Open Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders (OneSTEP), Denmark

[Andy]

The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program "One step at a time" designed for the treatment of patients with moderate to severe functional somatic disorders (FSDs).

The trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with "One step at a time") or the active control condition ("GetStarted"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established multi-organ BDS diagnosis with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.

https://clinicaltrials.gov/ct2/show/NCT05525598

 

[Creekside]

Perhaps a good control would be to have another set of patients watching Disney movies, or Action/Adventure movies, or cooking shows or nature shows. Just a wild guess that entertainment shows will be just as (in)effective.

 

[rvallee]

novel

Always novel. As in: belongs in the fiction section.

Always novel. Always the same plot. The same characters. The same ending. The same everything. Always novel, never any different. Words have no meaning in this ideology, they are merely gotchas or empty vessels.

 

[Jonathan Edwards]

They don't get it do they?
Calling one treatment experimental and the other active control with open label and subjective outcomes has already kiboshed any useful meaning to results.

If they had genuine equipoise they would have billed the treatments equally.

 

[FMMM1]

The aim ---is to assess the effect of a novel internet-based therapist-assisted treatment program ---

Thought occurs that the aim might be to brand this as a treatment and monetise all of that "valuable expertise" they have.

I think I'm correct in saying that, as per comment above, surely they could have called these interventions "A" and "B" then looked at the variance in response re "A" and "B" --- if they have similar mean & variance then there's no difference.

But oh they know it works --- I nearly blame the care commissions who commission/fund this sort of stuff more than the charlatans, simply genuinely haven't a clue (although I doubt it) who run these studies.

 

[Sean]

The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I).

At this stage continuing to insist on using unblinded self-report outcomes on their own is straight scientific fraud, IMHO.

They don't get it do they?

Nah. They know exactly what they are doing. That's the problem.

 

[Ravn]

2 self-reported subjective primary outcome measures

22 self-reported subjective secondary outcome measures

0 objective outcome measures

Last follow-up only 3 months after 'treatment'.

Bias built into the design: the study compares two Internet-delivered programmes, the control one unguided and the experimental one with plenty of 'assistance' from a nice therapist.

Investigators from Fink's lab.

Also an interesting definition of 'severe'

Inclusion Criteria:

• Patients must fulfil the criteria for severe FSD operationalized as multi-organ BDS.
• Patients must have symptom duration > 6 months.
• Patients must have been active in the labor market or educational system for at least 12 months during the last 2 years.
• [...]

What could possibly go wrong

 

[Sean]

It is not a controlled trial. It is just another example of the BPS club systematically eliminating adequate control from their trial design.

Control is how we reveal causal pathways (including direction of causation), which is the whole point of science.

Deliberately eliminating adequate control is about as anti-scientific as it gets.

 

[rvallee]

Nah. They know exactly what they are doing. That's the problem.

It's very successful. Why would they change when it continues to be massively successful despite having delivered absolutely nothing? They get nothing but praise, awards and funding for it.

When people have a good scam running, they rarely stop on their own. Turns out even in healthcare this is true. Same issue with corrupt judges. They're judges! They are especially expected to follow the law, it breaks the premise of the entire system otherwise. And yet, corrupt judges do exist, can run scams for years before they get caught, some never get caught. People will be people, especially when there is zero oversight or accountability. All their incentives are built on harming us, of course that's what they do, they don't know any better.

 

[FMMM1]

It is not a controlled trial.

You guys have a much more detailed grasp of this than I have but when it's internet based then it strikes me that it's a really good opportunity to blind and thereby they could use subjective controls---

But Jonathan nails it - they way they've avoided/failed to blind [title of test and "control" group] means that they've removed the opportunity to actually trial the intervention --- what a waste. But then that's the sum total of their contribution -- what a waste.