Efficacy of web-based cognitive–behavioural therapy for chronic fatigue syndrome: randomised controlled trial (2018) Knoop

We have another CBT trial to look forward to:

From the protocol paper:
This study has some potential limitations. We have no controlled follow-up assessment in our study. We will not be able to determine if the expected positive effects of the web-based intervention are sustained over a longer period. A longer follow-up period is not possible as our study will be continued as a randomized noninferiority trial comparing the two forms of web-based CBT followed by face to face CBT if patients have not profited from the internet intervention (stepped care) with care as usual, i.e. face to face CBT following the waiting list. This randomized noninferiority trial is registered in the Netherlands trial register (NTR4809). Second potential limitation is that the treatment effects cannot be controlled for non-specific factors of the interventions. As this study will be continued as a randomized controlled noninferiority trial an active control was not possible. Previous research has shown that CBT is significantly more effective than other active interventions, like guided support groups and specialist medical care (Prins et al., 2001 and White et al., 2011).
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The intervention sounds designed to bias self-report outcomes.

Maybe actometer results were poor for the next step of the trial, and that led to them playing them down their positive results here? I can see how an 'easy-to-ignore' form of internet CBT would be less likely to be unhelpful, and therefore if some people might still benefit from it, that could lead to better results than we see for face-to-face CBT. It's so hard to say anything when this group have such a history of misrepresenting the evidence.
 
Valentijn said:
The Dutch BPS group engage in some interesting shenanigans at times, like declaring completely untreated patients cured by CBT. They might be downplaying actometer results to avoid further scrutiny.
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Quite possibly. I just found it interesting because if (in isolation from any other flaws the trial might have) I had an objective measure that appears to show a statistically significant benefit, I wouldn't be squirreling that away.
 
Londinium said:
Quite possibly. I just found it interesting because if (in isolation from any other flaws the trial might have) I had an objective measure that appears to show a statistically significant benefit, I wouldn't be squirreling that away.
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Just to point out that the actometer data was neither a primary nor a secondary outcome measure.

There is a chance they might not have published it if it didn't suit.
They used actometers in Nijhof et al. (2012) https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-11-23 but have never published the data.
Janse et al. 2015 said:
Primary outcome measure

Fatigue severity will be assessed with the subscale fatigue severity of Checklist Individual Strength [23]. This subscale consists of eight items assessing fatigue severity over the past two weeks. Scores range between eight (no fatigue) and 56 (severe fatigue). The cut-off score for severe fatigue is 35. This is two standard deviations above the mean of healthy controls [24]. The CIS is a reliable and valid instrument for the assessment of fatigue in CFS patients [23–25]. The Cronbach's alpha reliability coefficient for the subscale fatigue severity is .88 [23]. This outcome measure and cutoff point was also used in previous trials assessing the efficacy of a minimal intervention for CFS [26].

Secondary outcome measures

Level of disability will be measured with the total score of the Sickness Impact Profile (SIP8) [25]. The SIP8 assesses functional disability on the following eight domains: ambulation, home management, mobility, alertness behaviour, sleep and rest, work, social interactions, and recreation and pastimes. A weighted total score is computed from the scores on the eight subscales [12, 27]. This widely used measure has good reliability [27] and validity [5, 11]. Physical functioning will be assessed with the Medical Outcomes Survey Short Form-36 (SF-36) [28]. The subscale ‘physical functioning’ will be used. Scores on both scales range from 0 (maximum limitations) to 100 (no limitations). The SF-36 is a reliable and valid instrument to assess self-reported health status in CFS patients [28, 29]. Psychological distress will be assessed with the total score of the Symptom Checklist 90 (SCL-90) [30]. In total 90 items are answered on a five-point Likert scale. Total scores range from 90 to 450, with higher scores being indicative of more psychological distress. This widely used measure has good reliability and discriminating validity [31]. Clinical significant improvement in fatigue is defined as a reliable change index > 1.96 [32] and a score of < 35 on the CIS ‘fatigue severity’ subscale at second assessment.

Other study parameters

Based on the CBT for CFS model several fatigue related behaviours and cognitions will be assessed [33, 34]. The therapist will register invested therapist time for each patient. Actigraphy will be used to assess the level of physical activity. The actometer has been shown to be a reliable and valid instrument for the assessment of physical activity in CFS [18]. The presence of psychiatric disorders will be assessed using a structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI) screen test [19].
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"Hmmm. Disappointing. Well, let's move on to you, Captain Piett. Have you found these
online sessions helpful?"

ForceChoke-660x330.jpg
 


Direct link to the text:
Cambridge Core: Frank Twisk & Lou Corsius: Cognitive-behavioural therapy for chronic fatigue syndrome: neither efficacious nor safe

The authors label their intervention CBT. However, looking at the protocol, the intervention investigated not only incorporated CBT, aimed at ‘behaviours and beliefs’ perpetuating ‘fatigue and impairment’, but also included a graded activity programme, known as graded exercise therapy (GET). Several large-scale patient surveys and studies, for example Cheshire et al,4indicate that CBT, especially when combined with GET, can cause iatrogenic harm and is not safe.

In conclusion, the study does not substantiate the claim that iCBT/GET for CFS is efficacious, while there are several indications CBT/GET is not a safe therapy.
 
Dolphin said:
Just to point out that the actometer data was neither a primary nor a secondary outcome measure.

There is a chance they might not have published it if it didn't suit.
They used actometers in Nijhof et al. (2012) https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-11-23 but have never published the data.
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This study is one of the 3 trials the German IQWiG draft report assessed (cited as Janse 2018)

https://www.s4me.info/threads/germa...-by-11-november-2022.21266/page-2#post-441477

Did I understand correctly that this is another example of the studies who used actimetry as part of the treatment but not as trial outcome measures and didn't report results?

Do the authors nevertheless claim that there was an increase in activity measured by actometers or is their argument that only subjective measures on a perceived increase in activity are relevant so they didn't even analyze the actometer data?
 
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