Protocol Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised... 2026 Kanaan et al

[Andy]

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

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.

Open access

 

[rvallee]

Despite this, treatment options for FS are limited.

The paper later references the CODES trial, which is used by some to argue that CBT is such an option and that validates the model that this is a psychological condition, in fact asserts it despite the trial failing. A discipline stuck in a perpetual state of amnesia, where neither the past nor the present exist, unless convenient.

The recommended treatment for FS is usually psychotherapy; however, a review of psychotherapy found no validated treatments offering sustained benefit.

So, the recommended treatment does not work. Why is it recommended, then? And what is the point of doing more of it? This is clearly not about breathing problems, this is just a psychological therapy wrapped in biobabble.

Further, patient compliance is problematic and many patients do not attend or complete therapy,11 in large part because of the stigmatisation of psychiatric diagnoses.

And what, pray tell, is the source of this stigma? Oh, the medical profession is? Well that's awkward and pretty much self-defeating, now is it?

There is an association between FS and panic attacks, though the reason for this is unclear.13 We propose that the association is due to a common mechanism—hyperventilation.

Can't lose the plot if you never had it.

The human slop machine is infinite. Unlike the AI slop machines, which can be reasoned with.

 

[Utsikt]

The data they will collect includes:

Childhood Experience of Care and Abuse Questionnaire​

A self-reported version of the clinician administered childhood experience of care and abuse developed in 1994. The CECA-Q asks participants about relationships with their caregivers and other close relationships before they were 17 years of age. The CECA-Q is estimated to take between 20 and 30 min to complete.29

Life Events and Difficulties Schedule​

A semi-structured interview designed to explore significant life events and related difficulties such as times of financial strain, unemployment, unstable housing, illnesses suffered by self or a family member and relationship difficulties; as well as important sources of social support for the interviewee. In this study, participants will be eligible to complete the LEDS if their FS have commenced within the preceding 2 years; however, it will be optional for eligible participants to complete.

If they are willing, the RA will administer the LEDS at the Week 12 visit, and questions will be asked based on experiences within the 12 months prior to the onset of their FS. The administration time of the LEDS can vary; however, it usually takes between 2 and 3 hours and will be audio recorded to assist analysis. To improve reliability, interview details will be presented (in a de-identified manner) and reviewed by a panel who are blind to the participant’s subjective perceptions of explored events, as well as their health status at time of interview.31

The statistical analysis plan hasn’t been written yet. How convenient:

Statistical analysis​

A formal detailed statistical analysis plan for the study will be written prior to unblinding of the database. All analyses will follow the intention-to-treat principle.

They also seem to be completely oblivious to the issues with combining subjective outcomes with no blinding of the participants:

The large sample size and randomised placebo-controlled design are significant methodological strengths in the current study. A further strength is the assessment of clinical outcomes at prolonged follow-up.

 

[Sean]

Further, patient compliance is problematic and many patients do not attend or complete therapy,11 in large part because of the stigmatisation of psychiatric diagnoses.

And what, pray tell, is the source of this stigma?

Exactly.

How do they now it is (unjustified) stigma/fear of psychiatric diagnoses and therapies that is the problem, as opposed to those diagnoses and therapies being false, and useless, and sometimes a lot worse than merely useless, and hence the stigma and fear of them being entirely justified?

Where is the space in their model for that very real possibility? Or are they going to claim it is literally or virtually impossible for such a thing to be true?

 

[SNT Gatchaman]

Patients were involved in the design and conduct of the trial. A representative of the consumer organisation for functional neurological disorders (FND), ‘FND Hope’, contributed to the design of the study and to obtaining funding, and sits on the trial steering committee.

 

[SNT Gatchaman]

The control condition, Befriending, is specifically designed to be the control intervention for clinical trials of psychology-based or ‘talking’ therapies. It offers the same clinician contact and involves meeting and talking with the participant in a supportive, friendly, but non-directive manner. It has been manualised and its outcomes formally assessed to allow it to serve as a theoretically justified ‘placebo’ group. It has become the standard control group in therapy trials for mental health, as it matches for expectancy, acceptability, enjoyment and engagement, while delivering no specific benefit on most outcomes.

That control was evaluated for people with psychosis.

Ref is The Credibility and Acceptability of Befriending as a Control Therapy in a Randomized Controlled Trial of Cognitive Behaviour Therapy for Acute First Episode Psychosis (2006) —

The questionnaire also yielded skewed responses to all items in the direction of overall satisfaction with both kinds of therapy. This meant sample sizes in many cells were too small for statistical analysis and the percentages in each cell were examined. This did allow for detection of differences in the pattern of satisfaction responses between the ACE and Befriending groups, even though they did not reach significance. This shows that, despite low numbers, “clinically” significant differences in satisfaction were able to be detected using this design. The study is also flawed by the collection of satisfaction data at two time points. Ideally, the satisfaction questionnaire should be completed at the end of treatment.