Self-guided digital behavioural therapy versus active control for [FM] (PROSPER-FM): a phase 3, multicentre, randomised controlled trial 2024 Arnold+

Summary

Background
International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. We aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.

Methods
In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22–75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.gov, NCT05243511 (now fully closed).

Findings
Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9–58·9; p<0·0001). No device-related safety events were reported.

Interpretation
Digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.

Funding
Swing Therapeutics.

Paywall, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00909-7/abstract

 

Here's a press release about the trial from November 2023, which provides a little more info: https://swingtherapeutics.com/swing-results-stanza-digital-therapy-for-fibromyalgia-symptoms/

I was tempted to comment more about this trial, but without seeing the whole paper, it's tricky. They claim to have used a "blind-to-hypothesis" model, presumably to get round the fact that it is not double-blinded. But this really is a bit of a fig leaf. The patients will know whether they are getting the ACT intervention or the symptom tracker, and if they don't know what the two "interventions" are, then I suspect some unethical informed consent violation shenanigans have been going on. (Probably told some guff about, "oh we don't know which of these two probably effective interventions work, which is why we are trialling them" or somesuch.)

The interpretation is key. This is a management strategy. Not a treatment as such.

 

Haven't read through this yet but here's how they describe how they informed the patients:

Not sure that this approach is indeed consistent with truly informed consent. Impossible to determine whether the results are just the result of the usual biases including short-term altered questionnaire-answering behaviour as we've seen so many times before. Also noticed there's quite a significant declaration of interests.

 

I can't wrap my head around exactly what the benefits of ACT are supposed to be and what that means...

when the pain continues whether or not you adopt a positive attitude and the exhaustion ensues when you try to up your activity level.

 

It is a polite way of patient blaming which is more expensive but saves the doctors from admitting how little they know about your illness.

 

Patient not seen again in clinic. Presumed recovered. File closed.

If they'd never see anyone again after that first consult, no matter how disabled the patients are, no matter any other variable, they'd be happy with the outcome. For decades we heard people confidently state that X won't be heard anymore in a few years, once it's out of fashion. It never happens, but they never stop trying to erase it from existence.

It's never about the patients, it's not even about the costs, it's about direct health care expenses. They'd rather society pay 1000x the total costs if it means they save a single dollar in health care budget. Basically it's a systematic application of lack of object permanence.