Effect of Brain-gut Behavioral Treatments on Abdominal Pain in Irritable Bowel Syndrome: Systematic Review and Network Meta-analysis.

BACKGROUND AND AIMS: Some brain-gut behavioral treatments (BGBTs) are beneficial for global symptoms in irritable bowel syndrome (IBS). US management guidelines suggest their use in patients with persistent abdominal pain but their specific effect on this symptom has not been assessed systematically. METHODS: We searched the literature through 16th December 2023 for randomized controlled trials (RCTs) assessing efficacy of BGBTs for adults with IBS, compared with each other, or a control intervention. Trials provided an assessment of abdominal pain resolution or improvement at treatment completion. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of abdominal pain not improving with 95% confidence intervals (CIs), ranking therapies according to P-score. RESULTS: We identified 42 eligible RCTs, containing 5220 participants. After treatment completion, the BGBTs with the largest numbers of trials, and patients recruited, demonstrating efficacy for abdominal pain, specifically, included self-guided/minimal contact cognitive behavioral therapy (CBT) (RR = 0.71; 95% CI 0.54-0.95, P-score 0.58), face-to-face multicomponent behavioral therapy (RR = 0.72; 95% CI 0.54-0.97, P score 0.56), and face-to-face gut-directed hypnotherapy (RR = 0.77; 95% CI 0.61-0.96, P-score 0.49). Among trials recruiting only patients with refractory global IBS symptoms, group CBT was more efficacious than routine care for abdominal pain, but no other significant differences were detected. No trials were low risk of bias across all domains and there was evidence of funnel plot asymmetry. CONCLUSIONS: Several BGBTs, including self-guided/minimal contact CBT, face-to-face multicomponent behavioral therapy, and face-to-face gut-directed hypnotherapy may be efficacious for abdominal pain in IBS, although none were superior to another.

The presence of attentional and interpretation biases in patients with severe MS-related fatigue.

OBJECTIVE: Severe fatigue is a prevalent and disabling symptom in multiple sclerosis (MS). This study tested if a fatigue- and physical activity-related attentional bias (AB) and a somatic interpretation bias (IB) are present in severely fatigued patients with MS. Biases were compared to healthy controls and patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). METHOD: Severely fatigued patients with MS or ME/CFS and healthy controls completed a Visual Probe Task (VPT) assessing fatigue- and physical activity-related AB and an IB task that assesses the tendency to interpret ambiguous information in either a somatically threatening way or in a more neutral manner. The VPT was completed by 38 MS patients, 44 ME/CFS patients, and 46 healthy controls; the IB task was completed by 156, 40 and 46 participants respectively. RESULTS: ANOVA showed no statistically significant group differences in a fatigue-related AB or physical activity-related AB (omnibus test of interaction between topic × condition: F2,125 = 1.87; p = .159). Both patient groups showed a tendency to interpret ambiguous information in a somatically threatening way compared to healthy controls (F1,2 = 27.61, p < .001). This IB was significantly stronger in MS patients compared to ME/CFS patients. IB was significantly correlated with cognitive responses to symptoms in MS patients. CONCLUSION: MS patients tend to interpret ambiguous information in a somatically threatening way. This may feed into unhelpful ways of dealing with symptoms, possibly contributing to the perpetuation of severe fatigue in MS.

Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.

BACKGROUND: Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties. METHODS: We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197). FINDINGS: 1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures. INTERPRETATION: MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people. FUNDING: UK National Institute for Health Research Programme Grants for Applied Research programme and Epilepsy Research UK Endeavour Project Grant.

A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. CONCLUSION: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. TRIAL REGISTRATION: NCT04535778.

Do interventions for mood improve inflammatory biomarkers in inflammatory bowel disease?: a systematic review and meta-analysis.

BACKGROUND: Psychoneuroimmunological mechanisms and the gut-brain axis appear relevant to disease activity and progression in Inflammatory Bowel Disease (IBD). A recent review showed no effect of psychological therapies on self-reported disease activity in IBD. This meta-analysis aims to establish whether interventions targeting mood outcomes (e.g., depression, anxiety and stress) impact inflammation levels in IBD and possible moderators of these effects. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. We searched five electronic databases and included randomised controlled trials where interventions targeted mood and assessed inflammatory outcomes pre- and post-intervention in adults with IBD. Independent reviewers screened studies, extracted data, and assessed methodological quality. Data were pooled to estimate standardised mean differences (SMDs) with 95% Confidence Intervals (CIs). A random-effects robust variance estimation accounted for studies measuring multiple biomarkers. Intervention type, mood as a primary or secondary outcome, effect on mood outcomes and IBD subtype were investigated as treatment effect moderators. Where there were sufficient biomarkers, individual meta-analyses were run (Pre-registration PROSPERO: CRD42023389401). FINDINGS: 28 RCTs involving 1789 participants met inclusion criteria. Interventions demonstrated small, statistically significant effects on biomarkers (-0.35, 95% CI: -0.48, -0.22, p < 0.001) and medium effects on mood outcomes (-0.50, 95% CI: -0.73, -0.27, p < 0.001), without evidence of substantive heterogeneity or publication bias. Individual analyses showed small effects for improved faecal calprotectin (-0.19, 95% CI: -0.34, -0.03, p = 0.018) and C-Reactive Protein (-0.29, 95% CI: -0.47, -0.10, p = 0.002). Effect sizes were larger for psychological therapy interventions (compared with exercise or antidepressants) and when there was an effect (SMD ≥0.2) on mood. INTERPRETATION: Treatments which address mood outcomes have beneficial effects on generic inflammation as well as disease-specific biomarkers (faecal calprotectin and C-Reactive Protein). Psychological interventions and interventions with larger treatment effects on mood accentuated the effect on biomarkers. More research is required to understand the biological or behavioural mechanisms underlying this effect. FUNDING: The Medical Research Council and the National Institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre.

'Symptom-free' when inflammatory bowel disease is in remission: Expectations raised by online resources.

OBJECTIVES: Up to 60% of patients with inflammatory bowel disease (IBD) experience symptoms when in remission. Qualitative research suggests patients seldom feel they receive adequate explanations for these. This study explores how, and how often, ongoing symptoms during remission are represented on readily searchable patient websites. METHODS: Bing, Google, and Yahoo were searched for websites providing medical information about IBD. Thematic analysis was used to inductively explore themes around symptoms during quiescent IBD, followed by deductive content analysis to quantify core themes. RESULTS: Results indicated that remission is commonly defined as "few or no symptoms" and that there is limited information available on symptoms during remission. 55.6% of IBD websites provided a definition of remission based on symptom control only, while 44.4% also incorporated inflammatory control. The few websites that mentioned that symptoms may continue during remission (21.7%) related these to IBS. CONCLUSIONS: Current website information is predominantly biomedical and fails to adequately explain how symptoms may persist during remission and how IBS and IBD may be linked. PRACTICE IMPLICATIONS: Lack of explanatory models of symptoms in remission may lead to distress and increase anxiety about symptoms. Clearer explanations of these symptoms are needed.

Exploring the complexities of illness identity and symptom management in seeking a diagnostic label of postural orthostatic tachycardia syndrome (POTS): An inductive approach.

OBJECTIVES: Postural orthostatic tachycardia syndrome (POTS) is a debilitating and under-recognized condition of the autonomic nervous system. This study applied Leventhal's Common-Sense Model of Illness Representations to explore the journey to a diagnosis of POTS and to understand its relevance to poorly understood conditions which have common comorbidities. DESIGN: An inductive qualitative approach was used to explore the processes by which patients formulate explanations and management of symptoms within the search for a diagnostic label and to investigate illness identity in the context of existing diagnoses or multimorbidity. METHODS: Participants (n = 29) for this nested qualitative study were recruited from a larger longitudinal study of people who had been newly referred to a specialist POTS service. Semi-structured interviews were conducted via video call. Three researchers coded and analysed data using Reflexive Thematic Analysis and elements of Grounded Theory. RESULTS: The analysis resulted in three overarching themes: 'Seeking physiological coherence and validation', 'Individual persistence', and 'Navigating the cumulative burden'. 'Accessibility and disparities of health care' was noted as a contextual factor. Receiving a POTS diagnosis was regarded by participants as providing legitimacy and increased access to treatment. Overall, delays in the diagnostic journey and the lack of a clear diagnosis impacted negatively on patients through increased uncertainty and a lack of clear guidance on how to manage symptoms. Findings also suggested there were great complexities in assigning symptoms to labels in the context of multimorbidity. CONCLUSIONS: Participants' stories highlighted the urgent need for better recognition of POTS so that the self-regulatory process can be initiated from the early stages of symptom detection.

Validation of symptom measures in patients under investigation for postural orthostatic tachycardia syndrome (POTS): The Orthostatic Grading Scale (OGS) and the Symptom Screen for Small-fiber Polyneuropathy (SSS).

OBJECTIVES: Postural Orthostatic Tachycardia Syndrome (POTS) presents with a range of poorly delineated symptoms across several domains. There is an urgent need for standardized symptom reporting in POTS, but a lack of validated symptom burden instruments. Our aim was to evaluate the psychometric properties of two symptom burden measures: the Orthostatic Grading Scale (OGS) and the Symptom Screen for Small-Fiber Polyneuropathy (SSS), in patients under investigation for suspected POTS. DESIGN: Psychometric validation study. METHODS: Confirmatory factor analysis (CFA) tested the factor structure of the SSS and OGS completed by 149 patients under investigation for POTS. Scale reliability and validity were assessed. The uni-dimensionality of the SSS was assessed through principal component analysis (PCA). RESULTS: CFA of the OGS revealed that a 1-factor structure had adequate fit. CFA of the SSS revealed that a 5-factor structure had generally appropriate fit supporting the originally proposed 5 factors (1: Gastrointestinal, 2: Somatosensory, 3: Miscellaneous, 4: Microvascular, and 5: Urological). In addition, the SSS demonstrated sufficient uni-dimensionality in the PCA, warranting use of a single total score. Omega coefficients of both measures indicated satisfactory internal reliability (0.668-0.931). Correlations with related constructs (distress (K10 score), r = 0.317-0.404, p < 0.001) and heart rate indices (with the OGS, r = 0.211-0.294, p < 0.05) suggested sound convergent and divergent validity. CONCLUSIONS: Initial evidence suggests that the OGS and SSS have good psychometric properties for use in populations with suspected and confirmed POTS.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial.

AIM: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST). METHOD: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention. The inclusion criteria were age 18-70 years; attending specialist hospitals in England; self-reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease-specific and psychological questionnaires and cost-effectiveness (based on EQ-5D-5L). RESULTS: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST-guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately -0.8 points of a 4-point scale) with no statistically significant difference between HT and HTBF (-0.03 points; 95% CI -0.33 to 0.27; P = 0.85) or INVEST versus no-INVEST (0.22; -0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost-effectiveness of HTBF or INVEST compared with HT. CONCLUSION: The results of the study at 6 months were inconclusive. However, with the caveat of under-recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost-effective than more complex and invasive approaches.

Acceptance and commitment therapy processes and their association with distress in cancer: a systematic review and meta-analysis.

Around 42% of individuals with cancer experience distress. Acceptance and commitment therapy (ACT) can reduce distress, but effects are small, and mechanisms unclear. This review aimed to identify associations between ACT processes and distress in cancer. Search terms included cancer, ACT processes, self-compassion, and distress. Six online databases and grey literature were searched until March 2022. Of 6555 papers screened, 108 studies were included with 17,195 participants. Five meta-analyses of 77 studies were conducted. Random effects meta-analyses of correlations revealed higher scores on flexible processes (acceptance, present moment awareness, self-compassion) were associated with lower distress (rpooled = -0.24, -0.39, -0.48, respectively); whilst higher scores on inflexible processes (experiential avoidance, cognitive fusion) were associated with higher distress (rpooled = 0.58, 0.57, respectively). Meta-analyses displayed moderate-to-high heterogeneity with most studies assessed as low risk of bias. Meta-regressions revealed no significant moderators (stage, time since diagnosis, gender and age). This review provides a theoretically aligned evidence base for associations between ACT processes and distress in cancer, supporting elements of ACT theory and providing targeted directions for intervention development. Due to limited evidence, future research should focus on self-as-context, values and committed action and conduct mediation analysis in controlled trials of ACT processes on distress in cancer.

Internet-delivered cognitive behavioural therapy programme to reduce depressive symptoms in patients with multiple sclerosis: a multicentre, randomised, controlled, phase 3 trial.

BACKGROUND: Depression is three to four times more prevalent in patients with neurological and inflammatory disorders than in the general population. For example, in patients with multiple sclerosis, the 12-month prevalence of major depressive disorder is around 25% and it is associated with a lower quality of life, faster disease progression, and higher morbidity and mortality. Despite its clinical relevance, there are few treatment options for depression associated with multiple sclerosis and confirmatory trials are scarce. We aimed to evaluate the safety and efficacy of a multiple sclerosis-specific, internet-based cognitive behavioural therapy (iCBT) programme for the treatment of depressive symptoms associated with the disease. METHODS: This parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. Patients with a neurologist-confirmed diagnosis of multiple sclerosis and depressive symptoms were randomly assigned (1:1:1; automated assignment, concealed allocation, no stratification, no blocking) to receive treatment as usual plus one of two versions of the iCBT programme Amiria (stand-alone or therapist-guided) or to a control condition, in which participants received treatment as usual and were offered access to the iCBT programme after 6 months. Masking of participants to group assignment between active treatment and control was not possible, although raters were masked to group assignment. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. This trial is registered at ClinicalTrials.gov, NCT02740361, and is complete. FINDINGS: Between May 3, 2017, and Nov 4, 2020, we screened 485 patients for eligibility. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. The dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group (BDI-II between-group mean differences: control vs stand-alone iCBT 6·32 points [95% CI 3·37-9·27], p<0·0001, effect size d=0·97 [95% CI 0·64-1·30]; control vs guided iCBT 5·80 points [2·71-8·88], p<0·0001, effect size d=0·96 [0·62-1·30]). Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group. No occurrences of suicidality were observed during the trial and there were no deaths. INTERPRETATION: This trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers. FUNDING: National Multiple Sclerosis Society (USA).

A cognitive-behavioural therapy programme for managing depression and anxiety in long-term physical health conditions: mixed-methods real-world evaluation of the COMPASS programme.

BACKGROUND: Mental health comorbidities are common in physical long-term health conditions. AIMS: We evaluate the effectiveness of COMPASS, a therapist-supported, digital cognitive-behavioural therapy programme specifically designed to treat anxiety/depression in the context of long-term conditions. We also investigate patient experiences of the programme. METHOD: We utilised a mixed-methods, non-randomised design. We analysed pre-post data from 76 patients with long-term conditions who were receiving psychological treatment (COMPASS) via local NHS services, using paired sample t-tests and Cohen's d, with depression, anxiety, distress and functional impairment self-report scales. Qualitative interviews explored patients' experiences of using COMPASS. Twenty-one semi-structured interviews were completed and underwent inductive thematic analysis. RESULTS: Patients who received COMPASS had significantly reduced depression (-2.47, 95% CI -3.7 to -1.3, P < 0.001; Cohen's d = -0.376), anxiety (-2.30, 95% CI -3.6 to -1.2, P < 0.001; Cohen's d = -0.420) and psychological distress (-4.87, 95% CI -7.0 to -2.7, P < 0.001; Cohen's d = -0.422) and significantly improved functional impairment (-3.00, 95% CI -4.8 to -1.2, P ≤ 0.001; Cohen's d = -0.282). Effect sizes were larger when analyses included only patients with clinically significant baseline symptoms: depression (-4.02, 95% CI -5.6 to -2.5, P < 0.001; Cohen's d = -0.701), anxiety (-3.60, 95% CI -5.3 to -1.9, P < 0.001; Cohen's d = -0.739), psychological distress (-5.58, 95% CI -7.9 to -3.2, P < 0.001; Cohen's d = -0.523), functional impairment (-3.28, 95% CI -5.4 to -1.1, P ≤ 0.001; Cohen's d = -0.355). Qualitative analysis yielded two meta-themes: engagement and integration of mental and physical health. CONCLUSIONS: Results suggest that COMPASS is effective in NHS settings, and is acceptable to patients. Content tailored to long-term conditions, therapist support and clear delivery strategies should be prioritised to aid intervention implementation.

Refractory inflammatory arthritis definition and model generated through patient and multi-disciplinary professional modified Delphi process.

OBJECTIVE: Various definitions have been proposed for Refractory Disease in people with Rheumatoid Arthritis; however, none were generated for Polyarticular Juvenile Idiopathic Arthritis or involving adult and paediatric multidisciplinary healthcare professionals and patients. The study aim is to redefine Refractory Disease, using Delphi methodology. METHODS: Three rounds of surveys (one nominal group and two online (2019-2020)) to achieve consensus using a predetermined cut-off were conducted voting on: a) name, b) treatment and inflammation, c) symptoms and impact domains, and d) rating of individual components within domains. Theoretical application of the definition was conducted through a scoping exercise. RESULTS: Votes were collected across three rounds from Patients, Researchers and nine multi-disciplinary healthcare professional groups (n = 106). Refractory Inflammatory Arthritis was the most popular name. Regarding treatment and inflammation, these were voted to be kept broad rather than specifying numbers/cut-offs. From 10 domains identified to capture symptoms and disease impact, six domains reached consensus for inclusion: 1) Disease Activity, 2) Joint Involvement, 3) Pain, 4) Fatigue, 5) Functioning and Quality of Life, and 6) Disease-Modifying Anti-Rheumatic Drug Experiences. Within these domains, 18 components, from an initial pool (n = 73), were identified as related and important to capture multi-faceted presentation of Refractory Inflammatory Arthritis, specifically in Rheumatoid Arthritis and Polyarticular Juvenile Idiopathic Arthritis. Feasibility of the revised definition was established (2022-2023) with good utility as was applied to 82% of datasets (n = 61) incorporating 20 outcome measures, with two further measures added to increase its utility and coverage of Pain and Fatigue. CONCLUSION: Refractory Inflammatory Arthritis has been found to be broader than not achieving low disease activity, with wider biopsychosocial components and factors incorporating Persistent Inflammation or Symptoms identified as important. This definition needs further refinement to assess utility as a classification tool to identify patients with unmet needs.

The bidirectional effect of stress and functionality in multiple sclerosis and the interaction role of anxiety, coping and social support.

OBJECTIVE: The present study aims to analyse the bidirectional hypothesis between stress and multiple sclerosis with several measures of stress, impairment and functionality, considering also the interaction role of stress-related psychosocial factors such as anxiety, coping and social support. METHODS: A one-year follow-up was conducted with 26 people with multiple sclerosis. Participants reported i) at baseline, anxiety (State-Trait Anxiety Inventory), and social support (Multidimensional Scale of Perceived Social Support); ii) daily, Ecological Momentary Assessment through self-reported diaries of stressful events and coping strategies; iii) monthly, the perceived stress (Perceived Stress Scale), iv) trimonthly, the self-reported functionality (Functionality Assessment in multiple sclerosis) and v) at baseline and at the end, neurologist rated impairment (Expanded Disability Status Scale). Mixed-effect regression models were conducted. RESULTS: The bidirectional hypothesis was confirmed with perceived stress and self-reported functionality, which were negatively related in both directions. Coping and anxiety showed an interaction effect: active coping increased functionality only with high levels of stress, and high-trait anxiety showed lower functionality whereas low-trait anxiety showed higher functionality but only with low stress levels. CONCLUSION: People with multiple sclerosis may benefit from different types of psychological therapies, from gold-standard therapies like Cognitive Behavioural Therapy to third-waves therapies like Dialectical Behaviour Therapy or mindfulness, that focus on dealing with stress and affective symptoms, adjusting to the disease, and to improving their overall quality of life. More research is needed in this field under the biopsychosocial model.

The Cognitive and Behavioural Responses to Symptoms Questionnaire (CBRQ): Development, reliability and validity across several long-term conditions.

OBJECTIVES: Cognitive and behavioural responses to symptoms can worsen or maintain the severity of symptoms across long-term conditions (LTCs). Although the Cognitive and Behavioural Responses Questionnaire (CBRQ) has been used in research, its original development and psychometric properties as a transdiagnostic measure have not been reported. Our aim was to evaluate the psychometric properties of the CBRQ and a recently proposed short version, across different LTCs. DESIGN: Psychometric validation study. METHODS: Confirmatory factor analysis (CFA) tested the factor structure of the CBRQ in two datasets from the CBRQ's original development; (chronic fatigue syndrome, N = 230; and multiple sclerosis, N = 221) and in additional groups: haemodialysis (N = 174), inflammatory bowel disease (N = 182) and chronic dizziness (N = 185). Scale reliability and construct validity were assessed. The factor structure of the shortened CBRQ (CBRQ-SF) was also assessed. RESULTS: CFA revealed that a 7-or 8-factor structure had generally appropriate fit supporting the originally proposed 7 factors (Fear avoidance, Damage beliefs, Catastrophising, Embarrassment avoidance, Symptom focusing, All-or-nothing behaviour and Avoidance/Resting behaviour). Omega coefficients indicated satisfactory internal reliability. Correlations with related constructs suggested construct validity. The scale appeared sensitive to change. The CBRQ-SF also displayed good psychometric quality, with a better model fit than the CBRQ. CONCLUSIONS: The CBRQ and the shortened version were shown to be reliable and valid at assessing a range of cognitive and behavioural responses to symptoms, highlighting the multi-symptom, transdiagnostic properties of this questionnaire. Further research is necessary to determine the test-retest reliability and sensitivity to change of the CBRQ and CBRQ-SF and a thorough evaluation of the content validity of the items.

Self-reported symptom burden in postural orthostatic tachycardia syndrome (POTS): A narrative review of observational and interventional studies.

BACKGROUND AND OBJECTIVE: Postural Orthostatic Tachycardia Syndrome (POTS) is a chronic health condition affecting mostly women of childbearing age, and significantly impacting their health and quality of life. It is currently poorly understood with no approved licensed treatments. The aim of this systematic review was to contextualize the symptom burden of POTS, and review factors associated with this burden that may guide future treatments. The specific questions were (1) How does symptom burden in POTS compare to the burden in other long term conditions (LTCs), (2) Which factors are associated with POTS symptom burden, and (3) Which interventions show promise in reducing symptom burden in POTS. DATABASES AND DATA TREATMENT: Electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, APA PsycArticles, OpenGrey) were searched from inception to January 2022 for observational studies reporting on the association between any biological, psychological or social factors and symptom burden, and randomized controlled trials reporting on interventions for symptom burden in adults with POTS. Two reviewers independently conducted eligibility screening, data extraction and quality assessment. A narrative synthesis was undertaken. RESULTS/CONCLUSION: 5159 entries were screened for eligibility. Twenty-nine studies were included (1372 participants with POTS of a total sample size of 2314, 17 High-, 12 Medium-quality), seventeen were observational and twelve were randomized controlled experimental and intervention trials. Overall methodological quality of the evidence was medium-high but heterogeneity was high and sample sizes modest, allowing moderately robust conclusions. Orthostatic symptom burden was higher in POTS than other LTCs. Serum activity against adrenergic α1 receptors, physical functioning, depression, catastrophizing, prolonged cognitive stress testing and anxiety were significantly associated with symptom burden in medium-high quality studies. Preliminary medium-high quality evidence from predominantly proof-of-concept (n = 11) studies and one 3-month 2 × 2 factorial design trial suggest that compression garments, propranolol, pyridostigmine, desmopressin, and bisoprolol may hold promise in reducing symptom burden. Directions for future research include investigating associated factors over time, the development of complex interventions which address both biological and psychosocial factors associated with symptom burden, and effectiveness trials of these interventions. SIGNIFICANCE: POTS symptom burden is high, particularly in relation to orthostatic intolerance when compared to other long-term conditions (LTCs). Despite this burden, there are no effectiveness randomized controlled trials of treatment to reduce symptoms in POTS. This review provides a starting point to understanding researched biological and psychosocial factors associated with this burden. There was however inconsistency in the measurement of symptom burden, lowering the confidence of cross-study inferences. A coherent definition of POTS symptom range, severity and impact along with a validated and reliable POTS-specific instrument is currently lacking. A standardized questionnaire to assess POTS symptom burden as a core outcome measure will help clarify future research and clinical practice.

'I don't know which is the chicken and which is the egg': A qualitative study of weight loss-related beliefs and behaviours among adults with psoriasis and comorbid obesity.

OBJECTIVES: Obesity is a common (30%-40%) comorbidity of psoriasis. Weight loss is shown to improve the severity of psoriasis; however, little is known about the factors that may influence successful weight loss in the context of obesity and psoriasis. The current qualitative study aimed to explore the obesity-associated beliefs, perceptions, and behaviours related to weight loss in psoriasis. Preferences for a weight loss intervention were also explored. DESIGN: Qualitative in-depth semi-structured interviews were conducted with 24 adults (62.5% male) with moderate-to-severe psoriasis and obesity (mean body mass index = 35.2 kg/m2 , SD = 4.1), recruited through a patient organization website in the UK. Data were analysed using inductive thematic analysis. RESULTS: Most participants viewed psoriasis as unrelated to obesity. A well-controlled psoriasis and improvements in psoriasis symptoms were considered as major motivators for engaging in a weight loss program by individuals who viewed psoriasis and obesity as related conditions. Comfort eating was perceived as an escape strategy from the psoriasis-induced negative emotions. Participants shared their dissatisfaction with current weight loss recommendations which were too generic. They suggested that a desirable weight loss program would require both emotional and behavioural support, with an emphasis on psoriasis' burden. CONCLUSION: The findings accentuate the importance of (1) clinicians discussing the link between obesity and psoriasis with patients, (2) weight loss advice to include both behavioural and emotional support, and (3) a weight loss advice to consider the psoriasis burden and the perceived barriers which may potentially lead to improved outcomes to obesity management in psoriasis.

Experiences of a cognitive behavioural therapy (CBT) intervention for fatigue in patients receiving haemodialysis.

BACKGROUND: A feasibility randomised-controlled trial found that a cognitive-behavioural therapy intervention for renal fatigue has the potential to reduce fatigue in patients receiving haemodialysis, but uptake was low. OBJECTIVES: Nested in the randomised-controlled trial (RC) qualitative interviews were undertaken to understand the acceptability of renal fatigue, the facilitators of, and barriers to, engagement, and the psychosocial processes of change. DESIGN: The trial included 24 participants at baseline. Semi-structured interviews were conducted with nine participants from the intervention arm (n = 12). Approach Interviews were carried out immediately following treatment (3 months post-randomisation). Data were analysed using inductive thematic analysis. FINDINGS: Five main themes were formulated. The overarching theme was a sense of coherence (whether the illness, symptoms and treatment made sense to individuals), which appeared to be central to acceptability and engagement. Two themes captured the key barriers and facilitators to engagement, cognitive and illness/treatment burdens and collaboration with the therapist. Participants described changes related to their activity, thoughts and social identity/interactions, which shaped perceptions of change in fatigue. Lastly, participants discussed the optimal delivery of the intervention. CONCLUSIONS: This study revealed the importance of patients' understanding of fatigue and acceptance of the treatment model for the acceptability of and engagement with a cognitive-behavioural therapy-based intervention for fatigue. Overall, there was an indication that such an intervention is acceptable to patients and the mechanisms of change align with the proposed biopsychosocial model of fatigue. However, it needs to be delivered in a way that is appealing and practical to patients, acknowledging the illness and treatment burdens.

A systematic review of behavioural and exercise interventions for the prevention and management of chemotherapy-induced peripheral neuropathy symptoms.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) can result in functional difficulties. Pharmacological interventions used to prevent CIPN either show low efficacy or lack evidence to support their use and to date, duloxetine remains the only recommended treatment for painful CIPN. Non-pharmacological interventions such as exercise and behavioural interventions for CIPN exist. PURPOSE: The aims were to (1) identify and appraise evidence on existing behavioural and exercise interventions focussed on preventing or managing CIPN symptoms, (2) describe psychological mechanisms of action by which interventions influenced CIPN symptoms, (3) determine the underpinning conceptual models that describe how an intervention may create behaviour change, (4) identify treatment components of each intervention and contextual factors, (5) determine the nature and extent of patient and clinician involvement in developing existing interventions and (6) summarise the relative efficacy or effectiveness of interventions to lessen CIPN symptoms and to improve quality of life, balance and muscle strength. METHODS: A systematic search of Ovid Medline, Cochrane Library, EMBASE, PsycINFO, Health Management Information Consortium, Global Health and CINAHL was performed to identify articles published between January 2000 to May 2020, followed by OpenGrey search and hand-searching of relevant journals. Studies that explored behavioural and/or exercise interventions designed to prevent or improve symptoms of CIPN in adults who had received or were receiving neurotoxic chemotherapy for any type of cancer, irrespective of when delivered within the cancer pathway were included. RESULTS: Nineteen randomised controlled trials and quasi-experimental studies which explored behavioural (n=6) and exercise (n=13) interventions were included. Four studies were rated as methodologically strong, ten were moderate and five were weak. Ten exercise and two behavioural interventions, including those that improved CIPN knowledge and self-management resources and facilitated symptom self-reporting, led to reduced CIPN symptoms during and/or after chemotherapy treatment. CONCLUSIONS: The extent of potential benefits from the interventions was difficult to judge, due to study limitations. Future interventions should incorporate a clear theoretical framework and involve patients and clinicians in the development process. IMPLICATIONS FOR CANCER SURVIVORS: Our findings show exercise interventions have beneficial effects on CIPN symptoms although higher quality research is warranted. Behavioural interventions that increase patient's CIPN knowledge, improve self-management capacity and enable timely access to symptom management led to reduced CIPN symptoms.