Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome

Abstract:

Most evaluations of cognitive behavioural therapy to treat people with chronic fatigue syndrome/myalgic encephalomyelitis rely exclusively on subjective self-report outcomes to evaluate whether treatment is effective. Few studies have used measures appropriate to assessing whether cognitive behavioural therapy changes in more objective measures. A review of studies incorporating objective measures suggests that there is a lack of evidence that cognitive behavioural therapy produces any improvement in a patient’s physical capabilities or other objective measures such as return to work. Future studies of chronic fatigue syndrome/myalgic encephalomyelitis should include some objective assessments as primary outcomes. If this is to include activity monitors, we first need a sound baseline dataset.

Source: Graham McPhee. Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome. Journal of Health Psychology. First Published June 19, 2017. http://journals.sagepub.com/doi/abs/10.1177/1359105317707215 

Long-term follow-up after cognitive behaviour therapy for chronic fatigue syndrome

Abstract:

OBJECTIVE: Cognitive behaviour therapy (CBT) is an effective treatment for chronic fatigue syndrome (CFS). Main aim was to determine whether treatment effects were maintained up to 10years after treatment.

METHODS: Participants (n=583) of previously published studies on the effects of CBT for CFS were contacted for a long-term follow-up assessment. They completed questionnaires on main outcomes fatigue severity (CIS) and physical functioning (SF-36). The course of these outcomes since post-treatment assessment was examined using mixed model analyses.

RESULTS: Between 21 and 125months after finishing CBT, 511 persons (response rate 88%) completed a follow-up assessment. At follow-up, mean fatigue severity was significantly increased to 37.60 (SD=12.76) and mean physical functioning significantly decreased to 73.16 (SD=23.56) compared to post-treatment assessment. At follow-up still 37% of the participants had fatigue scores in the normal range and 70% were not impaired in physical functioning.

CONCLUSION: Positive effects of CBT for CFS on fatigue and physical functioning were partly sustained at long-term follow-up. However, a subgroup of patients once again reported severe fatigue, and compromised physical functioning. Further research should elucidate the reasons for this deterioration to facilitate the development of treatment strategies for relapse prevention.

Copyright © 2017 Elsevier Inc. All rights reserved.

Source: Janse A1, Nikolaus S2, Wiborg JF2, Heins M2, van der Meer JWM3, Bleijenberg G4, Tummers M5, Twisk J6, Knoop H7. Long-term follow-up after cognitive behaviour therapy for chronic fatigue syndrome. J Psychosom Res. 2017 Jun;97:45-51. doi: 10.1016/j.jpsychores.2017.03.016. Epub 2017 Mar 27. https://www.ncbi.nlm.nih.gov/pubmed/2860649

Once again, the PACE authors respond to concerns with empty answers

Abstract:

In their response to Geraghty, the PACE investigators state that they have “repeatedly addressed” the various methodological concerns raised about the trial. While this is true, these responses have repeatedly failed to provide satisfactory explanations for the trial’s very serious flaws. This commentary examines how the current response once again demonstrates the ways in which the investigators avoid acknowledging the obvious problems with PACE and offer non-answers instead—arguments that fall apart quickly under scrutiny.

Source: David Tuller. Once again, the PACE authors respond to concerns with empty answers. Journal of Health Psychology. First Published April 27, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317703788 (Full article)

PACE investigators’ response is misleading regarding patient survey results

Abstract:

The PACE investigators’ citation of a patient survey might mislead readers into thinking that the experience of people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) supports PACE findings. In fact, patient survey evidence directly contradicts the results of the PACE trial. A review of survey data published between 2001 and 2015 reveals that for most patients, graded exercise therapy leads to worsening of symptoms, cognitive behavioural therapy leads to no change in symptoms, and pacing leads to improvement. The experience of people with ME/CFS as reflected in surveys is a rich source of information, made more compelling by the consistency of results. Consequently, patient survey evidence can be used to inform practice, research and guidelines. Misrepresentation of patient experience must be vigorously challenged, to ensure that patients and health professionals make decisions about therapies based on accurate information.

Source: Karen D. Kirke. PACE investigators’ response is misleading regarding patient survey results. Journal of Health Psychology. First Published May 11, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317703787 (Full article)

Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis?

Abstract:

Reducing the psychological distress associated with chronic fatigue syndrome/myalgic encephalomyelitis is seen as a key aim of cognitive behavioural therapy. Although cognitive behavioural therapy is promoted precisely in this manner by the National Institute of Clinical Excellence, the evidence base on distress reduction from randomised controlled trials is limited, equivocal and poor quality. Crucially, data derived from multiple patient surveys point to worsening and increase distress; however, despite being invited, such data have been dismissed as second class by National Institute of Clinical Excellence. Crucially, the claim by National Institute of Clinical Excellence that cognitive behavioural therapy reduces distress in chronic fatigue syndrome/myalgic encephalomyelitis is not only at odds with what patients repeatedly report in surveys, but with their own gold-standard randomised controlled trial and meta-analytic data.

Source: Keth R. Laws. Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis? Journal of Health Psychology.  First Published May 17, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317710246 (Full article)

Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial

Abstract:

BACKGROUND: Publications from the PACE trial reported that 22% of chronic fatigue syndrome patients recovered following graded exercise therapy (GET), and 22% following a specialised form of CBT. Only 7% recovered in a control, no-therapy group. These figures were based on a definition of recovery that differed markedly from that specified in the trial protocol.

PURPOSE: To evaluate whether these recovery claims are justified by the evidence.

METHODS: Drawing on relevant normative data and other research, we critically examine the researchers’ definition of recovery, and whether the late changes they made to this definition were justified. Finally, we calculate recovery rates based on the original protocol-specified definition.

RESULTS: None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’. When recovery was defined according to the original protocol, recovery rates in the GET and CBT groups were low and not significantly higher than in the control group (4%, 7% and 3%, respectively).

CONCLUSIONS: The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.

 

Source: Carolyn Wilshire, Tom Kindlon, Alem Matthees & Simon McGrath. Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial. Fatigue: Biomedicine, Health & Behavior Volume 5, 2017 – Issue 1. http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1259724 (Full article)

 

PACE trial claims of recovery are not justified by the data: a rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White (2017)

Abstract:

Background: Recently, we critically evaluated the claim from the PACE trial that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) can lead to recovery from chronic fatigue syndrome (CFS). We showed that the trial’s definition of recovery was so loose it failed to capture the term’s core meaning. Also, this definition was substantially loosened very late in the trial, in ways that favoured the study hypotheses. The investigators do not acknowledge any of these criticisms and stand by their original analyses.

Purpose: To examine the arguments advanced in defence of PACE’s recovery claims.

Methods: Drawing on various sources of evidence, we consider three major arguments raised in defence of PACE’s recovery claims: (1) that since there is no agreed definition of recovery, it comes down to a matter of opinion; (2) that the original definition was ‘too stringent’; and (3) the revised definition generates results that align with previous studies.

Results: We find that: (1) ‘recovery’ is a strong claim, which implies evidence a return to health, and that the trial’s final definition did not preserve this core meaning; (2) there is no evidence to suggest that the original protocol-specified definition was ‘too stringent’; (3) absolute recovery rates from other studies are not a legitimate source of support for the recovery definition used.

Conclusions: The PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians.

 

Source: Carolyn Wilshire, Tom Kindlon & Simon McGrath. PACE trial claims of recovery are not justified by the data: a rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White (2017). Fatigue: Biomedicine, Health & Behavior. Volume 5, 2017 – Issue 1. http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1299358

 

Stress vulnerability in adolescents with chronic fatigue syndrome: experimental study investigating heart rate variability and skin conductance responses

Abstract:

BACKGROUND: Stress vulnerability has been implicated in adolescent chronic fatigue syndrome (CFS), but has rarely been investigated directly. This study compared psychological and physiological responses to a laboratory social performance task in adolescents with CFS with chronic illness (asthma) and healthy control groups.

METHODS: Adolescents with CFS (n = 60), adolescents with asthma (n = 31) and healthy adolescents (n = 78) completed questionnaires before and after a social performance task. Skin conductance responses (SCR; mean SCR and Max-Min) and heart rate variability (low frequency/high frequency; LF/HF and root mean square difference of successive RR intervals; RMSSD) was measured before, during and after the task.

RESULTS: Baseline heart rate variability (HRV) (RMSSD) was significantly lower in the CFS and Asthma groups than the HC. During the speech, the CFS and Asthma groups had higher HRV (LF/HF) than the HC, adjusting for baseline LF/HF. Although the asthma group showed a subsequent reduction in HRV during recovery, the CFS group did not. Similarly, during recovery after the task, the CFS group showed a continued increase in skin conductance (Min-Max), unlike the Asthma and HC groups. Compared to control groups, adolescents with CFS expected to find the task more difficult, were more anxious beforehand and afterwards, rated it as more difficult, evaluated their performance more negatively and had lower observer ratings of performance. Parents of adolescents with CFS expected that their child would perform less well in the task than parents of control participants.

CONCLUSIONS: Adolescents with CFS showed autonomic nervous system responses that are consistent with chronic stress vulnerability, difficulty coping with acute stress and slower recovery after acute stress. Self-report measures also indicated greater trait, pre- and posttask anxiety in the CFS group.

© 2017 Association for Child and Adolescent Mental Health.

 

Source: Rimes KA, Lievesley K, Chalder T. Stress vulnerability in adolescents with chronic fatigue syndrome: experimental study investigating heart rate variability and skin conductance responses. J Child Psychol Psychiatry. 2017 Mar 9. doi: 10.1111/jcpp.12711. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28276066

 

Long-term economic evaluation of cognitive-behavioural group treatment versus enhanced usual care for functional somatic syndromes

Abstract:

OBJECTIVE: Patients with functional somatic syndromes (FSS) such as fibromyalgia and chronic fatigue syndrome have a poor outcome and can incur high healthcare and societal costs. We aimed to compare the medium-term (16 months) cost-effectiveness and the long-term (40 months) economic outcomes of a bespoke cognitive-behavioural group treatment (STreSS) with that of enhanced usual care (EUC).

METHODS: We obtained complete data on healthcare and indirect costs (i.e. labour marked-related and health-related benefits) from public registries for 120 participants from a randomised controlled trial. Costs were calculated as per capita public expenses in 2010 €. QALYs gained were estimated from the SF-6D. We conducted a medium-term cost-effectiveness analysis and a long-term cost-minimization analysis from both a healthcare (i.e. direct cost) and a societal (i.e. total cost) perspective.

RESULTS: In the medium term, the probability that STreSS was cost-effective at thresholds of 25,000 to 35,000 € per QALY was 93-95% from a healthcare perspective, but only 50-55% from a societal perspective. In the long term, however, STreSS was associated with increasing savings in indirect costs, mainly due to a greater number of patients self-supporting. When combined with stable long-term reductions in healthcare expenditures, there were total cost savings of 7184 € (95% CI 2271 to 12,096, p=0.004) during the third year after treatment.

CONCLUSION: STreSS treatment costs an average of 1545 €. This cost was more than offset by subsequent savings in direct and indirect costs. Implementation could both improve patient outcomes and reduce costs.

Copyright © 2017 Elsevier Inc. All rights reserved.

 

Source: Schröder A, Ørnbøl E, Jensen JS, Sharpe M, Fink P. Long-term economic evaluation of cognitive-behavioural group treatment versus enhanced usual care for functional somatic syndromes. J Psychosom Res. 2017 Mar;94:73-81. doi: 10.1016/j.jpsychores.2017.01.005. Epub 2017 Jan 10. https://www.ncbi.nlm.nih.gov/pubmed/28183406

 

Activity Patterns in Response to Symptoms in Patients Being Treated for Chronic Fatigue Syndrome: An Experience Sampling Methodology Study

Abstract:

Objective: Cognitive-behavioral models of chronic fatigue syndrome (CFS) propose that patients respond to symptoms with 2 predominant activity patterns-activity limitation and all-or-nothing behaviors-both of which may contribute to illness persistence. The current study investigated whether activity patterns occurred at the same time as, or followed on from, patient symptom experience and affect.

Method: Twenty-three adults with CFS were recruited from U.K. CFS services. Experience sampling methodology (ESM) was used to assess fluctuations in patient symptom experience, affect, and activity management patterns over 10 assessments per day for a total of 6 days. Assessments were conducted within patients’ daily life and were delivered through an app on touchscreen Android mobile phones. Multilevel model analyses were conducted to examine the role of self-reported patient fatigue, pain, and affect as predictors of change in activity patterns at the same and subsequent assessment.

Results: Current experience of fatigue-related symptoms and pain predicted higher patient activity limitation at the current and subsequent assessments whereas subjective wellness predicted higher all-or-nothing behavior at both times. Current pain predicted less all-or-nothing behavior at the subsequent assessment. In contrast to hypotheses, current positive affect was predictive of current activity limitation whereas current negative affect was predictive of current all-or-nothing behavior. Both activity patterns varied at the momentary level.

Conclusions: Patient symptom experiences appear to be driving patient activity management patterns in line with the cognitive-behavioral model of CFS. ESM offers a useful method for examining multiple interacting variables within the context of patients’ daily life. (PsycINFO Database Record

(c) 2016 APA, all rights reserved).

 

Source: Band R, Barrowclough C, Caldwell K, Emsley R, Wearden A. Activity Patterns in Response to Symptoms in Patients Being Treated for Chronic Fatigue Syndrome: An Experience Sampling Methodology Study. Health Psychol. 2016 Nov 7. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/27819461