ABSTRACT
BACKGROUND: Common mental health problems, such as stress, anxiety and depression, are highly prevalent among workers and often lead to long-term absenteeism and work disability. Effective elements found in previous researched interventions were to explicitly focus on return to work (RTW) and not solely on symptom reduction, to take into account the employees' cognition towards RTW and to include the workplace environment. Based on these elements, a stepped-care approach was developed. The aim of this paper is to present the study design of a randomized controlled trial (RESTART), evaluating the effectiveness of the stepped-care approach on lasting RTW and the implementation process. METHODS: RESTART is a randomized controlled trial with a 2 × 2 factorial design and a follow-up of one year. Employees eligible for this study are those who reported sick within 2 to 8 weeks with psychological distress based on a distress screener. Participants will be randomized to a group receiving a tailored e-Health app or usual care, as well as randomized to a group receiving a Participatory Approach (PA; conversational method) in the workplace or usual care. The PA will however only be provided in case of persistent sickness absence at 8 weeks. Measurements take place at baseline, after the e-Health intervention period (3 months), and after the PA intervention period (6 months) and 12 months. Primary outcome is lasting RTW, defined as full RTW in previous or equal work for at least four consecutive weeks. Secondary outcomes are (the severity of) stress-related symptoms, total number of sickness absence days, self-efficacy for RTW and self-reported health. A process evaluation including a realist evaluation will also be conducted. DISCUSSION: Early intervention that focuses on RTW, the cognition towards RTW despite symptoms and involves the workplace environment, plays a crucial role in managing sickness absence among employees with psychological distress. If effective, the stepped-care approach is relevant for employees, employers and society as a whole. TRIAL REGISTRATION: ISRCTN: 90663076. Registered on 5 October 2023.