Mental Health Promotion and Intervention in Occupational Settings (MENTUPP): a cluster-Randomized Controlled Trial

Depression and anxiety are the most common mental health difficulties in the
workplace in the EU, causing immense suffering and costing the global economy
¤1 trillion each year in lost productivity. Research has consistently shown
that in the construction, healthcare and Information and Communication
Technology (ICT) sectors, a relatively large number of employees suffer from
mental health difficulties and have an elevated risk of developing more severe
mental health problems, such as suicidal ideation, depression and comorbid
anxiety or stress related symptoms. Those working in small and medium
enterprises (SMEs) are particularly vulnerable, as available studies indicate
elevated levels of depression, psychological distress, burnout, absenteeism and
presenteeism among SME employers and employees, compared to large enterprises.
Overall, SMEs comprise more than 90% of all EU businesses, meaning there is a
huge potential to influence population health through the implementation of the
proposed intervention programme.

The primary objective of the MENTUPP research project is to improve mental
health in the workplace by developing, implementing and evaluating the
effectiveness of a multicomponent intervention (MENTUPP) targeting mental
health difficulties (non-clinical and clinical) in the workplace in SMEs across
construction, health and ICT sectors. A secondary aim is to reduce depression,
anxiety and suicidal behaviour, as well as stigma related to mental health
problems. The main aim of the current research project is to conduct a
multi-country clustered Randomized Controlled Trial (cRCT), in order to assess
effectiveness and cost-effectiveness of the MENTUPP intervention, in nine
implementation countries, among which the Netherlands.

The multi-country cRCT will use a mixed-methods approach, in which both
qualitative and quantitative outcomes are collected during the thirtheen-month
study period (June 2022 - July 2023). Within each of the nine intervention
countries, among which the Netherlands, a total of 6 SMEs will be recruited
(two from the construction, two from the health care and two from the ICT
sector). Per sector, the recruited SMEs will be randomly assigned to either the
intervention or the delayed intervention control group, in order to allow an
evaluation of the (cost-)effectiveness of the MENTUPP intervention compared to
the control group. Quantitative and qualitative measures will be collected at
baseline, upon completion of the intervention (9 months post-baseline) and at a
four-month post-intervention follow-up (13 months post-baseline).

The MENTUPP intervention will contain three intervention components:
Component A focuses on promoting mental wellbeing and targeting non- and
pre-clinical mental health aspects including stress, burnout, and depressive
symptoms.
Component B focuses on depressive disorders, anxiety, and co-morbid physical
health difficulties (clinical in accordance with ICD-10).
Component C targets destigmatisation of mental health problems in the SMEs
workplace Interventions.
All three components will be developed for the MENTUPP project and are
primarily delivered through the online MENTUPP Hub which contains educational
materials, such as information packages in textual form, interactive
assignments, leaflets and videos. Participants are able to login to the MENTUPP
Hub and follow the intervention components of their choice, using their own
account and going at their own pace. In addition, workshops will be organized
where possible. The MENTUPP intervention targets three interconnected levels:
the individual, the peer and the organizational level.

Participation in the workshops and online materials of the MENTUPP intervention
are voluntarily. Online materials, related to the three components of the
MENTUPP intervention, are offered in the MENTUPP Hub, but participants are not
obligated to complete a certain set of specific materials or workshops. The
materials are freely accessible to all participants and they are free to use
any of the materials at any time and in any order depending on individual
interests and/or needs. However, participants are required to complete several
questionnaires during baseline and follow-up assessments, and participants are
only able to access all MENTUPP materials after they completed the baseline
assessment. Completion of these questionnaires will take approximately 30
minutes per assessment. Participation in qualitative focus groups is also
voluntarily. Outcome data will be processed and managed in accordance with
Dutch and European GDPR guidelines. As the MENTUPP intervention will be
implemented within the SMEs, anonymous participation of employees related to
their employers and leaders cannot be guaranteed, but it might be possible if
they choose to only participate in the online intervention materials. Given the
potential stigma and risk associated with mental health issues, particular care
will be taken when members of the project team engage with employees and
employers with mental health issues after informed consent has been received.
Although the target groups comprise individuals who may be vulnerable, in
previous research projects of several consortium partners, the interventions
offered have been shown to have beneficial effects on mental health without any
adverse effects. Therefore, the benefits of participating are expected to
outweigh any potential risks.