Process evaluation protocol for the SLEEP study: a hybrid digital CBT-I intervention for working people with insomnia

Introduction The Supporting Employees with Insomnia and Emotional Regulation Problems (SLEEP) pilot uses hybrid digital Cognitive Behavioural Therapy for Insomnia (CBT-I) to help working people address their sleep and emotion regulation problems, using cognitive, behavioural, and psychoeducation techniques. A process evaluation within this trial will improve our understanding of how the intervention brought about change, including identifying barriers and facilitators to engagement and subsequent change, and the extent to which contextual factors played a role. Methods and analysis This qualitative process evaluation will use semi-structured interviews, conducted via online videoconferencing, to explore participant experiences of the SLEEP intervention. Twenty-five participants who completed the SLEEP intervention (16 %) will be randomly sampled. Interviews will be analysed using a thematic and framework analytic approach. A codebook style thematic analysis will be used, and a framework focusing on the research questions will be applied to the codebook. The final report will present themes generated, alongside the finalised codebook. The report resulting from this research will adhere to CORE-Q quality guidelines. Ethics and dissemination Full approval for the SLEEP study was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). All data collection adheres to data collection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written and verbal (audio-recorded) consent. The results of the process evaluation will be published in a peer-reviewed journal and presented at conferences. A lay report will be provided to all participants. Trial registration ISRCTN13596153; Pre-results.