Esther12
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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:
On the plus side, this trial does have pedometers as a secondary outcome measure:
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/
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/
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