Study Design and Setting
pain
MAY, RECRUITMENT
The Prevent Sick leave (PS) project is a two-armed cluster randomized controlled trial, comparing a psychosocial prevention program for pain and stress-related ill-health, to an active control. Clusters consisted of workplace-units of supervisor (-s) and their employees, which were randomized together. Supervisors and employees were recruited via occupational health care services. Participants were assessed at baseline, immediately after the intervention, and at a 6-month follow up. The project was registered at ClinicalTrials.gov (NCT03993444) and was approved by the Regional Ethical Review Board in Uppsala, Sweden (Number 2018/479). All participants provided written informed consent prior to study participation. Recruitment was initiated in December 2018 (information to workplaces, etc.), and enrolment of participants started in March 2019. Recruitment ended September 2020. There was four intervention periods, one each semester 2019–2020. The data collection periods were April 2019 to May 2021 for questionnaires, and November 2018 to May 2021 for social insurance register data. Due to the outbreak of the Covid-19 pandemic, the project was paused March 2020 to August 2020, and a revised ethical approval to deliver the remaining intervention groups online was obtained. Follow-up time for register data was shortened from original study plan, due to the delays in the project from to the Covid-19 pandemic.