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Objective: To compare the cost-utility of transdiagnostic cognitive behavioural therapy (TDT-CBT) plus standardised medical care (SMC) to SMC alone to support people with persistent physical symptoms in contact with specialist services., Methods: This study compared the cost-utility of TDT-CBT. A two-arm randomised controlled trial was conducted in secondary care settings. Participants received either TDT-CBT + SMC or SMC alone. Measures were taken at baseline and at 9-, 20-, 40-, and 52-week follow-up. Service use was measured, and costs calculated. Costs were combined with quality-adjusted life years (QALYs) based on the EQ-5D-5L using incremental cost-utility ratios with uncertainty addressed using cost-effectiveness planes and acceptability curves., Results: The costs during the follow-up period were £3473 for TDT-CBT + SMC and £3104 for SMC alone. The incremental cost for TDT-CBT + SMC adjusting for baseline was £482 (95 % CI, -£399 to £1233). QALYs over the follow-up were 0.578 for TDT-CBT + SMC and 0.542 for SMC alone. The incremental QALY was 0.038 (95 % CI, -0.005 to 0.080). The incremental cost per QALY was £12,684 for TDT-CBT + SMC. There was a 68.3 % likelihood that TDT-CBT + SMC was the most cost-effective option at a threshold of £20,000 per QALY., Conclusion: Adding TDT-CTB to SMC results in slightly increased costs and slightly better outcomes in terms of QALYs. This represents a cost-effective option based on the conventional QALY threshold value., Competing Interests: Declaration of competing interest PM has received grants from Wellcome, NIHR, MRC, European Commission, and charities. MHo reported grants from Innovative Medicines Initiative and European Federation of Pharmaceutical Industries and Associations, outside the submitted work. MHo is principal investigator of RADA R-CNS (Remote Assessment of Disease and Relapse) a pre-competitive public–private partnership funded by European Commission and Janssen, Biogen, UCB, MSD and Lundbeck. TC is part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, King's College London. TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms. TC has received grants from NIHR programme grants, HTA, RfPB, Guy's and St Thomas Charity, King's Challenge Fund. Personal financial interests: TC is the author of several self-help books on chronic fatigue and received royalties in the past. TC received expenses for workshops on evidence-based treatments for persistent physical symptoms for BABCP and IAPT services (travel and accommodation). RMM reports grants from NIHR programme grants, grants from MS Society UK, grants from Crohn's and Colitis UK, grants from Breast Cancer Now, grants from National MS society, grants from NIHR HTA grants, personal fees from National Advisor to NHS England for Increasing Access to Psychological Therapies (IAPT) for People with Long-Term Conditions from 2011 to 2016, personal fees from Ad hoc payments for workshop training, personal fees from Consultancy payments from Mahana Therapeutics, other from travel expenses to present invited talks to conferences WBCBT, ICBM, ECTRIMS, EHPS, ARPH, outside the submitted work; and King's College London has signed a license agreement with Mahana Therapeutics for a digital version of CBT for Irritable Bowel Syndrome that was developed by RMM and colleagues at Southampton and King's College London. RMM and other inventors are beneficiaries of this license through contracts with their respective universities. SL has received grants from NIHR, MRC, ESRC, Wellcome Trust, Stanley Medical Research, MND and ALS Associations, Parkinson's disease Society, Psychiatry Research Trust, KCL Translational Research, PPP Healthcare Medical Trust and Johnson and Johnson., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: We aimed to study the prevalence of sleep disturbances in patients with long COVID-19., Methods: We conducted a systematic review and meta-analysis of the pooled prevalence of sleep disturbances in patients post COVID-19. We systematically searched relevant studies from three databases, including Medline, Embase and Scopus. Original articles were included based on specific criteria: peer-reviewed, observational studies involving adults (18 or older) with confirmed post COVID-19 status through PCR testing and focused on sleep in the context of post COVID-19. Exclusion criteria included non-English articles, studies with insufficient data, and narrative/systematic reviews. The search was performed from 31st July 2023 to 15th August 2023. We identified 35 eligible papers; however, we excluded 6 studies which did not describe the sleep assessment. We used a random-effects meta-analysis model to estimate the pooled prevalence of sleep disturbances., Results: 29 studies involved 13,935 long COVID-19 patients; approximately 39% of participants were male aged 18 to 97 years. The overall pooled prevalence of sleep disturbance was 46% (95% CI: 38-54%). Subgroup analyses revealed that the pooled prevalence of poor sleep quality was 56% (95% CI: 47-65%). The pooled prevalence of insomnia was 38% (95% CI: 28-48%). Finally, the pooled prevalence of excessive daytime sleepiness was 14% (95% CI: 0-29%)., Conclusion: Sleep disturbances are common in long COVID-19 patients. The healthcare sector should recognise these sleep issues and provide an early, effective treatment to prevent long-term sequelae of sleep problems., Competing Interests: Declaration of Competing Interest TC has grants from UKRI, NIHR and St Thomas' Charity. TC is the author of several self-help books on chronic fatigue for which she has received royalties. TC(KCL) has received ad hoc payments for workshops carried out in long-term conditions and travel expenses and accommodation costs of attending Conferences – BABCP, EABCT and ATS., (Copyright © 2023. Published by Elsevier Inc.)

Background: Research suggests that psychological factors may influence vulnerability to SARS-CoV-2 infection, although the mechanisms are unclear., Purpose: We examined whether the hypothalamic-pituitary-adrenal axis may be a possible mechanism, by measuring the relationship between indices of psychological distress and cortisone in hair (hairE) in a UK cohort during the COVID-19 pandemic., Methods: Participants (N = 827) provided two 3 cm hair samples over a 6-month period between April-September 2020. Samples reflected hairE in the 3 months prior to the collection date., Results: HairE in the first samples (T1: commenced April 2020) did not differ significantly from pre-pandemic population norms. However, hairE in the second samples (T2: commenced July 2020) were significantly higher than T1 and pre-pandemic population norms, with a 23% increase between T1 and T2. Linear regressions, controlling for age and gender, demonstrated that at both timepoints, hairE levels were greatest in people with a history of mental health difficulties. In addition, stress reported at T1 predicted greater hairE at T2 and a greater change in hairE between T1 and T2., Conclusions: These findings demonstrate that during the COVID-19 pandemic hairE was substantially elevated across a large community cohort, with greatest levels in those with a history of mental health difficulties and greatest changes in those reporting greatest levels of stress early in the pandemic. Further research is required with verified SARS-CoV-2 outcomes to determine whether the HPA axis is among the mechanisms by which a history of mental health difficulties and stress influence SARS-CoV-2 outcomes., Competing Interests: Conflict of interest AM is the director of Cortigenix (www.cortigenix.com). Cortigenix provided guidance on remote self-collection of hair samples by participants., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: When measuring latent traits, such as those used in psychology and psychiatry, it can be unclear whether the instruments used are measuring different concepts. This issue is particularly important in the context of mediation analysis, since for a sound mediation hypothesis the mediator and outcome should be distinct. We sought to assess the extent of measurement overlap between cognitive and behavioural mediators and physical functioning and fatigue outcomes in a large trial of treatments for chronic fatigue syndrome., Methods: A secondary analysis of 640 participants in the "Pacing, graded Activity, and Cognitive behaviour therapy" trial was conducted. Potential measurement overlap was assessed using generalised linear latent variable models where confirmatory factor models quantified the extent to which the addition of cross-loading items significantly improved model fit., Results: We considered 13 mediators and two outcomes, giving a total of 26 mediator-outcome pairs. Of these, only six showed evidence of cross-loading items, supporting the suggestion that the chosen mediator and outcome constructs were conceptually distinct., Conclusion: This study highlights how established psychometric methods can be applied to assess measurement overlap in mediation analyses. We found minimal overlap between cognitive and behavioural mediators and physical functioning and fatigue outcomes that are often used in studies of chronic fatigue syndrome. The use of such methods in mediational studies where questionnaires are used to quantify latent traits would add to their robustness and transparency., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The PHQ-9 is a self-administered depression screening instrument. Little is known about its utility and accuracy in detecting depression in adults with dissociative seizures (DS)., Objectives: Using the Mini - International Neuropsychiatric Interview as a reference, we evaluated the diagnostic accuracy of the PHQ-9 in adults with DS, and examined its convergent and discriminant validity and uniformity., Methods: Our sample comprised 368 people with DS who completed the pre-randomisation assessment of the CODES trial. The uniformity of the PHQ-9 was determined using factor analysis for categorical data. Optimal cut-offs were determined using the area under the curve (AUC), Youden Index, and diagnostic odds ratio (DOR). Convergent and discriminant validity were assessed against pre-randomisation measures., Results: Internal consistency of the PHQ-9 was high (α = 0.87). While the diagnostic odds ratio suggested that a cut-off of ≥10 had the best predictive performance (DOR = 14.7), specificity at this cut off was only 0.49. AUC (0.74) and Youden Index (0.48) suggested a ≥ 13 cut-off would yield an optimal sensitivity (0.81) and specificity (0.67) balance. However, a cut-off score of ≥20 would be required to match specificity resulting from a cut-off of ≥13 in other medical conditions. We found good convergent and discriminant validity and one main factor for the PHQ-9., Conclusions: In terms of internal consistency and structure, our findings were consistent with previous validation studies but indicated that a higher cut-off would be required to identify DS patients with depression with similar specificity achieved with PHQ-9 screening in different clinical and non-clinical populations., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Fatigue is a highly prevalent and debilitating problem in women with breast cancer. This study investigated the cognitive, behavioural, interpersonal and affective responses associated with fatigue and functional impairment for women with breast cancer undergoing chemotherapy. A nested prospective study examined factors predictive of cancer-related fatigue after three cycles of chemotherapy., Method: 159 women with breast cancer who were about to begin or undergoing chemotherapy completed a range of measures. Correlational and multiple regression analyses explored associations between fatigue severity, functioning and a range of psychological, behavioural, demographic and clinical variables. Forty-two patients were followed-up prospectively to examine the relationship between psychosocial variables, fatigue and functioning after three cycles of chemotherapy., Results: A range of cognitive, behavioural and affective variables were associated with increased fatigue severity and poorer functioning. Key cognitive and behavioural correlates included, all-or-nothing behaviour, avoidance behaviour, cancer-related catastrophising and critical/punishing responses from others. For the women in the nested prospective study, fatigue significantly increased after three cycles of chemotherapy. Increased fatigue was predicted by increased anxiety before starting chemotherapy., Conclusions: Behavioural factors and cancer-specific cognitions make important contributions to cancer-related fatigue and associated impairments. Such factors are potentially amenable to change within the context of cognitive behavioural therapy., Competing Interests: Declaration of Competing Interest TC receives royalties for self-help books on chronic fatigue. The authors have no other competing interests to report., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Functional symptoms are a common mimic of stroke in acute stroke settings, but there are no guidelines on how to manage such patients and scant research on their clinical profile. We explore the presentation of patients with functional stroke symptoms at admission and 2-month follow-up., Methods: We conducted a prospective observational study across four SE London acute stroke units, with two-month follow-up. Demographic information, clinical data and GP attendances were recorded. Patients completed self-report measures: Cognitive Behavioural Responses Questionnaire short version, Brief Illness Perception Questionnaire, Hospital Anxiety and Depression Scale, Work and Social Adjustment Scale and Short Form Health Survey., Results: Fifty-six patients (mean age: 50.9 years) were recruited at baseline; 40 with isolated functional symptoms, the remaining functional symptoms in addition to stroke. Thirty-one completed self-report follow-up measures. Of 56 participants, 63% were female. Patients presented symptoms across modalities, with unilateral and limb weakness the most frequent. There was inconsistent and ambiguous recording of symptoms on medical records. Approximately 40% of patients reported levels of anxiety and depression above the threshold indicating a probable diagnosis. Higher anxiety was associated with greater resting or all-or-nothing behaviours, embarrassment avoidance and symptom focussing on the CBRQ. Only SF-36 physical functioning improved at follow-up. Less than 50% who responded at follow-up were accessing a treatment, though 82% had ongoing symptoms., Conclusion: Patients with functional symptoms in stroke settings report substantial distress, associated with cognitive-behavioural responses to symptoms. Follow-up data suggest recovery can be slow, indicating access to supportive interventions should be improved., Competing Interests: Declaration of Competing Interest The authors have no competing interests., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterised by abdominal pain and altered bowel movements. Cognitive behavioural therapy (CBT) has been shown to be effective in reducing symptom severity in IBS and enhancing quality of life/functioning. The present study sought to identify how CBT achieves change in these outcomes., Method: Secondary analysis was conducted on 149 patients with irritable bowel syndrome who had been randomised to cognitive behavioural therapy plus an antispasmodic medication or antispasmodic alone. Single and sequential mediation was modelled using structural equation modelling. Gastrointestinal (GI) related avoidance behaviour, safety behaviour, cognitions and general anxiety were included as mediators., Results: GI safety behaviours, cognitions and general anxiety mediated treatment effect on the outcomes of symptom severity and work and social adjustment. Avoidance behaviour was not a significant mediator for either outcome. Sequential mediation models indicated that unhelpful GI related cognitions reduced before anxiety did, and this sequential path (R➔GI related cognitions➔anxiety➔outcome) was significant for both symptom severity (b = -0.22, CI [-0.40 to -0.90], p = .005) and work and social adjustment (b = -0.26, CI [-0.44 to -0.11], p = .003) where 'R' is randomisation. Reduction in GI safety behaviours also preceded reduction in anxiety. This sequence (R ➔GI safety behaviours➔anxiety➔outcome) was significant for both symptom severity (b = -0.11, CI [-0.24 to -0.01], p = .049) and work and social adjustment (b = -0.12, CI [-0.23 to -0.03], p = .03)., Conclusion: Results suggest that it is important for psychological treatments to target IBS specific factors for change., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The role of immune or infective triggers in the pathogenesis of Chronic Fatigue Syndrome (CFS) is not yet fully understood. Barriers to obtaining immune measures at baseline (i.e., before the trigger) in CFS and post-infective fatigue model cohorts have prevented the study of pre-existing immune dysfunction and subsequent immune changes in response to the trigger. This study presents interferon-alpha (IFN-α)-induced persistent fatigue as a model of CFS. IFN-α, which is used in the treatment of chronic Hepatitis C Virus (HCV) infection, induces a persistent fatigue in some individuals, which does not abate post-treatment, that is, once there is no longer immune activation. This model allows for the assessment of patients before and during exposure to the immune trigger, and afterwards when the original trigger is no longer present. Fifty-five patients undergoing IFN-α treatment for chronic HCV were assessed at baseline, during the 6-12 months of IFN-α treatment, and at six-months post-treatment. Measures of fatigue, cytokines and kynurenine pathway metabolites were obtained. Fifty-four CFS patients and 57 healthy volunteers completed the same measures at a one-off assessment, which were compared with post-treatment follow-up measures from the HCV patients. Eighteen patients undergoing IFN-α treatment (33%) were subsequently defined as having 'persistent fatigue' (the proposed model for CFS), if their levels of fatigue were higher six-months post-treatment than at baseline; the other 67% were considered 'resolved fatigue'. Patients who went on to develop persistent fatigue experienced a greater increase in fatigue symptoms over the first four weeks of IFN-α, compared with patients who did not (Δ Treatment Week (TW)-0 vs. TW4; PF: 7.1 ± 1.5 vs. RF: 4.0 ± 0.8, p = 0.046). Moreover, there was a trend towards increased baseline interleukin (IL)-6, and significantly higher baseline IL-10 levels, as well as higher levels of these cytokines in response to IFN-α treatment, alongside concurrent increases in fatigue. Levels increased to more than double those of the other patients by Treatment Week (TW)4 (p =  0.011 for IL-6 and p = 0.001 for IL-10). There was no evidence of an association between persistent fatigue and peripheral inflammation six-months post-treatment, nor did we observe peripheral inflammation in the CFS cohort. While there were changes in kynurenine metabolites in response to IFN-α, there was no association with persistent fatigue. CFS patients had lower levels of the ratio of kynurenine to tryptophan and 3-hydroxykynurenine than controls. Future studies are needed to elucidate the mechanisms behind the initial exaggerated response of the immune system in those who go on to experience persistent fatigue even if the immune trigger is no longer present, and the change from acute to chronic fatigue in the absence of continued peripheral immune activation., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Individuals with IBS report higher levels of psychological distress compared to healthy controls. Distress has been associated with emotional processing difficulties but studies have not explored how the relationship between distress and emotional processing affects IBS. There is little research on the role of positive affect (PA) in IBS., Aims: (a) If difficulties in self-reported emotional processing are associated with affect and IBS measures (i.e., symptom severity, interference in life roles) (b1) If affect mediates the relationship between emotional processing and IBS measures (b2) Alternative model: if affect mediates the relationship between IBS and emotional processing (c) If PA moderates the relationship between distress and IBS., Methods: Participants with a confirmed diagnosis of IBS (n=558) completed a questionnaire including measures of emotional processing (i.e., unhelpful beliefs about negative emotions, impoverished emotional experience), distress, PA, and IBS symptoms/interference. Mediation and moderation analyses were conducted with Maximum Likelihood Estimation., Results: Distress and PA mediated or partly mediated the relationship between unhelpful beliefs about negative emotions/impoverished emotional experience and both IBS measures. The alternative models were also valid, suggesting a two-way relationship between emotional processing and IBS through affect. PA did not moderate the relationship between distress and IBS., Conclusion: Future interventions in IBS may benefit from not only targeting the management of physical symptoms and their daily impact but also aspects related to the experience of both negative and positive affect, and the acceptance and expression of negative emotions. Longitudinal studies are needed to confirm causal relationships within the explored models., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: The Work and Social Adjustment Scale (WSAS) is designed to measure patients' perceived functional impairment associated with a health problem. There is a paucity of studies that explore the stability of the item hierarchy in the WSAS across different disease populations. This study investigated the unidimensional structure of the WSAS across different disease populations., Methods: Secondary data analysis was conducted on pooled patient data (HIV, breast cancer, and inflammatory conditions) to create a new dataset (n=554). The data were analysed using Rasch analysis and exploratory factor analysis., Results: Exploratory factor analysis and principle component analysis of the WSAS showed a good fit as a unidimensional scale, person and item separation indices were >2 suggesting that the WSAS is sensitive enough to distinguish between participants of varying levels of ability. Some differential item functioning was seen by diagnosis and by sex for items 1 and 5 of the WSAS., Conclusions: Overall, a one dimensional structure was identified for the WSAS. However, a small number of differential item functioning (DIF) was identified, suggesting that scores from the WSAS cannot be compared across groups., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: Fatigue is common in autoimmune rheumatic diseases (ARD). This study compared symptom-related cognitions, beliefs, behaviours, quality of sleep, lack of acceptance and distress in participants with ARD such as rheumatoid arthritis (RA), seronegative spondyloarthropathy (SpA), and connective tissue disease (CTD), and participants with chronic fatigue syndrome (CFS)., Methods: 303 participants with RA, SpA, CTD and CFS completed questionnaire measures of fatigue, social adjustment, cognitive-behavioural responses, lack of acceptance, distress and quality of sleep. The RA, SpA and CTD groups were first compared with each other. They were then combined into one group and compared with the CFS group., Results: There were no statistically significant differences between the RA, SpA or CTD groups for any of the measures. The CFS group was more fatigued, reported more distress and sleep disturbance and had worse social adjustment than the ARD group after adjustment for age and illness duration. After adjustment for fatigue, age, and illness duration, the CFS group scored more highly on lack of acceptance and avoidance/resting behaviour while the ARD group showed significantly higher levels of catastrophizing, damage beliefs, and symptom focusing than the CFS group., Conclusion: Fatigue in rheumatic diseases may be perpetuated by similar underlying transdiagnostic processes. The ARD and CFS groups showed similarities but also key differences in their responses to symptoms. Specific aspects of treatment may need to be tailored towards each group. For example, lack of acceptance and avoidance behaviour may be particularly important in perpetuating fatigue in CFS., (Copyright © 2016. Published by Elsevier Inc.)

Objective: Medically unexplained symptoms/syndromes are common, highly distressing and are often associated with profound disability. One of the controversies surrounding this area relates to which umbrella term should be used to group such symptoms. The purpose of this research was to establish the preferences of patients with chronic fatigue syndrome (CFS) for an umbrella term for medically unexplained symptoms., Methods: A cross-sectional mixed methods survey design was used. Participants were asked to indicate their three most preferred terms out of a list of commonly used terms and to provide any extra comments. Frequency analysis was employed to look at the preferences of terms for each rank. Comments were analysed using principles of inductive thematic analysis., Results: Eighty-seven patients with CFS completed a self-report survey. The term "Persistent Physical Symptoms" was the most popular first choice term chosen by 20.7% of patients. Terms containing the word "physical" were consistently more likely to be chosen. Three main themes emerged from the thematic analysis: 1) Physical nature of the illness, 2) Stigma, and 3) Evaluation of the terms, giving a more in-depth understanding of the findings., Conclusion: According to CFS patients, an umbrella term has to reflect the physical experience of MUS., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: This study examined cortisol in adolescents with chronic fatigue syndrome (CFS) compared to healthy adolescents and changes in cortisol after cognitive behavioural guided self-help treatment. Exploratory analyses investigated the association between cortisol output and psychological variables., Methods: Salivary cortisol was measured upon awakening, at 15, 30, 45 and 60 min afterwards and at 12 noon, 4:00 p.m. and 8:00 p.m., in adolescents with CFS and healthy controls (HC). Groups were matched for age, gender, menarche status, menstrual cycle and awakening time. Twenty-four adolescents with CFS provided saliva samples six months after treatment. The main outcome measure was total salivary output over the day, calculated by area under the curve (AUC). The salivary awakening response was also assessed., Results: Cortisol output over the day was significantly lower in the CFS group (n=46) than in healthy controls (n=33). Within the CFS group, lower daily cortisol output was associated with higher self-reported perfectionist striving and prosocial behaviour. There were no significant group differences in the awakening response (n=47 CFS versus n=34 HC). After treatment, adolescents with CFS (n=21) showed a significant increase in daily cortisol output, up to normal levels., Conclusion: The reduced daily cortisol output in adolescents with CFS is in line with adult findings. Associations between reduced cortisol output and two psychological variables-perfectionism and prosocial behaviour-are consistent with cognitive behavioural models of chronic fatigue syndrome. The mild hypocortisolism is reversible; cortisol output had returned to healthy adolescent levels by six months after cognitive behavioural guided self-help treatment., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them., Methods: AEs were recorded on three occasions over one year in 641 participants. We compared the numbers and nature of AEs between treatment arms of specialist medical care (SMC) alone, or SMC supplemented by adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). We examined associations with baseline measures by binary logistic regression analyses, and compared the proportions of participants who deteriorated by clinically important amounts., Results: Serious adverse events and reactions were infrequent. Non-serious adverse events were common; the median (quartiles) number was 4 (2, 8) per participant, with no significant differences between treatments (P=.47). A greater number of NSAEs were associated with recruitment centre, and baseline physical symptom count, body mass index, and depressive disorder. Physical function deteriorated in 39 (25%) participants after APT, 15 (9%) after CBT, 18 (11%) after GET, and 28 (18%) after SMC (P<.001), with no significant differences in worsening fatigue., Conclusions: The numbers of adverse events did not differ significantly between trial treatments, but physical deterioration occurred most often after APT. The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments. Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data., (Copyright © 2013. Published by Elsevier Inc.)

Objective: Muscle diseases are currently untreatable and people with muscle disease experience reduced quality of life (QoL) and low mood. Patient's illness perceptions explain large proportions of the variance in QoL and mood, even after considering the impact of disease severity. Therefore a psychological intervention which helps patients modify their illness perceptions may improve QoL and mood even as the disease progresses. However, it is unknown which profile of illness perceptions (illness schema) an intervention should seek to promote. We aimed to fully describe and compare the illness schemata of clusters associated with better and worse outcomes., Method: Following a cluster analysis of 217 people with muscle disease, a between-cluster comparison of QoL and mood identified the clusters associated with better and worse outcomes. Functional impairment was compared between-clusters to indicate if this could account for observed differences. Inter-correlations between the illness perceptions held within each cluster were examined across the clusters., Results: Three stable clusters holding distinct illness schemata emerged. One cluster was characterised by greater functional impairment, worse QoL and mood than the other two clusters. The other two clusters did not differ in functional impairment but differed significantly in QoL and mood. The cluster associated with better outcomes was characterised by realistic views of timeline, greater coherence, reduced emotional representation and identity, and a lack of association between emotional representation and consequences., Conclusion: Detailed comparison of beneficial and unhelpful illness schemata, taking into account disease-specific concerns, can help inform both the content and composition of an intervention., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: In this paper we consider the role that acceptance plays in fatigue and physical and social functioning. We predicted that lack of acceptance would be positively correlated with fatigue and impairment in functioning; that there would be a significant relationship between perfectionism and acceptance; and cognitive behavioural therapy (CBT) would increase acceptance., Methods: Two hundred and fifty nine patients with chronic fatigue syndrome (CFS) completed questionnaires measuring fatigue, physical functioning, work and social adjustment, lack of acceptance, perfectionism and depression. Ninety consecutive attenders received a course of CBT and completed further questionnaires at discharge and 3months post-treatment. Correlations and multiple hierarchical regressions were used to determine relationships between acceptance, perfectionism and clinical outcome variables., Results: At baseline, lack of acceptance was the key factor associated with impaired physical functioning and work and social adjustment. Lack of acceptance and doubts about actions were associated with fatigue in a multiple regression analysis. At discharge and follow-up patients showed significantly increased acceptance, as well as reduced Concern over Mistakes, less fatigue and impairment of physical functioning, and improved work and social adjustment., Conclusion: This is the first study to our knowledge which shows a change in acceptance after CBT and a relationship between acceptance and perfectionism. Acceptance may be an important factor to consider within treatments for CFS., (2011 Elsevier Inc. All rights reserved.)

Background: Disability is a defining feature of chronic conditions, and it is an increasingly used measure of therapy effectiveness. The Work and Social Adjustment Scale (WSAS) is a simple and clear measure of disability. Although the scale is widely used, no study has yet investigated its psychometric properties in patients with chronic fatigue syndrome (CFS)., Methods: Data from two samples of patients were used, one from a multicenter randomized controlled clinical trial of treatments for CFS (n =639) and the other from a clinic that specializes in CFS (n=384). All patients completed the WSAS as well as other measures., Results: Internal consistency and the Spearman-Brown split-half coefficient values indicated that the scale is reliable. CFS patients who had comorbid diagnoses of depression, anxiety or fibromyalgia had higher WSAS scores. High levels of disability were associated with high number of physical symptoms, severe fatigue, depression, anxiety, poor sleep quality and poor physical fitness, with correlation coefficients ranging between 0.41 and 0.11. Lower scores on the WSAS were modestly associated with better physical functioning as well as higher levels of physical capacity as assessed by a walking test. Sensitivity to change was evaluated in a subgroup of patients who had undergone a course of cognitive behavioral therapy. Disability significantly decreased after therapy and remained stable at follow-ups., Conclusion: The WSAS is a reliable and valid assessment tool for disability in patients with CFS., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: This study investigated a cognitive-behavioural model of adjustment to multiple sclerosis (MS). It aimed to determine the contribution of cognitions and behaviours to the explanation of two distinct adjustment outcomes above and beyond measures of MS severity. Illness-related functional impairment was anticipated to be most strongly related to unhelpful thoughts and behaviours that were specific for MS and the experience of symptoms. Psychological distress was hypothesised to be most strongly related to more general unhelpful cognitions about the self and emotions., Methods: Ninety-four people with MS completed questionnaires. Correlations and hierarchical multiple regressions determined the relative contribution of illness severity, cognitions, and behaviours to the prediction of psychological distress and functional impairment., Results: Illness-related functional impairment was related to disease severity, progressive versus relapsing-remitting disease, and unhelpful illness perceptions and cognitive and behavioural responses to symptoms. Illness severity factors accounted for a significant 23.7% of the variance in functional impairment (P<.001). Cognitive and behavioural variables explained a further 22.6% of the variance (P<.001), with behavioural responses to symptoms emerging as the strongest predictor. The correlates of distress were unhelpful beliefs about the self, unhelpful beliefs about emotions, acceptance, and unhelpful cognitive responses to symptoms and illness perceptions. Illness severity factors explained only 2.2% of the variance in distress (P>.05), while cognitive and behavioural variables accounted for 37.1% (P<.001). Unhelpful beliefs about the self were the strongest predictor., Conclusion: Longitudinal and experimental research is required to investigate potential causal relationships. However, the cognitions and behaviours identified as important for adjustment are potentially modifiable and thus may be useful to address within interventions for adjustment to MS., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objective: Unhelpful behavior related to irritable bowel syndrome (IBS) is often targeted and expected to change in treatments such as cognitive behavioral therapies. However, no scale has previously been produced to assess these dimensions. The aim of this study was to develop and validate an IBS-specific behavioral responses questionnaire., Methods: A total of 153 patients with IBS as diagnosed by a general practitioner completed the 28-item Irritable Bowel Syndrome-Behavioral Responses Questionnaire (IBS-BRQ). A total of 117 persons without IBS also completed the IBS-BRQ and were used as a control group. Tests of internal consistency and principal components analyses (PCAs) were performed on both sets of data., Results: The scale was found to be both reliable and valid with a high degree of internal consistency for both IBS patients (Cronbach's alpha=.86) and controls (Cronbach's alpha=.89). The scale differentiated significantly between IBS patients and controls (F=221, P<.01). The PCA supported a two-factor solution in both sets of data. Two items were removed from the scale due to low discriminative ability. The criterion validity was high as evidenced by a strong correlation with the Cognitive Scale for Functional Bowel Disorders (CS-FBD) (r =.67, P<.001)., Conclusion: The IBS-BRQ is a valid and reliable scale that can be used for clinical as well as empirical purposes., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Objective: The Chalder Fatigue Scale (CFQ) is a widely used instrument to assess fatigue in both clinical and nonclinical settings. Psychometric properties of the scale and discriminative abilities were examined., Methods: A total of 361 patients with CFS and 1615 individuals in the community were assessed with the CFQ. Principal component analysis (PCA) was used to explore the structure of the scale. Receiver-operating characteristic curve (ROC) was used to investigate the discriminative properties., Results: Two components, physical and mental fatigue, were identified in the CFS patient group and in the general population samples. Area under the curve for ROC was .91. The fatigue scale effectively discriminates, at high scores, between CFS patients and the general population., Conclusion: Physical and mental fatigue are clearly separable components of fatigue. The CFQ can discriminate reliably between clinical and nonclinical conditions., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Objective: To examine predictors of treatment outcome in IBS-patients who participated in a randomized controlled trial in primary care, where 149 irritable bowel syndrome (IBS) patients were randomized to mebeverine hydrochloride (n=77) or mebeverine+cognitive behavior therapy (CBT) (n=72). CBT offered additional benefit over mebeverine alone., Methods: Regression analyses were used to identify predictors of work and social adjustment 12 months after treatment ended. The intervention groups were analyzed separately in order to look at the separate effects in each group., Results: Lower levels of psychological distress (anxiety and depression) at baseline predicted a good outcome in the mebeverine group [beta=0.388 (95% CI: 0.065-0.936), P=.025] but not in the mebeverine+CBT group. In the adjusted model for the mebeverine+CBT group less adaptive IBS related behavioral coping predicted a good outcome [beta=0.285 (95% CI: 0.002-0.210), P=.045]., Conclusion: Different factors are associated with outcome depending on the treatment received. At assessment clinicians should assess patients coping styles and may want to consider recommending CBT to those patients with IBS in primary care who are engaging in unhelpful coping behavior., (Copyright 2010 Elsevier Inc. All rights reserved.)

Objective: Beliefs about the unacceptability of experiencing or expressing negative emotions have been noted in individuals with a range of problems, including chronic fatigue syndrome (CFS), irritable bowel syndrome, somatization disorder, depression, eating disorders, social phobia, posttraumatic stress disorder, and borderline personality disorder. These beliefs are likely to have implications for emotion regulation and processing, and are addressed explicitly or implicitly within many therapies including cognitive behavior therapy (CBT), mindfulness-based cognitive therapy (MBCT), and Acceptance and Commitment Therapy (ACT). This article describes the development, validation, and internal reliability of the Beliefs about Emotions Scale (BES), a self-report questionnaire to assess such beliefs., Methods: The new scale was completed by people with CFS (n=121) and healthy controls (n=73). Twenty-two individuals with CFS completed the scale before and after CBT., Results: People with CFS had significantly higher scores on this new questionnaire than healthy controls. Principal components analysis identified one factor, and the scale had high internal consistency (0.91). Scores on the BES were most highly correlated with a measure of negative perfectionism (r=0.59) and also showed significant correlations with measures of dysfunctional attitudes, self-sacrifice, depression, anxiety, and fatigue. When completed before and after CBT for CFS, the questionnaire was sufficiently sensitive to detect a significant reduction in endorsement of unhelpful beliefs about emotions., Conclusion: The new Beliefs about Emotions Scale showed good internal reliability, validity and sensitivity to change., (Copyright 2010 Elsevier Inc. All rights reserved.)

Objective: This cross-sectional study aimed to measure the discrepancy between actual and perceived IQ in a sample of adolescents with CFS compared to healthy controls. We hypothesized that adolescents with CFS and their parent would have higher expectations of the adolescent's intellectual ability than healthy adolescents and their parent., Methods: The sample was 28 CFS patients and 29 healthy controls aged 11-19 years and the parent of each participant. IQ was assessed using the AH4 group test of general intelligence and a self-rating scale which measured perceived IQ., Results: Parents' perceptions of their children's IQ were significantly higher for individuals with CFS than healthy controls., Conclusions: High expectations may need to be addressed within the context of treatment.

Objective: The objective of this study was to assess the prevalence of chronic fatigue (CF) and its association with somatization syndrome [Somatization Syndrome Index (SSI) 4/6: >/=4 somatoform symptoms in men, 6 in women] in the general population., Methods: A representative sample of the German population (N=2412) completed a fatigue questionnaire and a screening instrument for current somatoform symptoms (Screening for Somatoform Symptoms 7)., Results: The prevalence rate of CF was 6.1% (n=147). Females were affected significantly more often as compared with males (7% vs. 5.1%). The mean number of somatoform symptoms was higher in CF cases than in control subjects without CF (11 vs. 2; P<.001). Seventy-two percent of the subjects with CF fulfilled the SSI4/6 criterion for somatization syndrome. Quality of life (EUROHIS-QOL and 8-item Short-Form Health Survey) and well-being (5-item WHO Well-Being Index) were markedly decreased in CF and SSI4/6. The results of regression analyses suggest that fatigue and somatization severity had a similar impact on quality of life., Conclusions: The results suggest that CF is relevant in the general population. Its substantial overlap with somatization syndrome supports the hypothesis that the two syndromes are only partially different manifestations of the same underlying processes.

Objective: The Chalder Fatigue Questionnaire (CFQ) is an instrument used to measure physical and mental fatigue. We translated and adapted the questionnaire and tested its reliability and validity in a Brazilian primary care setting., Method: A pilot study with 204 consecutive primary care attenders in Sao Paulo, Brazil, verified the internal consistency and factor structure of the questionnaire. After some modifications through a rigorous translation, back-translation, and cross-cultural adaptation procedure, a validation study was conducted with 304 attenders, who also completed the fatigue section of the Revised Clinical Interview Schedule (CIS-R)., Results: The internal consistency of the Brazilian CFQ slightly improved from the pilot to the validation study: Cronbach's alpha from .86 to .88. The two-factor structure (physical and mental fatigue) also improved. According to the receiver operating curve analysis with the fatigue section of the CIS-R as the standard criterion, 3/4 was chosen as the cutoff for Brazilian primary care (sensitivity 69.1% and specificity 79.4%)., Conclusion: The Brazilian CFQ had good reliability and validity. The cutoff was determined as 3/4 and the factor structure of the English CFQ was closely reproduced.

Objective: The aim of this study was to describe the advice that patients with acute infectious mononucleosis recall having been given by their general practitioner (GP; family or primary care doctor)., Methods: Individuals with a recent diagnosis of infectious mononucleosis were recruited for a randomised controlled trial assessing the effectiveness of a brief educational intervention on recovery. All participants were asked at their initial assessment what advice that they had been given by their GP. They were not given any prompts and were free to give several responses. Responses were grouped into various themes., Results: Seventy-one patients took part. Of these, 11 (15%) recalled being given no specific advice. Of the remaining 60 participants, 70% recalled being given advice to rest, or to "take it easy", usually without any qualification; 10% recalled being given dietary advice, and 17% advice on simple symptom management., Conclusion: The majority of individuals with recent onset infectious mononucleosis recall being given advice to rest by their GPs. This finding is discussed in relation to evidence suggesting that rest may be unhelpful.

Objectives: Glandular fever is associated with an approximate fivefold increase in fatigue at 6 months. Reduced levels of fitness and illness beliefs may be important predictors of fatigue following glandular fever. We therefore developed a brief psycho-educational intervention aimed at improving recovery from infectious mononucleosis, and piloted a randomised controlled trial to evaluate the intervention., Methods: We performed a randomised-controlled trial in primary health care in Southeast London and Kent. Sixty-nine patients aged between 16 and 45 years who were diagnosed, serologically and clinically, with acute infectious mononucleosis between December 1999 and December 2000 were randomised. The control group received a standardised fact-sheet about infectious mononucleosis, which gave no advice on rehabilitation. Patients who were randomised to the intervention received an individual treatment session, two follow-up telephone calls, and an information booklet. Fatigue score 6 months after the onset of infectious mononucleosis was the main outcome measure., Results: Sixty-nine out of 139 patients referred were recruited and randomised. Eighty-seven percent of those recruited completed the Fatigue Questionnaire at 6 months. The intervention was acceptable to all who received it. There were fewer fatigue cases in the intervention group than the control group at 6 months follow-up (odds ratio 0.31, 95% confidence interval 0.09-0.91)., Conclusions: A brief intervention at the diagnosis of infectious mononucleosis is acceptable, and may help prevent the development of chronic fatigue. Definitive randomised controlled trials are required to test the intervention.

Objective: To investigate the strength of chronic fatigue syndrome (CFS) patients' negative illness perceptions by comparing illness perceptions and self-reported disability in patients with CFS and rheumatoid arthritis (RA)., Methods: Seventy-four RA patients and 49 CFS patients completed the Illness Perception Questionnaire-Revised and the 36-item Short-Form Health Survey., Results: When compared to the RA group, the CFS group attributed a wider range of everyday somatic symptoms to their illness, perceived the consequences of their illness to be more profound and were more likely to attribute their illness to a virus or immune system dysfunction. Both groups reported equivalent levels of physical disability but the CFS group reported significantly higher levels of role and social disability., Conclusion: Although the symptoms of CFS are largely medically unexplained, CFS patients have more negative views about their symptoms and the impact that these have had on their lives than do patients with a clearly defined and potentially disabling medical condition. The data support the cognitive behavioural models of CFS that emphasise the importance of patients' illness perceptions in perpetuating this disorder.

Objective: There are many similarities between chronic fatigue syndrome (CFS), the somatoform disorders and problems otherwise known as "medically unexplained symptoms." There is some evidence to suggest that a combination of inadequate parenting and early illness experience may predispose the individual to develop medically unexplained symptoms in adult life. The aim of this investigation was to compare the contributions of childhood experiences of illness and parenting in adults with CFS with a fracture clinic control group., Method: A retrospective case control design was used. Thirty patients with a diagnosis of CFS and 30 patients attending a fracture clinic in an inner London teaching hospital completed questionnaires measuring parental care and protection and were interviewed about childhood experiences of illness., Results: There were no differences in childhood experience of illness in the two groups. However, logistic regression revealed that maternal overprotection and depression were associated with the diagnosis of CFS., Conclusion: The findings may represent risk factors for the development of CFS in adult life. It is possible that maternal overprotection in particular is related to the formation of belief systems about avoiding activity that operate to adversely influence behaviour in patients with CFS.

Objective: It has been suggested that people with chronic fatigue syndrome (CFS) have low self-esteem; however, this is not necessarily apparent when self-esteem is measured overtly. This study is the first to investigate underlying self-esteem using information-processing measures and overtly administered measures of self-esteem with this population., Methods: The study comprised 68 participants (24 CFS, 24 healthy volunteers, and 20 chronic illness volunteers). A Self-Statements Questionnaire (SSQ) and an Emotional Stroop Test (EST) using neutral, positive, and negative trait words were administered., Results: Participants with CFS reported lower self-esteem than the two comparison groups on overt measures. Overt responses, however, did not fully account for the full extent of the interference effect from the negative word Stroop compared to the positive word Stroop., Conclusion: In contrast to previous studies, participants with CFS reported lower levels of self-esteem on overt measures than two comparison groups. It is suggested, however, that the extent to which participants reported low self-esteem did not fully reflect their underlying low self-esteem and that this may result from the use of rigidly held defence mechanisms. Further use of information-processing measures, in contrast to relying only on self-report measures, is advocated for future research., (Copyright 2002 Elsevier Science Inc.)