Tag: nonsensical study

Cognitive behavioural therapy for chronic fatigue and chronic fatigue syndrome: outcomes from a specialist clinic in the UK

Editor’s Comment: Cognitive Behavioral Therapy (CBT) has been roundly disputed as a treatment for ME/CFS. In fact, CBT has never been shown to be an effective treatment for any disease, including most psychiatric disorders. In addition, it has no greater success as a therapy for psychological complaints than any other form of therapy. This abstract is included in the AMMES library strictly for purposes of reference.

Abstract:

Objectives: Cognitive behavioural therapy is commonly used to treat chronic fatigue syndrome and has been shown to be effective for reducing fatigue and improving physical functioning. Most of the evidence on the effectiveness of cognitive behavioural therapy for chronic fatigue syndrome is from randomised control trials, but there are only a few studies in naturalistic treatment settings. Our aim was to examine the effectiveness of cognitive behavioural therapy for chronic fatigue syndrome in a naturalistic setting and examine what factors, if any, predicted outcome.

Design: Using linear mixed effects analysis, we analysed patients’ self-reported symptomology over the course of treatment and at three-month follow-up. Furthermore, we explored what baseline factors were associated with improvement at follow-up.

Setting: Data were available for 995 patients receiving cognitive behavioural therapy for chronic fatigue syndrome at an outpatient clinic in the UK.

Participants: Participants were referred consecutively to a specialist unit for chronic fatigue or chronic fatigue syndrome.

Main outcome measures: Patients were assessed throughout their treatment using self-report measures including the Chalder Fatigue Scale, 36-item Short Form Health Survey, Hospital Anxiety and Depression Scale and Global Improvement and Satisfaction.

Results: Patients’ fatigue, physical functioning and social adjustment scores significantly improved over the duration of treatment with medium to large effect sizes (|d| = 0.45-0.91). Furthermore, 85% of patients self-reported that they felt an improvement in their fatigue at follow-up and 90% were satisfied with their treatment. None of the regression models convincingly predicted improvement in outcomes with the best model being (R2 = 0.137).

Conclusions: Patients’ fatigue, physical functioning and social adjustment all significantly improved following cognitive behavioural therapy for chronic fatigue syndrome in a naturalistic outpatient setting. These findings support the growing evidence from previous randomised control trials and suggest that cognitive behavioural therapy could be an effective treatment in routine treatment settings.

Source: Adamson J, Ali S, Santhouse A, Wessely S, Chalder T. Cognitive behavioural therapy for chronic fatigue and chronic fatigue syndrome: outcomes from a specialist clinic in the UK. J R Soc Med. 2020 Sep 15:141076820951545. doi: 10.1177/0141076820951545. Epub ahead of print. PMID: 32930040. https://pubmed.ncbi.nlm.nih.gov/32930040/

Post-exertional malaise is associated with greater symptom burden and psychological distress in patients diagnosed with Chronic Fatigue Syndrome

Abstract:

OBJECTIVE: Post-exertional malaise (PEM) is often considered a cardinal symptom of Chronic Fatigue Syndrome (CFS). There is no gold standard diagnostic method for CFS, however, and the Centers for Disease Control (CDC) Fukuda case definition does not require PEM. Research has identified differences in symptom burden between patients according to PEM, but whether it is associated with psychological distress has not been investigated.

METHODS: The CDC CFS Inventory, Fatigue Symptom Inventory, Profile of Mood States, Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, and subscales of the Sickness Impact Profile were administered to 261 patients diagnosed with the Fukuda criteria. PEM status (loPEM/hiPEM) was determined via self-reported post-exertional fatigue severity. Analyses of covariance (ANCOVA), controlling for age and gender, assessed cross-sectional group differences, and cross-sectional linear regressions using the continuous PEM severity predictor paralleled these analyses.

RESULTS: hiPEM patients reported greater symptom intensity, frequency, and interference than loPEM counterparts (p’s < .001). hiPEM patients also reported greater social disruption, depressive symptoms, and mood disturbance (p’s ≤ .011). Groups did not differ in recent negative life experiences, perceived stress, or demographic variables. The results of regression analyses mirrored those of ANCOVAs.

CONCLUSION: This study replicates the association between PEM and symptom burden and additionally associates PEM with psychological distress; psychological distress could, however, be a consequence of symptom burden. Differences between hiPEM and loPEM CFS patients highlight the heterogeneity of diagnoses resulting from the Fukuda criteria. It is also possible that PEM identifies particularly distressed patients for whom psychological intervention would be most beneficial.

Copyright © 2019 Elsevier Inc. All rights reserved

Source: May M, Milrad SF, Perdomo DM, Czaja SJ, Fletcher MA, Jutagir DR, Hall DL, Klimas N, Antoni MH. Post-exertional malaise is associated with greater symptom burden and psychological distress in patients diagnosed with Chronic Fatigue Syndrome. J Psychosom Res. 2019 Dec 16;129:109893. doi: 10.1016/j.jpsychores.2019.109893. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/31884303

Intimate Partner Violence and the Risk of Developing Fibromyalgia and Chronic Fatigue Syndrome

Abstract:

Intimate partner violence (IPV) is a global public health issue with a variety of ill health consequences associated with exposure. Due to the stimulation of chronic stress and inflammatory pathways, childhood abuse has been associated with the subsequent development of functional syndromes such as fibromyalgia and chronic fatigue syndrome (CFS). Although IPV in women appears to elicit similar biochemical responses, this association has not been tested thoroughly in IPV survivors. These functional syndromes are complex in etiology and any indication of their risk factors would benefit health care professionals managing this population. Therefore, we aimed to investigate the association between exposure to IPV with functional syndromes: fibromyalgia and CFS.

We conducted a retrospective open cohort study using “The Heath Improvement Network” database between January 1, 1995 and December 1, 2017. A total of 18,547 women who were exposed to IPV were each matched by age to four controls who were not exposed (n = 74,188). The main outcome measures were the risk of developing fibromyalgia and CFS. These were presented as adjusted incidence rate ratios (aIRR) with 95% confidence intervals (CIs).

We found that 97 women in the exposed group developed fibromyalgia (incidence rate [IR] = 1.63 per 1,000 person-years) compared to 239 women in the unexposed group (IR = 0.83 per 1,000 person-years). Following adjustment, this translated to an IRR of 1.73 (95% CI = [1.36, 2.22]). Similarly, 19 women developed CFS in the exposed group (IR = 0.32 per 1,000 person-years), compared to 53 in the unexposed group (0.18 per 1,000 person-years), which translates to an aIRR of 1.92 (95% CI = [1.11, 3.33]).

Therefore, we have identified an association between a history of IPV in women and the development of these functional syndromes, which may provide more information to inform the biopsychosocial pathway precipitating the development of fibromyalgia and CFS.

Source: Chandan JS, Thomas T, Raza K, Bradbury-Jones C, Taylor J, Bandyopadhyay S1, Nirantharakumar K. Intimate Partner Violence and the Risk of Developing Fibromyalgia and Chronic Fatigue Syndrome. J Interpers Violence. 2019 Dec 6:886260519888515. doi: 10.1177/0886260519888515. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/31805821

Fatigue Is Associated With Altered Monitoring and Preparation of Physical Effort in Patients With Chronic Fatigue Syndrome

Abstract:

BACKGROUND: Chronic fatigue syndrome (CFS) is characterized by disabling fatigue, which is suggested to be maintained by dysfunctional beliefs. Fatigue and its maintenance are recently conceptualized as arising from abnormally precise expectations about bodily inputs and from beliefs of diminished control over bodily states, respectively. This study used functional neuroimaging to identify the neural correlates of fatigue and its maintenance by beliefs during a physical effort task.

METHODS: We isolated behavioral adjustments and cerebral activity during feedback processing and motor preparation, in the context of a task in which patients with CFS (n = 85) and healthy control subjects (n = 29) produced 30%, 50%, and 70% of their right-hand maximal voluntary contraction, and received directional feedback on performance (e.g., too little force).

RESULTS: Patients with CSF showed an effort-dependent behavioral bias toward less effort investment in response to directional feedback for the highest effort level as compared with healthy control subjects. This bias was associated with reduced feedback-related activity in the dorsolateral prefrontal cortex. These effects were proportional to state-related fatigue and prior beliefs about CFS patients’ ability to perform the task. Patients with CFS also showed higher activity in the supplementary motor area, proportional to their state-related fatigue, and reduced connectivity between the supplementary motor area and sensorimotor cortex during motor preparation as compared with control subjects.

CONCLUSIONS: These findings link fatigue symptoms to alterations in behavioral choices on effort investment, prefrontal functioning, and supplementary motor area connectivity, with the dorsolateral prefrontal cortex being associated with prior beliefs about physical abilities.

Copyright © 2018 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Source: van der Schaaf ME, Roelofs K, de Lange FP, Geurts DEM, van der Meer JWM, Knoop H, Toni I. Fatigue Is Associated With Altered Monitoring and Preparation of Physical Effort in Patients With Chronic Fatigue Syndrome. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Apr;3(4):392-404. doi: 10.1016/j.bpsc.2018.01.015. Epub 2018 Feb 12. https://www.ncbi.nlm.nih.gov/pubmed/29628071

Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial

Editor’s Comment: Numerous critiques of the Lightning Process have been made by physicians, medical practitioners, and patient organizations. There are cases in which LP has resulted in long-lasting physical harm. (You can read about these cases here and here.)  Dr. Charles Shepherd, an ME/CFS specialist, does not recommend LP for any ME/CFS patients.

Abstract:

OBJECTIVE: Investigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome (CFS)/myalgic encephalitis (ME).

DESIGN: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

SETTING: Specialist paediatric CFS/ME service.

PATIENTS: 12-18 year olds with mild/moderate CFS/ME.

MAIN OUTCOME MEASURES: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

RESULTS: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

CONCLUSION: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.

TRIAL REGISTRATION NUMBER: ISRCTN81456207.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Source: Crawley EM, Gaunt DM, Garfield K, Hollingworth W, Sterne JAC, Beasant L, Collin SM, Mills N, Montgomery AA. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Arch Dis Child. 2017 Sep 20. pii: archdischild-2017-313375. doi: 10.1136/archdischild-2017-313375. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28931531

Response to the editorial by Dr Geraghty

Abstract:

This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, graded Activity and Cognitive behaviour therapy; a randomised Evaluation (PACE) trial, which we led, implemented and published. The PACE trial compared four treatments for people diagnosed with chronic fatigue syndrome. All participants in the trial received specialist medical care. The trial found that adding cognitive behaviour therapy or graded exercise therapy to specialist medical care was as safe as, and more effective than, adding adaptive pacing therapy or specialist medical care alone. Dr Geraghty has challenged these findings. In this article, we suggest that Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial; these are corrected.

Source: White PD, Chalder T, Sharpe M, Angus BJ, Baber HL, Bavinton J, Burgess M, Clark LV, Cox DL, DeCesare JC, Goldsmith KA, Johnson AL, McCrone P, Murphy G, Murphy M, O’Dowd H, Potts L, Walwyn R, Wilks D. Response to the editorial by Dr Geraghty. J Health Psychol. 2017 Aug;22(9):1113-1117. doi: 10.1177/1359105316688953. Epub 2017 Jan 24. https://www.ncbi.nlm.nih.gov/pubmed/28805524

The PACE trial: It’s time to broaden perceptions and move on

Abstract:

The continued critiques of the PACE trial highlight how differing beliefs about the causes of chronic fatigue syndrome still influence how scientific studies in this area are accepted and evaluated. Causal beliefs about chronic fatigue syndrome and a modern version of Cartesian dualism are important in understanding the reaction to the PACE trial. The continued debate on the PACE trial seems to miss the fact that science is incremental. An unfortunate outcome of the PACE controversy and intimidation of researchers may be less research in the area. It is time to move on from criticism and collect more data on effective treatments.

Source: Petrie KJ, Weinman J. The PACE trial: It’s time to broaden perceptions and move on.J Health Psychol. 2017 Aug;22(9):1198-1200. doi: 10.1177/1359105317703789. Epub 2017 Apr 10. https://www.ncbi.nlm.nih.gov/pubmed/28805523

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

 

Housebound versus nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome

Abstract:

OBJECTIVES: The objective of this study was to examine individuals with myalgic encephalomyelitis and chronic fatigue syndrome who are confined to their homes due to severe symptomatology. The existing literature fails to address differences between this group, and less severe, nonhousebound patient populations.

METHODS: Participants completed the DePaul Symptom Questionnaire, a measure of myalgic encephalomyelitis and chronic fatigue syndrome symptomology, and the SF-36, a measure of health impact on physical/mental functioning. ANOVAs and, where appropriate, MANCOVAS were used to compare housebound and nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome across areas of functioning, symptomatology, and illness onset characteristics.

RESULTS: Findings indicated that the housebound group represented one quarter of the sample, and were significantly more impaired with regards to physical functioning, bodily pain, vitality, social functioning, fatigue, postexertional malaise, sleep, pain, neurocognitive, autonomic, neuroendocrine, and immune functioning compared to individuals who were not housebound.

DISCUSSION: Findings indicated that housebound patients have more impairment on functional and symptom outcomes compared to those who were not housebound. Understanding the differences between housebound and not housebound groups holds implications for physicians and researchers as they develop interventions intended for patients who are most severely affected by this chronic illness.

© The Author(s) 2016.

 

Source: Pendergrast T, Brown A, Sunnquist M, Jantke R, Newton JL, Strand EB, Jason LA. Housebound versus nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome. Chronic Illn. 2016 Dec;12(4):292-307. Epub 2016 Apr 28. https://www.ncbi.nlm.nih.gov/pubmed/27127189

 

Randomised controlled trial of cognitive behaviour therapy delivered in groups of patients with chronic fatigue syndrome

Abstract:

BACKGROUND: Meta-analyses have been inconclusive about the efficacy of cognitive behaviour therapies (CBTs) delivered in groups of patients with chronic fatigue syndrome (CFS) due to a lack of adequate studies.

METHODS: We conducted a pragmatic randomised controlled trial with 204 adult CFS patients from our routine clinical practice who were willing to receive group therapy. Patients were equally allocated to therapy groups of 8 patients and 2 therapists, 4 patients and 1 therapist or a waiting list control condition. Primary analysis was based on the intention-to-treat principle and compared the intervention group (n = 136) with the waiting list condition (n = 68). The study was open label.

RESULTS: Thirty-four (17%) patients were lost to follow-up during the course of the trial. Missing data were imputed using mean proportions of improvement based on the outcome scores of similar patients with a second assessment. Large and significant improvement in favour of the intervention group was found on fatigue severity (effect size = 1.1) and overall impairment (effect size = 0.9) at the second assessment. Physical functioning and psychological distress improved moderately (effect size = 0.5). Treatment effects remained significant in sensitivity and per-protocol analyses. Subgroup analysis revealed that the effects of the intervention also remained significant when both group sizes (i.e. 4 and 8 patients) were compared separately with the waiting list condition.

CONCLUSIONS: CBT can be effectively delivered in groups of CFS patients. Group size does not seem to affect the general efficacy of the intervention which is of importance for settings in which large treatment groups are not feasible due to limited referral.

© 2015 S. Karger AG, Basel.

 

Source: Wiborg JF, van Bussel J, van Dijk A, Bleijenberg G, Knoop H. Randomised controlled trial of cognitive behaviour therapy delivered in groups of patients with chronic fatigue syndrome. Psychother Psychosom. 2015;84(6):368-76. doi: 10.1159/000438867. Epub 2015 Sep 25. https://www.ncbi.nlm.nih.gov/pubmed/26402868

 

Comment

Tom Kindlon 2015 Oct 06 4:36 p.m.

No objective outcome measures were used

This trial just used subjective outcome measures. Objective outcome measures are important as subjective outcome measures may not translate into objective improvements with graded activity-oriented interventions in Chronic Fatigue Syndrome (CFS) (1-3). Examples of more objective outcome measures that have been used in CFS interventional studies include actigraphy, employment data, disability payments data and exercise testing.

References:

1 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;321-322.

2 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. 2010:40;1281-7.

3 Kindlon T. Comment on: Exercise therapy for chronic fatigue syndrome. http://www.ncbi.nlm.nih.gov/pubmed/25674924#cm25674924_11779