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CBT treatment for a range of functional somatic syndromes: RCT (Schröder et al., 2012)

Dolphin

Senior Member
Messages
17,567
Letter sent to doctors involved in care of the patients in the treatment group:

http://funktionellelidelser.dk/file...Consultation_letter__additional_material_.pdf

(It's in English)

via: http://funktionellelidelser.dk/en/for-specialists-researchers/doctors/stress-manual/ RE: Patient NN


It is probably a little clearer at the link. However, many might not follow it, so here it is. :(

Dear doctor NN

For your information, we have carried out the randomisation procedure for <patient name>, who participates in the scientific study

Treatment of patients with chronic functional disorders

Your patient has been randomised to receive specialised treatment at our department.

Specialised treatment at our department consists of 9 modules of cognitive behavioural therapy, 3.5 hours each, delivered in groups of 9 patients.

At the same time, we are able to offer you consultancy service meaning that you are welcome to contact us if you experience any kind of clinical problems with the patient that you want to discuss with us. In any event, we would be grateful to be informed of any major changes in the patient’s treatment and initiation of new diagnostic procedures.

Since some kinds of problems are common for our patients, we enclose general advice on the management of patients with chronic functional disorders / bodily distress syndromes. Furthermore, we refer to our homepage, where additional information is available.

Your patient is scheduled to attend the first session of the group treatment at our department on <day>, <dd.mm.year>. We have informed the patient by mail.

Kind regards,

Per Fink, Ph.D., Dr. Med. Sc. Head of department

Emma Rehfeld, MD. Consultant, specialist in Psychiatry

Andreas Schröder, MD Senior resident psychiatry, research fellow

General advice on the management of chronic functional disorders

Physical

1. Make a brief physical examination focusing on the organ system from which the patient has (new) complaints.
- Look for signs of disease instead of symptoms.
- Avoid tests and procedures, unless indicated by objective signs of disease or a welldefined (new) clinical illness picture.

2. Reduce unnecessary drugs, do not use on-demand prescriptions, and avoid habitforming medication Psychological

3. Acknowledge the reality of the patient’s symptoms.

4. Be direct and honest with the patient about the areas you agree on and those you do not agree on, but be careful as not to make the patient feel ignorant or not respected.

5. Be stoic; do not expect rapid changes or cures.

6. Consider, whether worsening of or new symptoms can be perceived as emotional communication, rather than as manifestation of a new disease. Psychopharmacological treatment

7. The Research Clinic would be happy to give advice and be informed in case of psychopharmacological treatment.

8. Choose non-habit-forming medication, and, if possible, choose medication that can be serum monitored.

9. Start with a smaller dosage than usual and increase slowly. Be stoic about side effects.

10. Take regular serum levels in order to ensure compliance and to validate complaints of adverse effects.

11. Treat any coexisting psychiatric disorders according to usual guidelines. Administrative

12. If the patient has a job, sick leave should be accompagnied by a specific treatment plan.

13. Try to become the patient’s only physician and mimimize the patient’s contact to other health care professionals, doctors on call, and alternative therapists.

14. Inform your colleagues of your management plan and develop contingency plans for when you are not accesible.

15. In case of risk for drop-out: Motivate the patient to continue group treatment.

Additional information:
1. Fink P., Rosendal M., Toft T. Assesment and Treatment of Functional Disorders in General Practice: The Extended Reattribution and Management Model – An Advanced Educational Program for Nonpsychiatric Doctors. Psychosomatics 2002;43 (2): 93-131
2. www.functionaldisorders.dk
 

Dolphin

Senior Member
Messages
17,567
UPDATE I've now seen the full text and the increase is slightly larger than I'd thought.

The findings with the aggregated scle findings (PF, pain and vitality) are probably too complicated to bother with so I'll focus on the SF36 Physical Function scores which were helpfully included for comparison with other trials (eg PACE). However, these are the 'norm-based' scores where 50= population mean and each 10 points from the mean = 1SD.

What's a little odd is that the 'control' group SF36 PF score declined slightly over the 16 months of the study. So just looking at the intervention group, from baselines:

Baseline= 32.5
16 months= 38.7

which gives a mean increase of 6.2points = 0.62 SD ie over the 0.5SD often used for 'minimally useful difference'.The increase relative to control was larger at 8.8 points, 0.88 SD.

For comparison, PACE showed a 1.2SD gain from baseline, but 0.47SD gain relative to the control group, which improved a lot. Of course, all these gains are self-reported and in both cases the control group knew they were in the control group and not receiving the intervention being tested in the trial.
No, I'm afraid you've misinterpreted it. The scores you quoted are for the SF-36 Physical Composite Score (PCS). This is one of two summary scores for the SF-36 - the other is the Mental Health Composite Scores (MCS)

To calculate each of these is complicated: it involves using weightings from the eight individual subscales, with some of the weightings being negative! e.g. see Table 6 in http://www.chime.ucla.edu/Maglinte-...r telephone administration of the SF-36v2.pdf
 

Dolphin

Senior Member
Messages
17,567
A few observations:
You have to wonder how suitable 3.5 hour sessions are for many with ME/CFS.
It doesn't say how CFS is defined that I can see (incl. there is no CFS criteria paper in the references).

We included only adults aged 20–45 years, as we regarded the possibility of improvementto be lower in older people and the exclusion of disease to be more difficult.

--

Why they say they changed the outcome measures:
We found an unexpected moderate negative correlation of the physical and mental component summary measures, which are constructed as independent measures. According to the SF-36 manual, a low or zero correlation of the physical and mental components is a prerequisite of their use. Moreover, three SF-36 scales that contribute considerably to the PCS did not fullfil basic scaling assumptions.31 These findings, together with a recent report of problems with the PCS in patients with physical and mental comorbidity,32 made us concerned that the PCS would not reliably measure patients’ physical health in the study sample. We therefore decided before conducting the analysis not to use the PCS, but to use instead the aggregate score as outlined above as our primary outcome measure. This decision was made on 26 February 2009 and registered as a protocol change at clinicaltrials. gov on 11 March 2009. Only baseline data had been analysed when we made our decision and the follow-up data were still concealed. A post hoc power analysis revealed that power was slightly reduced (80% instead of 83%) by the change of primary outcome definition.
A negative correlation means as the scores for one go up, the scores for the other go down.

--

Since the intervention group was smaller than the comparison group, it was not possible to mask the statistician to group assignment.

(they thought more from the comparison group would drop out)

However:
Contrary to our expectation, the proportions completing the study were similar in both inter- vention and usual care groups: 44 (81%) v. 50 (76%), P = 0.45.

--
Over half (56%) of patients in the usual care group reported their physical health to be worse than before randomisation, which was the case for only a quarter (25%) of the STreSS group.

--
Compared with psychological interventions delivered in mental health settings, an important strength of the STreSS inter- vention is its integrated approach.7,8 This treatment provides patients with a positive and evidence-based understanding of their illness that aims to transcend the mind–body dualism inherent in the current diagnostic classifications,37,38 and that contrasts with the usual approach to management, which tends to suggest either physical or mental disease.
I question their use of "evidence-based understanding", whatever about claiming the outcomes from CBT are evidence based (which isn't necessarily the same thing, I think).
--
In Limitations section:


The efficacy of STreSS in this trial may have been influenced by the fact that treatment was carried out by a few highly skilled psychiatrists, and our findings therefore require replication. However, the fact that patients in the comparison group also received a specific intervention (the clinical assessment) is likely to have improved their outcome, and potentially diminished the treatment effect observed.
I'm not sure about the second sentence: I'm not sure the assessment would have helped much.

--
They are fishing for money for very big trials:
The results of our study need to be confirmed in large, multicentre trials designed to explore the effectiveness and cost- effectiveness of STreSS or similar complex interventions in people with functional somatic syndromes before widespread implementation is justified. These trials should be powered to allow subgroup analyses of the effect of STreSS on different types of functional somatic syndromes and on patients with and without psychiatric comorbidity.
 

Dolphin

Senior Member
Messages
17,567
This is possibly important - it's buried in the limitations:
Finally, although we were able to demonstrate a clear treatment effect, with the point estimate reaching the pre-specified clinically important difference of 4 points, the wide confidence intervals do not definitely establish a clinically significant treatment effect. A much larger sample would be needed to determine this.
I can't see any non-significant results mentioned in the main results section so I'm not sure what is being said here.
 

Dolphin

Senior Member
Messages
17,567
Looks like another study showing an intervention that aims to change perceptions of illness is moderately effective at changing perceptions of illness.

I'm sure you could recruit 54 participants with brain tumours, give them 31.5 hours of therapy designed to make them believe the tumours were smaller, then using questionnaires show they now perceived the tumours to be smaller, and conclude the therapy was effective in shrinking the tumours.
Yes, agree. I was about to send an e-letter to the BJPsychiatry to make this point.
However, near the end, they say:
We are not yet able to provide cost comparison data, and the cost-effectiveness of the STreSS intervention therefore remains currently unclear. A thorough cost-effectiveness analysis that also includes societal costs such as sick leave and social benefits is in progress.
so I think I might hold off till that data comes out. I don't believe it has been published yet?
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
While correlation has no bearing on causation, why on earth do they "assume" that mental and physical should be seperated and independant of each other?

That is surely a dualist position. One the Psychs say they do not take!
 
Messages
13,774
Thanks for posting your thoughts D.

We found an unexpected moderate negative correlation of the physical and mental component summary measures, which are constructed as independent measures. According to the SF-36 manual, a low or zero correlation of the physical and mental components is a prerequisite of their use. Moreover, three SF-36 scales that contribute considerably to the PCS did not fullfil basic scaling assumptions.31

Sorry if I've missed something, but this reminded me of the research which found that housebound CFS patients scored better for the measures of mental health they used than those patients who were doing more (I just looked, and couldn't find a copy of this, but I'm sure it got briefly discussed here - maybe I'm misrepresenting it).

I went shopping a few days ago, and it was okay-ish (I got a couple of bargains!). I had easy food available so didn't need to worry about eating, and it was nice to be out in town. It did leave me feeling more tired, and that made me feel worse than I normally do. It reminded me a lot of when I was devoting myself to various activity management, exercise things: I was doing more, expecting to recover and feeling sicker.

This may not be at all relevant, but I thought I'd share my anecdote.