RELEASE: REdressing Long-tErm Antidepressant uSE in adults in general practice (RELEASE): A two arm parallel-group cluster RCT effectiveness-implementation hybrid type-1 study

The REdressing Long-tErm Antidepressant uSE in general practice (RELEASE) trial is a pragmatic cluster randomized controlled trial (cRCT) that seeks to determine whether a novel multi-strategy intervention that supports safe cessation of long-term antidepressants is superior to Usual Care.1 Pragmatic trials are designed to determine how well interventions work in clinical practice under everyday conditions.2 The multi-strategy intervention has two forms, known as RELEASE and RELEASE+. RELEASE for patients includes direct patient education and resources3 and an invitation to medication review; RELEASE for general practitioners (GPs) includes education, training in the brief intervention (Ask, Advise, Assist) and printable resources via practice management software. RELEASE+ additionally includes for patients links to freely available information online via an App, and for GPs clinical audit and feedback on practice prescribing of antidepressants. Patient directed education material has the potential to support safer prescribing, including in this case improved recognition and management of antidepressant withdrawal symptoms.4, 5 Brief interventions have the potential to change GP prescribing behaviour.6 The primary comparison of interest is whether any RELEASE intervention is superior to Usual Care. A secondary comparison will be between the two types of RELEASE interventions (RELEASE and RELEASE+). The purpose of this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan (SAP) will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison.