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Objective: This paper describes the protocol of a process evaluation of a cluster randomised controlled trial designed to evaluate the effectiveness, cost-effectiveness and implementation of a digital mental health intervention, called DIALOG+, in five lowand middle-income countries in Southeast Europe (Bosnia and Herzegovina, Kosovo1, Montenegro, North Macedonia and Serbia). The objectives of the process evaluation are: a) to explore attributes of context that might impact on the implementation of the DIALOG+ intervention; b) to assess intervention fidelity and c) to explore patients’ and clinicians’ retrospective (i.e. experienced) acceptability of the intervention. Materials and methods: This is a mixed-method process evaluation nested within the cluster randomised controlled trial. We adopted the guidance on process evaluations of complex interventions published by the United Kingdom Medical Research Council. Data collected during and after the trial, but prior to awareness of trial outcomes, include transcripts, questionnaire responses, routinely collected monitoring data and audio-recordings of intervention and control sessions. Data analysis is descriptive and involves triangulation methods to compare findings across countries, stakeholder groups (healthcare provider, patient) and data type (qualitative, quantitative). Results: This work is part of a larger study entitled ‘Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle-income countries in Southeast Europe’ (IMPULSE). The study is funded by the European Union’s Horizon 2020 research and innovation programme. The IMPULSE trial recruited 81 clinicians and 458 patients. The clinician clusters were randomised to the intervention (six sessions of DIALOG+ over 12 months) or treatment-as-usual arm. Process data collection began in parallel with the trial, starting in April 2019. Data collection and analysis will be completed before the main trial findings are known. Process evaluation findings will be used to interpret the trial results including assessing the effect of context on outcomes. Conclusion: This process evaluation will explore the context, intervention fidelity and acceptability to contextualise the trial results, help in optimising sustainability of the intervention and inform its future dissemination. The methods described here may also inform the development and implementation of other complex psychosocial interventions in low-resource settings.

Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial