BREATHS Trial

Uses

Preparation

Risks & contraindications

Background

Highlighted claims

• 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. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• The primary outcome is seizure remission, defined as zero seizures in the preceding four weeks recorded in a seizure diary, measured at Week 12. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• The trial is conducted at four public hospitals in Melbourne, Australia and at the New Zealand Brain Research Institute in Christchurch. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• Recruitment commenced in February 2024 and is expected to remain open for four years. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• Participants are individually randomised 1:1 using randomly permuted blocks stratified by site and baseline Nijmegen score. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• The principal limitation of the trial is that participant and therapist blinding is not possible; only the research assistant and statisticians are blinded. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol
• Consumer organisation FND Hope contributed to study design, funding, and sits on the trial steering committee. — Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol