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Aim: To validate child-adapted shortened versions of the Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBS-BRQ; short scale denoted BRQ-C) and the Visceral Sensitivity Index (VSI; short scale denoted VSI-C) for children with functional abdominal pain disorders (FAPDs)., Methods: A child psychologist supervised by a child gastroenterologist was responsible for shortening the scales (BRQ-C, 11 items; and VSI-C, 7 items). Then, a sample of 89 children aged 8-12 years with FAPDs was used in the validation. Construct validity was assessed with correlations. Measures included gastrointestinal symptoms, quality of life, pain intensity and anxiety. Also, internal consistency, test-retest reliability, administration time and factor structure were assessed., Results: Internal consistency for the BRQ-C and the VSI-C was α = 0.84 and α = 0.80, respectively. Correlations with related scales were similar between child-adapted scales and original scales, indicating construct validity equivalence. Correlations between short scales and original scales were high. Mean administration time was reduced by 47% (BRQ-C) and 42% (VSI-C), compared with original scales. Test-retest reliability was r = 0.72 for BRQ-C and r = 0.83 for VSI-C. BRQ-C had two factors (Avoidance and Bowel control). VSI-C had a unifactorial structure., Conclusion: The BRQ-C and the VSI-C were found to be time-saving, reliable and valid for children with FAPDs., (© 2022 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.)

Introduction: The burden of chronic breathlessness on individuals, family, society and health systems is significant and set to increase exponentially with an ageing population with complex multimorbidity, yet there is a lack of services. This has been further amplified by the coronavirus disease 2019 pandemic. Online breathlessness interventions have been proposed to fill this gap, but need development and evaluation based on patient preferences and choices. This study aimed to explore the preferences and choices of patients regarding the content of an online self-guided chronic breathlessness supportive intervention (SELF-BREATHE)., Methods: Semi-structured telephone interviews were conducted with adults living with advanced malignant and nonmalignant disease and chronic breathlessness (July to November 2020). Interviews were analysed using conventional and summative content analysis., Results: 25 patients with advanced disease and chronic breathlessness (COPD n=13, lung cancer n=8, interstitial lung disease n=3, bronchiectasis n=1; 17 male; median (range) age 70 (47-86) years; median (range) Medical Research Council dyspnoea score 3 (2-5)) were interviewed. Individuals highlighted strong preferences for focused education, methods to increase self-motivation and engagement, interventions targeting breathing and physical function, software capability to personalise the content of SELF-BREATHE to make it more meaningful to the user, and aesthetically designed content using various communication methods including written, video and audio content. Furthermore, they identified the need to address motivation as a key potential determinant of the success of SELF-BREATHE., Conclusion: Our findings provide an essential foundation for future digital intervention development (SELF-BREATHE) and scaled research., Competing Interests: Conflict of interest: C.C. Reilly reports receiving support for the present manuscript from NIHR Clinical Lectureship ICA-CL-2018-04-ST2-001, which funds all aspects of this research; grants or contracts from King's Together: Multi and Interdisciplinary research scheme and Royal Brompton Hospital – King's Health Partnership Transformation funding, outside the submitted work. Conflict of interest: K. Bristowe reports receiving grants or contracts from National Institute for Health Research, Medical Research Council, Health Education England, European Commission and Marie Curie, outside the submitted work. Conflict of interest: A. Roach has nothing to disclose. Conflict of interest: T. Chalder reports receiving support for the present manuscript via salary support from the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London (KCL). The views expressed in this article are those of the authors and not necessarily those of the NIHR or the NHS. Conflict of interest: M. Maddocks reports receiving grants or contracts from National Institute for Health Research (NIHR) Career Development Fellowship (CDF-2017–10-009), and NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust, outside the submitted work. Conflict of interest: I.J. Higginson reports receiving grants or contracts from NIHR, UKRI, Cicely Saunders International and Marie Curie, outside the submitted work., (Copyright ©The authors 2022.)

Given the large numbers of people infected and high rates of ongoing morbidity, research is clearly required to address the needs of adult survivors of COVID-19 living with ongoing symptoms (long COVID). To help direct resource and research efforts, we completed a research prioritisation process incorporating views from adults with ongoing symptoms of COVID-19, carers, clinicians and clinical researchers. The final top 10 research questions were agreed at an independently mediated workshop and included: identifying underlying mechanisms of long COVID, establishing diagnostic tools, understanding trajectory of recovery and evaluating the role of interventions both during the acute and persistent phases of the illness., Competing Interests: Competing interests: LH-W reports grants from the NIHR and ARC, outside the submitted work. TC reports grants from UK NIHR, UKRI and Guy’s and St Thomas’ Charity. She has delivered workshops on persistent physical symptoms in the context of long-term conditions, during the conduct of the study for which she has received payment. She is the author of self-help books on fatigue. She is a member of the NICE expert advisory panel for Covid19 Rapid Guidelines.JJ reports fees from Boehringer Ingelheim, Roche, NHSX and GlaxoSmithKline unrelated to the submitted work. JJ is supported by Wellcome Trust Clinical Research Career Development Fellowship 209,553/Z/17/Z and the NIHR UCLH Biomedical Research Centre, UK.SH reports consultancy for Eli Lily, NovoNordisk and Zealand Pharma for which his institution has received payment. He serves on a speaker panel for NovoNordisk for which he and his institution receive payment. MR is currently employed by Roches on a one year senior academic/ industry fellowship. JDC reports grants and personal fees from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, and Insmed, personal fees from Chiesi, Zambon, Janssen, and Grifols, and grants from Gilead Sciences, outside the submitted work. AH reports personal fees from Vertex Pharmaceuticals, Mylan Healthcare, and the Cystic Fibrosis Foundation, and grants from JP Moulton Trust and NIHR, outside the submitted work. MT reports personal fees from Merck Sharp & Dohme and GlaxoSmithKline, and grants and personal fees from Bayer and Actelion, during the conduct of the study. LVW reports grants from GlaxoSmithKline and Orion, outside the submitted work. ADS reports grants and personal fees from AstraZeneca, Bayer, Boehringer, Chiesi, Forest Laboratories, GlaxoSmithKline, Grifols, Insmed, MedImmune, Novartis, Pfizer, and 30T, outside the submitted work. RAE reports grants from GlaxoSmithKline during the conduct of the study; and grants from the National Institute for Health Research (NIHR) and personal fees from GlaxoSmithKline, AstraZeneca, and Chiesi, outside the submitted work. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objective: We explored moderators of cognitive behavioural therapy (CBT) treatment effects and predictors of outcome at 12-month follow-up in the CODES Trial (N = 368) comparing CBT plus standardised medical care (SMC) vs SMC-alone for dissociative seizures (DS)., Methods: We undertook moderator analyses of baseline characteristics to determine who had benefited from being offered CBT 12 months post-randomisation. Outcomes included: monthly DS frequency, psychosocial functioning (Work and Social Adjustment Scale - WSAS), and health-related quality of life (Mental Component Summary (MCS) and Physical Component Summary (PCS) SF-12v2 scores). When moderating effects were absent, we tested whether baseline variables predicted change irrespective of treatment allocation., Results: Moderator analyses revealed greater benefits (p < 0.05) of CBT on DS frequency for participants with more (≥22) symptoms (Modified PHQ-15) or ≥ 1 current (M.I.N.I.-confirmed) comorbid psychiatric diagnosis at baseline. The effect of CBT on PCS scores was moderated by gender; women did better than men in the CBT + SMC group. Predictors of improved outcome included: not receiving disability benefits, lower anxiety and/or depression scores (PCS, MCS, WSAS); shorter duration, younger age at DS onset, employment, fewer symptoms and higher educational qualification (PCS, WSAS); stronger belief in the diagnosis and in CBT as a "logical" treatment (MCS). Some variables that clinically might be expected to moderate/predict outcome (e.g., maladaptive personality traits, confidence in treatment) were not shown to be relevant., Conclusion: Patient complexity interacted with treatment. CBT was more likely to reduce DS frequency in those with greater comorbidity. Other patient characteristics predicted outcome regardless of the received intervention., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: SURECAN (SUrvivors' Rehabilitation Evaluation after CANcer) is a multi-phase study developing and evaluating an Acceptance and Commitment Therapy (ACT) intervention integrated with exercise and work when highly valued (thus we called the intervention ACT+), for people who have completed treatment for cancer but who have low quality of life. We developed a training programme for therapists working in different psychological services to be delivered over 2-3 days. Our aim was to evaluate the extent to which the training could improve therapists' knowledge and confidence to deliver ACT+ to cancer patients in a trial setting., Methods: Three interactive workshops were delivered to 29 therapists from three clinical settings in London and in Sheffield. A mixed-methods approach was used. Questionnaires were designed to assess knowledge and confidence in using ACT+ with people who have low quality of life after cancer treatment. They were self-administered immediately prior to and after each workshop. Open text-based questions were used to elicit feedback about the workshops alongside a satisfaction scale. Semi-structured interviews were conducted with a purposive sample of therapists (n = 12) to explore their views about the training more deeply, and how it might be optimised., Results: Quantitative analysis showed that knowledge of ACT, as well as confidence in using the ACT+ intervention in this setting increased significantly after training (28.6 and 33.5% increase in the median score respectively). Qualitative analysis indicated that most therapists were satisfied with the content and structure of the programme, valued the rich resources provided and enjoyed the practice-based approach. Potential barriers/facilitators to participation in the trial and to the successful implementation of ACT+ were identified. For some therapists, delivering a manualised intervention, as well as supporting exercise- and work-related goals as non-specialists was seen as challenging. At the same time, therapists valued the opportunity to be involved in research, whilst training in a new therapy model., Conclusions: Training can effectively improve the knowledge and confidence of therapists from different clinical backgrounds to deliver a modified ACT intervention to cancer patients in a trial setting., (© 2022. The Author(s).)

Objective: The objectives of this study were to examine the reasons patients give for nonadherence to allopurinol and to examine differences in intentional nonadherence for patients who did and did not achieve serum urate (SU) levels at treatment target., Methods: Sixty-nine men with gout attending rheumatology clinics, all prescribed allopurinol for ≥ 6 months, completed the Intentional Non-Adherence Scale (INAS). Differences in the types of intentional nonadherence were analyzed between those who did and did not achieve SU at treatment target (< 0.36 mmol/L, 6 mg/dL)., Results: The most frequently endorsed reasons for not taking their urate-lowering therapies (ULT) were because participants wanted to lead a normal life (23%) or think of themselves as a healthy person again (20%). Patients also reported not taking allopurinol as a way of testing if they really needed it (22%). Participants with SU above target endorsed significantly more INAS items as reasons for not taking their medication, had more medicine-related concerns, and were more likely to give Testing treatment as a reason for nonadherence. Participants who were younger, single, and non-New Zealand European also endorsed more reasons for not taking their allopurinol., Conclusion: The major reasons behind the patient's decision not to take allopurinol relate to the desire to lead a normal life and the strategy of testing the treatment to see if they could reduce the dose without getting symptoms. These results provide some potentially modifiable targets for adherence interventions and some recommendations to clinicians about how to reframe ULT for patients in order to improve adherence., (Copyright © 2022 by the Journal of Rheumatology.)

Background: Previous research has shown that psychological factors, such as stress and social support, are associated with greater susceptibility to viral respiratory illnesses and more severe symptoms. During the COVID-19 pandemic there has been a well-documented deterioration in psychological well-being and increased social isolation. This raises questions as to whether those experiencing psychological adversity during the pandemic are more at risk of contracting and/or experiencing COVID-19 symptoms., Purpose: To examine the relationship between psychological factors and the risk of COVID-19 self-reported infection and the symptomatic experience of SARS-CoV-2 (indicated by the number and severity of symptoms)., Methods: As part of a longitudinal prospective observational cohort study, 1,087 adults completed validated measures of psychological well-being during April 2020 and self-reported incidence of COVID-19 infection and symptom experience across the pandemic through to December 2020. Regression models were used to explore these relationships controlling for demographic and occupational factors., Results: Greater psychological distress during the early phase of the pandemic was significantly associated with subsequent self-reported SARS-CoV-2 infection as well as the experience of a greater number and more severe symptoms., Conclusions: COVID-19 infection and symptoms may be more common among those experiencing elevated psychological distress. Further research to elucidate the mechanisms underlying these associations is needed., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society of Behavioral Medicine.)

Background: Few studies into chronic fatigue syndrome (CFS) have emphasized work-related consequences, including return to work after illness., Aims: This paper explores socio-demographic, work and clinical characteristics that are associated with occupational status among patients who were assessed at baseline and a follow-up point., Methods: Longitudinal data were assessed from patients affected by CFS who attended an outpatient CFS treatment service between 2007 and 2014. Employment status at baseline and follow-up was available for 316 patients. Data were also included on gender, age, duration of CFS, fatigue severity, type and number of treatment sessions, coping strategies, functional impairment, common mental disorders and physical functioning., Results: Most patients were female (73%) and had been affected by CFS for longer than 2 years (66%). Patients were followed up for an average of 285 days and over this period 53% of patients who were working remained in employment. Of the patients who were not working at baseline, 9% had returned to work at follow-up. However, of those working at baseline, 6% were unable to continue to work at follow-up. Age, fatigue severity, functional impairment, cognitive and behavioural responses, and depressive symptoms impacted on a patients' work status at follow-up., Conclusions: The findings indicated that it is possible for people with CFS to remain in work or return to work, despite having had a disabling illness. Work-related outcomes should be targeted in all people of working age., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: We describe post-COVID symptomatology in a non-hospitalised, national sample of adolescents aged 11-17 years with PCR-confirmed SARS-CoV-2 infection compared with matched adolescents with negative PCR status., Methods: In this national cohort study, adolescents aged 11-17 years from the Public Health England database who tested positive for SARS-CoV-2 between January and March, 2021, were matched by month of test, age, sex, and geographical region to adolescents who tested negative. 3 months after testing, a subsample of adolescents were contacted to complete a detailed questionnaire, which collected data on demographics and their physical and mental health at the time of PCR testing (retrospectively) and at the time of completing the questionnaire (prospectively). We compared symptoms between the test-postive and test-negative groups, and used latent class analysis to assess whether and how physical symptoms at baseline and at 3 months clustered among participants. This study is registered with the ISRCTN registry (ISRCTN 34804192)., Findings: 23 048 adolescents who tested positive and 27 798 adolescents who tested negative between Jan 1, 2021, and March 31, 2021, were contacted, and 6804 adolescents (3065 who tested positive and 3739 who tested negative) completed the questionnaire (response rate 13·4%). At PCR testing, 1084 (35·4%) who tested positive and 309 (8·3%) who tested negative were symptomatic and 936 (30·5%) from the test-positive group and 231 (6·2%) from the test-negative group had three or more symptoms. 3 months after testing, 2038 (66·5%) who tested positive and 1993 (53·3%) who tested negative had any symptoms, and 928 (30·3%) from the test-positive group and 603 (16·2%) from the test-negative group had three or more symptoms. At 3 months after testing, the most common symptoms among the test-positive group were tiredness (1196 [39·0%]), headache (710 [23·2%]), and shortness of breath (717 [23·4%]), and among the test-negative group were tiredness (911 [24·4%]), headache (530 [14·2%]), and other (unspecified; 590 [15·8%]). Latent class analysis identified two classes, characterised by few or multiple symptoms. The estimated probability of being in the multiple symptom class was 29·6% (95% CI 27·4-31·7) for the test-positive group and 19·3% (17·7-21·0) for the test-negative group (risk ratio 1·53; 95% CI 1·35-1·70). The multiple symptoms class was more frequent among those with positive PCR results than negative results, in girls than boys, in adolescents aged 15-17 years than those aged 11-14 years, and in those with lower pretest physical and mental health., Interpretation: Adolescents who tested positive for SARS-CoV-2 had similar symptoms to those who tested negative, but had a higher prevalence of single and, particularly, multiple symptoms at the time of PCR testing and 3 months later. Clinicians should consider multiple symptoms that affect functioning and recognise different clusters of symptoms. The multiple and varied symptoms show that a multicomponent intervention will be required, and that mental and physical health symptoms occur concurrently, reflecting their close relationship., Funding: UK Department of Health and Social Care, in their capacity as the National Institute for Health Research, and UK Research and Innovation., Competing Interests: Declaration of interests TS is Chair of the Health Research Authority and therefore recused himself from the research ethics application. TC is a member of the National Institute for Health and Care Excellence committee for long COVID. She has written self-help books on chronic fatigue and has done workshops on chronic fatigue and post infectious syndromes. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: The COVID-19 pandemic has had profound consequences for population mental health. However, it is less clear for whom these effects are sustained., Aims: To investigate the prevalence, incidence, prognosis and risk factors for symptoms of depression and anxiety in a UK cohort over three distinct periods in the pandemic in 2020., Method: An online survey was completed by a UK community cohort at three points (n = 3097 at baseline, n = 878 completed all surveys): April (baseline), July to September (time point 2) and November to December (time point 3). Participants completed validated measures of depression and anxiety on each occasion, and we prospectively explored the role of sociodemographic and psychological factors (loneliness, positive mood and perceived risk of and worry about COVID-19) as risk factors., Results: Depression (Patient Health Questionnaire-9 means: baseline, 7.69; time point 2, 5.53; time point 3, 6.06) and anxiety scores (Generalised Anxiety Disorder-7 means: baseline, 6.59; time point 2, 4.60; time point 3, 4.98) were considerably greater than pre-pandemic population norms at all time points. Women reported greater depression and anxiety symptoms than men. Younger age, history of mental health disorder, more COVID-19-related negative life events, greater loneliness and lower positive mood at baseline were all significant predictors of poorer mental health at time point 3., Conclusions: The negative impact of the COVID-19 pandemic on mental health has persisted to some degree. Younger people and individuals with prior mental health disorders are at greatest risk. Easing of restrictions and resumption of social interaction could mitigate the risk factors of loneliness and positive mood.

Purpose: The CODES Trial for adults with dissociative seizures had a predesignated 12-month post-randomisation follow-up point for outcome evaluation. We undertook an exploratory, unplanned, secondary analysis to evaluate the effectiveness of cognitive behavioural therapy plus standardised medical care (CBT+SMC) compared to SMC alone at 6 months post-randomisation, i.e., closer to the end of treatment., Methods: The analysis of 6-month data followed our previous method of using multiple imputation and an intention-to-treat approach to analyse variables 12 months post-randomisation., Results: The original trial primary outcome of monthly seizure frequency showed greater benefit from CBT+SMC than SMC-alone at 6 months (at p < 0.05). Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months. The average effect size of the comparable previously-defined primary and secondary continuous outcomes was 0.33 at 6 months vs 0.26 at 12 months. The estimated Incidence Rate Ratio (IRR) quantifying monthly seizure reduction was IRR = 0.72 (95%CI from 0.55 to 0.93) at 6 months compared to IRR = 0.78 at 12 months., Conclusion: DS-specific CBT (plus SMC) produced evidence of significant benefits at 6 months post- randomisation (around which time CBT was complete) compared to SMC alone; for the majority of these outcomes, better results following CBT (plus SMC) had previously been reported at 12 months. Our pattern of results suggests that short- and longer-term follow-ups are necessary to understand treatment effects in this disorder. Studies only providing short-term follow-up data should be interpreted with caution., (Copyright © 2022. Published by Elsevier Ltd.)

The effectiveness of antiretroviral therapy (ART) depends on prompt uptake of treatment and a high level of adherence over the long-term, yet these behaviors are suboptimal. Previous interventions have significantly improved adherence but effect sizes are generally small. The aim of this article is to describe the design and content of an intervention to support uptake and adherence to treatment in HIV positive patients (SUPA intervention), utilizing cognitive behavioral and motivational interviewing (MI) techniques. The intervention was developed in line with Medical Research Council (MRC) guidance for the development of complex interventions and informed by the NICE (National Institute for Health and Care Excellence) Guidelines for adherence, empirical evidence and focus groups. Behavior change techniques were mapped to perceptual and practical barriers to uptake and adherence to ART, identified in previous research. Intervention materials were designed and later discussed within focus groups, where feedback enabled an iterative process of development. We conclude it is possible to transparently report the design and content of a theory-based intervention to increase uptake and adherence to ART. The intervention has been evaluated within a randomized controlled trial (RCT) at 10 HIV clinics in England, the results of which will be reported elsewhere., (© Society of Behavioral Medicine 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Severe Acute Respiratory Coronavirus 2 (SARS-CoV-2) was identified in late 2019, spreading to over 200 countries and resulting in almost two million deaths worldwide. The emergence of safe and effective vaccines provides a route out of the pandemic, with vaccination uptake of 75-90% needed to achieve population protection. Vaccine hesitancy is problematic for vaccine rollout; global reports suggest only 73% of the population may agree to being vaccinated. As a result, there is an urgent need to develop equitable and accessible interventions to address vaccine hesitancy at the population level., Study Design: & Method: We report the development of a scalable digital intervention seeking to address COVID-19 vaccine hesitancy and enhance uptake of COVID-19 vaccines in the United Kingdom. Guided by motivational interviewing (MI) principles, the intervention includes a series of therapeutic dialogues addressing 10 key concerns of vaccine-hesitant individuals. Development of the intervention occurred linearly across four stages. During stage 1, we identified common reasons for COVID-19 vaccine hesitancy through analysis of existing survey data, a rapid systematic literature review, and public engagement workshops. Stage 2 comprised qualitative interviews with medical, immunological, and public health experts. Rapid content and thematic analysis of the data provided evidence-based responses to common vaccine concerns. Stage 3 involved the development of therapeutic dialogues through workshops with psychological and digital behaviour change experts. Dialogues were developed to address concerns using MI principles, including embracing resistance and supporting self-efficacy. Finally, stage 4 involved digitisation of the dialogues and pilot testing with members of the public., Discussion: The digital intervention provides an evidence-based approach to addressing vaccine hesitancy through MI principles. The dialogues are user-selected, allowing exploration of relevant issues associated with hesitancy in a non-judgmental context. The text-based content and digital format allow for rapid modification to changing information and scalability for wider dissemination., (Copyright © 2021 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

Importance: Infection with SARS-CoV-2 is associated with fatigue and sleep problems long after the acute phase of COVID-19. In addition, there are concerns of SARS-CoV-2 infection causing psychiatric illness; however, evidence of a direct effect is inconclusive., Objective: To assess risk of risk of incident or repeat psychiatric illness, fatigue, or sleep problems following SARS-CoV-2 infection and to analyze changes according to demographic subgroups., Design, Setting, and Participants: This cohort study assembled matched cohorts using the Clinical Practice Research Datalink Aurum, a UK primary care registry of 11 923 499 individuals aged 16 years or older. Patients were followed-up for up to 10 months, from February 1 to December 9, 2020. Individuals with less than 2 years of historical data or less than 1 week follow-up were excluded. Individuals with positive results on a SARS-CoV-2 test without prior mental illness or with anxiety or depression, psychosis, fatigue, or sleep problems were matched with up to 4 controls based on sex, general practice, and year of birth. Controls were individuals who had negative SARS-CoV-2 test results. Data were analyzed from January to July 2021., Exposure: SARS-CoV-2 infection, determined via polymerase chain reaction testing., Main Outcomes and Measures: Cox proportional hazard models estimated the association between a positive SARS-CoV-2 test result and subsequent psychiatric morbidity (depression, anxiety, psychosis, or self-harm), sleep problems, fatigue, or psychotropic prescribing. Models adjusted for comorbidities, ethnicity, smoking, and body mass index., Results: Of 11 923 105 eligible individuals (6 011 020 [50.4%] women and 5 912 085 [49.6%] men; median [IQR] age, 44 [30-61] years), 232 780 individuals (2.0%) had positive result on a SARS-CoV-2 test. After applying selection criteria, 86 922 individuals were in the matched cohort without prior mental illness, 19 020 individuals had prior anxiety or depression, 1036 individuals had psychosis, 4152 individuals had fatigue, and 4539 individuals had sleep problems. After adjusting for observed confounders, there was an association between positive SARS-CoV-2 test results and psychiatric morbidity (adjusted hazard ratio [aHR], 1.83; 95% CI, 1.66-2.02), fatigue (aHR, 5.98; 95% CI, 5.33-6.71), and sleep problems (aHR, 3.16; 95% CI, 2.64-3.78). However, there was a similar risk of incident psychiatric morbidity for those with a negative SARS-CoV-2 test results (aHR, 1.71; 95% CI, 1.65-1.77) and a larger increase associated with influenza (aHR, 2.98; 95% CI, 1.55-5.75)., Conclusions and Relevance: In this cohort study of individuals registered at an English primary care practice during the pandemic, there was consistent evidence that SARS-CoV-2 infection was associated with increased risk of fatigue and sleep problems. However, the results from the negative control analysis suggest that unobserved confounding may be responsible for at least some of the positive association between COVID-19 and psychiatric morbidity.

Background: We examined demographic, clinical, and psychological characteristics of a large cohort (n = 368) of adults with dissociative seizures (DS) recruited to the CODES randomised controlled trial (RCT) and explored differences associated with age at onset of DS, gender, and DS semiology., Methods: Prior to randomisation within the CODES RCT, we collected demographic and clinical data on 368 participants. We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life. We undertook comparisons based on reported age at DS onset (<40 v. ⩾40), gender (male v. female), and DS semiology (predominantly hyperkinetic v. hypokinetic)., Results: Our cohort was predominantly female (72%) and characterised by high levels of socio-economic deprivation. Two-thirds had predominantly hyperkinetic DS. Of the total, 69% had ⩾1 comorbid M.I.N.I. diagnosis (median number = 2), with agoraphobia being the most common concurrent diagnosis. Clinical levels of distress were reported by 86% and characteristics associated with maladaptive personality traits by 60%. Moderate-to-severe functional impairment, high levels of somatic symptoms, and impaired quality of life were also reported. Women had a younger age at DS onset than men., Conclusions: Our study highlights the burden of psychopathology and socio-economic deprivation in a large, heterogeneous cohort of patients with DS. The lack of clear differences based on gender, DS semiology and age at onset suggests these factors do not add substantially to the heterogeneity of the cohort.

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: Telephone therapist delivered CBT (TCBT) and web-based CBT (WCBT) have been shown to be significantly more clinically effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. In this paper we assess the cost-effectiveness of the interventions., Methods: Participants were recruited from 74 general practices and three gastroenterology centres in England. Interventions costs were calculated, and other service use and lost employment measured and costed for one-year post randomisation. Quality-adjusted life years (QALYs) were combined with costs to determine cost-effectiveness of TCBT and WCBT compared to TAU., Results: TCBT cost £956 more than TAU (95% CI, £601-£1435) and generated 0.0429 more QALYs. WCBT cost £224 more than TAU (95% CI, - £11 to £448) and produced 0.029 more QALYs. Compared to TAU, TCBT had an incremental cost per QALY of £22,284 while the figure for WCBT was £7724. After multiple imputation these ratios increased to £27,436 and £17,388 respectively. Including lost employment and informal care, TCBT had costs that were on average £866 lower than TAU (95% CI, - £1133 to £2957), and WCBT had costs that were £1028 lower than TAU (95% CI, - £448 to £2580)., Conclusions: TCBT and WCBT resulted in more QALYs and higher costs than TAU. Complete case analysis suggests both therapies are cost-effective from a healthcare perspective. Imputation for missing data reduces cost-effectiveness but WCTB remained cost-effective. If the reduced societal costs are included both interventions are likely to be more cost-effective. Trial registration ISRCTN44427879 (registered 18.11.13).

This study aimed to identify the prevalence and predictors of current fatigue and fatigue at 1-year follow-up, in people with HIV. Participants were recruited from HIV outpatient clinics in London, England. We explored a range of bio-psychosocial factors associated with current fatigue severity, identifying the most salient factors in a multifactorial model. A prospective study explored the predictive value of specific psychological and behavioral factors in predicting fatigue severity at one year. Sixty-four of 131 (49%) participants met the criteria for clinically significant fatigue at baseline. Psychological and behavioral variables, but not immune-virologic markers or antiretroviral treatment, were associated with current fatigue severity. In the multifactorial model, catastrophizing and distress independently predicted current fatigue severity. Higher levels of fatigue at 1 year was predicted by baseline catastrophizing, symptom focusing, distress and sleep quality, when controlling for baseline fatigue, clinical and demographic variables. These findings suggest psychological and behavioral factors are important in the maintenance of fatigue in people with HIV and identify potential opportunities for treatment. Future interventions for fatigue in HIV should not only address anxiety, depression and distress but could be optimized by targeting psychological processes such as catastrophic thinking styles and symptom focusing.

Background: Using a laboratory-based exercise task, this study investigated objective exercise performance as well as expectations, anxiety and perceived task performance ratings in adolescents with CFS compared to healthy controls and illness controls., Method: Trials of a sit-stand exercise task (SST) were undertaken (CFS: n = 61, asthma (AS): n = 31, healthy adolescents (HC): n = 78). Adolescents rated their expectations, pre- and post-task anxiety, and perceived task difficulty. Their parents independently rated their performance expectations of their child., Results: The CFS group took significantly longer to complete the SST than the AS group (MD 3.71, 95% CI [2.41, 5.01] p < .001) and HC (MD 3.61, 95% CI [2.41, 4.81], p < .001). Adolescents with CFS had lower expectations for their performance on the exercise task than AS participants (MD -11.79, 95% CI [-22.17, -1.42] p = .022) and HC (MD -15.08, 95% CI [-23.01, -7.14] p < .001). They rated their perceived exertion as significantly greater than AS (MD 3.04, 95% CI [1.86, 4.21] p < .001) and HC (MD 2.98, 95% CI [1.99, 3.98], p < .001). The CFS group reported greater anxiety pre-task than AS (MD 14.11, 95% CI [5.57, 22.65] p < .001) and HC (MD 11.19, 95% CI [2.64, 19.75], p. = 007). Parental group differences showed similar patterns to the adolescents''., Conclusions: Lower expectations and greater anxiety regarding exercise may reflect learning from previous difficult experiences which could impact future exercise performance. Further examination of pre-exercise expectations and post-exercise appraisals could improve our understanding of the mechanisms by which fatigue is maintained., (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.)

Background: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited., Objectives: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive-behavioural therapy for adults with dissociative seizures., Design: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial., Setting: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive-behavioural therapy services., Participants: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017., Interventions: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive-behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care., Main Outcome Measures: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness., Results: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n  = 182; and cognitive-behavioural therapy plus standardised medical care, n  = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1-35 dissociative seizures); cognitive-behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0-20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p  = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive-behavioural therapy at a p -value < 0.05, including the following at a p -value ≤ 0.001: the longest dissociative seizure-free period in months 7-12 inclusive post randomisation (incidence rate ratio 1.64, 95% confidence interval 1.22 to 2.20; p  = 0.001); better psychosocial functioning (Work and Social Adjustment Scale, standardised treatment effect -0.39, 95% confidence interval -0.61 to -0.18; p  < 0.001); greater self-rated and clinician-rated clinical improvement (self-rated: standardised treatment effect 0.39, 95% confidence interval 0.16 to 0.62; p  = 0.001; clinician rated: standardised treatment effect 0.37, 95% confidence interval 0.17 to 0.57; p  < 0.001); and satisfaction with treatment (standardised treatment effect 0.50, 95% confidence interval 0.27 to 0.73; p  < 0.001). Rates of adverse events were similar across arms. Cognitive-behavioural therapy plus standardised medical care produced 0.0152 more quality-adjusted life-years (95% confidence interval -0.0106 to 0.0392 quality-adjusted life-years) than standardised medical care alone. The incremental cost-effectiveness ratio (cost per quality-adjusted life-year) for cognitive-behavioural therapy plus standardised medical care versus standardised medical care alone based on the EuroQol-5 Dimensions, five-level version, and imputed data was £120,658. In sensitivity analyses, incremental cost-effectiveness ratios ranged between £85,724 and £206,067. Qualitative and quantitative process evaluations highlighted useful study components, the importance of clinical experience in treating patients with dissociative seizures and potential benefits of our multidisciplinary care pathway., Limitations: Unlike outcome assessors, participants and clinicians were not blinded to the interventions., Conclusions: There was no significant additional benefit of dissociative seizure-specific cognitive-behavioural therapy in reducing dissociative seizure frequency, and cost-effectiveness over standardised medical care was low. However, this large, adequately powered, multicentre randomised controlled trial highlights benefits of adjunctive dissociative seizure-specific cognitive-behavioural therapy for several clinical outcomes, with no evidence of greater harm from dissociative seizure-specific cognitive-behavioural therapy., Future Work: Examination of moderators and mediators of outcome., Trial Registration: Current Controlled Trials ISRCTN05681227 and ClinicalTrials.gov NCT02325544., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 43. See the NIHR Journals Library website for further project information.

Objectives: The COVID-19 pandemic has caused unprecedented disruption to daily life. This study investigated depression, anxiety and stress in New Zealand (NZ) during the first 10 weeks of the COVID-19 pandemic, and associated psychological and behavioural factors. It also compares the results with a similar cross-sectional study in the UK., Design: Cross-sectional study., Setting: NZ community cohort., Participants: N=681 adults (≥18 years) in NZ. The cohort was predominantly female (89%) with a mean age of 42 years (range 18-87). Most (74%) identified as NZ European and almost half (46%) were keyworkers. Most were non-smokers (95%) and 20% identified themselves as having clinical risk factors which would put them at increased or greatest risk of COVID-19., Main Outcome Measures: Depression, anxiety, stress, positive mood and engagement in health behaviours (smoking, exercise, alcohol consumption)., Results: Depression and anxiety significantly exceeded population norms (p<0.0001). Being younger (p<0.0001) and most at risk of COVID-19 (p<0.05) were associated with greater depression, anxiety and stress. Greater positive mood, lower loneliness and greater exercise were protective factors for all outcomes (p<0.0001). Smoking (p=0.037) and alcohol consumption (p<0.05) were associated with increased anxiety. Pet ownership was associated with lower depression (p=0.006) and anxiety (p=0.008). When adjusting for age and gender differences, anxiety (p = 0.002) and stress (p = 0.007) were significantly lower in NZ than in the UK. The NZ sample reported lower perceived risk (p<0.0001) and worry about COVID-19 (p<0.0001) than the UK sample., Conclusions: The NZ population had higher depression and anxiety compared with population norms. Younger people and those most at risk of COVID-19 reported poorer mental health. Interventions should promote frequent exercise, and reduce loneliness and unhealthy behaviours., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Medically unexplained symptoms or persistent physical symptoms are common, real and are associated with significant distress, loss of functioning and high healthcare costs. History, examination and appropriate investigations are essential to make a diagnosis. Once the diagnosis has been made, exploring the impact of the symptoms helps us to tailor our advice to patients. This paper sets out a practical approach to taking a history, assessment and stepwise management principles., (© Royal College of Physicians 2021. All rights reserved.)

Background: Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain. Although accumulating evidence suggests that exposure to stressful events increases the risk for this complex disorder, this is the first meta-analysis to compare the impact of a full range of lifetime stressors (e.g. physical trauma through to emotional neglect) on adult fibromyalgia., Methods: This review was performed in accordance with PRISMA guidelines. Random-effects models examined associations between different stressor exposures and fibromyalgia status with meta-regression investigating the effects of publication year and study quality on effect sizes., Results: Nineteen studies were included in the meta-analysis. Significant associations with fibromyalgia status were observed for all six exposure types examined: odds ratios (OR) were highest for physical abuse (OR 3.23, 95% confidence interval 1.99-5.23) and total abuse (3.06, 1.71-5.46); intermediate for sexual abuse (2.65, 1.85-3.79) and smaller for medical trauma (1.80, 1.19-2.71), other lifetime stressors (1.70, 1.31-2.20), and emotional abuse (1.52, 1.27-1.81). Results were not significantly changed when childhood, as opposed to adult, exposures were used in studies that reported both. Meta-regression analyses demonstrated no effect of publication year or study quality on effect sizes., Conclusions: This study confirmed a significant association between stressor exposure and adult fibromyalgia with the strongest associations observed for physical abuse. Limitations related to current available literature were identified; we provide several suggestions for how these can be addressed in future studies. Stressors are likely to be one of many risk factors for fibromyalgia which we argue is best approached from a biopsychosocial perspective.

Stroke services have been reconfigured in recent years to facilitate early intervention. Throughout stroke settings, some patients present with functional symptoms that cannot be attributed to a structural cause. Emphasis on fast diagnosis and treatment means that a proportion of patients entering the care pathway present with functional symptoms that mimic stroke or have functional symptoms in addition to vascular stroke. There is limited understanding of mechanisms underlying functional stroke symptoms, how the treatment of such patients should be managed, and no referral pathway or treatment. Predisposing factors vary between individuals, and symptoms are heterogeneous: onset can be acute or insidious, and duration can be short-lived or chronic in the context of new or recurrent illness cognitions and behaviors. This article proposes a conceptual model of functional symptoms identified in stroke services and some hypotheses based on a narrative review of the functional neurological disorder literature. Predisposing factors may include illness experiences, stressors, and chronic autonomic nervous system arousal. Following the onset of distressing symptoms, perpetuating factors may include implicit cognitive processes, classical and operant conditioning, illness beliefs, and behavioral responses, which could form the basis of treatment targets. The proposed model will inform the development of theory-based interventions as well as a functional stroke care pathway.

Objectives: The number of people testing positive for Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) in the UK, particularly among young adults, is increasing. We report here on the mental health of young adults and related psychological and behavioural responses to the pandemic and consider the role of these factors in fuelling the increase in coronavirus disease 2019 (COVID-19) in this group., Methods: An online survey was completed during the first six weeks of the first UK-wide lockdown by 3097 respondents, including data for 364 respondents aged 18-24 years. The survey included measures of mental health and indices capturing related psychological and behavioural responses to the pandemic., Results: The mental health of 18- to 24-years-olds in the first 6 weeks of lockdown was significantly poorer than that of older respondents and previously published norms: with 84% reporting symptoms of depression and 72% reporting symptoms of anxiety. Young adults also reported significantly greater loneliness and reduced positive mood, both of which were also associated with greater mental health difficulties., Conclusions: We contend that the combination of mental health, social and economic considerations may have contributed to the rise of COVID-19 infections in young adults, and ascribing blame to this group will not aid our efforts to regain control of the disease., (Copyright © 2020 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

Background: Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT., Objective: Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results., Methods: A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data., Results: Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified., Conclusions: Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS., (©Stephanie Hughes, Alice Sibelli, Hazel A Everitt, Rona Moss-Morris, Trudie Chalder, J Matthew Harvey, Andrea Vas Falcao, Sabine Landau, Gilly O'Reilly, Sula Windgassen, Rachel Holland, Paul Little, Paul McCrone, Kimberley Goldsmith, Nicholas Coleman, Robert Logan, Felicity L Bishop. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.11.2020.)

Background: Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit., Methods: A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level., Results: Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small., Conclusions: It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation., Trial Registration: NCT02444520  (ClinicalTrials.gov).

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 (R 2  = 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.

Sleep problems have a negative impact on a range of outcomes and are very common in adolescents with chronic fatigue syndrome (CFS). We aimed to (a) establish whether adolescents with CFS have more self-reported sleep problems than illness controls as well as healthy controls, (b) investigate changes in sleep problems and (c) explore the extent to which sleep problems at baseline predict fatigue and functioning at follow-up in adolescents with CFS. The Insomnia Scale was completed by 121 adolescents with CFS, 78 healthy adolescents and 27 adolescents with asthma. Eighty (66%) treatment-naïve adolescents with CFS completed questionnaires approximately 3 months later. Adolescents with CFS reported increased sleep problems compared to healthy controls and adolescents with asthma. In CFS, there was no significant change in sleep problems without treatment over a 3-month follow-up. Sleep problems at baseline predicted a significant proportion of the variance in sleep problems at follow-up. Sleep problems should be targeted in treatment. Regulating the 'body clock' via the regulation of sleep could influence outcomes not assessed in this study such as school attainment.

Background: Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change., Methods: A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA)., Results: Analysis yielded three overarching themes: taking part in a treatment trial - "the only thing out there", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an "unpredictable recovery"., Conclusions: People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new., Competing Interests: Declaration of competing interest Markus Reuber is the paid Editor-in-Chief of Seizure-European Journal of Epilepsy and receives authorship fees from Oxford University Press in relation to a number of books about dissociative seizures. Jon Stone reports independent expert testimony work for personal injury and medical negligence claims, royalties from UpToDate for articles on functional neurological disorder and runs a free nonprofit self-help website, www.neurosymptoms.org. The remaining authors have no conflict of interest to declare., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Previous pandemics have resulted in significant consequences for mental health. Here, we report the mental health sequelae of the COVID-19 pandemic in a UK cohort and examine modifiable and non-modifiable explanatory factors associated with mental health outcomes. We focus on the first wave of data collection, which examined short-term consequences for mental health, as reported during the first 4-6 weeks of social distancing measures being introduced., Design: Cross-sectional online survey., Setting: Community cohort study., Participants: N=3097 adults aged ≥18 years were recruited through a mainstream and social media campaign between 3 April 2020 and 30 April 2020. The cohort was predominantly female (n=2618); mean age 44 years; 10% (n=296) from minority ethnic groups; 50% (n=1559) described themselves as key workers and 20% (n=649) identified as having clinical risk factors putting them at increased risk of COVID-19., Main Outcome Measures: Depression, anxiety and stress scores., Results: Mean scores for depression ([Formula: see text] =7.69, SD=6.0), stress ([Formula: see text] =6.48, SD=3.3) and anxiety ([Formula: see text] = 6.48, SD=3.3) significantly exceeded population norms (all p<0.0001). Analysis of non-modifiable factors hypothesised to be associated with mental health outcomes indicated that being younger, female and in a recognised COVID-19 risk group were associated with increased stress, anxiety and depression, with the final multivariable models accounting for 7%-14% of variance. When adding modifiable factors, significant independent effects emerged for positive mood, perceived loneliness and worry about getting COVID-19 for all outcomes, with the final multivariable models accounting for 54%-57% of total variance., Conclusions: Increased psychological morbidity was evident in this UK sample and found to be more common in younger people, women and in individuals who identified as being in recognised COVID-19 risk groups. Public health and mental health interventions able to ameliorate perceptions of risk of COVID-19, worry about COVID-19 loneliness and boost positive mood may be effective., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Chronic fatigue syndrome (CFS) has a major impact on functioning. However, no validated measures of functioning for this population exist., Aims: We aimed to establish the psychometric properties of the 5-item School and Social Adjustment Scale (SSAS) and the 10-item Physical Functioning Subscale of the SF-36 in adolescents with CFS., Method: Measures were completed by adolescents with CFS (n = 121)., Results: For the Physical Functioning Subscale, a 2-factor solution provided a close fit to the data. Internal consistency was satisfactory. For the SSAS, a 1-factor solution provided an adequate fit to the data. The internal consistency was satisfactory. Inter-item and item-total correlations did not indicate any problematic items and functioning scores were moderately correlated with other measures of disability, providing evidence of construct validity., Conclusion: Both measures were found to be reliable and valid and provide brief measures for assessing these important outcomes. The Physical Functioning Subscale can be used as two subscales in adolescents with CFS.

Objectives: To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type., Methods: 579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group., Results: 124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance., Conclusion: We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication., Competing Interests: Declaration of Competing Interest PDW is a member of the Independent Medical Experts Group, which advises the UK Ministry of Defence regarding its Armed Forces Compensation Scheme, as well as providing consultancy advice to a re-insurance company. MS has received royalties from several publishers of academic books, TC is the author of Coping with chronic fatigue, published by Sheldon Press, and is a co-author of Overcoming Chronic Fatigue, published by Constable and Robinson. The other authors declare no conflict of interest., (Crown Copyright © 2020. Published by Elsevier Inc. All rights reserved.)

Introduction: A proportion of patients admitted to acute-stroke settings have not had a stroke, but have conditions mimicking a stroke. Approximately 25% of suspected stroke cases are "stroke mimics" and 2% are patients with functional symptoms - "functional stroke mimics". This study aimed to explore experiences and illness perceptions of patients with functional symptoms admitted to hyperacute stroke wards., Methods: This study used mixed methods. Patients with functional stroke symptoms participated in semistructured qualitative interviews immediately after admission to one of two acute-stroke units in London and again 2 months after hospital discharge. Qualitative data were assessed using thematic analysis. The Brief Illness Perception Questionnaire (Brief-IPQ) measured illness perceptions at admission and at 2-month follow-up., Results: A total of 36 participants completed baseline interviews and 25 completed follow-up. Six themes emerged: physical symptom experience, emotional and coping responses, symptom causes, hospital experiences, views on the future, and uncertainty after hospital discharge. Mean Brief-IPQ score at admission was 49.3 (SD: 9.9), indicating a moderate-high level of perceived illness threat. Participants presented with a range of functional symptoms. At baseline, participants were highly concerned about their symptoms, but this had decreased at 2-month follow-up. Two months later, many were confused as to the cause of their admission., Conclusion: This is the first study to examine functional stroke patients' experiences of acute-stroke admission. At admission, patients expressed confusion regarding their diagnosis, experienced high levels of emotional distress, and were concerned they were perceived as time wasting by stroke clinicians. While most participants experienced symptom recovery, there was a significant subgroup for whom symptoms persisted or worsened. A lack of care guidelines on the management of functional stroke patients may perpetuate functional symptoms., Competing Interests: Professor Trudie Chalder reports grants from the King’s Challenge Fund (£78,468; April 1, 2018–March 31, 2019). The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article. Some of the results of this study were reported in NOC’s PhD thesis; however, this has been substantially reworded and contains new data that did not appear in the original thesis. The authors report no other conflicts of interest in this work., (© 2020 O’Connell et al.)

Background: Envy is depicted as motivating destructive desires and actions intended to spoil or destroy that which is envied., Aim: To develop a new valid and reliable measure of malicious envy (C-BRES), which included items representing the cognitive, emotional and behavioural responses empirically associated with this emotion., Method: A total of 203 adults completed the new 22-item cognitive and behavioural responses to envy scale (C-BRES). Exploratory factor analysis was carried out to test for reliability and internal consistency of the C-BRES. Evidence towards the concurrent construct validity (convergent and discriminant) of the C-BRES was assessed through correlations with the Dispositional envy scale and other measures of psychosocial outcomes empirically linked to envy., Results: Factor analysis for categorical data identified five dimensions of envy, namely: injustice, hostility, malicious action tendencies, malicious feelings and behavioural responses. The reliability indices of the five factors and the total scale were satisfactory (>0.85). Evidence towards the concurrent construct validity (convergent and discriminant) of the C-BRES is reported. In particular, envy was associated with higher levels of depression, psychoticism, neuroticism, anger and lower levels of self-esteem and quality of life., Conclusion: All findings support the psychometric adequacy of the C-BRES.

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: Altered attentional processing (automatically attending to negative or illness-relevant information) and interpretative biases (interpreting ambiguous information as negative or illness relevant) may be mechanistically involved in functional neurological disorder (FND). Common mechanisms between FND and chronic fatigue syndrome (CFS) have been proposed but not compared experimentally., Methods: We compared the cognitive task performance of FND, CFS, and healthy control (HC) groups. The tasks assessed attentional bias toward illness-relevant stimuli (visual probe task), attentional control (attention network task), and somatic interpretations (interpretative bias task), alongside self-reported depression, anxiety, fatigue, and general health., Results: Thirty-seven participants diagnosed with FND, 52 participants diagnosed with CFS, and 51 HC participants were included. Although participants with CFS showed attentional bias for illness-relevant stimuli relative to HC (t = -3.13, p = .002, d = 0.624), individuals with FND did not (t = -1.59, p = .118, d = 0.379). Both the FND (t = 3.08, p = .003, d = 0.759) and CFS (t = 2.74, p = .007, d = 0.548) groups displayed worse attentional control than did the HC group. Similarly, the FND (t = 3.63, p < .001, d = 0.801) and CFS groups (t = 4.58, p < .001, d = 0.909) showed more somatic interpretative bias than did the HC group., Conclusions: Similar attentional control deficits and somatic interpretative bias in individuals with FND and CFS support potential shared mechanisms underlying symptoms. Interpretative bias toward somatic and illness-relevant stimuli in functional disorders may prove a therapeutic target.

Chronic fatigue syndrome (CFS) is a long-term illness with a wide range of symptoms and condition trajectories. To improve the understanding of these, automated analysis of large amounts of patient data holds promise. Routinely documented assessments are useful for large-scale analysis, however relevant information is mainly in free text. As a first step to extract symptom and condition trajectories, natural language processing (NLP) methods are useful to identify important textual content and relevant information. In this paper, we propose an agnostic NLP method of extracting segments of patients' clinical histories in CFS assessments. Moreover, we present initial results on the advantage of using these segments to quantify and analyse the presence of certain clinically relevant concepts.

Background: Approximately, half of stroke survivors experience fatigue. Fatigue may persist for many months and interferes with participation in everyday activities and has a negative impact on social and family relationships, return to work, and quality of life. Fatigue is among the top 10 priorities for 'Life after Stroke' research for stroke survivors, carers, and clinicians. We previously developed and tested in a small uncontrolled pilot study a manualised, clinical psychologist-delivered, face-to-face intervention, informed by cognitive behavioural therapy (CBT). We then adapted it for delivery by trained therapists via telephone. We now aim to test the feasibility of this approach in a parallel group, randomised controlled feasibility trial ( P ost S troke I ntervention T rial I n F atigue, POSITIF)., Methods/design: POSITIF aims to recruit 75 stroke survivors between 3 months and 2 years post-stroke who would like treatment for their fatigue. Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only. The aims of the intervention are to (i) provide an explanation for post-stroke fatigue, in particular that it is potentially reversible (an educational approach), (ii) encourage participants to overcome the fear of taking physical activity and challenge negative thinking (a cognitive approach) and (iii) promote a balance between daily activities, rest and sleep and then gradually increase levels of physical activity (a behavioural approach). Fatigue, mood, quality of life, return to work and putative mediators will be assessed at baseline (just before randomisation), at the end of treatment and 6 months after randomisation. POSITIF will determine the feasibility of recruitment, adherence to the intervention and the resources required to deliver the intervention in a larger trial., Discussion: The POSITIF feasibility trial will recruit until 31 January 2020. Data will inform the utility and design of a future adequately powered randomised controlled trial., Trial Registration: ClinicalTrials.gov, NCT03551327. Registered on 11 June 2018., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Objectives: We aimed to identify existing outcome measures for functional neurological disorder (FND), to inform the development of recommendations and to guide future research on FND outcomes., Methods: A systematic review was conducted to identify existing FND-specific outcome measures and the most common measurement domains and measures in previous treatment studies. Searches of Embase, MEDLINE and PsycINFO were conducted between January 1965 and June 2019. The findings were discussed during two international meetings of the FND-Core Outcome Measures group., Results: Five FND-specific measures were identified-three clinician-rated and two patient-rated-but their measurement properties have not been rigorously evaluated. No single measure was identified for use across the range of FND symptoms in adults. Across randomised controlled trials (k=40) and observational treatment studies (k=40), outcome measures most often assessed core FND symptom change. Other domains measured commonly were additional physical and psychological symptoms, life impact (ie, quality of life, disability and general functioning) and health economics/cost-utility (eg, healthcare resource use and quality-adjusted life years)., Conclusions: There are few well-validated FND-specific outcome measures. Thus, at present, we recommend that existing outcome measures, known to be reliable, valid and responsive in FND or closely related populations, are used to capture key outcome domains. Increased consistency in outcome measurement will facilitate comparison of treatment effects across FND symptom types and treatment modalities. Future work needs to more rigorously validate outcome measures used in this population., Competing Interests: Competing interests: AAA-P reports honoraria from Cobel Daruo, Sanofi and RaymandRad, and royalty from Oxford University Press (book publication). AJC reports independent expert testimony work for personal injury and medical negligence claims, is a paid associate editor of JNNP and runs a free non-profit self-help website (www.headinjurysymptoms.org). AJE has received personal compensation as a consultant/scientific advisory board member for Abbvie, Adamas, Acadia, Acorda, Neuroderm, Impax/Amneal, Sunovion, Lundbeck, Osmotica Pharmaceutical and US WorldMeds; publishing royalties from Lippincott Williams & Wilkins, Cambridge University Press and Springer; and honoraria from US WorldMeds, Lundbeck, Acadia, Sunovion, the American Academy of Neurology and the Movement Disorders Society. BM has received honoraria from The Cleveland Clinic and runs a free non-profit self-help website (www.fndhope.org). WCLF has served on the editorial boards of Epilepsia, Epilepsy & Behavior; Journal of Neurology, Neurosurgery and Psychiatry and Journal of Neuropsychiatry and Clinical Neurosciences; receives editor’s royalties from the publication of Gates and Rowan’s Nonepileptic Seizures, 3rd ed. (Cambridge University Press, 2010) and 4th ed. (2018); author’s royalties for Taking Control of Your Seizures: Workbook and Therapist Guide (Oxford University Press, 2015); has received research support from the Department of Defense (DoD W81XWH-17-0169), National Institutes of Health (NIH) (NINDS 5K23NS45902 [PI]), Providence VAMC, Center for Neurorestoration and Neurorehabilitation, Rhode Island Hospital, the American Epilepsy Society (AES), the Epilepsy Foundation (EF), Brown University and the Siravo Foundation; serves on the Epilepsy Foundation New England Professional Advisory Board; received honoraria for the American Academy of Neurology Meeting Annual Course; served as a clinic development consultant at University of Colorado Denver, Cleveland Clinic, Spectrum Health, Emory University and Oregon Health Sciences University; and provided medicolegal expert testimony. DLP has received honoraria from the American Academy of Neurology, Movement Disorder Society and Harvard Medical School. JS reports independent expert testimony work for personal injury and medical negligence claims, receives royalties from UpToDate for articles on functional neurological disorder and runs a free non-profit self-help website (www.neurosymptoms.org). KLF has received honoraria from the American Academy of Neurology and the Movement Disorder Society. MH may accrue revenue on a US patent for an Immunotoxin (MAB-Ricin) for the treatment of focal movement disorders and for a coil for magnetic stimulation and methods for using the same (H-coil); in relation to the latter, he has received licence fee payments from the NIH (from Brainsway). He is on the medical advisory boards of CALA Health, Brainsway and Cadent. He is on the editorial board of approximately 15 journals and receives royalties and/or honoraria from publishing from Cambridge University Press, Oxford University Press, Springer and Elsevier. Grant research funds have come from Merz for treatment studies of focal hand dystonia; Allergan for studies of methods to inject botulinum toxins; Medtronic, Inc. for a study of DBS for dystonia; and CALA Health for studies of a device to suppress tremor. MJE reports independent expert testimony work for personal injury and medical negligence claims and receives royalties from the Oxford Specialist Handbook of Parkinson’s Disease and Other Movement Disorders. He has received honoraria from Merz Pharma and Boeringher Ingleheim. AEL reports consultancy support from Abbvie, AFFiRis, Biogen, Janssen, Lilly, Lundbeck, Merck, Paladin, Roche, Sun Pharma, Theravance, and Corticobasal Degeneration Solutions; advisory board support form Jazz Pharma, PhotoPharmics, Sunovion; other honoraria from Sun Pharma, AbbVie, Sunovion, American Academy of Neurology and the International Parkinson and Movement Disorder Society; grants from Brain Canada, Canadian Institutes of Health Research, Corticobasal Degeneration Solutions, Edmond J Safra Philanthropic Foundation, Michael J. Fox Foundation, the Ontario Brain Institute, Parkinson Foundation, Parkinson Canada, and W. Garfield Weston Foundation and royalties from Elsevier, Saunders, Wiley-Blackwell, Johns Hopkins Press, and Cambridge University Press., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency., Methods: In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544., Findings: Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events., Interpretation: CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach., Funding: National Institute for Health Research, Health Technology Assessment programme., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)