| Title: |
Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol |
| Authors: |
Kanaan, Richard; Duncan, Rod; Mihalopoulos, Cathrine; Braat, Sabine; O’Brien, Terence J; Velakoulis, Dennis; Kwan, Patrick; Mulder, Roger T; Cook, Mark; Mullen, Saul; Mayne, Deeanne; Oliver, Gina; Eleftheriadis, Dina; Ameen, Ozayr; Chatterton, Mary Lou; D’Souza, Wendyl; Nicolo, John-Paul; Perucca, Piero; Winton-Brown, Toby; Zaloumis, Sophie; Berlowitz, David |
| Contributors: |
National Health and Medical Research Council |
| Source: |
BMJ Open ; volume 16, issue 1, page e107687 ; ISSN 2044-6055 2044-6055 |
| Publisher Information: |
BMJ |
| Publication Year: |
2026 |
| Description: |
Introduction Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results. Methods and analysis A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives. Ethics and dissemination The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1136/bmjopen-2025-107687 |
| Availability: |
https://doi.org/10.1136/bmjopen-2025-107687; https://syndication.highwire.org/content/doi/10.1136/bmjopen-2025-107687 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.A1E1ACAF |
| Database: |
BASE |