# Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol

## TL;DR

This study aims to test if breathing control training is an effective and acceptable treatment for functional seizures compared to a control intervention.

## Contribution

The study introduces a randomized controlled trial protocol to evaluate the efficacy of breathing control training for functional seizures.

## Key findings

- Participants will be assessed at baseline and at 4, 12, and 24 weeks to evaluate treatment outcomes.
- An economic evaluation will assess the cost-utility and cost-effectiveness of the intervention from health sector and societal perspectives.

## Abstract

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.

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.

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.