Occupational therapy intervention development, for individuals with a diagnosis of psychosis living in the community, to improve participation in activities of everyday life: a feasibility study for a pragmatic randomised controlled trial.
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Background: Having a diagnosis of schizophrenia is associated with employment difficulties, high mortality rates, substantial family burden and impoverished quality of life and it costs between 1.5 to 3 per cent of the total expenditure on national health care (Knapp et al 2004). However social functioning and participation can have a protective impact on mental health of people with a diagnosis of psychosis (Stain et al 2013). Method: A systematic and phased approach to complex intervention development was undertaken involving: (1) A systematic review of effectiveness and (2) a feasibility study, designed to explore and test the key uncertainties of an effectiveness study, was conducted in two phases. This involved the development of an occupational therapy intervention specification and a feasibility study for a pragmatic randomised controlled trial (RCT). It utilised the Developing and evaluating complex interventions guidelines (MRC 2008). A task analysis approach was applied to extrapolate occupational therapy theory, practice and outcomes for the intervention specification (Gitlin 2013). The feasibility study was carried out across two centres. It used the intervention specification and included both study and process outcomes. The primary outcome was participation in activities of everyday life and the secondary outcomes were health-related quality of life and self-reported experience of occupational performance and satisfaction with occupational performance. Service user and carer involvement was integrated into the method. Results: The systematic review highlighted that there was no evidence of effectiveness for individualised client-centred occupational therapy interventions on participation in activities of everyday life or quality of life/ health related quality of life. The methodological quality of the effectiveness studies was generally low and details provided regarding interventions made replication difficult. The feasibility study recruited less people (n=20) than planned (n=64). However the outcomes of self-reported experience of occupational performance (p=.002) and satisfaction with occupational performance (p=.001) and self-evaluated transition (SET) (p=.026) improved with occupational therapy and were found to be statistically significant (p<.05). The intervention specification captured 98% of occupational therapy provided and was shown to have good utility for research and practice purposes. Conclusion: An intervention specification that reflects practice and has utility has been developed. Methods of measuring fidelity and adherence of occupational therapy have been designed and tested. Knowledge about how occupational therapy enables participation has advanced. The essential preparatory work to address the previously key uncertainties in a pragmatic RCT has been completed and the foundations for the next stage — a larger pragmatic RCT — have been put in place.