title: A mixed-methods process evaluation of Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) – a blended digital intervention for relapse prevention in schizophrenia tested with a feasibility cluster randomised controlled trial in Scotland and Australia
Creators: name: Allan, Stephanie
Publisher: name: University of Glasgow
Year: 2023

description: Introduction: schizophrenia is described as a severe mental illness affecting individuals, their families, and society. Many people with schizophrenia across the world do not have access to evidence-based care. User-led digital interventions that deliver treatment to patients in the community may help upscale provision. However, this will only happen if the interventions are implemented, and digital interventions frequently face implementation barriers. Standard clinical trials do not always generate evidence which can help answer questions related to implementation which means additional studies are required. EMPOWER was a user-led relapse prevention mobile app trialled in a feasibility cluster randomised control trial both the UK and Australia. This provided an opportunity to conduct implementation research using process evaluations. Researchers conducting process evaluations are encouraged to engage in cumulative science and build upon previous work conducted in interventions underpinned by similar intervention theory. Methods: Seven studies were conducted. Following two introductory chapters, a systematic review (Chapter 3) summarised what user-led interventions exist and what intervention theory underpinned them. None were like EMPOWER which justified developing a novel process evaluation framework (Chapter 6) underpinned by the qualitative work from Chapters 4 and 5. Chapter 6 revealed key uncertainties such as the recruitment process which resulted in the ethnography conducted for Chapter 7, understanding end user experiences which resulted in the qualitative interviews in Chapter 8, and a need to more fully understand the underlying intervention theory using temporal methods which resulted in the multilevel vector autoregression of ecological momentary assessment data in Chapter 9. Results: Chapter 3 suggested user-led interventions target a variety of problems faced by people with schizophrenia, but the field is young and there is high risk of bias. Additionally, there is low adherence and high dropout suggesting a key need to understand implementation. Chapters 4 and 5 analysed data from focus groups to understand how early warning signs of relapse are managed in clinical care and implementation expectations and the data were used to develop the novel process evaluation framework in Chapter 6. The findings from Chapter 7 suggest trial recruitment process was complex and the patient participants who took part are likely to be a highly selective sample. Two overarching themes were constructed in Chapter 8 that were relevant for understanding end-user experiences within the EMPOWER trial: Affordances and Change Processes. Affordances described the processes underpinning how and why participants interacted with or avoided the various components of the intervention. Affordances spanned all EMPOWER components, including self-monitoring, peer support workers, clinical triaging, self-management messages and diary function. The affordances were Access to Social Connection, Access to Digital, Access to Mental Health Support, the Ability to Gauge Mental Health and Access to Mental Health Information. The affordances framework helped explain the multitude of engagement trajectories observed within the main EMPOWER trial. Chapter 9 found that experiencing fear of relapse predicted next day experiences of depression and anxiety which supports the assumptions of the underlying intervention theory. However, observed effect sizes were very small. Discussion: The findings present a holistic process evaluation of EMPOWER. Across all studies, implementation issues were found to be complex. Conducting qualitative research was essential for developing theory to explain and understand the implementation processes within the EMPOWER trial and highlights the value of conducting implementation research in parallel with RCTs. A revised logic model was created and is presented in Chapter 10 which can be used to evaluate a future full-scale trial.