Improving the mental health of working adults in Dutch small-to-medium-enterprises (SMEs): implementation of WHO*s Doing What Matters in times of stress (DWM)

Small-to-medium-sized enterprises (SMEs) often lack the resources to combat the
negative consequences of work stressors (e.g., high workplace digitalization).
This puts their employees at risk of developing mental health problems.
Literature on effective interventions at work for SME employees* mental health
is scarce and inconclusive. This project focuses on the implementation of Doing
What Matters in Times of Stress (DWM), a scalable, low-intensity, psychological
intervention developed by WHO adapted for use in Dutch SMEs. This study is part
of the larger EU H2022-ADVANCE project, which aims to improve the mental health
of vulnerable populations in Europe.

In the ADVANCE project, two interventions will be tested in Dutch SMEs: (1)
DWM: aimed at improving the mental health of SME employees; and (2) the novel
WHO-developed supervisor training (ASCEND): aimed at enhancing the supervisors*
confidence to manage their supervisees mental health.
Each intervention will be tested separately in a cluster randomized controlled
trial (cRCT). Therefore, two cRCTs will be conducted during the ADVANCE
project. Additionally, in order to understand whether the combination of ASCEND
and DWM is more effective than the implementation of only DWM or ASCEND, the
two cRCTs will be conducted sequentially in the same SMEs (see Section 3 of the
research protocol).

This protocol specifically relates to the implementation and evaluation of DWM.
The implementation of ASCEND is described in a separate protocol that has been
submitted for a non-WMO waiver at the Non-WMO Review Committee of the METC
Amsterdam UMC.

Main objectives:
a) examine and assess the (cost-)effectiveness of WHO*s Doing What Matters in
Times of Stress (DWM) in reducing psychological distress, improving mental
health, and enhancing work-related well-being and productivity compared to
care-as-usual (CAU) in employees of Dutch SMEs with increased psychological
distress levels. Another objective is to assess the implementation outcomes of
DWM (cRCT #2; study phase 4b).
b) identify barriers and facilitators to intervention engagement and adherence
and assess opportunities for scaling up the implementation of the DWM
intervention within the context of working adults in Dutch SMEs (process
evaluation; study phase 5).


Secondary objectives:
c) explore whether ASCEND combined with DWM improves mental health, well-being
and work-related outcomes among employees of Dutch SMEs in comparison with
ASCEND only, DWM only, or CAU only (study phase 4a and 4b combined).
d) examine the cost-effectiveness of ASCEND combined with DWM on mental health,
well-being and work productivity among employees of Dutch SMEs compared to
ASCEND only, DWM only, or ECAU only (the economic evaluation informed by the
effectiveness study phase 4a and 4b combined)

The complete ADVANCE study consists of five phases (see below). This proposal
concerns study phases 4b and 5.

Study phase 1 and 2 are described in separate non-WMO protocols for which
ethical clearance has been sought from the scientific and ethical review board
Vaste Commissie Wetenschap en Ethiek (VCWE), of the faculty of Behavioral and
Movement Sciences, Vrije Universiteit Amsterdam. Ethical clearance will be
sought from VCWE for study phase 3 as well. Study phase 4a is described in a
separate protocol that has been submitted for a non-WMO waiver at the Non-WMO
Review Committee of the METC Amsterdam UMC.


Study phase 1: Cultural and contextual adaptation of ASCEND and DWM for
supervisors and employees of Dutch SMEs
Study phase 2: Pilot studies investigating the feasibility of the ASCEND and
DWM interventions
Study phase 3: Cross-sectional study investigating the relation between
digitalization and mental health in employees of Dutch organizations
Study phase 4: Clustered Randomized Controlled Trials (cRCTs) with sequential
design
Study phase 4a (cRCT #1): Clustered RCT among supervisors of Dutch SMEs (ASCEND
and CAU vs. CAU)
Study phase 4b (cRCT #2): Clustered RCT among employees of Dutch SMEs (DWM and
CAU vs. CAU)
Study phase 5: Process evaluation with qualitative interviews and focus groups
to assess barriers and facilitators of engagement and adherence to the DWM
intervention and opportunities for scaling up the implementation of the
intervention.

All participants are randomized into a control or intervention group.

The control group receive CAU. The intervention group will receive CAU and also
DWM. Namely, participants will receive access to the digital self-help
intervention where they will need to complete the 5 modules in 5 consecutive
weeks (a new module is made available each week). Additionally, participants
will receive weekly support from a trained non-specialist helper.

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. 25 minutes each).

Study phase 4b:
Participants will be assessed online a total of three times over the course of
three months. Data will be collected by means of self-administered online
questionnaires. Questionnaires will be taken at baseline, 1-week
post-intervention, and 3 months follow-up. The six DWM helper support calls,
for participants in the treatment group, will be audiotaped for the purpose of
monitoring (if participants provide consent for this).


Study phase 5:
The interviews with participants in the target group in phase 4b (both
completers and drop-outs) will take approximately 1 hour. The FGDs with DWM
facilitators and professionals/representatives of SMEs will take approximately
2 hours.