Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue

[Yogi]

Yes, apologies - that has turned out unclear - I meant it to indicate that the Cochrane meta-analysis covered the same studies that underpin NICE CG53 (viz the York systematic review by Chambers et al 2006). Chambers et al did not look at 'distress' in CBT; the only other meta-analysis around that time (as you probably know) was by by Malouff et al (2008) and they did not mention 'distress' once in the review. So, the Cochrane (Price et al) is the best (and only) evidence on distress at the time of NICE CG53 guidance...and the studies at that time do not support CBT in reducing distress

Thanks for your response Prof Laws. I am glad you understood what I was saying as I clicked post before reading and there were a few mistakes which I have edited now (responding to Esther Crawley's smear campaign has made my eyes sore from using the computer this week).

It's nice to hear someone else complaining of their COIs. However what makes the ME issue so egregious is that it is a neurological disease which the PACE authors have spent their whole careers with insurance companies to redefine ME to be mental. The fact that they refuse to accept the WHO classification is a distress for patients and then to be given the wrong treatment of CBT/GET just adds to the distress.

I read with interest your articles. Thanks! I have not been aware of the wider problems with NICE and psychological therapies. The CG53 was published in 2007 before the wider move to classify physical illnesses as MUPS. They came for people with ME first and feel they have succeeded and now doing the same with other illnesses. With further welfare reforms, things will get much worse.

The COI of NICE itself as an arm of the government and the government pursuing welfare reforms using these PACE psychiatrists is astonishing.

http://www.centreforwelfarereform.org/uploads/attachment/492/in-the-expectation-of-recovery.pdf

No drug company would be allowed to get away with this.

 

[Snowdrop]

my experience of CBT was as a sausage machine of go away with this worksheet do the work yourself, come back for the next session talk briefly 5 or 10 minutes basically checking you;ve attempted the homework then the rest of the 30 minute session is telling you what to do next and giivng you the next worksheet, bye see you in 2 weeks

as Ive mentioned on other posts I have been fortunate enough to have been able to pay for private person-centred counselling for several years with significant benefits in coping with mild situational depression and enabling me to keep working. started years before ME/CFS diagnosis.

My understanding is that some of the people delivering CBT actually do counsellling under the radar instead alongside
so maybe if you're lucky to drop on one of those people you do a lot better, although in the format I had of fortnightly 30 minute sessions not sure you'd achieve much

no comparison between the 2 psychological approaches Ive experienced

My experience was similar. When seeking a diagnosis for my symptoms over a decade ago from my Dr (in Vancouver at the time) I was sent for CBT. It was boilerplate with a binder to work through. Everyone in the room was expected to respond in exactly the same way to whatever they were there for. The clinic leader was kind, calm and seemed to want to help. She also seemed to be in over her head the moment someone deviated from the script. This IS CBT as the medical establishment wants it rolled out.

I agree with @Esther12 -- some of the principles behind CBT are sound enough but they need to be explored in a way that makes it useful to the individual and their circumstance.

 

[Dolphin]

Although distress is a many-headed hydra, we might expect it to be a vital target for a psychological intervention such as CBT. Indeed, the National Institute of Clinical Excellence (NICE; 2007) guideline (CFS/ME or encephalopathy: diagnosis and management – clinical guideline (CG53) presents a virtual panacean view where CBT is used ‘… to reduce the levels of symptoms, disability and distress associated with CFS/ME’.

 

[Dolphin]

The PACE trial monitored adverse events (Dougall et al., 2014; Sharpe et al., 2015; White et al., 2011), but did not measure ‘distress’ directly.

That's something I missed.

 

[Dolphin]

The PACE trial monitored adverse events (Dougall et al., 2014; Sharpe et al., 2015; White et al., 2011), but did not measure ‘distress’ directly. The absence of evidence does not equate to evidence of absence, but PACE does provide some indirect evidence. The authors report that around 1 in 10 patients found CBT made them feel ‘much worse’ or ‘very much worse’ by follow-up – a not inconsiderable number of people who conceivably link the intervention to some increased experience of distress.

We also know from the PACE trial itself that around 10 per cent of patients find that CBT makes their condition ‘much worse’ or ‘very much worse’.

I'm afraid I don't find that a very strong point as it was similar in the no-individual-therapy group and also in the Adaptive Pacing Therapy group. This illness can fluctuate.

 

[Dolphin]

Somewhat more direct evidence on distress (at least as rated on scales) can be garnered from the Cochrane review (Price et al., 2008) that was used to inform the NICE CG53 guide. Price et al. reported that in comparison to usual care, CBT failed to reduce distress at end of trial (three trials: −0.27 (95% confidence interval (95% CI): −0.56, 0.01)) or in the sole trial using a follow-up assessment (mean diff: −0.24 (95% CI: −28.85, 28.37)). Additional comparisons of CBT versus ‘other psychological therapies’ did, however, point to a significant end-of-trial distress reduction (3 trials and 90 people in total receiving CBT: −0.41 (95% CI: −0.71, −0.11)) and in a further analysis of a sole follow-up trial (43 people receiving CBT mean diff: −3.60 (95% CI: −7.07, −0.13)). That CBT seems efficacious in a relative (other psychological interventions) but not an absolute comparison (vs Treatment As Usual[TAU]) is unexpected. A closer look at the three studies in each meta-analysis reveals that two are common to both analyses (Barrett, 1992; O’Dowd, 2000), that is, they have CBT, TAU and a psychological intervention control; and a quick look at both trials reveals that distress was greater in the psychological intervention than the TAU control condition. This suggests not that CBT reduced distress so much as some psychological interventions increase distress.

These were the measures used in Price et al.:

4)General psychological distress, using measures such as Symptom Checklist-90 (SCL-90) or General Health Questionnaire

 

[Dolphin]

No decision about me without me

The position(ing) of patients in this arena is noteworthy. The preface to NICE CG53 asserts how in developing the guideline an aim is to enable ‘… patients to receive therapy appropriate for, and acceptable to them’ (p.7). Acceptability is similarly placed centre-stage by Price et al. in their Cochrane review when they state that ‘Effective treatments are of little value to health services unless they are acceptable to the recipients – poor acceptability will reduce treatment uptake and adherence’ (p. 21). They, however, go further and assert that ‘CBT may be an acceptable form of treatment for CFS, although this evidence is currently based on a small number of individual studies’ – possibly an overstated inference given that Price et al. failed to locate a single study measuring acceptability at end-of-trial and just one at follow-up.

Acceptability is naturally linked to whether people persist with interventions. The Cochrane meta-analyses (Price et al., 2008) revealed a significant – almost 50 per cent – greater drop-out rate for CBT compared to TAU in eight trials (20.6% vs 13.9%; odds ratio (OR): 1.70; 95% CI: 1.10 to 2.63). Similarly, four studies assessing short- to medium-term follow-up revealed a significantly larger attrition rate, which was 50 per cent greater for CBT than usual care (22.7% vs 14.8%; OR: 1.46; 95% CI: 0.52 to 4.10). Such findings point to an acceptability problem and are at least consistent with the idea that a CBT-related increase in distress may have led more to leave the CBT arms of trials.

From Price et al.:

6) Acceptability of treatment, measured through:
a) self-rated acceptability/satisfaction scales
b) dropout rates from trials due to adverse effects or ineffectiveness

I think this angle and the related term, "patient preferences", is a useful angle that could probably be used more in the ME/CFS realm. I think CBT and GET would do badly when these sort of issues are looked at.

 

[Dolphin]

This may be true, but it is notable that of 19 mentions of bias in the CG53, 13 are used to dismiss these survey data (the remaining six occasions are generic bias statements). By contrast, the NICE committee made little attempt to even mention the limitations and biases of randomised controlled trials (RCTs). To take just one example, although NICE remark on selection bias in surveys, they ignore the fact that more than half of the ‘RCTs’ in the Cochrane review failed to describe randomisation procedures, thus similarly making it impossible to assess the extent to which selection bias may have occurred.

 

[Dolphin]

I never thought it was a good idea that people pushed for NICE guidelines for CFS/ME. NICE only tends to recommend therapies which have at least 2 positive RCTs: the only ones that seemed likely to fit that criteria were CBT and GET. It would have been better not to have NICE guidelines than to have guidelines which embedded CBT and GET in the system. The system then tends to like to justify whatever it is offering.

 

[Dolphin]

NICE, however, display substantial bias in their dismissal of comparable methodological issues in RCT data. As far as distress in CFS/ME is concerned, CBT currently seems to promise no gain but the possibility of some pain.

 

[Dolphin]

It's a pity that @Keith Laws didn't read the PACE manuals as I believe he would have found things in them which could show the particular form of CBT proposed could increase distress.

I do understand that he probably has a very full workload and so his time available for this is limited.

http://www.wolfson.qmul.ac.uk/current-projects/pace-trial/#trial-information

3. CBT treatment manual http://www.wolfson.qmul.ac.uk/images/pdfs/3.cbt-therapist-manual.pdf

Appendix to (3) http://www.wolfson.qmul.ac.uk/images/pdfs/4a.CBT_PACE_final_participants_landscape_charts-MREC_2.doc

4. CBT participant manual http://www.wolfson.qmul.ac.uk/images/pdfs/4.cbt-participant-manual.pdf NB copyright © Constable and Robinson

Appendix to (4) http://www.wolfson.qmul.ac.uk/images/pdfs/4a.CBT_PACE_final_participants_landscape_charts-MREC_2.doc

 

[Valentijn]

It would have been better not to have NICE guidelines than to have guidelines which embedded CBT and GET in the system.

On the other hand, it does give ME patients something concrete to fight against, instead of the amorphous bias and dismissal of various practitioners and institutions.