Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities

Background: People with severe psychiatric disabilities and impaired autonomy generally lead sedentary, solitary lives indoors and have significantly poorer health than others in the population. Meaningful everyday activities are important for the recovery towards an enrichening, agentic, social, and hopeful everyday life. The Everyday Life Rehabilitation (ELR) model – a person-centred activity- and recovery-oriented intervention – has shown positive outcomes in feasibility studies, and thus a randomised controlled trial (RCT) is required to establish the effectiveness of ELR, along with calculations of cost-effectiveness. Methods The ELR-RCT is a pragmatic, two-parallel-armed cluster RCT evaluating the effect and cost-effectiveness of using ELR from two measurement points over 6 months (pre-post intervention) and in two waves over 2 years. The primary outcome is recovering quality of life (ReQoL) at 6 months, and the secondary outcome is self-perceived recovery and daily functioning (RAS-DS) at 6 months. Additionally, Goal Attainment Scaling (GAS) will be used for the intervention group. Power analysis has been conducted for primary outcome measure. The first wave will include an internal pilot, to be evaluated after 6 months, used as basis for decisions on updating the required sample size and any other need for adaptations before continuing with the full-scale RCT in the second wave. All municipalities within a geographic distance of 270 kilometres from Umeå University, with a minimum of one sheltered or supported housing facility for people with severe psychiatric or neuropsychiatric disability, including access to occupational therapy, will be enrolled. Participants will be block-randomised to receive ELR plus treatment as usual (TAU) or TAU alone for a control period. The control group will thereafter receive delayed ELR. Occupational therapists and housing staff will receive an educational package, manuals, and tools, as well as reflections with colleagues during the intervention period. Housing managers will receive questions for monthly follow-up and coaching with staff. Discussion The pragmatic approach responds partly to the complex intervention, complex context, complex problems of participants, and complex research environment that is currently under study, and partly to an ambition that the research should contribute to usefulness in similar contexts. Trial registration: NCT05056415 [ClinicalTrials.gov, 24 September 2021]