The effectiveness and acceptability of Breathing Control Training (BCT) for Functional Seizures (FS)

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Breathing Control Training (BCT) teaches appropriate rate and depth of breathing and the development of a pattern of breathing appropriate to a person's current physical activity level. The elimination of dysfunctional breathing patterns, including hyperinflation and hyperventilation, is discussed. Diaphragmatic breathing is taught, and emphasis is placed on calm, slow, nasal expiration. Education on stress responses and their interactions with breathing patterns is given. The integration of appropriate breathing and relaxation techniques into daily living activities is encouraged. Initially exercises are taught in a semi‐recumbent position, progressing to sitting, then standing, then during everyday activities. Finally, the integration of breathing and relaxation techniques into speech is taught and practiced. In this project, BCT will be delivered by a respiratory physiotherapist with specific training in this technique at the participant’s primary care hospital, or via Telehealth if required. The physiotherapist will conduct a 60min initial session with the participant (one‐on‐one) and a 30min refresher (‘booster’) session (one‐on‐one) 1‐month later. Participants will be encouraged to practice the learnt BCT techniques daily (5‐10 minutes, twice daily) and record their adherence in a calendar style diary. The diary will be be reviewed by the physiotherapist at the booster session and compliance recorded in the participant s case report form, as well if they attended both treatment sessions (initial and booster). CONDITION: Mental Health ‐ Other mental health disorders Neurological ‐ Other neurological disorders Functional Seizures; ; Functional Seizures PRIMARY OUTCOME: Participant self‐reported seizure remission, defined as seizure frequency of zero in the preceding 4‐weeks.[Measured 3 months post initial treatment session of BCT/Befriending] ; ‐If they have received a diagnosis of a new medical condition/disease since baseline ; ‐If they have experienced a worsening in a pre‐existing medical condition since baseline ; ‐If any new symptoms have occurred since baseline ; ‐If they have been informed of any abnormal laboratory findings which are identified after randomisation into the trial ; [AEs will be reviewed 1‐month, 3‐month and 6‐months post the initial treatment (BCT/Befriending) session via an online self‐report questionnaire. After reviewing their responses, the research assistant will contact the participant if they require any further information (for example, clarifying onset, duration, severity of the AE) before reporting all AEs to an independent Data and Safety Monitoring Board (DSMB) comprising an epileptologist, psychiatrist and researcher/statistician for review. ] INCLUSION CRITERIA: i) 16 years of age or above ii) Able to provide written, informed consent iii) Diagnosis of Functional Seizures (FS; clinically established by an Epileptologist) iv) Self‐reported FS frequency of at least 2 per month v) English sufficient to complete questionnaires and understand the treatment intervention SECONDARY OUTCOME: Changes in healthcare utilisation from baseline, measured via a tailored self‐report resource use questionnaire (RUQ), as well as changes in health service use obtained from Services Australia (the latter for consenting participants based in Australia), assessed as a composite secondary outcome where possible. [The RUQ will be provided to participants at baseline, and 3‐months & 6‐months post the initial treatment (BCT/Befriending) session. Services Australia data will be requested for the period 3‐months prior to the participant's randomisation into the trial until the 6‐month final assessment date (6‐months post the initial BCT/Befriending treatment session). ] Acceptability of BCT assessed by a tailored participant self‐report questionnaire [Provided after attending the 1‐month ‘booster’ BCT treatment session] Changes in depression and anxiety symptoms from baseline, measured by the Hospital Anxiety and Depression Scale (HADS)[Provided to participants at baseline, and 1‐month, 3‐month & 6‐months post the initial treatment (BCT/Befriending) session. ] Changes in occupational and social functioning from baseline, measured by the Work and Social Adjustment Scale (WSAS) [ Provided to participants at baseline, and 1‐month, 3‐month & 6‐months post the initial treatment (BCT/Befriending) session. ] Changes in quality of life from baseline, measured by the Assessment of Quality of Life Eight Dimension (AQoL 8D)[ Provided at baseline, and 1‐month, 3‐month & 6‐months post the initial treatment (BCT/Befriending) session. ] Change in hyperventilation from baseline, measured by the Nijmegen scale of hyperventilation[Nijmegen scale of hyperventilation provided at baseline, and 1‐month, 3‐month & 6‐months post the initial treatment (BCT/Befriending) session ] Safety of BCT assessed by the occurrence of adverse events (AEs). From the investigator's own pilot data (unpublished at present), and randomised‐controlled trials of breathing exercises for asthma, BCT’s excellent safety and tolerability profile is evident. Nonetheless, AEs will be reviewed and monitored throughout the trial to further explore BCT’s safety profile in Functional Seizures specifically. Thus, participant's will be asked the following questions:
Epistemonikos ID: 544858db68fbe0c9a7d3dfbbf51c2954d47c782c
First added on: Aug 25, 2024