Primary Objective: To evaluate the (cost-)effectiveness, feasibility, and acceptability of the culturally and contextually adapted DWM/PM+ stepped-care program among labor migrants in the Netherlands during the COVID-19 pandemic in terms of mental…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
psychological symptoms of anxiety, depression and (posttraumatic) stress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study Phase 2:
The primary outcome will be the decrease in symptoms of anxiety and depression
from baseline to two-month follow-up (week 20), measured through the sum score
of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7
(GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to
detect a Cohen*s d effect size of 0.3 in the PM+ group at 2 months
post-treatment (week 20).
Secondary outcome
Study phase 2:
Secundary outcomes include level of anxiety (GAD-7) and depression (PHQ-9),
symptoms of posttraumatic stress disorder (PCL-5), resilience (Mainz Inventory
of MIcrostressors, MIMIS, Positive Appraisal Style Scale - content focused,
PASSc), quality of life (EQ-5D-5L), and costs of care (CSRI). Additional study
parameters will include demographic data, traumatic and COVID-19 related
(exposure) variables (Brief Trauma Questionnaire, BTQ), hair biomarkers
(cortisol concentrations (HCC), cortisone, dehydroepiandrosterone (sulfate)
(DHEA(S)), progesterone, and testosterone concentrations), digital markers,
treatment fidelity, satisfaction and acceptability of the intervention program,
and implementation indicators (such as reach, dose, resource use, intervention
implementation related costs).
Study phase 3:
Through FGDs and interviews at the end of the study, the feasibility of
scaling-up the implementation on the stepped-care DWM/PM+ intervention within
the Netherlands will be examined.
Background summary
The ongoing COVID-19 pandemic has a major and potentially long-lasting effect
on mental health and wellbeing across populations worldwide. Vulnerable groups,
such as labour migrants, are disproportionally affected by the COVID-19
pandemic. There is a high need for psychosocial interventions that can target
the most prevalent mental health problems arising from the COVID-19 pandemic,
addressing the needs of many people in a way that maximises the use of
resources. The World Health Organization (WHO) has developed two scalable,
low-intensity psychological interventions: Doing What Matters in times of
stress (DWM; a self-help intervention) and Problem Management Plus (PM+; a
face-to-face intervention). DWM and PM+ can be delivered by non-specialist
helpers, are applicable to a variety of mental health problems (depression,
anxiety and PTSD), and can be adapted to different populations, cultures and
languages. Both DWM and PM+ have been proven to be effective on their own. In
this study, DWM and PM+ will be combined into a stepped-care intervention
(DWM/PM+). This study is part of the larger EU H2020-RESPOND project, which
aims to improve the preparedness of European mental health care systems in the
face of future pandemics.
The main hypothesis is that the stepped-care DWM/PM+ intervention together with
psychological first aid (PFA), in addition to care-as-usual (CAU), will be more
effective in decreasing psychological distress and symptoms of mental health
problems than PFA and CAU alone.
Study objective
Primary Objective:
To evaluate the (cost-)effectiveness, feasibility, and acceptability of the
culturally and contextually adapted DWM/PM+ stepped-care program among labor
migrants in the Netherlands during the COVID-19 pandemic in terms of mental
health outcomes, resilience, wellbeing, health inequalities, and costs to
health systems.
Secondary Objective:
To identify (a) barriers and facilitators to treatment engagement and adherence
and (b) opportunities for scaling up among the target population in the
Netherlands (study phase 3).
Study design
This study consists of 3 phases.
Study phase 1: qualitative study consisting of individual interviews and a
focus group discussion (FGDs) to adapt the DWM/PM+ manuals to the culture and
context of labour migrants (protocol approved by VCWE).
Study phase 2: pragmatic implementation trial with a single-blinded,
randomised, parallel-group design.
Study phase 3: qualitative process evaluation consisting of individual
interviews and FGDs.
The current protocol focuses on phases 2 and 3.
Intervention
Participants will be randomized into a treatment and a comparison group.
- All participants (in both the treatment and comparison groups) will receive
Psychological First Aid (PFA) and CAU.
- In addition to PFA and CAU, the treatment group will receive the stepped-care
intervention (DWM with or without PM+). The stepped-care intervention consists
of DWM (step 1) and conditionally PM+ (step 2) if participants still meet
criteria for psychological distress (K10 >15.9) one week after having received
DWM.
- DWM, i.e. a self-help book with brief audio exercises to support practice,
will be adapted into a digital tool or application (phase 1) and delivered as a
guided self-help intervention with support from a briefly trained
non-specialist helper via teleconferencing.
- PM+ consists of five sessions and will be delivered by trained non-specialist
helpers in person or via teleconferencing in individual (or group) format. In
addition to PFA, the comparison group will only receive CAU which ranges from
community care to specialised psychological treatments.
Study burden and risks
The burden and risks resulting from participation in this study are minimal in
view of the naturalistic design, inclusion of only participants with mild to
moderate functional impairment and psychological distress and minimal duration
of the various questionnaire measurements (approx. 45-60 minutes).
Study phase 2: participants will be assessed online a total of four times over
the course of six months. Data will be collected by means of self-administered
online questionnaires. Questionnaires will be taken at baseline (week 0), week
6, week 12, and week 20. The six DWM helepr support calls, for participants in
the treatment group, will be audiotaped for the purpose of monitoring. The five
PM+ sessions, for participants in the treatment group who still meet inclusion
criteria after DWM, will be videotaped for the purpose of monitoring and for
analysis of digital markers. hair sampels are taken to examine stress-related
hormones such as cortisol, cortisone, dehydroepiandrosteron(sulphate),
progesterone, and testosterone.
Study phase 3: The interviews with participants in the target group in phase 2
(both completers and drop-outs), their family members/close persons, and
professionals will take approximately 1.5 hours. The FGDs with DWM/PM+
facilitators will take approximately 2 hours.
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
Participants will be eligible to participate in the study (phase 2 (and 3)) if
they meet all of the following criteria:
- 18 years or older;
- Living in the Netherlands as labour migrant
- Having elevated levels of psychological distress (Kessler Psychological
Distress Scale (K10) >15.9).
- Sufficient mastery (written and spoken) of one of the languages the DWM/PM+
intervention is being delivered in (e.g. English, Polish, Romanian).
- Having access to an electronic device with internet access and webcam to
follow the intervention
- Oral and written informed consent before entering the study.
Exclusion criteria
Potential participants who meet the inclusion criteria will be excluded from
participation in this study (phase 2 (and 3)) if they meet any of the following
criteria:
- Planning to move abroad, e.g. back to their home country or to another
country, before the last quantitative assessment at 2 months after PM+;
- Having acute medical conditions (requiring hospitalisation);
- Imminent suicide risk, or expressed acute needs or protection risks that
require immediate follow-up;
- Having a severe mental disorder (e.g. psychotic disorders,
substance-dependence);
- Having severe cognitive impairment (e.g. severe intellectual disability or
dementia);
- Currently receiving specialised psychological treatment (e.g. EMDR, CBT);
- In case of current psychotropic medication use: being on an unstable dose for
at least 2 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77644.029.21 |