Implementation and evaluation of a multi-level mental health promotion intervention for the workplace (MENTUPP): study protocol for a cluster randomised controlled trial
Authors: Arensman Ella , Leduc Mallorie , O’Brien Cliodhna , Corcoran Paul , Griffin Eve , Leduc Caleb , Coppens Evelien , Tsantila Fotini , Ross Victoria , Abdulla Kahar , Hauck Pia , Amann Benedikt L. , Aust Birgit , Pashoja Arlinda Cerga , Cresswell-Smith Johanna , D’Alessandro Luigia , Fanaj Naim , Greiner Birgit A. , Luyten Jeroen , Mathieu Sharna , Maxwell Margaret , Qirjako Gentiana , Reich Hanna , Sanches Sarita , Tóth Monika Ditta , Kilroy Joseph , Michell Karen , Reavley Nicola , McDaid David , Van Audenhove Chantal ,   the MENTUPP consortium, O’Connor Ainslie , Moreno-Alcázar Ana , Meksi Andia , Szekely Andras , LaMontagne Anthony , Como Ariel , Dushaj Arilda , Doukani Asmae , Justicia Azucena , Hogg Bridget , Holland Carolyn , Paterson Charlotte , Lockwood Chris , Guinart Daniel , Dhálaigh Doireann Ní , Kim Dooyoung , Williamson Eileen , Zsak Eva , Burazeri Genc , Cully Grace , Davey Grace , Purebl György , Serbanescu Ilinca , van Weeghel Jaap , Alcaraz Juan Carlos Medina , Eustace Joe , Hug Juliane , Kõlves Kairi , Mulcahy Karen , Thomson Katherine , Wahlbeck Kristian , de Winter Lars , Cox Laura , Fontana Marta , Trembeczky Peter , Driessen Pia , Lohmann-Devantier Rebecca , Rugulies Reiner , Benson Ruth , Rapeli Saara , Ihinonvien Sarah , Mustafa Sevim , Hackel Stefan , Alexander Susan , King Tanya , Hegerl Ulrich , Scott Vanda , Orchard Wendy 
Published: September 2023

Abstract
Background
Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia.

Methods
Each intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation.

Conclusions
At present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace.

Trial registration
Please refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022.