On 2013 Oct 24, Tom Kindlon commented:

Treating severely affected CFS patients with CBT

This study found that the "more severely disabled patients benefit less from the self-instructions" (to be more specific, "the treatment effect is more than halved for patients with an SIP8 score of 1 standard deviation above the mean").

At least one other Cognitive Behavioural Therapy (CBT) for Chronic Fatigue Syndrome (CFS) study found that the outcome may be related to the level of impairment at baseline[1]. In this study, 10 (37%) reported being "better or much better" following treatment and 17 (63%) were the same or worse (we are not given a breakdown between the two categories).

Comparing the two groups at baseline, the patients who reported improvement reported significantly less (p<0.05) functional impairment as measured by the SIP-8 [a mean (SD) of 1330 (417) vs 1985 (730)], less daily observed fatigue [7.4 (2.6) vs 9.7 (2.3)], and less daily observed pain [4.5 (2.6) vs 7.8 (3.5)]. For the pre-treatment variable "mean hours working a week" a trend (p=0.062) was found with improved patients working more hours at baseline compared to non-improved patients [10.9 (12.8) vs 2.6 (6.6)]. As with the current study, there was not a statistical difference on initial fatigue (CIS-fatigue). The paper¹ devotes quite a bit of space to this analysis including a table (Table 3).

Reference:

1 Bazelmans E, Prins JB, Lulofs R, van der Meer JW, Bleijenberg G. Cognitive behaviour group therapy for chronic fatigue syndrome: a non-randomised waiting list controlled study. Psychother Psychosom. 2005;74(4):218-24

On 2013 Oct 25, Tom Kindlon commented:

Andrew Kewley explored this issue in a recent commentary.¹

References:

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;3:321-322 DOI: 10.1111/cpsp.12042

On 2013 Oct 24, Tom Kindlon commented:

Are there CBT studies with CFS controls that found objective (e.g. actometer) increases in activity?

In an e-letter,¹ I pointed out the problem of the lack of use and/or reporting of objective outcome measures in the area.

I have read more papers on the topic since then and it is interesting that the Nijmegen group themselves have been aware of this issue for over a decade. For example, two of the three co-authors of this study co-wrote a paper in 1997² which said: "It is not clear whether subjective accounts of physical activity level adequately reflect the actual level of physical activity. Therefore the primary aims of the present study were to assess actual activity level in patients with CFS to validate claims of lower levels of physical activity and to validate the reported relationship between fatigue and activity level that was found on self-report questionnaires. In addition, we evaluated whether physical activity level adequately can be assessed by self-report measures. An Accelerometer was used as a reference for actual level of physical activity.". The authors reported on the correlations on 7 outcome measures in relation to the actometer readings: "none of the self-report questionnaires had strong correlations with the Actometer. Thus, self-report questionnaires are no perfect parallel tests for the Actometer." The authors pointed out that "the subjective instruments do not measure actual behaviour. Responses on these instruments appear to be an expression of the patients' views about activity and may be biased by cognitions concerning illness and disability."

This finding was re-iterated in another paper three years later again involving Bleijenberg and Van der Meer:³ "In earlier studies of our research group, actual motor activity has been recorded with an ankle-worn motion-sensing device (actometer) in conjunction with self-report measures of physical activity. The data of these studies suggest that self-report measures of activity reflect the patients' view about their physical activity and may have been biased by cognitions concerning illness and disability."

So could it be the case that Cognitive Behaviour Therapy for CFS is simply changing how patients respond to self-report questionnaires and that no actual changes of activity are occurring? Some research suggests this is possible.⁴

References

1 Kindlon T. How effective is the treatment for CFS? http://bjp.rcpsych.org/content/193/4/340.abstract/reply#bjprcpsych_el_22380

2 Vercoulen JH, Bazelmans E, Swanink CM, Fennis JF, Galama JM, Jongen PJ, Hommes O, Van der Meer JW, Bleijenberg G. Physical activity in chronic fatigue syndrome: assessment and its role in fatigue. J Psychiatr Res. 1997 Nov-Dec;31(6):661-73.

3 van der Werf SP, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G. Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. J Psychosom Res. 2000 Nov;49(5):373-9.

4 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 Aug;40(8):1281-7.

On 2013 Oct 24, Tom Kindlon commented:

Data subsequently releasted from on this study reveals that there was no change in activity levels

Some people may be interested to know that a review of three Dutch Chronic Fatigue Syndrome (CFS) studies that was subsequently released¹ showed that this intervention did not result in an increase in physical activity levels in this study² along with two other Dutch CBT studies ^3,4. The authors say these three studies were based on the same general therapeutic approach to the illness.⁵

The mean (standard deviations) for the guided self-instructions/CBT and Control groups were respectively 63.1 (23.5) and 63.5 (21.8) before treatment and 67.3 (22.5) and 67.8 (21.4) at the second assessment. In terms of change scores, this equates to: 4.3 (20.4) and 4.3 (21.0). Different devices can be used to measure activity levels; for the actometers used in this study, healthy controls were previously found to have a mean Actometer score of 91 (S.D.=25).⁶ That study found that the mean Actometer score of tested CFS patients was 66 (S.D.=22).⁶

Another research team in the US also found similar results with regard to physical activity.⁷ In a study investigating an intervention involving Cognitive Behavior Therapy (CBT) which included encouraging CFS patients for going for longer walks, they found that on the SF-36 Physical Functioning (PF) scale, patients improved from a pre-treatment mean (SD) of 49.44 (25.19) to 58.18 (26.48) post-treatment, equivalent to a Cohen's d value of 0.35. On the Fatigue Severity Scale (FSS), the improvement as measured by the cohen's d value was even great (0.78) from an initial pre-treatment mean (SD) of 5.93 (0.93) to a 5.20 (0.95) post-treatment. However on actigraphy there was actually a numerical decrease from a pre-treatment mean (SD) of 224696.90 (158389.64) to 203916.67 (122585.92) post-treatment (cohen's d: -0.13).

These studies raise questions about what are the best outcome measures to use in trials of CBT for CFS.

References:

[1] 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 Jan 5:1-7. [Epub ahead of print]

[2] Knoop H, van der Meer JW, Bleijenberg G (2008). Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial. British Journal of Psychiatry 193, 340-341.

[3] Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G (2005). Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. British Medical Journal 330. Published online : 7 December 2004. doi:10.1136/bmj.38301.587106.63.

[4] Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JW (2001). Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 357, 841-847.

[5] Bleijenberg G, Prins JB, Bazelmans E (2003). Cognitive behavioral therapies. In Handbook of Chronic Fatigue Syndrome (ed. L. A. Jason, P. A. Fennell and R. R. Taylor), pp. 493-526. Wiley: New York.

[6] Van der Werf SP, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G (2000). Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. Journal of Psychosomatic Research 49, 373-379.

[7] Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? J Clin Psychol. 2009 Feb 11.

On 2013 Oct 24, Tom Kindlon commented:

Data subsequently releasted from on this study reveals that there was no change in activity levels

Some people may be interested to know that a review of three Dutch Chronic Fatigue Syndrome (CFS) studies that was subsequently released¹ showed that this intervention did not result in an increase in physical activity levels in this study² along with two other Dutch CBT studies ^3,4. The authors say these three studies were based on the same general therapeutic approach to the illness.⁵

The mean (standard deviations) for the guided self-instructions/CBT and Control groups were respectively 63.1 (23.5) and 63.5 (21.8) before treatment and 67.3 (22.5) and 67.8 (21.4) at the second assessment. In terms of change scores, this equates to: 4.3 (20.4) and 4.3 (21.0). Different devices can be used to measure activity levels; for the actometers used in this study, healthy controls were previously found to have a mean Actometer score of 91 (S.D.=25).⁶ That study found that the mean Actometer score of tested CFS patients was 66 (S.D.=22).⁶

Another research team in the US also found similar results with regard to physical activity.⁷ In a study investigating an intervention involving Cognitive Behavior Therapy (CBT) which included encouraging CFS patients for going for longer walks, they found that on the SF-36 Physical Functioning (PF) scale, patients improved from a pre-treatment mean (SD) of 49.44 (25.19) to 58.18 (26.48) post-treatment, equivalent to a Cohen's d value of 0.35. On the Fatigue Severity Scale (FSS), the improvement as measured by the cohen's d value was even great (0.78) from an initial pre-treatment mean (SD) of 5.93 (0.93) to a 5.20 (0.95) post-treatment. However on actigraphy there was actually a numerical decrease from a pre-treatment mean (SD) of 224696.90 (158389.64) to 203916.67 (122585.92) post-treatment (cohen's d: -0.13).

These studies raise questions about what are the best outcome measures to use in trials of CBT for CFS.

References:

[1] 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 Jan 5:1-7. [Epub ahead of print]

[2] Knoop H, van der Meer JW, Bleijenberg G (2008). Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial. British Journal of Psychiatry 193, 340-341.

[3] Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G (2005). Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. British Medical Journal 330. Published online : 7 December 2004. doi:10.1136/bmj.38301.587106.63.

[4] Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JW (2001). Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 357, 841-847.

[5] Bleijenberg G, Prins JB, Bazelmans E (2003). Cognitive behavioral therapies. In Handbook of Chronic Fatigue Syndrome (ed. L. A. Jason, P. A. Fennell and R. R. Taylor), pp. 493-526. Wiley: New York.

[6] Van der Werf SP, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G (2000). Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. Journal of Psychosomatic Research 49, 373-379.

[7] Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? J Clin Psychol. 2009 Feb 11.

On 2013 Oct 24, Tom Kindlon commented:

Are there CBT studies with CFS controls that found objective (e.g. actometer) increases in activity?

In an e-letter,¹ I pointed out the problem of the lack of use and/or reporting of objective outcome measures in the area.

I have read more papers on the topic since then and it is interesting that the Nijmegen group themselves have been aware of this issue for over a decade. For example, two of the three co-authors of this study co-wrote a paper in 1997² which said: "It is not clear whether subjective accounts of physical activity level adequately reflect the actual level of physical activity. Therefore the primary aims of the present study were to assess actual activity level in patients with CFS to validate claims of lower levels of physical activity and to validate the reported relationship between fatigue and activity level that was found on self-report questionnaires. In addition, we evaluated whether physical activity level adequately can be assessed by self-report measures. An Accelerometer was used as a reference for actual level of physical activity.". The authors reported on the correlations on 7 outcome measures in relation to the actometer readings: "none of the self-report questionnaires had strong correlations with the Actometer. Thus, self-report questionnaires are no perfect parallel tests for the Actometer." The authors pointed out that "the subjective instruments do not measure actual behaviour. Responses on these instruments appear to be an expression of the patients' views about activity and may be biased by cognitions concerning illness and disability."

This finding was re-iterated in another paper three years later again involving Bleijenberg and Van der Meer:³ "In earlier studies of our research group, actual motor activity has been recorded with an ankle-worn motion-sensing device (actometer) in conjunction with self-report measures of physical activity. The data of these studies suggest that self-report measures of activity reflect the patients' view about their physical activity and may have been biased by cognitions concerning illness and disability."

So could it be the case that Cognitive Behaviour Therapy for CFS is simply changing how patients respond to self-report questionnaires and that no actual changes of activity are occurring? Some research suggests this is possible.⁴

References

1 Kindlon T. How effective is the treatment for CFS? http://bjp.rcpsych.org/content/193/4/340.abstract/reply#bjprcpsych_el_22380

2 Vercoulen JH, Bazelmans E, Swanink CM, Fennis JF, Galama JM, Jongen PJ, Hommes O, Van der Meer JW, Bleijenberg G. Physical activity in chronic fatigue syndrome: assessment and its role in fatigue. J Psychiatr Res. 1997 Nov-Dec;31(6):661-73.

3 van der Werf SP, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G. Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. J Psychosom Res. 2000 Nov;49(5):373-9.

4 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 Aug;40(8):1281-7.

On 2013 Oct 24, Tom Kindlon commented:

Treating severely affected CFS patients with CBT

This study found that the "more severely disabled patients benefit less from the self-instructions" (to be more specific, "the treatment effect is more than halved for patients with an SIP8 score of 1 standard deviation above the mean").

At least one other Cognitive Behavioural Therapy (CBT) for Chronic Fatigue Syndrome (CFS) study found that the outcome may be related to the level of impairment at baseline[1]. In this study, 10 (37%) reported being "better or much better" following treatment and 17 (63%) were the same or worse (we are not given a breakdown between the two categories).

Comparing the two groups at baseline, the patients who reported improvement reported significantly less (p<0.05) functional impairment as measured by the SIP-8 [a mean (SD) of 1330 (417) vs 1985 (730)], less daily observed fatigue [7.4 (2.6) vs 9.7 (2.3)], and less daily observed pain [4.5 (2.6) vs 7.8 (3.5)]. For the pre-treatment variable "mean hours working a week" a trend (p=0.062) was found with improved patients working more hours at baseline compared to non-improved patients [10.9 (12.8) vs 2.6 (6.6)]. As with the current study, there was not a statistical difference on initial fatigue (CIS-fatigue). The paper¹ devotes quite a bit of space to this analysis including a table (Table 3).

Reference:

1 Bazelmans E, Prins JB, Lulofs R, van der Meer JW, Bleijenberg G. Cognitive behaviour group therapy for chronic fatigue syndrome: a non-randomised waiting list controlled study. Psychother Psychosom. 2005;74(4):218-24