cognitive behavioural and personalised exercise interventions for fatigue in inflammatory rheumatic diseases (LIFT), 2022, Bachmair et al

Andy

Andy

Senior Member (Voting rights)
Merged
Abstract here


Brief Summary:
Fatigue is common and disabling for most patients with inflammatory rheumatic disease. Therapies designed to improve physical activity and 'talking' treatments, which positively help patients change the way they think and behave, are both helpful in reducing the burden of the fatigue. However, few patients have access to these treatments in most health services. This situation results from the absence of standardised programmes and limited availability of relevant therapists.

The investigators aim to enhance access to fatigue alleviating physical activity and talking therapies by testing innovative,standardised and cost-effective approaches to treatment delivery.

The investigators will also use this opportunity to understand how to select the best treatment for a patient based on their individual profile and to better understand how these treatments actually work. This in turn may lead to more refined and effective therapies in the future.
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At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:
  1. To complete questionnaires which collect information about various outcomes which we think will improve in response to the therapies under evaluation as well as factors which will help us understand how the treatments may work, and factors which may help identify those patients better suited to one therapy over another
  2. To provide a blood sample for research
  3. To take part in an aerobic fitness test
  4. To wear an activity monitor for the next 7 days which will be fitted at each visit
  5. To answer three short questions about engagement with intervention delivered by telephone from trial office at the time of session 4 and 8 (CBA and PEP intervention only). Similarly, the allocated therapists will be asked to give their view of the participants' engagement with the intervention.
All participants will be asked to keep a diary on any other treatments they are using in addition to the treatments they may receive during the study and how costly these other treatments are. The diary period will last for the first 6 months and then for 2 weeks after the third visit and 2 weeks before the last visit.

After they finished the study, the investigators may approach a subgroup of participants who received either the talking therapy or the personalised exercise programme again and ask for an interview to enable more detailed feedback on if they found the intervention helpful and how it has changed their daily life.
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https://clinicaltrials.gov/ct2/show/NCT03248518

Also see, https://www.abdn.ac.uk/iahs/research/epidemiology/bsrbras-1286.php
 
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so your'e sick and exhausted and these morons want to increase your'e daily workload with useless heavily biased report forms whilst keeping a daily diary that just reinforces how difficult your day to day experiences have become . would that not count as negative reinforcement and symptom focussing . talk about having your cake and eating it .
 
Fatigue is not lack of motivation no matter how many drooling idiots insist otherwise. If you have to redefine the meaning of common words then you have failed before you even got started.

Up is red. Left means lilas. Pain means emotions. Who cares about the meaning of words? Let's just make stuff up and change the meaning of words.
 
"Blood sample for research"

None of the outcomes listed have anything to do with blood markers.

Is that normal? Or just fishing for some random improvement in some cytokine or whatever that they can hype in the press release, or bury if it doesn't happen?
 
Primary Outcome Measures
  1. Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 56 weeks ]
    Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks

  2. Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 10 weeks ]
    Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

  3. Fatigue (severity) using Chalder Fatigue Scale (Likert) [ Time Frame: 28 weeks ]
    Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

  4. Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 56 weeks ]
    Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks

  5. Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 10 weeks ]
    Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC

  6. Fatigue (impact) using Fatigue Severity Scale [ Time Frame: 28 weeks ]
    Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC
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no objective measures despite the activity monitors etc


study team https://www.abdn.ac.uk/iahs/research/epidemiology/bsrbras-1286.php#panel1308
 
It's about time someone did a study on the correlation between the use of a dodgy acronym in the title and the Chalder Fatigue Scale and a few of the usual psychobabbler names appearing in the study team. Correlation isn't causation, of course, but it might throw up a plausible hypothesis worthy of further investigation.
 
Merged thread - article discussed first
Abstract here


Came across this article in the telegraph reporting CBT and exercise improves fatigue in RA:

https://www.telegraph.co.uk/news/2022/06/28/arthritis-getting-positive-thinking-could-ease-symptoms/

It seems to be in connection to this paper:

https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(22)00156-4/fulltext

Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial

Background
Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases.

Methods
LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518).

Findings
From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3·03 [97·5% CI −5·05 to −1·02], p=0·0007; CBA: −2·36 [–4·28 to −0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: −0·64 [–0·95 to −0·33], p<0·0001; CBA: −0·58 [–0·87 to −0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported.

Interpretation
Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice.

Funding
Versus Arthritis
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It has a very familiar experimental set up i.e no blinding and subjective outcomes (chalder and fatigue severity scales)
 
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I was looking yesterday at a meta review of meta reviews for CBT efficacy in all sorts of conditions, and it found positive evidence of CBT efficacy in just about everything they looked at:

"substance use disorder, schizophrenia and other psychotic disorders, depression and dysthymia, bipolar disorder, anxiety disorders, somatoform disorders, eating disorders, insomnia, personality disorders, anger and aggression, criminal behaviors, general stress, distress due to general medical conditions, chronic pain and fatigue, distress related to pregnancy complications and female hormonal conditions"

I looked at some of the papers they were based on and unblinded trials with subjective outcomes are common and tolerated. Some have objective outcomes but i didn't look any deeper at their methodologies.

I'm wondering what everyone's opinion here is about how trustworthy CBT and pyschological research is in general if this is the tolerated standard. I could be generalising too much here but it's disconcerting.
 
Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT)
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Just in case any of you were like me - mostly worried about what appeared to be an extraordinarily poor trial name acronym, I found this in the text
Lessening the Impact of Fatigue in Inflammatory Rheumatic Disease Trial (LIFT) study
 
chillier said:
I looked at some of the papers they were based on and unblinded trials with subjective outcomes are common and tolerated. Some have objective outcomes but i didn't look any deeper at their methodologies.

I'm wondering what everyone's opinion here is about how trustworthy CBT and pyschological research is in general if this is the tolerated standard. I could be generalising too much here but it's disconcerting.
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Sorry for my cross-posted flippancy. You are right of course. Unblinded trials with subjective outcomes are standard, and only good for generating positive results for the treatment in question. Digging deeper into the methodologies of the trials with objective outcomes typically finds all sorts of problems. I don't think you are generalising too much.

@Brian Hughes has a nice book on issues with psychology research that you might enjoy.
 
Hutan said:
Sorry for my cross-posted flippancy. You are right of course. Unblinded trials with subjective outcomes are standard, and only good for generating positive results for the treatment in question. Digging deeper into the methodologies of the trials with objective outcomes typically finds all sorts of problems. I don't think you are generalising too much.

@Brian Hughes has a nice book on issues with psychology research that you might enjoy.
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Thanks, I was trying to find an audiobook version of this yesterday in fact but with no luck. I'll take a look at the text copy instead
 
chillier said:
I'm wondering what everyone's opinion here is about how trustworthy CBT and pyschological research is in general if this is the tolerated standard. I could be generalising too much here but it's disconcerting.
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Harking back to the recent ‘Psychology needs to get tired of winning’ thread (see https://www.s4me.info/threads/psychology-needs-to-get-tired-of-winning-2022-haeffel.28228/ ), it would be pertinent to ask are there any studies of CBT in which the authors do not claim to have demonstrated it helps their particular condition(s)?

Though it is perhaps worth noting that the PACE study could be claimed to have shown that CBT does not work for CFS, even with the over inclusive definition, despite the original authors contrary claims that it does.
 
I am sure that CBT to treat the frustrations of city drivers stopped at red traffic lights would subjectively reduce the length of time they seemed to have to wait at red lights.

Indeed when living in London, I practiced ‘traffic light mindfulness’ where I sought to develop complete equanimity over the issue of what colour the lights were, but rather to just enjoy the colours for their own sake and be grateful those moments of tranquility that red lights offered. It certainly felt like the time the lights were on red was much shorter. And thus we enter a realm of magical thinking where we believe that our thoughts change the world.

Also I am reminded of the more naïve practitioners of Nichiren Buddhism who genuinely believe that sufficient repetitions of their mantra will materialise what they desire, be it personal growth or a BMW.

[edited final sentence]
 
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When picturing @Peter Trewhitt at the traffic lights, I am reminded of the Ladybird Book of Mindfulness that has Alison spending her day being at one with nature*. I imagine Peter in his car tranquilly enjoying the colours as they changed from red to green to amber to red...


[*Alison has been staring at the beautiful tree for five hours.
She was meant to be in the office.
Tomorrow she will be fired.
In this way, mindfulness will have
solved her work-related stress.]
 
chillier said:
I was looking yesterday at a meta review of meta reviews for CBT efficacy in all sorts of conditions, and it found positive evidence of CBT efficacy in just about everything they looked at:
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We have this thread (maybe on the same paper as the one you were looking at) discussing the evidence for CBT and the problems with CBT trials.
The evidence for CBT in any condition, population or context... A meta-review... and panoramic meta-analysis, 2021, Fordham et al.

There's more criticism of CBT on the threads labelled with the tags 'CBT' + 'critical' - here
 
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