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Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for CFS Vos-Vromans

Dolphin

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17,567
New study with an intervention that did better than CBT.

Lots of comments to follow

Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

J Intern Med. 2015 Aug 26. doi: 10.1111/joim.12402. [Epub ahead of print]

Vos-Vromans DC1, Smeets RJ2,3,4, Huijnen IP2,3,4, Köke AJ4, Hitters WM5, Rijnders LJ1, Pont M6, Winkens B7, Knottnerus JA8.

Author information

Abstract

OBJECTIVES:

The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS).

DESIGN:

Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT.

SETTING:

Four rehabilitation centres in the Netherlands.

SUBJECTS:

A total of 122 patients participated in the trial.

MAIN OUTCOME MEASURES:

Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36.

Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation.

RESULTS:

A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks.

MRT was significantly more effective than CBT in reducing fatigue at 52 weeks.

The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks.

Patients showed an improvement in quality of life over time, but between-group differences were not significant.

CONCLUSION:

This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS.

Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.

© 2015 The Association for the Publication of the Journal of Internal Medicine.

KEYWORDS:

chronic fatigue syndrome; cognitive behavioural therapy; fatigue; multidisciplinary rehabilitation treatment; quality of life

PMID: 26306716 [PubMed - as supplied by publisher]
 
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Dolphin

Senior Member
Messages
17,567
Lots and lots of questionnaire data in this paper.

There is one set of objective measurements from an actometer:

Multidisciplinary rehabilitation treatment
Physical activity
Baseline 206233.65 (40264.16)
26 weeks 227283.24 (45698.55)
52 weeks 218214.41 (48564.30)
So a 5.8% increase.

cognitive behavioural therapy
Physical activity
Baseline 202033.66 (43379.41)
26 weeks 210019.75 (48068.09)
52 weeks 215262.14 (57074.22)
So a 6.55% increase

Note however that this was over 12 months and people after they get diagnosed are more likely to improve than disimprove, I think it's fair to say.

Quite a lot of people were in fairly early stages so quite likely to improve:

Duration of complaints (at referral),n(%) MRT CBT
0.5–1 year 3 (4.8) 8 (13.3)
1–2 years 16 (25.8) 14 (23.3)
2–5 years 19 (30.7) 13 (21.7)
>5 years 24 (38.7) 25 (41.7)
Even the people who are ill more than >5 years might improve "naturally", without therapy, if they have only been diagnosed. I think lots of people get a bounce in the year after getting diagnosed.

There is quite a lot of missing data with the activity monitors:
At baseline, 26 and 52 weeks, activity monitor data were available for 122, 97 and 80 participants, respectively. Skin rash and unwillingness to either wear the monitor or travel to the rehabilitation centre to collect the monitor were the main reasons for not providing activity monitor data.
The researchers don't mention any sort of analysis to see whether the groups are different.
 
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Hutan

Senior Member
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1,099
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New Zealand
So, no control group with standard care.

And for the only objective measure, activity levels as measured by an actometer, both treatment groups show a very marginal increase. But there's no evidence that the CBT has a worse impact on activity than the multidisciplinary rehabilitation treatment (in fact some very weak evidence to the contrary). And yet the abstract is written to make it sound as though the rehabilitation treatment is a great success.

Presumably the actometer was only used for a week or so at each time of measure? And both treatment groups would have been told pretty clearly that increased activity was a sign that they were good diligent people. I wonder how the patients felt in the week after the actometer measurement.
 

Dolphin

Senior Member
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17,567
The therapies were not matched for contact hours. MRT involved 44.5 contact hours and CBT 16 contact hours. This could affect how people might respond to questionnaires.
These therapies, especially MRT, would not be cheap.

Also 44.5 hours isn't the full cost of MRT. There would also be some discussion time between the people working with the patient
e.g.
This phase was followed by 2 weeks without treatment in which the therapists and the consultant in rehabilitation medicine discussed their findings and defined the treatable components and proposed treatment.
and
Interdisciplinary team meetings were scheduled to discuss the progress and focus of treatment and how interventions should be tailored.
 

Dolphin

Senior Member
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17,567
One of the Dutch ME charities co-funded this study:
Funding

The trial was funded by the Netherlands Organisation for Health Research and Development (ZonMw; Grant Number 56100007; http://www.zon mw.nl/en/), Rehabilitation Fund (the Netherlands; Grant Number 2007176/sw; http://www.revali datiefonds.nl), Foundation Nutsohra (Grant Number 0801-06; http://www.fondsnutsohra.nl) and ME/CVS Stichting Nederland (http://www.me-cvsstichting.nl). The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript
 

Dolphin

Senior Member
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17,567
There's an open access protocol. I haven't read it. This provides descriptions of the therapies.

It would be interesting if somebody compared the protocol and what was actually published.


Free full text: http://www.trialsjournal.com/content/13/1/71

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronicfatigue syndrome: study protocol for a randomised controlled trial (FatiGo).

Trials. 2012 May 30;13:71. doi: 10.1186/1745-6215-13-71.

Vos-Vromans DC1, Smeets RJ, Rijnders LJ, Gorrissen RR, Pont M, Köke AJ, Hitters MW, Evers SM, Knottnerus AJ.
Author information

Abstract
BACKGROUND:
Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo(Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome.

METHODS:
One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments.

DISCUSSION:
The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinaryrehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence oftreatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome.

TRIAL REGISTRATION:
Current Controlled Trials ISRCTN77567702.

PMID: 22647321
[PubMed - indexed for MEDLINE]
PMCID: PMC3781576
 

alkt

Senior Member
Messages
339
Location
uk
Lots and lots of questionnaire data in this paper.

There is one set of objective measurements from an actometer:

Multidisciplinary rehabilitation treatment

So a 5.8% increase.

cognitive behavioural therapy

So a 6.55% increase

Note however that this was over 12 months and people after they get diagnosed are more likely to improve than disimprove, I think it's fair to say.

Quite a lot of people were in fairly early stages so quite likely to improve:


Even the people who are ill more than >5 years might improve "naturally", without therapy, if they have only been diagnosed. I think lots of people get a bounce in the year after getting diagnosed.

There is quite a lot of missing data with the activity monitors:

The researchers don't mention any sort of analysis to see whether the groups are different.
i have not always been able to keep up with the press/news over the past 25 years. but the only instances of violence involving people with m.e that has come to my attention has been when the person with m.e has been assaulted. in one case the victim of assault died. he was assaulted in a supermarket cue in the uk.
 

Dolphin

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17,567
There were stark differences based on level of education. There was only a difference between people with MRT and CBT for people with a low level of education:


Table 6 Estimated differences in fatigue severity between MRT and CBT depending on education level
Between-group (CBT and MRT) difference (95% CI) a P-value

Low level of education
26 weeks 5.68 (12.05 to 0.69) 0.08
52 weeks 9.27 (15.48 to3.05) 0.004

Medium/high level of education
26 weeks 2.44 (5.80 to 10.68) 0.56
52 weeks 0.72 (7.44 to 8.88) 0.86
a
Data are presented as estimated differences between MRT
and CBT. The estimated differences between groups are
calculated using linear mixed models with centre, treatment
allocation, time and interaction between education, time
and treatment allocation (and their lower order interactions)
as covariates (unstructured covariance).
MRT, multidisciplinary rehabilitation treatment; CBT,
cognitive behavioural therapy; CI, confidence interval.

This is what they say in the discussion:

In the effect modification analysis, the interaction between education level and treatment allocation was associated with the final result of treatment. Patients with a lower level of education might be less willing to accept that CFS may respond to a solely psychological treatment such as CBT and be more willing to believe that physical therapy and occupational therapy are necessary. Previous research also showed that treatments in which a physiological explanation of fatigue perpetuation was provided had larger effect sizes compared to trials in which a solely psychologically based explanation of the chronicity was given [43].

A physiological explanation may be viewed as more credible by patients. Future research should further analyse which patient characteristics have the greatest impact on the positive outcome.
I wonder could there be other things going on. Might low levels of education be associated on average with social deprivation and a greater array of problems in people's lives than perhaps could be helped a bit with all the contact hours they got with MRT?
 

Dolphin

Senior Member
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17,567
i have not always been able to keep up with the press/news over the past 25 years. but the only instances of violence involving people with m.e that has come to my attention has been when the person with m.e has been assaulted. in one case the victim of assault died. he was assaulted in a supermarket cue in the uk.
Not sure what the relevance of this is to what I wrote/the thread?
 

Dolphin

Senior Member
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17,567
I thought I'd copy in the descriptions of the therapies as some people might never follow the links:

(From the protocol: http://www.trialsjournal.com/content/13/1/71)

Individual cognitive behavioural therapy (CBT)
CBT is a psychotherapeutic approach in which elements of behavioural therapy and cognitive therapy approaches are incorporated. In CBT, a model of perpetuating cognitions and behaviour of CFS 14] is used to explain the persistence of CFS. This model shows that high physical attributions will decrease physical activity and increase fatigue and functional impairment. This model also explains that a low level of sense of control over symptoms and focusing on physical sensations have a direct causal effect on fatigue severity and functional impairment. A perceived lack of social support also increases the fatigue severity and functional impairment. These perpetuating factors (high physical attributions, decreased physical activity, low level of sense of control, focusing on physical sensations and perceived lack of social support) are the focus of the intervention in CBT 37,38].

CBT is divided into three phases:

1) Intake

2) Gradual reactivation

3) Prevention of relapse

1) Intake

During the intake phase (four sessions in 4 weeks), the cognitive behavioural therapist gets acquainted with the patient. The patient is asked about: the cause and course of the complaints, the present complaints, illness beliefs and illness behaviour, coping, social interactions/participation, and the expectations and personal goals of the patient. The therapist tries to determine the patient’s activity level by asking about activities during the day and week, and categorises the patient into a relatively active patient or a patient with a low activity pattern. The therapist explains the model of perpetuating cognitions and behaviour of CFS, and how to overcome CFS by changing patterns of thinking and changing behaviour.

2) Gradual reactivation

Graded exercise therapy (GET) is used to gradually increase physical activity. The patient follows a schedule to gradually increase activities at home (walking and bicycling). The schedule is provided by the therapist in accordance with the patient’s personal goals. The patient has to increase his/her activities at home and receives feedback afterwards during the next therapy session. If needed, schedules are made to increase social and/or mental activities as well. Another important subject during gradual reactivation is the balance between different activities and the patient’s personal responsibility to see to it.

In the dialogues with the therapist and by doing exercises at home, the patient is taught to change negative beliefs regarding symptoms of fatigue, self-expectations and self-esteem. Specific lifestyle changes are encouraged if deemed appropriate.

Sleep/wake rhythm: the patient is encouraged to change the sleep/wake rhythm immediately at the start of treatment into a regular sleep/wake rhythm. Sleeping during the day is not allowed.

In accordance with the principles of GET, a plan to return to work will be made.

3) Prevention of relapse:

If activities are increased and the sleep/wake rhythm is normalised, the patient is encouraged to unsettle him-/herself and to cope with these disturbances by applying the things he/she learned during therapy. Personal goals are evaluated and relapse prevention is addressed.

The patient assigned to this group will attend 16 individual therapy sessions, spread out over 6 months with a psychologist or behavioural therapist. The first 6 weeks, the patient has weekly contact with the therapist, followed by once every 2 weeks for the next 20 weeks. The CBT protocol is fixed and different for relatively active patients and patients with a low activity pattern37,38]. In the treatment for the relatively active patient, the patient learns to spread out activities during the day and to vary different activities during the day. The patient learns to be active within physical and mental boundaries to overcome overburdening. With the use of cognitive therapy, cognitions and behaviour that may lead to overburdening (like not accepting boundaries in activity, and having high expectations) are the primary focus of treatment. After reaching the baseline (without peaks in complaints of the CFS) there will be a gradual increase of activities. For patients with a low activity pattern, activities will be increased from the beginning of therapy.
 

Dolphin

Senior Member
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17,567
Description of MRT from the protocol: http://www.trialsjournal.com/content/13/1/71

Individual multidisciplinary rehabilitation treatment (MRT)
In multidisciplinary treatment, a biopsychosocial model of CFS is used including biological, physical and psychosocial aspects 10,31]. In the biopsychosocial model of CFS various precipitating, predisposing and perpetuating factors are merged, suggesting that multiple pathways may lead to the causation and persistence of CFS 31]. The protocol of the MRT is not fixed, but varies between patients, depending on the relation between treatable components (precipitating, predisposing and perpetuating factors), present complaints and personal needs of a patient. The focus of treatment can be different for each patient depending on these relations. During treatment every therapist fills in treatment checklists for every patient to register which methods are used.

MRT is divided into three phases:

1) Observation

2) Treatment

3) Prevention of relapse

1) Observation

During a 2-week observation, therapists (psychologist, social worker, physical therapist and occupational therapist) get acquainted with the patient. During observation, they ask the patient about: the cause and course of the complaints, the present complaints, illness beliefs and illness behaviour, coping, the social environment the patient lives in, expectations and personal goals. The psychologist (two 1-h sessions) further elaborates on the psychological history, present psychological wellbeing, use of medical care including medication, stress factors, cognitions, attitudes and mood (state of mind). The social worker (two 1-h sessions) assesses the social context in which the patient lives (relationships, family and role in a family), work situation and communication. The physical therapist (five 30-min sessions) makes an estimation of the physical condition and the patient’s body awareness. The occupational therapist (four 30-min sessions) aims at ergonomics, lifestyle, day/week schedule and the variety of activities during the day/week. During observation, the treatable components are weighted in relation to the present complaints. If a strong relation exists between these components and the present complaints, these components will be addressed during treatment. In a team meeting, therapists and the rehabilitation physician discuss the components and methods that will be used during the treatment phase. The rehabilitation physician will discuss the conclusions of this meeting with the patient and ask for commitment to the proposed therapy. A treatment contract will be signed by the rehabilitation physician and the patient.

2) Treatment

Two weeks after ending the observation phase, the treatment phase starts. This phase takes 10 weeks to complete. Depending on the patient goals/needs and the relation between treatable components and present complaints, different methods will be more or less used in the treatment phase. The following methods can be incorporated:

Body awareness therapy 39,40]: aims to establish an increased awareness and consciousness of the body and its relation to psychological wellbeing. The patient learns to discriminate bodily symptoms other than fatigue and pain and learns to react on these healthy bodily symptoms. The patient will be coached by a physical therapist. Bodyscan, grounding, awareness exercises of the influence of thoughts and emotions on the body are some of the exercises that will be practised during treatment. In the end, the patient will be aware of the relation between the body, its physical function, psychological wellbeing and social interaction, and is able to react on stress in an appropriate way.

Cognitive behavioural therapy: A psychotherapeutic approach in which elements of behavioural and cognitive therapy approaches are incorporated. CBT facilitates the identification of unhelpful, negative emotion-provoking thoughts, dysfunctional emotions, behaviours and cognitive patterns, and challenges them through a goal-oriented, systematic procedure. The patient learns to identify negative beliefs regarding the symptoms of fatigue, self-expectations or self-esteem, and is encouraged to challenge and change them into new, more realistic, more helpful alternatives.

Gradual reactivation: At the start of treatment, activities are trained time contingent under close supervision of the physical therapist and occupational therapist. The patient follows schedules to gradually increase activities and receives immediate feedback during treatment when needed. The schedules of fitness exercises and swimming are provided by the physical therapist in accordance with the patient’s personal goals. Another schedule is provided by the occupational therapist in accordance with the patient’s personal goals to increase activity and vary activities at home. In the final phase of treatment, schedules are of less importance and the patient is encouraged to increase activities on his/her own without following a schedule (see pacing).

Pacing: During the second phase of treatment, the patient is taught to pace his/her activities during the day/week. By developing awareness of healthy bodily symptoms the patient will be able to balance his/her activities (psychological as well as physical activities) before extreme fatigue or pain prevails. The schedule of time-contingent increase is no longer followed. The patient will pace his/her activities based on his/her own experiences.

Principles of mindfulness. Mindfulness is a non-elaborative, non-judgemental, present-centred awareness in which each thought, feeling or sensation that arises is acknowledged and accepted as it is. The patient learns to self-regulate attention that is maintained on immediate experience, thereby allowing for increased recognition of mental events in the present moment. They also learn to observe the thoughts, emotions and sensations that arise, without making judgements about their truth, importance or value, and without trying to escape, avoid or change them. Regular practice of mindfulness skills increases self-awareness and self-acceptance, reduces reactivity to passing thoughts and emotions, and improves the ability to make adaptive choices41]. In patients who have been chronically ill, mindfulness skills have a positive effect on depression, mood and activity level 42].

Normalising of the sleep/wake rhythm. The sleep/wake rhythm will be discussed and with a schedule of 4 weeks will be gradually changed to the sleep/wake rhythm the patient desires. Sleeping during the day will be stopped immediately. If there are problems with the quality of sleep, principles of sleep hygiene are prescribed by the psychologist. Relaxation therapy is used to increase the efficiency of the resting moments during the day and to improve the quality of sleep during the night if needed.

Social reintegration. Under supervision of the occupational therapist and social worker, the patient is coached to reintegrate into society by making a plan to return to his/her work or school, and to increase their social activities.

3) Prevention of relapse

Six weeks after ending the treatment phase, the patient will visit the social worker. Thirteen weeks after ending the treatment phase, the patient will visit two therapists of his/her choice who were involved in the previous treatment. Both after-care visits are used to stimulate and motivate the patient to practice at home what he/she has learned during the treatment phase.

Although MRT and CBT have three corresponding aims—modification of dysfunctional beliefs, gradual increase of activities and normalisation of sleep/wake rhythm—many differences can be detected between the two treatments. The main differences are viewed in Table 1.
 

alkt

Senior Member
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339
Location
uk
Not sure what the relevance of this is to what I wrote/the thread?
in advertisements for clinical posts .in two different uk c.f.s clinics the wording in the job descriptions made it seem like people with m.e c.f.s are more prone to dangerous violent outbursts. basically setting the background for respondents to see people as mentally ill. sorry i have mixed this up with an earlier post about the psychiatric treatment of patients with m.e c f s.in reference to the patient handout in liverpool. it was a carry on from that.
 
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Dolphin

Senior Member
Messages
17,567
in advertisements for clinical posts .in two different uk c.f.s clinics the wording in the job descriptions made it seem like people with m.e c.f.s are more prone to dangerous violent outbursts. basically setting the background for respondents to see people as mentally ill.
Ok. Thanks for replying. I still don't see how that directly relates to what I wrote/you quoted but I suppose worthwhile mentioning now and again.
 

Dolphin

Senior Member
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17,567
Data processing

Before analysing data from the EET, responses to each of the five questions were dichotomized to categorize patients as satisfied or not satisfied, and improved or not improved. The categories ‘very much satisfied’ and ‘satisfied’ were merged into one category ‘satisfied’. The categories ‘neutral’, ‘dissatisfied’ and ‘very much dissatisfied’ were merged into ‘not satisfied’ In addition, the categories ‘very much improved’ and ‘improved’ were grouped as ‘improved’ and the categories ‘neutral’, ‘declined’ and ‘very much declined’ as ‘not improved’.
I find it disappointing when they do this. One can't see who said "dissatisfied or very much dissatisfied" as opposed to simply "neutral".
Similarly, one can't find who said "declined" and "very much declined" as opposed to "neutral".
 

Dolphin

Senior Member
Messages
17,567
Withdrawals.

CBT (12):

Reasons:
1 increase in complaints
3 no improvement
2 unwillingness to change behaviour
1 did not feel tired anymore
2 problems combining treatment with
work and home
1 unable to set treatment goals
1 wanted to be transferred to MRT to get
more guidance during the physical
training
1 unknown

MRT (6)

Reasons:
1 increase of complaints
2 unwillingness to change behaviour
1 team advised rehabilitation for lung complaints
1 could not follow treatment due to multiple
resistant cystitis and removal
1 never started treatment due to unknown illness
 

Dolphin

Senior Member
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17,567
Adherence (70% is an arbitrary figure):
Of the 104 participants receiving treatment, five in the CBT group did not reach the 70% level of adherence to treatment; all participants in the MRT group reached the 70% adherence level.
 

Dolphin

Senior Member
Messages
17,567
At 52 weeks, 49% of the patients in the MRT group had a CIS fatigue subscale score of less than 35 compared to 26% of the patients receiving CBT. This difference between treatment allocation was statistically significant (P=0.014).
35 is a fairly arbitrary figure though it does tend to be used quite a lot in Dutch CBT studies.
 

Dolphin

Senior Member
Messages
17,567
For MRT, the CIS-fatigue scores were:
baseline: 51.47 (5.08)
52 weeks: 33.84 (14.33).

The scale is 8-56, so if one translates the scores to a 0-48 scale they're:
43.47 (out of 48) (or 90.5625% fatigued)
25.84 (out of 48) (or 53.8333% fatigued)

That's a big difference compared to the the objective change (mentioned previously above) i.e.

Multidisciplinary rehabilitation treatment
Physical activity
Baseline 206233.65 (40264.16)
26 weeks 227283.24 (45698.55)
52 weeks 218214.41 (48564.30)

A 5.8% increase from baseline to 52 weeks.
 

Dolphin

Senior Member
Messages
17,567
2 big differences between MRT and CBT:

At 52 weeks of follow-up, 37 participants in the MRT group (66.1%) were satisfied with the results of treatment compared to 22 participants in the CBT group (40.0%; P=0.006),
and
significantly, more participants would recommend treatment to others in the MRT (n=47; 83.9%) than CBT (n=28; 51.9%; P=0.001).