{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Psychiatry, Austin Health, The University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Richard Kanaan"
    },
    {
      "affiliations": [
        "New Zealand Brain Research Institute, Christchurch, Canterbury, New Zealand"
      ],
      "name": "Rod Duncan"
    },
    {
      "affiliations": [
        "School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia"
      ],
      "name": "Cathrine Mihalopoulos"
    },
    {
      "affiliations": [
        "Centre for Epidemiology and Biostatistics, University of Melbourne School of Population and Global Health, Carlton, Victoria, Australia",
        "MISCH (Methods and Implementation Support for Clinical Health) Research Hub, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia"
      ],
      "name": "Sabine Braat"
    },
    {
      "affiliations": [
        "Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Terence J O’Brien"
    },
    {
      "affiliations": [
        "Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Dennis Velakoulis"
    },
    {
      "affiliations": [
        "Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"
      ],
      "name": "Patrick Kwan"
    },
    {
      "affiliations": [
        "New Zealand Brain Research Institute, Christchurch, Canterbury, New Zealand",
        "Psychological Medicine, University of Otago, Dunedin, New Zealand"
      ],
      "name": "Roger T Mulder"
    },
    {
      "affiliations": [
        "The University of Melbourne St Vincent’s Department of Medicine, Fitzroy, Victoria, Australia"
      ],
      "name": "Mark Cook"
    },
    {
      "affiliations": [
        "Department of Neurology, Bladin-Berkovic Comprehensive Epilepsy Program, Austin Health, Heidelberg, Victoria, Australia"
      ],
      "name": "Saul Mullen"
    },
    {
      "affiliations": [
        "FND Hope Australia, Perth, Western Australia, Australia"
      ],
      "name": "Deeanne Mayne"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Austin Health, The University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Gina Oliver"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Austin Health, The University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Dina Eleftheriadis"
    },
    {
      "affiliations": [
        "Department of Neurology, Christchurch Hospital, Christchurch, Canterbury, New Zealand",
        "University of Otago, Dunedin, Otago, New Zealand"
      ],
      "name": "Ozayr Ameen"
    },
    {
      "affiliations": [
        "School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Mary Lou Chatterton"
    },
    {
      "affiliations": [
        "The University of Melbourne St Vincent’s Department of Medicine, Fitzroy, Victoria, Australia"
      ],
      "name": "Wendyl D’Souza"
    },
    {
      "affiliations": [
        "Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia",
        "Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia",
        "Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"
      ],
      "name": "John-Paul Nicolo"
    },
    {
      "affiliations": [
        "Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia",
        "Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia",
        "Department of Neurology, Bladin-Berkovic Comprehensive Epilepsy Program, Austin Health, Heidelberg, Victoria, Australia",
        "Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Piero Perucca"
    },
    {
      "affiliations": [
        "Alfred Mental Health and Addictions, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Toby Winton-Brown"
    },
    {
      "affiliations": [
        "MISCH (Methods and Implementation Support for Clinical Health) Research Hub, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia",
        "Centre for Epidemiology and Biostatistics, The University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia"
      ],
      "name": "Sophie Zaloumis"
    },
    {
      "affiliations": [
        "The University of Melbourne Department of Physiotherapy, Carlton, Victoria, Australia"
      ],
      "name": "David Berlowitz"
    }
  ],
  "title": "Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol",
  "uid": "454006a2-536b-5350-b063-ffebbc9ecf74"
}
