BREATHS Trial

Recruitment commenced in February 2024 and is expected to remain open for four years. Consumer organisation FND Hope contributed to study design, funding, and sits on the trial steering committee. The trial is conducted at four public hospitals in Melbourne, Australia and at the New Zealand Brain Research Institute in Christchurch. Participants are individually randomised 1:1 using randomly permuted blocks stratified by site and baseline Nijmegen score. The principal limitation of the trial is that participant and therapist blinding is not possible; only the research assistant and statisticians are blinded. The primary outcome is seizure remission, defined as zero seizures in the preceding four weeks recorded in a seizure diary, measured at Week 12. The BREATHS trial is a 24-week, multicentre, individually randomised, assessor-blinded, two-arm, parallel-group superiority trial comparing BCT against a Befriending control in 220 participants aged 16 or over.