psychological First Aid (PFA)
Two to five days after screening, all participants will
receive Psychological First Aid (PFA) by telephone. PFA is
a support strategy for someone who is experiencing psy-
chological distress and may need support. It consists of
various themes, such as assessing and addressing (basic)
needs and concerns, providing practical care and sup-
port, listening and comforting people, connecting them to
information and protecting them from further harm [32].
At the end of the phone call, participants will be informed
of the group they have been randomized into.
Stepped‑care programme
Participants in the intervention group are offered a
stepped-care programme. All participants are offered
step 1. Participants who still report elevated levels of
psychological distress after step 1 (i.e. score > 15.9 on the
K10 at t2) are also offered step 2.
Step 1: Doing What Matters intimesof stress (DWM)
e DWM web app consists of five modules with accom-
panying audio exercises corresponding to each of the
five chapters of the SH + self-help book: (1) grounding,
(2) unhooking, (3) acting on your values, (4) being kind,
and (5) making room. Each week, a new module unlocks.
Based on Step-by-Step, a guided e-mental health inter-
vention [53], participants receive a total of six weekly
15-min support calls from a non-specialist (lay) helper
(see ‘Helpers’): one welcome call, and a total of five fol-
low-up calls – one at the end of each module. During
these calls, the previous module(s) and exercise(s) are
discussed and participants have the opportunity to ask
questions. Helpers have also limited access to partici-
pants’ metadata, such as if a participant has logged into
the web app and when they finished a module. Addi-
tionally, the web app has a chat support system through
which participants can chat with their helper at the
weekly support moment in case they are unable to have
a phone call.
Step 2: Problem Management Plus (PM +)
PM + teaches four strategies: (1) stress management,
(2) problem solving, (3) behavioural activation, and (4)
strengthening social support, and has a psycho-educa-
tion component [27]. PM + is delivered over five weekly
sessions with a non-specialist (lay) helper (see ‘Helpers’).
For this project, PM + has been adapted to be delivered
in individual 60 (instead of 90) minute video-call sessions
(MS Teams). Before implementation of the stepped-care
interventions, a qualitative sub-study is performed to
assess the main daily-life problems and psychosocial care
needs of IMWs in the Netherlands, to contextually adapt
both interventions [76]. Data collected for this qualita-
tive assessment is conducted following Module 1 of the
Design, Implementation, Monitoring and Evaluation
(DIME) research model, which consists of free listing
interviews, key-informant interviews with both IMWs
and professionals and a focus group discussion [77]. Core
elements of the interventions remained the same, while
case examples and pictures were adapted. Details of this
adaptation process will be published elsewhere.
Helpers
Helpers are Polish migrants living in the Netherlands.
Participants are linked to a helper who delivers all calls in
DWM or all sessions in PM + . For participants who con-
tinue to PM + , this may be the same helper as they had
for DWM, but this is not necessary. Helpers delivering
the DWM support calls and PM + sessions will be Polish
people living in the Netherlands. ey have been trained
in the intervention by mental health professionals, who
themselves have been trained by so-called Master train-
ers in both the intervention and the supervision process.
Training of trainers (ToT) was online and consisted of
a two-day DWM and a five-day PM + training (August
September 2021). Training of helpers (ToH) was hybrid
and consisted of a two-day DWM and an eight-day
PM + training (January-March 2022). roughout the
trial, helpers will receive weekly online supervision by
these trainers. Trainers will receive online supervision by
the Master trainers on an as-needed basis.
Treatment delity
Treatment fidelity will be assessed in various ways. First,
helpers will fill in a session checklist after each DWM call
and PM + session, and supervisors do so after each super-
vision. Second, 10% of the recordings of the DWM phone
calls and PM + sessions will be assessed with fidelity check-
lists. is will be done for a random sample, stratified on
helpers for DWM and PM + separately. Fidelity checks take
place throughout the delivery of the programme, resulting
in an iterative process of programme monitoring inform-
ing programme delivery. ird, metadata on participants’
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Page 10 of 14
Roosetal. BMC Psychiatry (2023) 23:801
app usage, e.g. if a participant has completed a module,
will be collected.
Care‑as‑usual (CAU)
CAU refers to all (mental) health care available to IMWs,
both in and outside the Netherlands. IMWs become eli-
gible for (mental) health care in the Netherlands upon
signing up for health insurance, which is mandatory for
all residents as well as those subject to payroll tax. ey
can access health care by registering with a general prac-
titioner. No aspect of care will be altered or withheld as a
result of participation in this study.
Analysis
Sample size
We aim to detect a small-to-medium Cohen’s d effect
size of 0.3 on the PHQ-ADS composite score (primary
outcome) at the t4 follow-up assessment point, which is
based on previous RCTs on PM + [28, 29]. Power calcula-
tions suggested a minimum sample size of 74 per group
(power = 0.95, α = 0.05, two-sided). With an expected 30%
attrition at t4, we aim to include 212 study participants
(intervention group: n = 106, control group: n = 106) over
an 18-month inclusion period.
Data analysis
Data will be analyzed once all data has been collected; no
interim analyses will be conducted.
Quantitative data (RCT)
Intention-to-treat (ITT) and per-protocol (PP) analy-
sis will be conducted for both the primary and second-
ary outcomes. ITT analysis will include all randomized
participants (N = 212). PP analysis will include par-
ticipants in the intervention group only if they have (a)
clicked through at least three (out of five) modules of
the DWM web application, and (b), if they qualified for
PM + in terms of K10-distress score at t2, attended at least
four (out of five) PM + sessions. ITT analysis of the pri-
mary outcome will be used to answer the main research
question.
To compare differences between the two treatment
groups at baseline, t-tests (continuous variables) and chi-
squared tests (categorical variables) will be conducted for
normally distributed data. For continuous non-normally
distributed data, Mann–Whitney tests will be conducted.
To estimate the treatment effect on the primary out-
come at t2, t3, and t4, with t4 being our primary time
point of interest, a linear mixed model will be used.
is model will have time and treatment as fixed effects
(as well as their interaction parameters), a baseline
measure of the PHQ-ADS as a covariate, and subjects
as random effects. e mean difference between the
two treatment groups at each assessment with a 95%
confidence interval will be obtained from this mixed
model. e same linear mixed model will be used to
estimate the effect of the DWM/PM + stepped-care
programme on secondary outcomes: symptoms of
depression (PHQ-9), anxiety (GAD-7), PTSD (PCL-5),
quality of life (EQ-5D-5L), and an outcome-based resil-
ience variable, operationalised as the PHQ-ADS total
score against stressor exposure [78].
Missing data will not be imputed but will be treated as
missing at random (MAR) as linear mixed models can
handle missing data. If some items of a particular scale
are missing (i.e. < 50%), the Corrected Item Mean Sub-
stitution method will be used [79]. is method uses the
item mean across participants of the same study group
and time point, weighted by the subject’s mean of com-
pleted items. All the above-mentioned analyses will be
performed using Jamovi version 2.3.26 [80]. Jamovi is an
open-source graphical user interface for R.
As an exploratory additional analysis, digital mark-
ers will be assessed using open-source tools in a Python
environment, which is available on GitHub [38, 74].
Digital markers will be assessed using open source tools
in a Python environment, which is available on GitHub
[38, 74]. Change over time in digital markers will be cal-
culated using repeated measures analysis of variance
(ANOVA). A covariate mixed model of the primary end-
point will be conducted by adding relevant covariates at
baseline, including gender, age, education, migration and
work characteristics (e.g. duration of stay, type of con-
tract), relationship status, living situation, life events,
traumatic experiences, COVID-19-related events. An
exploratory analysis will also be conducted to see if ster-
oid hormone levels and baseline and between-session
change in digital markers are associated with treatment
recovery.
To determine the cost-effectiveness of the DWM/
PM + stepped-care programme, health economic analysis
will be conducted from a healthcare system and societal
perspective. is will be conducted by focusing on the
incremental cost per quality-adjusted life year (QALY,
based on the EQ-5D-5L) and per change in PHQ-ADS
composite score at the t4 follow-up assessment point
(week 21). To do so, the total cost of the delivery of the
intervention and changes in the uptake of health care will
be assessed, using the CSRI. Between-group compari-
son of mean costs will be conducted using appropriate
statistical tests, depending on the type and distribution
of data. Univariate sensitivity analysis will be conducted
using non-parametric bootstrapping to estimate the
uncertainty and variability on trial parameters, which will
be addressed by constructing cost-effectiveness planes
and acceptability curves.
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Page 11 of 14
Roosetal. BMC Psychiatry (2023) 23:801
Qualitative data (cultural adaptation andprocess
evaluation)
Interviews and FGD will be audio-recorded and tran-
scribed verbatim. Transcripts will be analysed themati-
cally through inductive coding using ATLAS.ti 23.1.2.
Data management
All data is fully accessible to the VU research team. e
management of data varies per study phase.
Quantitative data (RCT)
Data collected through Castor EDC is automati-
cally pseudonymised. Data is fully accessible to the
VU research team. Participants give separate permis-
sion for their data (a) to be shared with partners in the
RESPOND project, and (b) to be stored at the research
location for 15 years, so it can be used for future scien-
tific research into the health of IMWs. Audio and video
recordings of DWM support calls and PM + sessions
respectively are stored pseudonymously in an active but
secured data folder in Surfdrive (i.e., a cloud service for
Dutch education and research) that can only be accessed
by the members of the research team. At the end of the
trial, when all hair samples are collected, they will be sent
to the laboratory for analysis. Participants who submit-
ted a hair sample will be informed of the analysis results
of their sample. Participants can withdraw their consent
to use their information at any time. Already collected
data can still be used. Collected hair samples and record-
ings of DWM support calls and PM + video sessions that
have not yet been analysed will be destroyed.
Qualitative data (cultural adaptation andprocess
evaluation)
Audio recordings of interviews and FGD will be
destroyed after transcription. Pseudonymised tran-
scripts will be stored for 10 or 15 years for respectively
the cultural adaptation or the process evaluation. For the
process evaluation, participants must separately give per-
mission for the use of these stored transcripts in future
scientific research into the health of migrant workers.
Trial monitoring andadverse events reporting
e project has an Ethics and Data Advisory Board
(EDAB), that will monitor and advise on data manage-
ment, and ethical, legal, and societal issues that arise
within the project.
(Serious) adverse events ((S)AEs) are defined as any
undesirable experience occurring to a participant
during the study, regardless of its connection to the
study procedure or the DWM/PM + intervention. All
SAEs will be recorded in Castor EDC and reported
to the EDAB and the Medical Ethics Committee of
the Amsterdam University Medical Center (UMC),
location VU University Medical Center (VUmc). e
research team will follow up with all SAEs until they are
stabilized or have abated. If necessary, participants will
be referred to a general practitioner.
Participants can withdraw from the study at any
time. No withdrawal criteria have been stated. Based
on reported (S)AEs, the principal investigator (PI) can
decide to discontinue participation in the trial.
Discussion
is article presents the study protocol for an RCT in
which we aim to evaluate the (cost-) effectiveness of the
remotely delivered, stepped-care DWM/PM + interven-
tion among Polish migrant workers living in the Neth-
erlands who have elevated levels of distress. is study
is part of the larger EU H2020 RESPOND project, in
which three other RCTs in Western Europe will also
be conducted to test the effectiveness of this interven-
tion amongst two other migrant populations (Italy [81],
France as well as health care workers (Spain) [26].
As a result of the COVID-19 pandemic, the need for
psychological interventions that target the most prevalent
mental health problems has increased, particularly for vul-
nerable groups such as IMWs. In the Netherlands, IMWs
experience multiple barriers to (mental) health care [82].
To our knowledge, this is the first RCT that combines two
scalable, psychosocial WHO interventions into a stepped-
care programme for IMWs. As it is offered as a stepped-
care intervention, as IMWs may save time and money on
mental health care this as the first step may be sufficient
in improving mental health. By offering this stepped-care
intervention in a remote format and in IMW’s native lan-
guage, mental health care may become more accessible to
a population facing practical challenges in seeing a mental
health care professional in the country they are residing
in. Additionally, as IMWs relocate regularly (both nation-
ally and internationally), a remotely delivered interven-
tion allows for continuous care. If proven to be effective,
this offers the possibility for upscaling and implementing
the DWM/PM + programme across European health care
systems for IMWs and thereby bridging the treatment gap
this population faces.
Abbreviations
ACT Acceptance and commitment therapy
AE Adverse event
BTQ Brief Trauma Questionnaire
CAU Care‑as‑usual
CBT Cognitive behaviour therapy
CSRI Client Service Receipt Inventory
DHEA(S) Dehydroepiandrosterone (sulphate)
DIME Design, Implementation, Monitoring and Evaluation
DWM Doing What Matters in times of stress
eCAU Enhanced care‑as‑usual (in this study PFA + CAU)
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Page 12 of 14
Roosetal. BMC Psychiatry (2023) 23:801
EDC Electronic Data Capture
EQ‑5D‑5L EuroQol 5‑dimensional descriptive system—5‑level version
GAD‑7 Generalized Anxiety Disorder, seven‑item measurement
instrument
HCC Hair cortisol concentrations
ICF Informed consent form
IMW International migrant worker
ITT Intention‑to‑treat
K10 Kessler Psychological Distress Scale, 10‑item measurement
instrument
MAR Missing at random
MIMIS Mainz Inventory of Microstressors
PASS‑content Positive Appraisal Style Scale – content focused
PCL‑5 PTSD Checklist for DSM‑5, eight‑item measurement
instrument
PCL‑C PTSD Checklist for DSM‑5, 20‑item measurement instrument
PFA Psychological First Aid
PHQ‑9 Patient Health Questionnaire depression module, 9‑item
measurement instrument
PI Principal investigator
PM + Problem Management Plus
PP Per‑protocol
PTSD Posttraumatic stress disorder
QALY Quality‑adjusted life year
RCT Randomised controlled trial
SH + Self Help Plus
ToH Training of helpers
ToT Training of trainers
UMC University Medical Center
VUmc VU University Medical Center
WHO World Health Organization
Supplementary Information
The online version contains supplementary material available at https:// doi.
org/ 10. 1186/ s12888‑ 023‑ 05288‑5.
Additional le1.
Additional le2.
Acknowledgements
Not applicable
Authors’ contributions
RR and AW drafted this manuscript, and all authors contributed to review and
editing. All authors contributed to conceptualization, methodology, data cura‑
tion, and protocol development. All authors approved the final version.
Funding
The RESPOND project has received funding from the European Union’s
Horizon 2020 research and innovation programme Societal Challenges under
Grant Agreement number 101016127. The funder has no role in study design;
collection, management, analysis, and interpretation of data; writing of the
report; and the decision to submit the report for publication. The content of
this article reflects only the authors’ views and the European Commision is not
responsible for any use that may be made of the information it contains.
Availability of data and materials
Data sharing does not apply to this article as no datasets were generated or
analysed during the current study.
Declarations
Ethics approval and consent to participate
The present study protocol was approved by the Medical Ethics Committee of
Amsterdam University Medical Centre, location Vrije Universiteit Medical Cen‑
tre (protocol ID: 2021.0335, 31/08/2021). Any amendments on the protocol
will be communicated through updating in the public webpage of the Trial
Registry. The results of this trial will be published in peer‑reviewed journal arti‑
cles and the final trial dataset will be made available after de‑identification of
the participants. All participants enrolled in the trial have signed the informed
consent form (either on paper or digital).
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Author details
1 Department of Clinical, Neuro‑ and Developmental Psychology and WHO
Collaborating Center for Research and Dissemination of Psychological Inter‑
ventions, VU University, Amsterdam, Netherlands. 2 Department of Psychiatry,
Universidad Autónoma de Madrid (UAM), Madrid, Spain. 3 Department of Psy‑
chiatry, La Princesa University Hospital, Instituto de Investigación Sanitaria
Princesa (IIS‑Princesa), Madrid, Spain. 4 Centro de Investigación Biomédica en
Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III (ISCIII), Madrid,
Spain. 5 Department of Neuroscience, Biomedicine and Movement Sciences,
Section of Psychiatry, WHO Collaborating Centre for Research and Training
in Mental Health and Service Evaluation, University of Verona, Verona, Italy.
6 School of Psychology, University of New South Wales, Sydney, NSW, Australia.
7 Research and Development Unit, Parc Sanitari Sant Joan de Déu, Barcelona,
Spain. 8 Equipe de Recherche en Epidémiologie Sociale (ERES), Institut Pierre
Louis d’Epidémiologie et de Santé Publique (IPLESP), INSERM, Sorbonne
Université, Faculté de Médecine St Antoine, Paris, France. 9 Leibniz I nstitute
for Resilience Research (LIR), Mainz, Germany. 10 Focus Program Translational
Neuroscience (FTN), Neuroimaging Center (NIC), Johannes Gutenberg
University Medical Center, Mainz, Germany. 11 Care Policy and Evaluation
Centre, Department of Health Policy, London School of Economics and Politi‑
cal Science, London, UK. 12 Institute of Health and Society (IRSS), Université
Catholique de Louvain, Brussels, Belgium. 13 Independent Research Consultant,
Brighton, UK.
Received: 12 October 2023 Accepted: 17 October 2023
References
1. Leung CMC, Ho MK, Bharwani AA, Cogo‑Moreira H, Wang Y, Chow MSC,
et al. Mental disorders following COVID‑19 and other epidemics: a sys‑
tematic review and meta‑analysis. Transl Psychiatry. 2022;12(1):1–12.
2. Sun Y, Wu Y, Fan S, Santo TD, Li L, Jiang X, et al. Comparison of mental
health symptoms before and during the covid‑19 pandemic: evidence
from a systematic review and meta‑analysis of 134 cohorts. BMJ.
2023;380:e074224.
3. Pierce M, McManus S, Hope H, Hotopf M, Ford T, Hatch SL, et al. Mental
health responses to the COVID‑19 pandemic: a latent class trajectory
analysis using longitudinal UK data. Lancet Psychiatry. 2021;8(7):610–9.
4. Witteveen AB, Young S, Cuijpers P, Ayuso‑Mateos JL, Barbui C, Bertolini
F, et al. Remote mental health care interventions during the COVID‑19
pandemic: An umbrella review. Behav Res Ther. 2022;159:104226.
5. Bureau international du travail, editor. ILO global estimates on inter‑
national migrant workers: results and methodology. 3rd ed. Geneva:
International labour organization; 2021.
6. Moyce SC, Schenker M. Migrant Workers and Their Occupational Health
and Safety. Annu Rev Public Health. 2018;39(1):351–65.
7. Fasani F, Mazza J. A Vulnerable Workforce: Migrant Workers in the COVID‑
19 Pandemic. Luxembourg: Publications Office of the European Union;
2020.
8. Moroz H, Shrestha M, Testaverde M. Potential Responses to the COVID‑19
Outbreak in Support of Migrant Workers. World Bank, Washington, DC;
2020 [cited 2023 Jun 21]. Available from: https:// openk nowle dge‑ world
bank‑ org. vu‑ nl. idm. oclc. org/ handle/ 10986/ 33625
9. Simon J, Kiss N, Łaszewska A, Mayer S. Public health aspects of migrant
health: a review of the evidence on health status for labour migrants in
the European Region. World Health Organization. Regional Office for
Europe; 2015 [cited 2023 Jun 21]. 45 p. Available from: https:// apps. who.
int/ iris/ handle/ 10665/ 326345
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 13 of 14
Roosetal. BMC Psychiatry (2023) 23:801
10. Hargreaves S, Rustage K, Nellums LB, McAlpine A, Pocock N, Devakumar
D, et al. Occupational health outcomes among international migrant
workers: a systematic review and meta‑analysis. Lancet Glob Health.
2019;7(7):e872–82.
11. Mucci N, Traversini V, Giorgi G, Tommasi E, De Sio S, Arcangeli G. Migrant
Workers and Psychological Health: A Systematic Review. Sustainability.
2020;12(1):120.
12. Oliva‑Arocas A, Benavente P, Ronda E, Diaz E. Health of International
Migrant Workers During the COVID‑19 Pandemic: A Scoping Review.
Front Public Health. 2022;10:816597.
13. Ang JW, Chia C, Koh CJ, Chua BWB, Narayanaswamy S, Wijaya L, et al.
Healthcare‑seeking behaviour, barriers and mental health of non‑domes‑
tic migrant workers in Singapore. BMJ Glob Health. 2017;2(2):e000213.
14. Hennebry J, McLaughlin J, Preibisch K. Out of the Loop: (In)access
to Health Care for Migrant Workers in Canada. J Int Migr Integr.
2016;17(2):521–38.
15. Thomson MS, Chaze F, George U, Guruge S. Improving Immigrant Popula‑
tions’ Access to Mental Health Services in Canada: A Review of Barriers
and Recommendations. J Immigr Minor Health. 2015;17(6):1895–905.
16. Aragona M, Barbato A, Cavani A, Costanzo G, Mirisola C. Negative impacts
of COVID‑19 lockdown on mental health service access and follow‑up
adherence for immigrants and individuals in socio‑economic difficulties.
Public Health. 2020;186:52–6.
17. Liu ZH, Zhao YJ, Feng Y, Zhang Q, Zhong BL, Cheung T, et al. Migrant
workers in China need emergency psychological interventions during
the COVID‑19 outbreak. Glob Health. 2020;16(1):75.
18. World Health Organization. Scalable psychological interventions for peo‑
ple in communities affected by adversity: a new area of mental health
and psychosocial work at WHO. 2017 [cited 2023 Jun 21]; Available from:
https:// apps. who. int/ iris/ handle/ 10665/ 254581
19. World Health Organization. mhGAP intervention guide for mental, neu‑
rological and substance use disorders in non‑specialized health settings:
mental health Gap Action Programme (mhGAP). version 2.0. Geneva:
World Health Organization; 2016 [cited 2023 Jun 21]. 174 p. Available
from: https:// apps. who. int/ iris/ handle/ 10665/ 250239
20. Moshe I, Terhorst Y, Philippi P, Domhardt M, Cuijpers P, Cristea I, et al. Digi‑
tal interventions for the treatment of depression: A meta‑analytic review.
Psychol Bull. 2021;147:749–86.
21. Barnett P, Goulding L, Casetta C, Jordan H, Sheridan‑Rains L, Steare T,
et al. Implementation of Telemental Health Services Before COVID‑19:
Rapid Umbrella Review of Systematic Reviews. J Med Internet Res.
2021;23(7):e26492.
22. van Straten A, Hill J, Richards DA, Cuijpers P. Stepped care treatment
delivery for depression: a systematic review and meta‑analysis. Psychol
Med. 2015;45(2):231–46.
23. Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self‑help
as effective as face‑to‑face psychotherapy for depression and anxiety dis‑
orders? A systematic review and meta‑analysis of comparative outcome
studies. Psychol Med. 2010;40(12):1943–57.
24. Epping‑Jordan JE, Harris R, Brown FL, Carswell K, Foley C, García‑Moreno
C, et al. Self‑Help Plus (SH+): a new WHO stress management package.
World Psychiatry. 2016;15(3):295–6.
25. Karyotaki E, Sijbrandij M, Purgato M, Acarturk C, Lakin D, Bailey D, et al.
Self‑Help Plus for refugees and asylum seekers: an individual participant
data meta‑analysis. BMJ Ment Health. 2023;26(1). Available from: https://
menta lheal th‑ bmj‑ com. vu‑ nl. idm. oclc. org/ conte nt/ 26/1/ e3006 72
26. Mediavilla R, McGreevy KR, Felez‑Nobrega M, Monistrol‑Mula A, Bravo‑
Ortiz MF, Bayón C, et al. Effectiveness of a stepped‑care programme of
internet‑based psychological interventions for healthcare workers with
psychological distress: Study protocol for the RESPOND healthcare work‑
ers randomised controlled trial. Digit Health. 2022;8:20552076221129084.
27. Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer
A, et al. Problem Management Plus (PM+): a WHO transdiagnostic
psychological intervention for common mental health problems. World
Psychiatry. 2015;14(3):354–7.
28. Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, et al.
Effectiveness of a brief behavioural intervention on psychological distress
among women with a history of gender‑based violence in urban Kenya:
A randomised clinical trial. PLOS Med. 2017;14(8):e1002371.
29. Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, et al.
Effect of a Multicomponent Behavioral Intervention in Adults Impaired
by Psychological Distress in a Conflict‑Affected Area of Pakistan: A Rand‑
omized Clinical Trial. JAMA. 2016;316(24):2609–17.
30. de Graaff AM, Cuijpers P, McDaid D, Park A, Woodward A, Bryant RA,
et al. Peer‑provided Problem Management Plus (PM+) for adult Syrian
refugees: a pilot randomised controlled trial on effectiveness and cost‑
effectiveness. Epidemiol Psychiatr Sci. 2020;29:e162.
31. Graaff AM de, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, et al.
Peer‑provided psychological intervention for Syrian refugees: results of
a randomised controlled trial on the effectiveness of Problem Manage‑
ment Plus. BMJ Ment Health. 2023;26(1). Available from: https:// menta
lheal th‑ bmj‑ com. vu‑ nl. idm. oclc. org/ conte nt/ 26/1/ e3006 37
32. Psychological first aid: Guide for field workers. [cited 2023 Jun 22]. Avail‑
able from: https:// www. who. int/ publi catio ns‑ detail‑ redir ect/ 97892 41548
205
33. Mediavilla R, Felez‑Nobrega M, McGreevy KR, Monistrol‑Mula A, Bravo‑
Ortiz MF, Bayón C, et al. Effectiveness of a mental health stepped‑care
programme for healthcare workers with psychological distress in crisis
settings: a multicentre randomised controlled trial. BMJ Ment Health.
2023;26(1). Available from: https:// menta lheal th‑ bmj‑ com. vu‑ nl. idm. oclc.
org/ conte nt/ 26/1/ e3006 97
34. Moreno C, Wykes T, Galderisi S, Nordentoft M, Crossley N, Jones N, et al.
How mental health care should change as a consequence of the COVID‑
19 pandemic. Lancet Psychiatry. 2020;7(9):813–24.
35. Insel TR. Digital Phenotyping: Technology for a New Science of Behavior.
JAMA. 2017;318(13):1215–6.
36. Schultebraucks K, Yadav V, Galatzer‑Levy IR. Utilization of Machine
Learning‑Based Computer Vision and Voice Analysis to Derive Digital
Biomarkers of Cognitive Functioning in Trauma Survivors. Digit Biomark.
2020;5(1):16–23.
37. Galatzer‑Levy I, Abbas A, Ries A, Homan S, Sels L, Koesmahargyo V, et al.
Validation of Visual and Auditory Digital Markers of Suicidality in Acutely
Suicidal Psychiatric Inpatients: Proof‑of‑Concept Study. J Med Internet
Res. 2021;23(6):e25199.
38. Abbas A, Sauder C, Yadav V, Koesmahargyo V, Aghjayan A, Marecki S,
et al. Remote Digital Measurement of Facial and Vocal Markers of Major
Depressive Disorder Severity and Treatment Response: A Pilot Study.
Front Digit Health. 2021 [cited 2023 Jun 22];3. Available from: https:// doi.
org/ 10. 3389/ fdgth. 2021. 610006.
39. Stalder T, Steudte S, Miller R, Skoluda N, Dettenborn L, Kirschbaum C.
Intraindividual stability of hair cortisol concentrations. Psychoneuroendo‑
crinology. 2012;37(5):602–10.
40. Koumantarou Malisiova E, Mourikis I, Darviri C, Nicolaides NC, Zervas IM,
Papageorgiou C, et al. Hair cortisol concentrations in mental disorders: A
systematic review. Physiol Behav. 2021;229:113244.
41. Psarraki EE, Kokka I, Bacopoulou F, Chrousos GP, Artemiadis A, Darviri C. Is
there a relation between major depression and hair cortisol? A systematic
review and meta‑analysis Psychoneuroendocrinology. 2021;124:105098.
42. Herr RM, Barrech A, Gündel H, Lang J, Quinete NS, Angerer P, et al. Effects
of psychosocial work characteristics on hair cortisol – findings from a
post‑trial study. Stress. 2017;20(4):363–70.
43. Herr RM, Almer C, Loerbroks A, Barrech A, Elfantel I, Siegrist J, et al. Asso‑
ciations of work stress with hair cortisol concentrations – initial findings
from a prospective study. Psychoneuroendocrinology. 2018;89:134–7.
44. Wynne B, McHugh L, Gao W, Keegan D, Byrne K, Rowan C, et al. Accept‑
ance and Commitment Therapy Reduces Psychological Stress in Patients
With Inflammatory Bowel Diseases. Gastroenterology. 2019;156(4):935–
945.e1.
45. Dajani R, Hadfield K, van Uum S, Greff M, Panter‑Brick C. Hair cortisol
concentrations in war‑affected adolescents: A prospective intervention
trial. Psychoneuroendocrinology. 2018;89:138–46.
46. Castor Electronic Data Capture (2021.2). Castor EDC. Available from:
https:// casto redc. com.
47. Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SLT, et al.
Short screening scales to monitor population prevalences and trends in
non‑specific psychological distress. Psychol Med. 2002;32(6):959–76.
48. de Graaff AM, Cuijpers P, Acarturk C, Bryant R, Burchert S, Fuhr DC, et al.
Effectiveness of a peer‑refugee delivered psychological intervention to
reduce psychological distress among adult Syrian refugees in the Nether‑
lands: study protocol. Eur J Psychotraumatology. 2020;11(1):1694347.
49. Alozkan Sever C, Cuijpers P, Mittendorfer‑Rutz E, Bryant RA, Dawson KS,
Holmes EA, et al. Feasibility and acceptability of Problem Management
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Plus with Emotional Processing (PM+EP) for refugee youth liv‑
ing in the Netherlands: study protocol. Eur J Psychotraumatology.
2021;12(1):1947003.
50. Sulaiman‑Hill CM, Thompson SC. Selecting instruments for assessing
psychological wellbeing in Afghan and Kurdish refugee groups. BMC Res
Notes. 2010;3(1):237.
51. Donker T, Comijs H, Cuijpers P, Terluin B, Nolen W, Zitman F, et al. The
validity of the Dutch K10 and extended K10 screening scales for depres‑
sive and anxiety disorders. Psychiatry Res. 2010;176(1):45–50.
52. World Health Organization. Problem management plus (PM+): individual
psychological help for adults impaired by distress in communities
exposed to adversity. [cited 2023 Jun 23]. Available from: https:// www.
who. int/ publi catio ns‑ detail‑ redir ect/ WHO‑ MSD‑ MER‑ 16.2
53. Van’t Hof E, Heim E, Ramia JA, Burchert S, Cornelisz I, Cuijpers P, et al.
Evaluating the Effectiveness of an E‑Mental Health Intervention for
People Living in Lebanon: Protocol for Two Randomized Controlled Trials.
JMIR Res Protoc. 2021;10(1):e21585.
54. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al.
The Mini‑International Neuropsychiatric Interview (M.I.N.I.): The develop‑
ment and validation of a structured diagnostic psychiatric interview for
DSM‑IV and ICD‑10. J Clin Psychiatry. 1998;59(SUPPL. 20):22–33.
55. Kroenke K, Spitzer RL, Williams JBW. The PHQ‑9. J Gen Intern Med.
2001;16(9):606–13.
56. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A Brief Measure for
Assessing Generalized Anxiety Disorder: The GAD‑7. Arch Intern Med.
2006;166(10):1092–7.
57. Manea L, Gilbody S, McMillan D. Optimal cut‑off score for diagnosing
depression with the Patient Health Questionnaire (PHQ‑9): a meta‑analy‑
sis. CMAJ. 2012;184(3):E191–6.
58. Ślusarska BJ, Nowicki G, Piasecka H, Zarzycka D, Mazur A, Saran T, et al.
Validation of the Polish language version of the Patient Health Question‑
naire‑9 in a population of adults aged 35–64. Ann Agric Environ Med.
2019;26(3):420–4.
59. Okruszek Ł, Aniszewska‑Stańczuk A, Piejka A, Wiśniewska M, Żurek K.
Safe but lonely? Loneliness, mental health symptoms and COVID‑1. 2020
[cited 2023 Jun 23]. Available from: https:// doi. org/ 10. 31234/ osf. io/ 9njps.
60. Dragan M, Grajewski P, Shevlin M. Adjustment disorder, traumatic stress,
depression and anxiety in Poland during an early phase of the COVID‑19
pandemic. Eur J Psychotraumatology. 2021;12(1):1860356.
61. Gambin M, Sękowski M, Woźniak‑Prus M, Wnuk A, Oleksy T, Cudo A, et al.
Generalized anxiety and depressive symptoms in various age groups dur‑
ing the COVID‑19 lockdown in Poland. Specific predictors and differences
in symptoms severity. Compr Psychiatry. 2021;105:152222.
62. Price M, Szafranski DD, van Stolk‑Cooke K, Gros DF. Investigation of
abbreviated 4 and 8 item versions of the PTSD Checklist 5. Psychiatry Res.
2016;239:124–30.
63. Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The
PTSD Checklist for DSM‑5 (PCL‑5) – Standard [Measurement instrument];
2013. Available from https:// www. ptsd. va. gov/.
64. Ogińska‑Bulik N, Lis‑Turlejska M, Juczyński Z. Polish adaptation of the
PTSD checklist for DWM‑5 ‑ PCL‑5. A preliminary communication
PRZEGLAD Psychol. 2018;61(2):287–91.
65. Chmitorz A, Kurth K, Mey LK, Wenzel M, Lieb K, Tüscher O, et al. Assess‑
ment of Microstressors in Adults: Questionnaire Development and
Ecological Validation of the Mainz Inventory of Microstressors. JMIR Ment
Health. 2020;7(2):e14566.
66. Veer IM, Riepenhausen A, Zerban M, Wackerhagen C, Puhlmann LMC,
Engen H, et al. Psycho‑social factors associated with mental resilience in
the Corona lockdown. Transl Psychiatry. 2021;11(1):1–11.
67. Petri‑Romão P, Engen H, Rupanova A, Puhlmann L, Zerban M, Neumann
R, et al. Self‑report assessment of Positive Appraisal Style (PAS): develop‑
ment of a process‑focused and a content‑focused questionnaire for use
in mental health and resilience research. 2023. [cited 2023 Jul 31]. Avail‑
able from: https:// doi. org/ 10. 31234/ osf. io/ fpw94.
68. Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Devel‑
opment and preliminary testing of the new five‑level version of EQ‑5D
(EQ‑5D‑5L). Qual Life Res. 2011;20(10):1727–36.
69. EQ‑5D‑5L | Available modes of administration [Internet]. [cited 223AD Jun
23]. Available from: https:// euroq ol. org/ eq‑ 5d‑ instr uments/ eq‑ 5d‑ 5l‑ avail
able‑ modes‑ of‑ admin istra tion/
70. Beecham J, Knapp M. Costing psychiatric interventions. In: Measuring
mental health needs. London, England: Gaskell/Royal College of Psychia‑
trists; 1992. p. 163–83.
71. Schnurr P, Vielhauer M, Weathers F, Findler M. The brief trauma question‑
naire (BTQ). White River Junction: National Center for PTSD; 1999.
72. Conway LG, Woodard S, Zubrod A. Social Psychological Measurements of
COVID‑19: Coronavirus Perceived Threat, Government Response, Impacts,
and Experiences Questionnaire. 2020 [cited 2023 Jun 23]. Available from:
https:// doi. org/ 10. 31234/ osf. io/ z2x9a.
73. Wennig R. Potential problems with the interpretation of hair analysis
results. Forensic Sci Int. 2000;107(1–3):5–12.
74. Galatzer‑Levy IR, Abbas A, Yadav V, Koesmahargyo V, Aghjayan A, Marecki
S, et al. Remote digital measurement of visual and auditory markers of
Major Depressive Disorder severity and treatment response. medRxiv;
2020 [cited 2023 Jun 23]. p. 2020.08.24.20178004. Available from: https://
doi. org/ 10. 1101/ 2020. 08. 24. 20178 004.
75. WHO. (2018). Process of translation and adaptation of instruments.
Retrieved from http:// www. who. int/ subst ance_ abuse/ resea rch_ tools/
trans lation/ en/.
76. Bernal G, Sáez‑Santiago E. Culturally centered psychosocial interventions.
J Community Psychol. 2006;34(2):121–32.
77. Applied Mental Health Research Group. Design, implementation,
monitoring, and evaluation of mental health and psychosocial assistance
programs for trauma survivors in low resource countries: A user’s manual
for researchers and program implementers. United States: Johns Hopkins
University Bloomberg School of Public Health; 2013.
78. Kalisch R, Köber G, Binder H, Ahrens KF, Basten U, Chmitorz A, et al. The
Frequent Stressor and Mental Health Monitoring‑Paradigm: A Proposal
for the Operationalization and Measurement of Resilience and the Iden‑
tification of Resilience Processes in Longitudinal Observational Studies.
Front Psychol. 2021;12. Available from: https:// doi. org/ 10. 3389/ fpsyg.
2021. 710493.
79. Huisman M. Item nonresponse: occurrence, causes, and imputation of
missing answers to test items. 1999.
80. The jamovi project (2022). jamovi (Version 2.3) [Computer Software].
Retrieved from https:// www. jamovi. org.
81. Purgato M, Turrini G, Tedeschi F, Serra R, Tarsitani L, Compri B, et al.
Effectiveness of a stepped‑care programme of WHO psychological
interventions in migrant populations resettled in Italy: Study protocol for
the RESPOND randomized controlled trial. Front Public Health. 2023;11.
Available from: https:// doi. org/ 10. 3389/ fpubh. 2023. 11005 46.
82. Berntsen LE, Skowronek NJ. State‑of‑the‑art research overview of the
impact of COVID‑19 on migrant workers in the EU and the Netherlands.
2021; Available from: https:// repos itory. ubn. ru. nl/ handle/ 2066/ 233185
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... 11 Amidst this crisis, the European Commission funded the project 'Preparedness of health systems to reduce mental health and psychosocial concerns resulting from the COVID-19 pandemic' (RESPOND). The study involved four RCTs across various vulnerable populations experiencing high levels of psychological distress, including HCWs employed by the Departments of Health of the Community of Madrid and in Catalonia, 12 as well as Polish migrant workers living in the Netherlands, 13 migrant populations resettled in Italy 14 and people without stable housing conditions in France. 15 The overall goal was to provide decision-makers with scalable and effective psychological interventions during epidemics and other public health emergencies. ...
... These studies target different population groups, such as refugees and asylum seekers in Italy, people without stable working conditions in France, and migrant workers in the Netherlands. [13][14][15] These studies will help detect commonalities across populations and settings with potential implications for implementation research. ...
... Finally, considering the key role of unspecific factors such as the expectations or the therapeutic alliance, specific ingredients could be adapted or modified across contexts. Additional process evaluations of ongoing RESPOND trials [13][14][15] involving different population groups will help detect commonalities across populations and settings with potential implications for implementation research. ...
Article
Full-text available
Objectives This study presents the process evaluation of an effective stepped-care programme of eHealth interventions (Doing What Matters in Times of Stress [DWM] and Problem Management Plus [PM+]) for healthcare workers (HCWs) with psychological distress (RESPOND-HCWs trial) conducted in Spain. The aim is to analyse the context in which the programme was delivered, assess key implementation outcomes and explore mechanisms of action. Methods We used mixed methods. Quantitative data came from routine randomised control trial monitoring and structured observation, and qualitative data were collected using semi-structured, in-depth interviews with trial participants (n = 12) and decision-makers (n = 7) and a focus group discussion with intervention providers (n = 7). We conducted a descriptive analysis of quantitative data using R software and a thematic analysis of qualitative data using NVivo. Results Context analysis revealed implementation barriers, including unrealistic expectations of participants about the programme and mental health-related stigma. The flexibility of interventions and the opportunity for mental health actions were enabling factors. Implementation outcomes showed that the trial was feasible, appropriate and timely, and that the intervention was delivered with minimal protocol deviations and good acceptance among participants. Mechanisms of action included confidence in the positive effect of the intervention, a good therapeutic relationship and specific intervention components. Conclusions These results supplement the outcome evaluation and can help inform large-scale implementation in similar settings. Specific recommendations include increasing mental health awareness and reducing stigma in the implementation setting, including a short orientation session and ensuring flexibility in schedules and peer support. Trial registration number NCT04980326.
Article
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Question Refugees and asylum seekers are at high risk of mental disorders due to various stressors before, during and after forceful displacement. The WHO Self-Help Plus (SH+) intervention was developed to manage psychological distress and a broad range of mental health symptoms in vulnerable populations. This study aimed to examine the effects and moderators of SH+ compared with Enhanced Care as Usual (ECAU) in reducing depressive symptoms among refugees and asylum seekers. Study selection and analysis Three randomised trials were identified with 1795 individual participant data (IPD). We performed an IPD meta-analysis to estimate the effects of SH+, primarily on depressive symptoms and second on post-traumatic stress, well-being, self-identified problems and functioning. Effects were also estimated at 5–6 months postrandomisation (midterm). Findings There was no evidence of a difference between SH+ and ECAU+ in reducing depressive symptoms at postintervention. However, SH+ had significantly larger effects among participants who were not employed (β=1.60, 95% CI 0.20 to 3.00) and had lower mental well-being levels (β=0.02, 95% CI 0.001 to 0.05). At midterm, SH+ was significantly more effective than ECAU in improving depressive symptoms (β=−1.13, 95% CI −1.99 to −0.26), self-identified problems (β=−1.56, 95% CI −2.54 to −0.59) and well-being (β=6.22, 95% CI 1.60 to 10.90). Conclusions Although SH+ did not differ significantly from ECAU in reducing symptoms of depression at postintervention, it did present benefits for particularly vulnerable participants (ie, unemployed and with lower mental well-being levels), and benefits were also evident at midterm follow-up. These results are promising for the use of SH+ in the management of depressive symptoms and improvement of well-being and self-identified problems among refugees and asylum seekers.
Article
Full-text available
Background Evidence-based mental health interventions to support healthcare workers (HCWs) in crisis settings are scarce. Objective To evaluate the capacity of a mental health intervention in reducing anxiety and depression symptoms in HCWs, relative to enhanced care as usual (eCAU), amidst the COVID-19 pandemic. Methods We conducted an analyst-blind, parallel, multicentre, randomised controlled trial. We recruited HCWs with psychological distress from Madrid and Catalonia (Spain). The intervention arm received a stepped-care programme consisting of two WHO-developed interventions adapted for HCWs: Doing What Matters in Times of Stress (DWM) and Problem Management Plus (PM+). Each intervention lasted 5 weeks and was delivered remotely by non-specialist mental health providers. HCWs reporting psychological distress after DWM completion were invited to continue to PM+. The primary endpoint was self-reported anxiety/depression symptoms (Patient Health Questionnaire-Anxiety and Depression Scale) at week 21. Findings Between 3 November 2021 and 31 March 2022, 115 participants were randomised to stepped care and 117 to eCAU (86% women, mean age 37.5). The intervention showed a greater decrease in anxiety/depression symptoms compared with eCAU at the primary endpoint (baseline-adjusted difference 4.4, 95% CI 2.1 to 6.7; standardised effect size 0.8, 95% CI 0.4 to 1.2). No serious adverse events occurred. Conclusions Brief stepped-care psychological interventions reduce anxiety and depression during a period of stress among HCWs. Clinical implications Our results can inform policies and actions to protect the mental health of HCWs during major health crises and are potentially rapidly replicable in other settings where workers are affected by global emergencies. Trial registration number NCT04980326 .
Article
Full-text available
Objective: To synthesise results of mental health outcomes in cohorts before and during the covid-19 pandemic. Design: Systematic review. Data sources: Medline, PsycINFO, CINAHL, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang, medRxiv, and Open Science Framework Preprints. Eligibility criteria for selecting studies: Studies comparing general mental health, anxiety symptoms, or depression symptoms assessed from 1 January 2020 or later with outcomes collected from 1 January 2018 to 31 December 2019 in any population, and comprising ≥90% of the same participants before and during the covid-19 pandemic or using statistical methods to account for missing data. Restricted maximum likelihood random effects meta-analyses (worse covid-19 outcomes representing positive change) were performed. Risk of bias was assessed using an adapted Joanna Briggs Institute Checklist for Prevalence Studies. Results: As of 11 April 2022, 94 411 unique titles and abstracts including 137 unique studies from 134 cohorts were reviewed. Most of the studies were from high income (n=105, 77%) or upper middle income (n=28, 20%) countries. Among general population studies, no changes were found for general mental health (standardised mean difference (SMD)change 0.11, 95% confidence interval -0.00 to 0.22) or anxiety symptoms (0.05, -0.04 to 0.13), but depression symptoms worsened minimally (0.12, 0.01 to 0.24). Among women or female participants, general mental health (0.22, 0.08 to 0.35), anxiety symptoms (0.20, 0.12 to 0.29), and depression symptoms (0.22, 0.05 to 0.40) worsened by minimal to small amounts. In 27 other analyses across outcome domains among subgroups other than women or female participants, five analyses suggested that symptoms worsened by minimal or small amounts, and two suggested minimal or small improvements. No other subgroup experienced changes across all outcome domains. In three studies with data from March to April 2020 and late 2020, symptoms were unchanged from pre-covid-19 levels at both assessments or increased initially then returned to pre-covid-19 levels. Substantial heterogeneity and risk of bias were present across analyses. Conclusions: High risk of bias in many studies and substantial heterogeneity suggest caution in interpreting results. Nonetheless, most symptom change estimates for general mental health, anxiety symptoms, and depression symptoms were close to zero and not statistically significant, and significant changes were of minimal to small magnitudes. Small negative changes occurred for women or female participants in all domains. The authors will update the results of this systematic review as more evidence accrues, with study results posted online (https://www.depressd.ca/covid-19-mental-health). Review registration: PROSPERO CRD42020179703.
Article
Full-text available
Background The mental health burden among refugees in high-income countries (HICs) is high, whereas access to mental healthcare can be limited. Objective To examine the effectiveness of a peer-provided psychological intervention (Problem Management Plus; PM+) in reducing symptoms of common mental disorders (CMDs) among Syrian refugees in the Netherlands. Methods We conducted a single-blind, randomised controlled trial among adult Syrian refugees recruited in March 2019–December 2021 (No. NTR7552). Individuals with psychological distress (Kessler Psychological Distress Scale (K10) >15) and functional impairment (WHO Disability Assessment Schedule (WHODAS 2.0) >16) were allocated to PM+ in addition to care as usual (PM+/CAU) or CAU only. Participants were reassessed at 1-week and 3-month follow-up. Primary outcome was depression/anxiety combined (Hopkins Symptom Checklist; HSCL-25) at 3-month follow-up. Secondary outcomes included depression (HSCL-25), anxiety (HSCL-25), post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; PCL-5), impairment (WHODAS 2.0) and self-identified problems (PSYCHLOPS; Psychological Outcomes Profiles). Primary analysis was intention-to-treat. Findings Participants (n=206; mean age=37 years, 62% men) were randomised into PM+/CAU (n=103) or CAU (n=103). At 3-month follow-up, PM+/CAU had greater reductions on depression/anxiety relative to CAU (mean difference −0.25; 95% CI −0.385 to −0.122; p=0.0001, Cohen’s d =0.41). PM+/CAU also showed greater reductions on depression (p=0.0002, Cohen’s d =0.42), anxiety (p=0.001, Cohen’s d =0.27), PTSD symptoms (p=0.0005, Cohen’s d =0.39) and self-identified problems (p=0.03, Cohen’s d =0.26), but not on impairment (p=0.084, Cohen’s d =0.21). Conclusions PM+ effectively reduces symptoms of CMDs among Syrian refugees. A strength was high retention at follow-up. Generalisability is limited by predominantly including refugees with a resident permit. Clinical implications Peer-provided psychological interventions should be considered for scale-up in HICs.
Article
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Introduction Migrant populations, including workers, undocumented migrants, asylum seekers, refugees, internationally displaced persons, and other populations on the move, are exposed to a variety of stressors and potentially traumatic events before, during, and after the migration process. In recent years, the COVID-19 pandemic has represented an additional stressor, especially for migrants on the move. As a consequence, migration may increase vulnerability of individuals toward a worsening of subjective wellbeing, quality of life, and mental health, which, in turn, may increase the risk of developing mental health conditions. Against this background, we designed a stepped-care programme consisting of two scalable psychological interventions developed by the World Health Organization and locally adapted for migrant populations. The effectiveness and cost-effectiveness of this stepped-care programme will be assessed in terms of mental health outcomes, resilience, wellbeing, and costs to healthcare systems. Methods and analysis We present the study protocol for a pragmatic randomized study with a parallel-group design that will enroll participants with a migrant background and elevated level of psychological distress. Participants will be randomized to care as usual only or to care a usual plus a guided self-help stress management guide (Doing What Matters in Times of Stress, DWM) and a five-session cognitive behavioral intervention (Problem Management Plus, PM+). Participants will self-report all measures at baseline before random allocation, 2 weeks after DWM delivery, 1 week after PM+ delivery and 2 months after PM+ delivery. All participants will receive a single-session of a support intervention, namely Psychological First Aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire—Anxiety and Depression Scale summary score 2 months after PM+ delivery. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, resource utilization, cost, and cost-effectiveness. Discussion This study is the first randomized controlled trial that combines two World Health Organization psychological interventions tailored for migrant populations with an elevated level of psychological distress. The present study will make available DWM/PM+ packages adapted for remote delivery following a task-shifting approach, and will generate evidence to inform policy responses based on a more efficient use of resources for improving resilience, wellbeing and mental health. Clinical trial registration ClinicalTrials.gov, identifier: NCT04993534.
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Mitigating the COVID-19 related disruptions in mental health care services is crucial in a time of increased mental health disorders. Numerous reviews have been conducted on the process of implementing technology-based mental health care during the pandemic. The research question of this umbrella review was to examine what the impact of COVID-19 was on access and delivery of mental health services and how mental health services have changed during the pandemic. A systematic search for systematic reviews and meta-analyses was conducted up to August 12, 2022, and 38 systematic reviews were identified. Main disruptions during COVID-19 were reduced access to outpatient mental health care and reduced admissions and earlier discharge from inpatient care. In response, synchronous telemental health tools such as videoconferencing were used to provide remote care similar to pre-COVID care, and to a lesser extent asynchronous virtual mental health tools such as apps. Implementation of synchronous tools were facilitated by time-efficiency and flexibility during the pandemic but there was a lack of accessibility for specific vulnerable populations. Main barriers among practitioners and patients to use digital mental health tools were poor technological literacy, particularly when preexisting inequalities existed, and beliefs about reduced therapeutic alliance particularly in case of severe mental disorders. Absence of organizational support for technological implementation of digital mental health interventions due to inadequate IT infrastructure, lack of funding, as well as lack of privacy and safety, challenged implementation during COVID-19. Reviews were of low to moderate quality, covered heterogeneously designed primary studies and lacked findings of implementation in low- and middle-income countries. These gaps in the evidence were particularly prevalent in studies conducted early in the pandemic. This umbrella review shows that during the COVID-19 pandemic, practitioners and mental health care institutions mainly used synchronous telemental health tools, and to a lesser degree asynchronous tools to enable continued access to mental health care for patients. Numerous barriers to these tools were identified, and call for further improvements. In addition, more high quality research into comparative effectiveness and working mechanisms may improve scalability of mental health care in general and in future infectious disease outbreaks.
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Background and aims The coronavirus disease 2019 pandemic has challenged health services worldwide, with a worsening of healthcare workers’ mental health within initial pandemic hotspots. In early 2022, the Omicron variant is spreading rapidly around the world. This study explores the effectiveness and cost-effectiveness of a stepped-care programme of scalable, internet-based psychological interventions for distressed health workers on self-reported anxiety and depression symptoms. Methods We present the study protocol for a multicentre (two sites), parallel-group (1:1 allocation ratio), analyst-blinded, superiority, randomised controlled trial. Healthcare workers with psychological distress will be allocated either to care as usual only or to care as usual plus a stepped-care programme that includes two scalable psychological interventions developed by the World Health Organization: A guided self-help stress management guide (Doing What Matters in Times of Stress) and a five-session cognitive behavioural intervention (Problem Management Plus). All participants will receive a single-session emotional support intervention, namely psychological first aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire – Anxiety and Depression Scale summary score at 21 weeks from baseline. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, cost impact and cost-effectiveness. Conclusions This study is the first randomised trial that combines two World Health Organization psychological interventions tailored for health workers into one stepped-care programme. Results will inform occupational and mental health prevention, treatment, and recovery strategies. Registration details ClinicalTrials.gov Identifier: NCT04980326.
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COVID-19 has imposed a very substantial direct threat to the physical health of those infected, although the corollary impact on mental health may be even more burdensome. Here we focus on assessing the mental health impact of COVID-19 and of other epidemics in the community. We searched five electronic databases until December 9, 2020, for all peer-reviewed original studies reporting any prevalence or correlates of mental disorders in the general population following novel epidemics in English, Chinese or Portuguese. We synthesised prevalence estimates from probability samples during COVID-19 and past epidemics. The meta-analytical effect size was the prevalence of relevant outcomes, estimated via random-effects model. I ² statistics, Doi plots and the LFK index were used to examine heterogeneity and publication bias. This study is pre-registered with PROSPERO, CRD42020179105. We identified 255 eligible studies from 50 countries on: COVID-19 ( n = 247 studies), severe acute respiratory syndrome (SARS; n = 5), Ebola virus disease ( n = 2), and 1918 influenza ( n = 1). During COVID-19, we estimated the point prevalence for probable anxiety (20.7%, 95% CI 12.9–29.7), probable depression (18.1%, 13.0–23.9), and psychological distress (13.0%, 0–34.1). Correlates for poorer mental health include female sex, lower income, pre-existing medical conditions, perceived risk of infection, exhibiting COVID-19-like symptoms, social media use, financial stress, and loneliness. Public trust in authorities, availability of accurate information, adoption of preventive measures and social support were associated with less morbidity. The mental health consequences of COVID-19 and other epidemics could be comparable to major disasters and armed conflicts. The considerable heterogeneity in our analysis indicates that more random samples are needed. Health-care professionals should be vigilant of the psychological toll of epidemics, including among those who have not been infected.
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The outbreak of the COVID-19 pandemic has brought several structural labour mobil- ity issues to the fore. While the work of many migrants – suddenly coined essential workers – continued during the pandemic, their health and safety is not always well protected, thus leaving them at higher risk of COVID-19 infection. This working paper provides a target literature review of academic and policy papers on the impact of COVID-19 on migrants performing essential jobs. It draws out factors that potentially contribute to migrant workers’ vulnerabilities, related to the way migrant work is or- ganized, the extent of adequately regulation and effective enforcement and migrants’ limited social embeddedness in the country where they work. The COVID-19 pan- demic in fact exacerbates several pre-existing issues, such as the role of temporary agency firms in the Netherlands that facilitate work, housing and health care access in many cases as well. This state-of-the-art overview is a publication from the inter- disciplinary research project ‘Migrants in de Frontline’ that explores the impact of the COVID-19 measures on migrant workers in essential sectors and is meant to inform the empirical data collection among European migrant workers in essential industries in the Netherlands.
Preprint
Positive Appraisal Style Theory of Resilience posits that a person’s general style of evaluating stressors plays a central role in mental health and resilience. Specifically, a tendency to appraise stressors positively (positive appraisal style; PAS) is theorized to be protective of mental health and thus a key resilience factor. To this date no measures of PAS exist. Here, we present two scales that measure perceived positive appraisal style, one focusing on cognitive processes that lead to positive appraisals in stressful situations (PASS-process), and the other focusing on the appraisal contents (PASS-content). For PASS-process, the items of the existing questionnaires Brief COPE and CERQ-short were analyzed in exploratory and confirmatory factor analyses (EFA, CFA) in independent samples (N=1157 and N=1704) . The resulting 10-item questionnaire showed was internally consistent (α = .78, 95% CI [.86, .87]) and showed good convergent and discriminant validity in comparisons with self-report measures of trait optimism, neuroticism, urgency, and spontaneity. For PASS-content, a newly generated item pool of 29 items across stressor appraisal content dimensions (probability, magnitude, and coping potential) were subjected to EFA and CFA in two independent samples (N=1174 and N=1611). The resulting 14-item scale showed good internal consistency (α = .87, 95% CI [.86, .87]), as well as good convergent and discriminant validity within the nomological network. The two scales are a new and reliable way to assess self-perceived positive appraisal style in large-scale studies, which could offer key insights into mechanisms of resilience.