Protocol Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy ACT for post-COVID syndrome…l, 2026, Carvalho,Chalder+

[SNT Gatchaman]

Randomised controlled trial assessing the efficacy of balance acceptance and commitment therapy ACT for post-COVID syndrome: a study protocol

Spoiler: Authors

Nicole Carvalho; Michail Kalfas; Caroline Jolley; Gerrard F Rafferty; Oliver Pearson; Richard Emsley; Alan J Metcalfe; Barbara Barrett; Debbie Brewin; Lily Felton; Tasbiha Khan; Nicholas Hart; Emma L Duncan; Timothy Nicholson; Oliver C Witard; Rachael A Evans; Carole Beckwith; Trudie Chalder

INTRODUCTION
Post-COVID syndrome (PCS) is an ongoing legacy of the SARS-CoV-2 pandemic. Defined as symptoms persisting beyond 12 weeks following SARS-CoV-2 infection unexplained by an alternative diagnosis, many individuals continue to experience symptoms for months post-infection. Fatigue, breathlessness, cognitive difficulties and sleep disturbances are all commonly reported, frequently impairing daily functioning and quality of life. Acceptance and commitment therapy (ACT), which enhances psychological flexibility and supports values-based behaviour change, has shown effectiveness across long-term health conditions. This protocol describes the evaluation of Balance-ACT as a novel, adapted ACT-based intervention to address the complex physical and psychological needs of people with PCS.

METHODS AND ANALYSIS
A randomised controlled trial (RCT), co-developed with people with PCS, will evaluate the efficacy and cost-effectiveness of Balance-ACT for PCS. A total of 196 adults with PCS will be recruited from specialist long COVID services within secondary care across NHS organisations in England and randomised 1:1 to Balance-ACT or treatment as usual (TAU). Balance-ACT consists of 10 therapist-delivered sessions delivered over 13 weeks. TAU comprises brief educational videos and a self-help leaflet for COVID-19 recovery. Outcomes will be assessed at 7, 14 and 20 weeks post-randomisation. The primary outcome is health-related quality of life, measured using the SF-36 Physical Component Score at 14 weeks post randomisation. Secondary outcomes include physical health-related quality of life at 20 weeks, perceived fatigue, clinical global improvement, sleep disturbance, cognitive functioning, depressive symptoms, anxiety symptoms, post-exertional malaise, breathlessness, muscle strength, muscle fatigue and heart-rate variability. Mediation analyses will examine whether the intervention leads to changes in psychological flexibility, fear-avoidance beliefs, damage beliefs, embarrassment-avoidance, symptom focusing, muscle strength and physical activity and whether these changes are associated with physical health outcomes. We will also conduct a nested qualitative study to explore participants' views of the intervention. Cost-effectiveness will be assessed by comparing health and social care service costs and quality of life outcomes between Balance-ACT and TAU at 20 weeks.

ETHICS AND DISSEMINATION
Ethical approval has been granted by the NHS Camberwell St Giles Research Ethics Committee (reference 23/LO/0941). The study results will be disseminated in peer-reviewed journals and presented at international conferences.

TRIAL REGISTRATION NUMBER
NCT06231238.

Web | DOI | PDF | BMJ Open | Open Access

 

[Chandelier]

A randomised controlled trial (RCT), co-developed with people with PCS, will evaluate the efficacy and cost-effectiveness of Balance-ACT for PCS.

We co-developed an intervention using ACT integrated with the principles of homeostasis, the self-regulating process by which individuals maintain psychological and physiological stability in response to internal and external changes,17 called Balance-ACT.1,8
As disruptions in homeostatic processes may contribute to PCS symptoms,19–22the intervention is aligned with the principles of ACT (mindfulness strategies and values-based goal setting) alongside helping individuals to establish balance, regulating behaviours such as sleep and physical activity and reducing stress. Improving sleep and reducing stress may indirectly support homeostasis, given their influence on multiple physiological systems.23–27
Mindfulness has also been shown to improve sleep, self-reported fatigue and cognitive function, which are frequently impaired in PCS.28 29

To ensure acceptability, Balance-ACT was co-developed with patients and healthcare professionals through qualitative interviews18 30and a patient and public involvement (PPI) advisory group.
This paper presents a study protocol for Balance-ACT as a novel ACT-based intervention that is specifically tailored to address the complex needs of people with PCS.

Trial oversight​

A combined DMEC/TSC were established to provide oversight for this study. The DMEC/TSC is comprised of members independent of the study team. Members of the DMEC/TSC include independent clinicians, an independent statistician and one PPI member with lived experience of PCS. The DMEC/TSC meets every 6 months for the trial duration. The role of the DMEC/TSC is to provide oversight for the trial, safeguard the rights of the participants and ensure the trial is conducted to rigorous standards in line with Good Clinical Practice guidelines. The DMEC/TSC also provides advice to the TMG and the Sponsor of the trial. The DMEC/TSC has access to study data and is responsible for monitoring participant safety and trial data. Data extracts are requested by the Trial Statistician prior to each DMEC/TSC meeting, who prepares reports for the DMEC/TSC.

 

[SNT Gatchaman]

https://clinicaltrials.gov/study/NCT06231238

 

[Trish]

Trudie Chalder up to her old tricks I see.

 

[Chandelier]

This seems to be the larger follow-up study of this one:
Codeveloping a Novel Intervention for People With Post-COVID Condition: The Balance-ACT Study, 2025, Felton, Chalder+

 

[Turtle]

Trial oversight, no excuse anymore for being mathematically challenged @dave30th ?

 

[Adrian]

ETHICS AND DISSEMINATION
Ethical approval has been granted by the NHS Camberwell St Giles Research Ethics Committee (reference 23/LO/0941). The study results will be disseminated in peer-reviewed journals and presented at international conferences.

I wonder if it is worth complaining about the ethics approval and committee pointing out similar methodologies were rated as poor by NICE and therefore questioning whether the trial can be ethical if the results produced will not be reliable.

Trial oversight​

... The role of the DMEC/TSC is to provide oversight for the trial, safeguard the rights of the participants and ensure the trial is conducted to rigorous standards in line with Good Clinical Practice guidelines. ...

They've failed at ensuring rigorous standards already judging by the abstract. I suspect anyone willing to join this group would not have enough knowledge to enforce rigorous standards or they would be recommending rewriting the protocol

 

[Utsikt]

I wonder if it is worth complaining about the ethics approval and committee pointing out similar methodologies were rated as poor by NICE and therefore questioning whether the trial can be ethical if the results produced will not be reliable.

Good luck getting an ethics committee to deny approval for projects with poor methodology. That would mean stopping virtually all BPS trials.

 

[rvallee]

Pure slop-fed slop. The worst kind of AI slop is when AI slop is fed to train another AI, the system simply degenerates into hallucinations. This is multi-generational slop, what happens after several generations of a system have been fed on its own waste, producing potent hallucinations.

 

[Sean]

Ethical approval has been granted by the NHS Camberwell St Giles Research Ethics Committee​

Well clearly they are completely unfit for purpose.

 

[Hutan]

This protocol describes the evaluation of Balance-ACT as a novel, adapted ACT-based intervention to address the complex physical and psychological needs of people with PCS.

No, it really isn't novel Trudy. It's just the same old stuff, it's all been tried before. A nice new encouraging name isn't going to make the difference.

Mediation analyses will examine whether the intervention leads to changes in psychological flexibility, fear-avoidance beliefs, damage beliefs, embarrassment-avoidance, symptom focusing, muscle strength and physical activity and whether these changes are associated with physical health outcomes.

Cost-effectiveness will be assessed by comparing health and social care service costs and quality of life outcomes between Balance-ACT and TAU at 20 weeks.

And twenty weeks (including the 13 weeks of therapy) is nowhere near long enough to safely conclude anything about service use. How will they assess health and social care service costs given they don't seem to be collecting real time information for a period at baseline - will they be relying on people to self-report service use?

And, even if they did collect accurate information about past service use, don't they understand that people initially see a number of doctors trying to get some help? And then, when they eventually realise there is no help to be had (and are helped to understand that it is their own inadequacies that are keeping them sick), most people give up on the medical system.

 

[Sean]

and whether these changes are associated with physical health outcomes.​

Will you be collecting any data on this that reveals causation, especially direction of causation?

 

[Adrian]

Good luck getting an ethics committee to deny approval for projects with poor methodology. That would mean stopping virtually all BPS trials.

It would and I would be very surprised if they were to stop approving but I also think it is important to tell them why such trials are unethical (as they can't produce high quality evidence). They need to know they will be seen as complicit in bad practice (i.e. making decisions knowing about the issues) rather than just lazy or ignorant.

 

[Sean]

Yep, this.

Make it undeniable and inevitable, and make sure they understand that.

I am actually pretty sure that a lot of the smarter senior ones do, but they have committed themselves to the losing side far too hard, for far too long, to successfully negotiate such a major about-face and personal mea culpa, and are now just trying to obfuscate it and string it out long enough to make it through to retirement.

 

[bobbler]

No, it really isn't novel Trudy. It's just the same old stuff, it's all been tried before. A nice new encouraging name isn't going to make the difference.




And twenty weeks (including the 13 weeks of therapy) is nowhere near long enough to safely conclude anything about service use. How will they assess health and social care service costs given they don't seem to be collecting real time information for a period at baseline - will they be relying on people to self-report service use?

And, even if they did collect accurate information about past service use, don't they understand that people initially see a number of doctors trying to get some help? And then, when they eventually realise there is no help to be had (and are helped to understand that it is their own inadequacies that are keeping them sick), most people give up on the medical system.

Yea I read this and that name and just thought about recent fb announcements regarding another study that seems intent on keeping the current services from moving on (and thereby allowing decent cohorts for scientific research, as well as you know proper support)

and can't help but think how the need from some individuals to keep having the most entitled gravy train I could imagine rolling on feels behind it. As if pwme don't have enough to deal with having a horrible illness, bigotry as an additional doubling or more of disability thanks to misinfo spread across everyone by the same people, and then to be left as prey to predatory stuff from/across all sorts of actors .. I get quite shocked when I watch other scandals then think of the environment around pwme (and this crud of 're-education' is about making them sitting ducks to 'say the right thing' as pawns for the first number of years which are probably the most important ones of being ill as can make all the difference in whether you recover or get changes to your life that actually mean energy ends will have a chance of meeting)

Anyway ...

Outcomes will be assessed at 7, 14 and 20 weeks post-randomisation. The primary outcome is health-related quality of life, measured using the SF-36 Physical Component Score at 14 weeks post randomisation.

Of course all of this is nonsense without proper long-term measures. The authors are well aware of this, because Nice analysis for ME/CFS actually fed back on this short-term measure being one of the significant issues chosen by bps/therapist-delivered/behavioural/rehab authors to be a problem with their research, even though it doesn't tell anyone whether anyone is the better or worse really for the treatment even only a year after it.

It is farcical these people are still allowed to work only on taking measures at timepoints so short it is at best looking temporary induced responses because they are only just 'trying out' saying what they've been told to say (which often links directly to the questions they'll be asked), not whether their illness gets worse or disability increases or decreases due to it.


What precisely is meant by 'post-randomisation'? 14weeks after they finished, so just 3 months after - or 3months from the start when they are still maybe having someone basically telling them what to say in xweekly sessions whilst filling out questionnaires? (in the hope it changes what they think and 'what they feel' when it doesn't change their illness at all just gaslights them from accessing their words by using coercion, leaving people worse off because they can no longer even describe to themselves what is going on).

And why aren't researchers required to state a time after finishing treatment given they know most will only ever read the abstract (that annoys me too as it feels so set up to move the whole subject area away from decent methods or even thinking of methods and robustness when reading about any 'new treatments' as a norm of layout)

Anyway, this is at least a measure that wasn't 'specially developed' to be influenceable and ambiguous in the same way as the latter ones are - I feel like a watch this space on who these people are on whether the primary outcome ends up being not reported on (writing-up as if it wasn't the main outcome if they don't get the answer they like) or even just changed from being the primary outcome, as so many previous pieces of research from that bunch have been.

Because look at the amount of bandwidth they've set themselves up for in the following...

It feels like a 'choose your own title' exam essay question.. don't worry we'll just run it and see what we can squeeze out at the end as maybe looking like it's something positive to say - which if so... would be marketing research (and not the most ethical of that either - and most of us marketers have been working under regulations that mean we wouldn't do research or report selectively or inappropriately either, weird how 'behavioural/therapist-delivered treatments' seems to be under some exemption from the CMA etc regs that other industries aren't?)

in the sense of not caring about whether it harms (always a tick these days for bps and it seems rehab now), the thing that would/should make it medicine - this just looks like a list of 'avoiding the important question' (did it harm - have any of these been made worse, in a situation where there is demonstrably no coercion as it is completely independent of the services that might impact on or write eg medical reports for the participants),

the classic 'I tried getting up at the right time every day and it made both my sleep worse and over the next year a huge deterioration in my health' being the important thing to capture - but I can just imagine here we will have cherry-picking that for that example would pretend it was a success even if behaviourally forcing people to try 'getting up at the right time' was the success (rather than that being a case of huge respect due to the patients for hurting themselves to do this and just what that would have taken, based perhaps on false promises) rather than the 'mother knows best suggestion that ended up hurting their health' and the 'did it make their illness worse or better long term' not being measured.

Secondary outcomes include physical health-related quality of life at 20 weeks, perceived fatigue, clinical global improvement, sleep disturbance, cognitive functioning, depressive symptoms, anxiety symptoms, post-exertional malaise, breathlessness, muscle strength, muscle fatigue and heart-rate variability.

Every single one of the below should not be allowed to be reported except as a result that must be explicitly tied to and reported against the primary outcome as kind of independent variable/ 'behavioural treatment' (rather than a result). eg 'getting up on time increasing was linked to a reduction in physical function' 'fear-avoidance mantras leading to supposed reduction in saying the wrong thing for the fear-avoidance beliefs scale led to increased disability', 'reduced symptom-focusing was linked to no change/reduced in physical function' etc.

And the idea 'muscle strength' can be measured accurately by a 'mediation analysis' implemented by whom? (different person to the one delivering the therapy or with perceived power to impact access to medical care or other implications?) what is a mediation analysis and what will it be of? an interview after people have just been trained in what to say and think - or something else?

Mediation analyses will examine whether the intervention leads to changes in psychological flexibility, fear-avoidance beliefs, damage beliefs, embarrassment-avoidance, symptom focusing, muscle strength and physical activity and whether these changes are associated with physical health outcomes. We will also conduct a nested qualitative study to explore participants' views of the intervention. Cost-effectiveness will be assessed by comparing health and social care service costs and quality of life outcomes between Balance-ACT and TAU at 20 weeks.

focusing on cost-effectiveness (target market = people we are selling it to) not whether there is any effectiveness medically and then looking at cost for any effectiveness (Nice needs to update and put in regs for this I think it is about time). Anythign divided by 0 is infinity, if something is actively harming people then somehow we need a new number for something bigger than that.

Selling it as something that will be expensive in the sense of making certain people a lot of money, providing careers for others but claiming the usual 'per person it's cheaper' just reminds me of the cons of outsourcing contracts where eg commerical companies might bid low prices but ask for more later once the contract has been signed and the thing is up and running - why is it that a history of providing a treatment noone continued with because it harmed them and so defnitely not 'low cost per treatment' and certainly now low when dividing it by 0 on number of people it actually cures or helps.

 

[Sean]

Of course all of this is nonsense without proper long-term measures. The authors are well aware of this, because Nice analysis for ME/CFS actually fed back on this short-term measure being one of the significant issues chosen by bps/therapist-delivered/behavioural/rehab authors to be a problem with their research, even though it doesn't tell anyone whether anyone is the better or worse really for the treatment even only a year after it.

It is farcical these people are still allowed to work only on taking measures at timepoints so short it is at best looking temporary induced responses because they are only just 'trying out' saying what they've been told to say (which often links directly to the questions they'll be asked), not whether their illness gets worse or disability increases or decreases due to it.

I now regard this ongoing behaviour, after all that has happened, as among the most serious and systemic of scientific and ethical lapses in our time.

History is going to be brutal on these people and their system, and they will have earned it.