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Randomised Controlled Trial of Cognitive Behaviour Therapy Delivered in Groups of Patients with CFS

John Mac

Senior Member
Messages
321
Location
Liverpool UK
"We conducted a pragmatic randomised controlled trial with 204 adult CFS patients from our routine clinical practice who were willing to receive group therapy."

So they ruled out non believers.

"Thirty-four (17%) patients were lost to follow-up during the course of the trial. Missing data were imputed using mean proportions of improvement based on the outcome scores of similar patients with a second assessment."

Then they ruled out those that became non believers, but replaced their results with positive ones.
 

Dolphin

Senior Member
Messages
17,567
http://www.ncbi.nlm.nih.gov/pubmed/26402868

For the umpteenth time I would like for researchers to do an RCT of CBT in other physiological chronic and fatiguing illnesses. They will find the exact same "improvement" when doing CBT on SLE, MS, RA, etc.
Psychosom Med. 2008 Feb;70(2):205-13. doi: 10.1097/PSY.0b013e3181643065. Epub 2008 Feb 6.
A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue.
van Kessel K1, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E.
Author information

Abstract
BACKGROUND:
The purpose of this study was to assess the efficacy of cognitive behavior therapy (CBT) as a treatment for multiple sclerosis (MS) fatigue.

METHODS:
A randomized controlled design was used where 72 patients with MS fatigue were randomly assigned to eight weekly sessions of CBT or relaxation training (RT). RT was designed to control for therapist time and attention. Participants were assessed before and after treatment, and at 3 and 6 months posttreatment. The primary outcome was the Fatigue Scale. Secondary outcomes included measures of stress, mood, and fatigue-related impairment.

RESULTS:
Analysis was by intention-to-treat. A group by time interaction showed that the CBT group reported significantly greater reductions in fatigue across the 8 months compared with the RT group (p < .02). Calculated effect sizes for fatigue from baseline to the end of treatment were 3.03 [95% confidence interval, 2.22-3.68] for the CBT group and 1.83 [95% confidence interval, 1.26-2.34] for the RT group. Results also indicted that both groups showed clinically significant decreases in fatigue defined as fatigue levels equivalent or less than those reported by a non-fatigued healthy comparison group.* There were no significant interactions between group and any of the secondary outcome variables, with both groups showing improvements over time on all measures.

INTERPRETATION:
Both CBT and RT appear to be clinically effective treatments for fatigue in MS patients, although the effects for CBT are greater than those for RT. Even 6 months after treatment, both treatment groups reported levels of fatigue equivalent to those of the healthy comparison group.

PMID: 18256342
[PubMed - indexed for MEDLINE]
*For the group who had multiple sclerosis and were fatigued before treatment, the results were statistically better than the non-fatigued healthy comparison group after treatment and at 3 and 6 months posttreatment!
 

Sidereal

Senior Member
Messages
4,856
Missing data were imputed using mean proportions of improvement based on the outcome scores of similar patients with a second assessment.

Partying like it's 1995 not 2015. This method of handling missing data is based on the unacceptable assumption that the 17% of the sample who dropped out of the study would have had the same level of improvement as "similar patients" had they stayed in the study. What if they were getting no better or deteriorating and dropped out as a result? I take it they don't have linear mixed effects or multiple imputation in the Netherlands? :lol: If you're going to do a shitty obsolete imputation method they could have at least had the decency to use last observation carried forward (not that I would ever recommend doing this) which in this case would have given a more conservative (realistic) estimate of treatment effect.

Physical functioning and psychological distress improved moderately (effect size = 0.5).

I wanna know if this was measured by ticking boxes on questionnaires or actual physical functioning in the standard dictionary definition of the word functioning reflecting, you know, real-world activities like being able to go out of the house, working, getting off welfare etc.
 
Messages
15,786
I wanna know if this was measured by ticking boxes on questionnaires or actual physical functioning in the standard dictionary definition of the word functioning reflecting, you know, real-world activities like being able to go out of the house, working, getting off welfare etc.
With these people, it's always a questionnaire. They've learned not to use objective measurements, because it reveals their therapies for the useless bullshit that they are.
 
Messages
15,786
The trial lasted 6 months, and was largely focused on brain-washing which targeted the same questions that are asked on the primary questionnaire (Checklist Individual Strength):
The intervention was based on previous work of our research group [4, 13] and included personal goal setting, fixing sleep-wake cycles, reducing the focus on bodily symptoms, a systematic challenge of fatigue-related beliefs, regulation and gradual increase in activities, and accomplishment of personal goals. A formal exercise programme was not part of the intervention.

And to boost the brainwashing power:
In contrast to our previous work [4] , we communicated recovery in terms of fatigue and disabilities as general goal of the intervention [14].

"Clinically Significant Improvement" was defined as CIS fatigue score less than 35, SF36 Physical Function score (PF) of 65 or greater (out of 100), and reducing Sickness Impact Profile (SIP) score by at least 1 point. In the case of the CIS, entry score could be 35 or higher, so only one point improvement is needed in some cases, out of 56 possible points. The SIP entry score of 700+ had to fall by at least one point to be under 700, out of 5,799 possible points. No SF36-PF threshold was established for recruitment, so patients may have already started with a score of 65 or higher.

I think they've repeated a PACE error here in applying standard deviations to scores which are not normally distributed (not a nice bell curve result in the general population):
Our definition for recovery was based on mean scores of healthy controls + 1 standard deviation on the primary outcome measures and was operationalised as a CIS fatigue score of <27, an SF-36 physical functioning score of ≥ 80 and a total score of <203 on the SIP [14].

They've previously defined CIS scores of 8-26 to be normal, 27-34 as moderate fatigue, and 35-56 as severe fatigue. I'm not sure which SIP scores indicate normalcy, since I can't find any data regarding the weighting which they use.
 
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Messages
15,786
Compared to waiting list controls, 35.3% of treated patients improved and 13.9% recovered. They're not telling us if those who recovered already had SF36-PF scores at or above 80 at the start of the trial.

The biggest problem with the study, discussed a bit previously in this thread, is that the scores from drop-outs were imputed based on the scores of "similar" patients. They cite http://www.bmj.com/content/342/bmj.d40 for using this method, but that paper focuses on biological measurements carried forward to a final endpoint based on other patient endpoints when the missing patient displayed a similar progression at earlier assessment points. But in the current study, there were no intermediate assessment time points - just at baseline and at 6 months when treatment was finished.

So the data could not be extrapolated in the manner described by the paper which they cite. Yet they still manage to manufacture data for 15 patients who were never treated at all, after being randomly assigned to treatment groups. This is beyond bizarre ... who needs a sufficient number of patients to get statistically significant results when you can throw in some imaginary patients and pretend that they do the same as similar patients? Hell, why not just use 20 actual patients, and give them each 10 imaginary patients to generate identical scores for? :confused:

In total it looks like they lost 60 out of 136 patients (44.1%) in the treatment groups between randomization and follow-up. 34 of those were lost before treatment finished. 10 of 68 waiting list controls (14.7%) were lost between randomization and followup. Yet the full number of originally randomized patients was used in all calculations.

They also don't report any follow-up data, because the waiting list control group got treated in the meantime. A really stupid mistake, or a deliberate attempt to bury data indicating deterioration after the brainwashing wore off and reality couldn't be ignored any longer.
 
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Dolphin

Senior Member
Messages
17,567
Physical functioning and psychological distress improved moderately (effect size = 0.5).

I wanna know if this was measured by ticking boxes on questionnaires or actual physical functioning in the standard dictionary definition of the word functioning reflecting, you know, real-world activities like being able to go out of the house, working, getting off welfare etc.
No objective measures reported e.g. no actigraphy, employment data, etc.
 

Dolphin

Senior Member
Messages
17,567
Since some studies have reported that a significant minority of patients recovered from CFS following individual CBT, we decided to conduct a post hoc analysis examining rates of clinically significant improvement and recovery in our sample.
A post hoc analysis, for those that don't know, means that the analysis was not preplanned i.e. included in the protocol. They could have decided at any stage to do it including after they saw the data (as far as I know).
 

Dolphin

Senior Member
Messages
17,567
Here's the protocol they refer to. On a quick skim, it looks like they have reported everything.

http://www.isrctn.com/ISRCTN1582371...=1&page=1&pageSize=10&searchType=basic-search

ISRCTN15823716 DOI 10.1186/ISRCTN15823716
The effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study
Condition category
Nervous System Diseases
Date applied
12/10/2006
Date assigned
12/10/2006
Last edited
12/10/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Plain English Summary
Not provided at time of registration

Trial website

Contact information
Type
Scientific

Primary contact
Professor G Bleijenberg

ORCID ID

Contact details
University Medical Center St. Radboud
Expert Center Chronic Fatigue
P.O. Box 9011
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610030
g.bleijenberg@nkcv.umcn.nl

Additional identifiers
EudraCT number


ClinicalTrials.gov number


Protocol/serial number
CMO 2006/030

Study information
Scientific title


Acronym


Study hypothesis
There are two research questions:
1. Does Cognitive Behavioural Therapy (CBT) in groups lead to a significant decrease of fatigue and functional impairment of Chronic Fatigue Syndrome (CFS) patients compared to a waiting list condition?
2. For which patient is group therapy a suitable treatment method?

Ethics approval
Ethics approval received from the local medical ethics committee

Study design
Randomised controlled trial

Primary study design
Interventional

Secondary study design
Randomised controlled trial

Trial setting
Not specified

Trial type
Treatment

Patient information sheet


Condition
Chronic Fatigue Syndrome (CFS)

Intervention
After a basline assessment patients are randomly assigned to one of three conditions. There are two treatment conditions: small group (four patients and one therapist) and large group (eight patients and two therapists). Both group treatments consist of 16 sessions of two hours in a period of about six months. There is a second assessment after the treatment. The third condition is a waiting list condition. After the waiting period of at least six months, patients get a second assessment.

Intervention type
Other

Phase
Not Specified

Drug names


Primary outcome measures
1. Fatigue severity (measured with the CIS subscale fatigue severity).
2. Disabilities (measured with the Sickness Impact Profile (SIP) total score and the Short form health survey (SF-36) subscale 'physical functioning'). The CIS-f, SIP and SF-36 are used in two assessments, a baseline and a post-treatment (or post-waiting list) assessment. The change score between post-treatment and baseline of each of the treatment conditions is compared with the difference score between post-waiting list and baseline assessment of the waiting list condition.

Secondary outcome measures
Psychological distress measured with the Symptom Checklist 90 (SCL 90).

Overall trial start date
01/01/2008

Overall trial end date
01/12/2008

Reason abandoned


Eligibility
Participant inclusion criteria
1. Over 18 years old
2. Being able to speak and read Dutch
3. Meeting the 1994 research criteria for CFS as formulated by the US Center for Disease Control
4. Severely fatigued (having a Checklist Individual Strength (CIS)-fatigue severity score of more than or equal to 35)
5. Severely disabled (weighted total score on the Sickness Impact Profile of more than or equal to 700)
6. Motivated for treatment of CFS with CBT
7. Having functioned good in groups before (self-report) and willing to follow a group treatment for CFS
8. Given written informed consent for participation in the study

Participant type
Patient

Age group
Adult

Gender
Both

Target number of participants
204

Participant exclusion criteria
1. Patient does not meet the previously mentioned inclusion criteria
2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits

Recruitment start date
01/01/2008

Recruitment end date
01/12/2008

Locations
Countries of recruitment
Netherlands

Trial participating centre
University Medical Center St. Radboud
Nijmegen
6500 HB
Netherlands

Sponsor information
Organisation
University Medical Center St. Radboud (The Netherlands)

Sponsor details
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3611111
info@ozi.umcn.nl

Sponsor type
Hospital/treatment centre

Website

Funders
Funder type
Hospital/treatment centre

Funder name
University Medical Center St. Radboud (The Netherlands)

Alternative name(s)


Funding Body Type


Funding Body Subtype


Location


Results and Publications
Publication and dissemination plan
Not provided at time of registration

Intention to publish date


Participant level data
Not provided at time of registration

Results - basic reporting


Publication summary


Publication citations
Additional files

Editorial Notes
 

Research 1st

Severe ME, POTS & MCAS.
Messages
768
Psych CFS papers from self proclaimed 'experts' always lift my mood.

The hypothesis is always a work of comedy literature, as is the outcome.

With no objective measures necessary to prove their 'therapies' work (Science) in these clinical centres of excellence of fatigue, at least there won't be any shortage of comedians in the area out of work.
 

Dolphin

Senior Member
Messages
17,567
An example of where the authors are coming from:

Patients may find it easier to change by observing how other patients change rather than by just talking about their own process. This aspect may be of particular importance in the context of CFS because some patients continue to attribute their symptoms to a somatic cause despite medical reassurance that such a cause is unlikely.
 

Tom Kindlon

Senior Member
Messages
1,734
For what it's worth, I just posted a very quick comment on PubMed Commons: http://www.ncbi.nlm.nih.gov/pubmed/26402868#cm26402868_12202


No objective outcome measures were used

This trial just used subjective outcome measures. Objective outcome measures are important as subjective outcome measures may not translate into objective improvements with graded activity-oriented interventions in Chronic Fatigue Syndrome (1-3). Examples of more objective outcome measures that have been used in CFS interventional studies include actigraphy, employment data, disability payments data and exercise testing.

References:

1 Kewley AJ. Does Cognitive Behavioral Therapy or Graded Exercise Therapy Reduce Disability in Chronic Fatigue Syndrome Patients? Objective Measures Are Necessary. Clinical Psychology: Science and Practice 2013:20;321-322.

2 Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010:40;1281-7.

3 Kindlon T. Comment on: Exercise therapy for chronic fatigue syndrome. http://www.ncbi.nlm.nih.gov/pubmed/25674924#cm25674924_11779
 
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ScottTriGuy

Stop the harm. Start the research and treatment.
Messages
1,402
Location
Toronto, Canada
An example of where the authors are coming from:

Is there already a handy list of disorders 'diagnosed' by allo doctors as psychological and later proven to be biomedical diseases / disorders?

Off the top of my head:

Autism - was the mother's fault
Ulcer - was by psychological stress

others?
 

Research 1st

Severe ME, POTS & MCAS.
Messages
768
On a serious note there are two tragedies here in psych CFS research self promoted as 'evidence based'.

Tragedy one:
Patients who don't have psych or Fukuda CFS but an organic inflammatory neuro disease. They will never recover on innappropriate therapies.

Tragedy one:
CFS being diagnosed as 'fact' in people mentally ill. Mentally ill who then don't respond to CBT and GET (see PACE trial), thus the psych therapy is actually useless for them too.

So we have two sets of patients with ruined lives yet the insurance industry profits massively from this, by denying disabled people disability claims.

As long as the 'evidence' on Psych CFS is published, promoted and utilised in clinics then the disability insurance never has to pay out to people in their homes, and the companies who would have paid out to patients who now need looking after (but can't get care). This saves billions of dollars as do the socialised medical health care systems in Europe who can all treat people with a therapy based on ideas, not science.

It's a win for those with money, and a loss for disabled people with no power told to be silent by people who pay them a pittance to survive (welfare payments). Meanwhile there is no effective treatment as there are no large scale biomedical research and deleting Fukuda CFS in 'research' is taboo.

I think we could try stroking kittens next for Diabetes. Propose a theory that listening to purrs lowers blood glucose levels, and thus patients won't need insulin anymore if cats can be let free to roam endocrine units. Would it be funded?
 

Effi

Senior Member
Messages
1,496
Location
Europe
Is there already a handy list of disorders 'diagnosed' by allo doctors as psychological and later proven to be biomedical diseases / disorders?

Off the top of my head:

Autism - was the mother's fault
Ulcer - was by psychological stress

others?
MS - aka hysterical housewives disease aka faker's disease