The effect of counselling, graded exercise and usual care for people with CF-Ridsdale

[Dolphin]

Free full text: http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8501666 or
http://journals.cambridge.org/actio...bodyId=&membershipNumber=&societyETOCSession=

This uses a lot of the same measures as the PACE Trial so some people interested in that might be interested.

No results for CFS alone given unfortunately.

The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial.

Psychol Med. 2012 Feb 28:1-8. [Epub ahead of print]

Ridsdale L, Hurley M, King M, McCrone P, Donaldson N.

Source

Department of Clinical Neuroscience, King's College London, Institute of Psychiatry, Academic Neuroscience Centre, London, UK.

Abstract*

BACKGROUND:

To evaluate the effectiveness of graded exercise therapy (GET), counselling (COUNS) and usual care plus a cognitive behaviour therapy (CBT) booklet (BUC) for people presenting with chronic fatigue in primary care.

Method

A randomized controlled trial in general practice.

The main outcome measure was the change in the Chalder fatigue score between baseline and 6 months.

Secondary outcomes included a measure of global outcome, including anxiety and depression, functional impairment and satisfaction.

RESULTS:

The reduction in mean Chalder fatigue score at 6 months was 8.1 [95% confidence interval (CI) 6.6-10.4] for BUC, 10.1 (95% CI 7.5-12.6) for GET and 8.6 (95% CI 6.5-10.8) for COUNS.

There were no significant differences in change scores between the three groups at the 6- or 12-month assessment.

Dissatisfaction with care was high. In relation to the BUC group, the odds of dissatisfaction at the 12-month assessment were less for the GET [odds ratio (OR) 0.11, 95% CI 0.02-0.54, p=0.01] and COUNS groups (OR 0.13, 95% CI 0.03-0.53, p=0.004).

CONCLUSIONS:

Our evidence suggests that fatigue presented to general practitioners (GPs) tends to remit over 6 months to a greater extent than found previously.

Compared to BUC, those treated with graded exercise or counselling therapies were not significantly better with respect to the primary fatigue outcome, although they were less dissatisfied at 1 year.

This evidence is generalizable nationally and internationally.

We suggest that GPs ask patients to return at 6 months if their fatigue does not remit, when therapy options can be discussed further.

PMID: 22370004 [PubMed - as supplied by publisher]

* I gave each sentence its own paragraph.

WSAS scores are sometimes given out of 40 i.e. multiply these scores by 5.

 

[Valentijn]

Hehe, increased anxiety in the CBT group, and more than 65% dissatisfaction. No objective measurements for anyone of course.

52% dissatisfied with GET, and 54% dissatisfied with counseling. And that's with Oxford criteria patients

The authors seem to be concluding that dissatisfaction will contribute to the treatment failing, but they're not saying it plainly.

 

[Dolphin]

Missing outcome measures

The trial's protocol is here: http://www.controlled-trials.com/ISRCTN72136156

3 of the secondary outcome measures are not reported:

3. Certified sickness absence
4. Illness attributions (physical = 1; psychological = 5)
5. Health-related quality of years using the EuroQol/EQ-5D instrument, which allows quality adjusted life years (QALYs) to be generated

The paper even gives impression outcome measure #5 was only measured at baseline:

"At baseline, self-reported rating using the European Questionnaire measuring health-related quality of life in five dimensions with UK weights attached (EQ-5D; Dolan et al.1995) was measured, in addition to patients preferences for treatment and other characteristics, which were measured serially."

I'm not confident we are going to see those results. The WSAS scores and the "certified sickness absence" would tend to go together if one was going to publish them as a separate paper.

 

[Bob]

Thank you Dolphin.

I haven't read it through yet, but after an initial look at the results, it looks like this confirms that the meagre results of the PACE Trial are not transferable from a clinical trial setting to general practise setting.

Have you looked at it enough to know if you would agree with that?

 

[Dolphin]

Thank you Dolphin.

I haven't read it through yet, but after an initial look at the results, it looks like this confirms that CBT and GET do not work when transferred from a clinical trial setting to general practise setting.

Would you agree with that?

Not sure one can say that from this study.

 

[Bob]

Unfortunately, not sure one can say that from this study.

OK, thanks, I'll read it more closely later.

 

[Enid]

Be nice to know if they have their "numbers" right - bit more than number crunching ME/CFS. Recognised pathologies ?.

 

[Dolphin]

OK, thanks, I'll read it more closely later.

Unfortunately the fact that usual care involved Trudie Chalder's booklet complicates things.

 

[Bob]

I've had a closer look at it now, and it seems that it's yet another study without an adequate control group.

Why on earth use a CBT booklet in the 'usual care' control group to muddle things up?

I can't quite see the motivation of this study, unless it was to promote CBT and GET taking place in secondary care settings (i.e. the Maudesly Hospital.)


It concluded that GET was useless in a primary care setting.

And they conclude that patients get better over time, and so positive CBT/GET studies that have not used a control group in the past, cannot be relied upon.

"Our findings suggest that many patients improve substantially in the first 6 months. This factor, time, is likely to explain the improvement suggested in prior trials that used evidence from cohorts as comparators rather than randomized control groups (Ridsdale et al. 1993, 2001, 2004)."


On the down side, they can use the study to:

Promote GET and CBT in a secondary care settings

 

[Snow Leopard]

Ah, I just posted this on another thread. I hadn't seen it until today...

 

[Esther12]

Only just seen this. Interesting little read though. Ta D.

 

[alex3619]

"The results of the current study do not support
early implementation of a short course of either GET
or counselling for chronic fatigue in primary care."

They are focussed on chronic fatigue of short duration, with an implication that CBT/GET is warranted for fatigue of more than six months duration. They seem to use CF and CFS interchangeably. I may say more after I have read further. Bye, Alex