Study protocol for POSITIF, ... feasibility trial of a brief cognitive-behavioural intervention ... for post-stroke fatigue, 2020, Gillespie, Chalder

Sly Saint

Sly Saint

Senior Member (Voting Rights)
Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue

Abstract
Background
Approximately, half of stroke survivors experience fatigue. Fatigue may persist for many months and interferes with participation in everyday activities and has a negative impact on social and family relationships, return to work, and quality of life. Fatigue is among the top 10 priorities for ‘Life after Stroke’ research for stroke survivors, carers, and clinicians. We previously developed and tested in a small uncontrolled pilot study a manualised, clinical psychologist-delivered, face-to-face intervention, informed by cognitive behavioural therapy (CBT). We then adapted it for delivery by trained therapists via telephone. We now aim to test the feasibility of this approach in a parallel group, randomised controlled feasibility trial (Post Stroke Intervention Trial In Fatigue, POSITIF).

Methods/design
POSITIF aims to recruit 75 stroke survivors between 3 months and 2 years post-stroke who would like treatment for their fatigue. Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only. The aims of the intervention are to (i) provide an explanation for post-stroke fatigue, in particular that it is potentially reversible (an educational approach), (ii) encourage participants to overcome the fear of taking physical activity and challenge negative thinking (a cognitive approach) and (iii) promote a balance between daily activities, rest and sleep and then gradually increase levels of physical activity (a behavioural approach). Fatigue, mood, quality of life, return to work and putative mediators will be assessed at baseline (just before randomisation), at the end of treatment and 6 months after randomisation. POSITIF will determine the feasibility of recruitment, adherence to the intervention and the resources required to deliver the intervention in a larger trial.

Discussion
The POSITIF feasibility trial will recruit until 31 January 2020. Data will inform the utility and design of a future adequately powered randomised controlled trial.
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https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00622-0
 
Fatigue is among the top 10 priorities for ‘Life after Stroke’ research for stroke survivors, carers, and clinicians.
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Going off topic a bit - I assume this is the result of a Priority Setting Partnership process. It does worry me that these are being used to justify funding for this sort of Chalder junk trials. That's why I'm glad S4ME is represented on the ME/CFS PSP process. We need to ensure we don't end up with it justifying more crap psych research. It is concerning that with fatigue occurring in so many conditions, the Chalder CBT gravy train rolls on.
 
The people who approved this are a complete joke. Chalder is a lost cause, that's not an issue, many people are. But there are people who oversee her work and give approval for doing the exact same things in loops despite never delivering anything and that's just wrong. It makes a mockery of not only the system of medicine but the entire system of science.

And the obsession with fatigue despite Chalder being totally clueless about what it even means. You can't teach something you don't understand. Evidence-based medicine needs to be dismantled entirely, it has clearly failed while appearing to serve no specific purpose that cannot be served otherwise.
 
Apparently this would be the "feasibility" study: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183286. Quoted because those things are always performative, with the conclusion written far in advance.
Four participants dropped out and the remaining eight participants completed the intervention because things are designed to produce the desired outcome.
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1/3 dropped out.
Four participants (all women) dropped out: one participant withdrew after the first session as, following discussion with the therapist, she explained that she did not desire an intervention for her fatigue but that her chief purpose in participation had been to contribute to the research; a second participant withdrew after the initial session and the third participant after the second session because of unrelated physical ill-health problems; the fourth participant failed to attend any of the sessions despite reminders and gave no reasons.
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Everything is feasible if you just don't bother when it's not. What a total waste. The people overseeing this have failed completely in their duties.

That is, unless this is an unrelated feasibility study for the exact same thing. Chalder does have a habit of doing the same things over and over without there being any connection between those.
 
rvallee about the 12 person 2017 trial said:
Apparently this would be the "feasibility" study: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183286.
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Ha, the feasibility study for the feasibility study.

the abstract from this 2020 study protocol said:
The POSITIF feasibility trial will recruit until 31 January 2020. Data will inform the utility and design of a future adequately powered randomised controlled trial.
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@dave30th - one to watch
 
Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial

Abstract

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes.

Design: Randomised controlled parallel group trial.

Setting: Three Scottish stroke services.

Subjects: Stroke survivors with fatigue three months to two years post-stroke onset.

Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only.

Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation.

Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale -0.619 (95% CI -4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 -0.178 (95% CI -3.823, 3.467, p = 0.92), and the Patient Health Questionnaire -0.247 (95% CI -2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work.

Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue.

https://pubmed.ncbi.nlm.nih.gov/35866206/
 
886 > 188 > 76 > 64 > 39 > 23 ! Yes you can get 2.6% of a patient population to partially participate in a trial - but exactly what does that self selecting 2.6% represent ? The most well ? The most desperate ? The most bored ?

886 people and only 23 thought this was worth pursuing should be key evidence that there is something profoundly lacking in what is on offer, not "patients can be recruited to a trial of this design".
 
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