Protocol for Portugeses behavioural CFS RCT that seems to be lacking a decent control

[Esther12]

Edit: This is for 'unexplained chronic fatigue', not CFS

Protocol for the "four steps to control your fatigue (4-STEPS)" randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

http://www.biomedcentral.com/1471-2458/12/202

A common problem with CFS RCTs is that a lot of the components of 'treatments' for CFS are made up of what would normally be considered part of the placebo arm: having a good relationship with a therapist trying to help, being encouraged to believe that the treatments is helping or that patients are improving themselves by taking part in some ritual, etc... these sorts of things can lead to patients reporting improvements even if no real benefit has been gained, and there is no improvement in more objective measures of disability. This is also why things like homoeopathy can seem to be effective from non-blinded RCTs.

To me, it looks like this is going to be a problem with this study:

Interventions

Control group

In addition to standard medical care, patients that are assigned to this group receive a flyer with information about the general health benefits of physical activity and the current physical activity guidelines for adults [13].
Intervention group

In addition to standard care, patients in the intervention group receive the 4-STEPS program that consists of:
1. Two face-to-face individual motivational interviewing (MI) sessions aimed at exploring important health and life goals, increasing participants' motivation and confidence to be physically active and setting a specific personal physical activity goal. The first MI session takes place 1 week after the baseline assessment and the second MI session takes place 2 weeks after the first. The MI session is delivered by a psychologist with MI training (member of the research team). The duration of the sessions is approximately 1 hour. Details on the topics addressed in the MI sessions are presented in Table 1.
2. Two brief telephone counseling sessions: These sessions take about 20 minutes and are provided 2 weeks and 6 weeks after the last MI session. Details on the topics addressed during the telephone sessions are presented in Table 1.
3. Self-regulation (SR) booklets: There are two booklets that are designed to help patients change their level of physical activity (Informational booklet and Workbook). The Informational booklet is provided at the end of the baseline assessment, the "Step 1" part of the Workbook is provided at the first MI session and the parts "Step 2", "Step 3" and "Step 4" are given during the second MI session. Details on the topics that are addressed in the SR booklets are presented in Table 2.
4. A pedometer to register physical activity on a daily basis (steps taken) during the 3 month intervention period. Instructions on how to use the pedometer are given in the baseline assessment session (Table 2).
5. Daily activities record (Table 2): Patients receive several daily activity records (physical activities, mental activities and rest). The first daily activity record is given to the patient at the end of the first MI session; patients are asked to fill out the activity record in the time period between the first and second MI session. This homework assignment aims at evaluating the patients' daily activities management and possibly recognizing an erratic pattern of rest and activity (boom and bust cycle). At the end of the second MI session, patients receive daily activities records that can be used to monitor changes in daily activity patterns during the subsequent nine weeks.
6. Leaflet for family (Table 2): At the end of the first MI session patients receive a leaflet for their partner or significant other in order to increase social support.

On the plus side, this trial does have pedometers as a secondary outcome measure:

13. Physical activity: two different measures are used to assess physical activity level. The first is the pedometer (YAMAX SW-200), a portable device that counts the number of steps taken, by detecting hip motions. Participants are asked to use the pedometer on a daily basis for seven consecutive days and register their daily number of steps on a form that is provided to the patient. The second measure is the Sports subscale of the SQUASH [46]; in this subscale participants indicate the type of physical activity they do (e.g. swimming) including the frequency per week (e.g. 3 days per week) and duration per day (e.g. 50 minutes) for each of these activities. The intensity of each of these activities is calculated based on the Ainsworth's Compendium of Physical activities [47].

Unfortunately we've already seen how when RCTs show minor improvements in questionnaire scores, and no improvement in the amount of activity patients can take part in, this is presented as showing how wonderful the treatment is: it works without patients even needing to do more!

Edit: Discussion of published results here: http://forums.phoenixrising.me/inde...program-the-4-steps-for-unexplained-cf.32694/

 

[taniaaust1]

. A pedometer to register physical activity on a daily basis (steps taken) during the 3 month intervention period. Instructions on how to use the pedometer are given in the baseline assessment session (Table 2).

That is great. I wonder thou what they will pay this attention at all even if they are doing less steps per day if an improved exercise block is registered by the Sports Subscale part.

Many patients may put effort into the exercise section part but find their over all capability with the rest of the daily life stuff has gone (eg less over all steps done or less daily activities then done). I hate these studies as I know they will just end up focusing on the positives and hold back on any study parts in which negative things were found (and can even get away with not publishing the negative factors).

. Participants are asked to use the pedometer on a daily basis for seven consecutive days and register their daily number of steps on a form that is provided to the patient.

And only SEVEN days using the pedometre?? That is no where a enough to get a good guide for each person due to how much our illness flutulates. How are they going to get a good base line for each person to compare how they are at the start of this study to how they are at the end of it with using one of those for seven days all up?

4. A pedometer to register physical activity on a daily basis (steps taken)

Wishy washy wording.. in that part of the info by using the word "daily" it makes this study sound better then it is.. why put "daily" when they will only use pedometer on 7 days throughout the study.
One can see from this wording already just how they will be making this study look better then it is by how its worded, once its completed.

 

[Snow Leopard]

Tania, activity levels will be measured for three 7 day periods, at baseline, ten 3 months and 12 months after baseline.

I agree that this is insufficient in terms of measuring compliance during the therapy, but the 12 month measure will see if patients have actually improved their activity levels or not.

This will likely be the first study to really show that interventions designed to increase the physical activity of patients don't actually lead to increases in physical activity at followup.

 

[Esther12]

It could well lead to increases in physical activity, and decreases in other activity - I find that putting energy into reading and thinking seriously about things can lead to me being less able to do physical activity.

Also - it could be genuinely helpful.

I'm a bit concerned that the 'control group' intervention is going to piss patients off and lead to unusually negative responses, so the intervention will look more useful than it is.

 

[alex3619]

The use of pedometers is a step in the right direction, forgive the pun. However they should give them to the patients if they are serious.

Boom-bust can be an issue, and is not a constant factor, so measuring steps might not show the issue unless they are monitored for months. I would like to see patients monitored for every day of the whole year.

For me at least there is no boom-bust cycle. Instead when things really have to get done I drive through my symptoms and this leads to a bust - a substantive physiological decline. The boom-bust cycle, I suspect, is only a reflection of patients not reprioritizing and wanting to do too much, i.e. a failure of pacing. There really is a behavioural issue that can lead to physiological crash, but its also one tied to day to day survival. When stuff has to be done or worse stuff happens, I push. So it is life-demand driven, not some intrinsic cycle.

So if the behavioural researchers wanted to do promising research they would be researching ways to assist pacing, and by that I do not mean the anti-pacing that was called adaptive pacing therapy.

Bye, Alex

PS This is open access, full paper here:
http://www.biomedcentral.com/content/pdf/1471-2458-12-202.pdf

Please note they are being honest! Its not about CFS, its about unexplained chronic fatigue - a much more general group. They at least try to disambiguate CF, ICF and CFS. Every study with daily activity measurement so far has shown no sustained improvement, but as others have pointed out merely a substitution of one activity for another, and in some cases an overall decline. It is not clear this is the situation for all cases of CF though, it would have been helpful if a definition of ME were used since ME captures the notion of excessive fatigueability/PEM/PENE.

 

[Esther12]

Just ended up looking in on this:

http://www.controlled-trials.com/ISRCTN70763996

Not too sure what's going on.

Anticipated end date 28/02/2013
Status of trial Completed

Date applied 21/09/2011
Last edited 31/01/2012
Date ISRCTN assigned 25/01/2012

So was it completed early last year, and results have been slow to come out? Or maybe they're just due now?

Actually, this alternative source would seem to indicate that they're reporting results soon:
http://apps.who.int/trialsearch/trial.aspx?trialid=ISRCTN70763996

Register: ISRCTN
Last refreshed on: 20 January 2014
Main ID: ISRCTN70763996
Date of registration: 25/01/2012
Primary sponsor: Foundation for Science and Technology (Fundação para a Ciência e Tecnologia) (Portugal)
Public title: 4-STEPS: a physical activity program for unexplained chronic fatigue 4-STEPS
Scientific title: Four steps (4-STEPS): A self-regulation based intervention for physical activity adherence in chronic fatigue patients - A Randomized controlled trial
Date of first enrolment: Jan 1 2011

 

[alex3619]

If the results were abysmal we might never see them published.

 

[Esther12]

Still nothing on this, but their registration page now says "Last refreshed on: 12 May 2014".

Not sure what changed on it though... actually, maybe 'refreshed' just means that they got data from the ISRCTN page: http://www.controlled-trials.com/ISRCTN70763996 - which says it has not been updated since "Last edited 31/01/2012"

This prof also wrote:

A Cross-Cultural Perspective on Psychological Determinants
of Chronic Fatigue Syndrome: a Comparison
Between a Portuguese and a Dutch Patient Sample

http://repositorio.ispa.pt/bitstream/10400.12/1753/1/IJBM DOI 10.1007-s12529-012-9265-y.pdf

Looked pretty dump.

 

[Esther12]

Results for this have been published and discussed here: http://forums.phoenixrising.me/inde...program-the-4-steps-for-unexplained-cf.32694/