Cost-utility analysis of transdiagnostic cognitive behavioural therapy for people with persistent physical symptoms in contact with specialist services evaluated in the PRINCE secondary trial.

OBJECTIVE: To compare the cost-utility of transdiagnostic cognitive behavioural therapy (TDT-CBT) plus standardised medical care (SMC) to SMC alone to support people with persistent physical symptoms in contact with specialist services. METHODS: This study compared the cost-utility of TDT-CBT. A two-arm randomised controlled trial was conducted in secondary care settings. Participants received either TDT-CBT + SMC or SMC alone. Measures were taken at baseline and at 9-, 20-, 40-, and 52-week follow-up. Service use was measured, and costs calculated. Costs were combined with quality-adjusted life years (QALYs) based on the EQ-5D-5L using incremental cost-utility ratios with uncertainty addressed using cost-effectiveness planes and acceptability curves. RESULTS: The costs during the follow-up period were £3473 for TDT-CBT + SMC and £3104 for SMC alone. The incremental cost for TDT-CBT + SMC adjusting for baseline was £482 (95 % CI, -£399 to £1233). QALYs over the follow-up were 0.578 for TDT-CBT + SMC and 0.542 for SMC alone. The incremental QALY was 0.038 (95 % CI, -0.005 to 0.080). The incremental cost per QALY was £12,684 for TDT-CBT + SMC. There was a 68.3 % likelihood that TDT-CBT + SMC was the most cost-effective option at a threshold of £20,000 per QALY. CONCLUSION: Adding TDT-CTB to SMC results in slightly increased costs and slightly better outcomes in terms of QALYs. This represents a cost-effective option based on the conventional QALY threshold value.

Correlates and predictors of symptom severity over time in people under investigation for postural orthostatic tachycardia syndrome (POTS).

OBJECTIVE: Postural Orthostatic Tachycardia Syndrome (POTS) is a poorly understood chronic disorder characterised by an unexplained excessive increase in heartbeat upon standing. The aim of this study was to investigate psychosocial and physiological correlates and predictors of symptom severity over time in patients presenting with POTS-like symptoms. METHODS: Longitudinal cohort study of patients under investigation for POTS ( n = 149). Patients completed questionnaires at one month pre-clinic appointment and 6 months later. Diagnosis, blood pressure (BP) and heart rate (HR) measures were collected from medical records. Data were analysed using hierarchical linear multiple regression. RESULTS: Orthostatic and small fibre neuropathy (SFN) symptoms remained stable over time and were significantly correlated with distress, cardiac anxiety, threatening views of the illness, and cognitive-behavioural responses to symptoms, but not with emotional reactivity or social support. Baseline psychosocial factors collectively explained 48% (F = 5.37, p < .001) of the variance in orthostatic symptoms, and 35% (F = 3.49, p < .001) of the variance of SFN symptoms at baseline, but a non-significant amount of variance in symptoms at 6 months when controlling for baseline symptoms. Haemodynamic measures explained a significant 4% (F = 3.37, p = .026) of variance of orthostatic symptoms at 6 months. CONCLUSION: Symptom burden in patients with suspected POTS remained high over 6 months. Psychosocial factors explained a large amount of the variance in symptoms at baseline. As symptoms did not change/improve over time, baseline symptoms accounted for most of the variance in symptoms at 6 months. An integrated approach addressing psychosocial factors alongside medical treatments may promote adjustment to the condition and lessen symptom burden for this group.

Examining change in the mental health of young people with epilepsy following a successful psychological intervention.

OBJECTIVE: Evaluate the cognitive, behavioural and affective processes involved in therapeutic change for young people with epilepsy and mental health difficulties receiving an integrated mental health intervention. METHODS: As part of a mixed methods convergent design, qualitative data were gathered in parallel to quantitative data at two timepoints in a randomised controlled trial testing the Mental Health Intervention for Children with Epilepsy in addition to usual care. Twenty-five young people and/or their families were interviewed before and after the intervention about the young person's mental and physical health, and their experience of therapy. Interview data were analysed inductively, idiographically and longitudinally using Interpretative Phenomenological Analysis combined with Framework Analysis. RESULTS: The young people's emotional and behaviour problems improved, mirroring the trial's quantitative outcomes. Their anxiety decreased and behaviour improved as they acquired tools and understanding through therapy. Problems, like aggressive behaviours and emotional outbursts, were also reduced, with young people gaining increased awareness and ability to self-regulate and parents learning to contain their child's impulsive behaviours. CONCLUSIONS: The qualitative findings complement the MICE trial's significant positive quantitative results by providing insight and context to the therapeutic change, providing vivid insight into the mechanisms of therapy for individual families.

This study involves young people with epilepsy and mental health difficulties who received an integrated mental health intervention called the Mental Health Intervention for Children with Epilepsy (MICE). The effectiveness of the MICE intervention (in addition to usual care) was assessed by comparing it to only usual care. This article reports on the changes in the behaviour, thinking, feeling of the young people after they received therapy. The research data was qualitative, using transcripts from interviews with 25 young people and/or their families. There was also some quantitative data, in the form of questionnaires. Both types of data were gathered at two different time points and compared over time. Then the results from the two types of data were considered together in a so-called mixed methods approach. During the qualitative interviews, participants were asked about the young person's mental and physical health, as well as their therapy experiences. The interview data were analysed using an in-depth approach to the analysis. This article describes improvements in emotional and behavioural problems among the young participants, which align with the positive mental health outcomes observed in the trial's quantitative data. Participant quotes before and after the intervention reveal reduced anxiety and improved behaviour as the therapy gave the young people new tools and understanding. Parents of young people with intellectual disabilities also felt more confident in managing their children's fears. Aggressive behaviours and emotional outbursts decreased, and young people developed greater self-awareness and self-control. The qualitative findings provide context and insight into the therapeutic change observed in the MICE trial. Understanding the mechanisms of therapy is crucial. In summary, this study sheds light on how therapy positively impacts young people's mental health and behaviour, with benefits for both the young people and their families.

A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol.

INTRODUCTION: Co-morbid anxiety and depression (distress) in inflammatory bowel disease (IBD) results in poorer outcomes and increased healthcare burden. IBD services require scalable treatment pathways for distress to meet this need. This real-world longitudinal study evaluates the implementation of a new integrated care pathway for distress including: 1) routine mental health screening and 2) therapist-guided, digital CBT tailored to the challenges of living with IBD (compass with adaptations for IBD: COMPASS-IBD) in a UK National Health Service (NHS) large gastroenterology service (∼ 5000 patients). METHODS: We describe a mixed-methods, observational, real-world longitudinal study. Routine mental health screening in the IBD service will identify patients with distress (using pre-defined clinical cut-offs), who will be triaged to determine appropriate treatment pathways (including participation in the COMPASS-IBD study). Participants will receive COMPASS-IBD online for ∼12 weeks (including 6 × 30-min therapist sessions). Key implementation outcomes will assess reach and adoption of the new pathway using aggregate data on uptake of mental health screening, eligibility, and consent rates for COMPASS-IBD, and number of COMPASS-IBD sessions completed. Interviews with patients and healthcare providers will primarily assess acceptability of the new pathway. Potential effectiveness will be assessed using participant questionnaires at pre-intervention, 12-weeks (post-intervention), and 6-month follow-up. The primary effectiveness outcome will be pre-post changes in distress (PHQ-ADS scores). Quantitative data will be summarised using descriptive statistics and qualitative data analysed using reflexive thematic analysis. CONCLUSION: Study findings will inform treatment pathways for co-morbid distress in IBD, and highlight adaptations required to increase future scalability and effectiveness. TRIAL REGISTRATION NUMBER: NCT05330299 (clinicaltrials.gov).

Exploring Dietitians' Perspectives Toward Current Practices and Services in Relation to Irritable Bowel Syndrome Management in Clinical Settings Across the United Kingdom: A Qualitative Study.

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic and relapsing gastrointestinal condition that negatively impacts quality of life. Dietary triggers are common and dietary management is central to the IBS treatment pathway, and dietitians are the main education providers for patients. OBJECTIVE: The aim of this study was to explore dietitians' perspectives on current practices and services in relation to IBS management in clinical settings across the United Kingdom. DESIGN: Qualitative semi-structured interviews were undertaken from May to October 2021 via videoconferencing software. Eligible participants were dietitians specializing in gastroenterology and working in National Health Service (NHS) Trusts in the United Kingdom. Interviews were audio recorded and transcribed following intelligent transcription. Template analysis guided by naïve realism and its underlying epistemological assumptions was used. PARTICIPANTS/SETTING: Dietitians (N = 13) working in various NHS Trusts across the United Kingdom with at least 1 year of clinical experience in IBS management were included. QUALITATIVE DATA ANALYSIS: Template analysis, a form of thematic analysis with hierarchical coding, was used to explore dietitians' perspectives of IBS practices. RESULTS: Participating dietitians were mostly female (92.3%), of White race (84.6%), working in various NHS Trusts across the United Kingdom, and had more than 5 years of clinical experience (69.2%). The following 3 main themes emerged: 1) dietetics services as part of IBS referral pathways; 2) practices in relation to dietetics services; and 3) patients' expectations and feelings. Each main theme had subthemes to facilitate the description and interpretation of data. The increasing number of IBS referrals to dietitians and the need for accurate and timely IBS diagnosis and specialist dietitians were reported, along with the use of digital innovation to facilitate practice and access to dietetic care. The use of internet as a source of (mis)information by patients and the limited time available for educating patients were identified as potential barriers to dietetic practice. Dietitians follow a patient-centered approach to dietary counseling and recognize the negative implications of perceived IBS-related stigma by patients on their feelings and treatment expectations. CONCLUSIONS: The study identified areas and practices that can facilitate access to dietetic services and patient-centered care in IBS management, as outlined in UK-based guidelines.

Managing patients' reports of abdominal pain and irritable bowel syndrome-like symptoms during quiescent inflammatory bowel disease: a role for shared sensemaking.

Background: Patients with inflammatory bowel disease (IBD) are often faced with distressing and confusing abdominal pain during remission. Some people respond adversely to healthcare professionals' (HCPs) suggestions that this pain and related symptoms are due to secondary irritable bowel syndrome (IBS). Exploring how HCPs view, manage, and explain pain during quiescent disease may provide insights into how communication can be improved to increase understanding and mitigate negative responses. Methods: In-depth semi-structured interviews were conducted with 12 IBD-nurses (n = 4) and gastroenterologists (n = 8) working in the United Kingdom or the Netherlands. Reflexive thematic analysis was used to analyse interviews. Results: Findings suggest that HCPs pay relatively little attention to pain when there is no underlying pathology and prefer to concentrate on objectifiable causes of symptoms and treating disease activity (Theme 1: Focus on disease activity, not pain and associated symptoms). Explanations of abdominal pain and IBS-like symptoms during remission were not standardised (Theme 2: Idiosyncratic and uncertain explanations for pain during remission). Processes of shared decision-making were outlined and shared sensemaking was reported as a strategy to enhance acceptance of IBS explanations (Theme 3: Shared decision making versus shared sensemaking). Conclusion: Future work should focus on establishing how pain during remission may be best defined, when to diagnose IBS in the context of IBD, and how to explain both to patients. The formulation of standardised explanations is recommended as they might help HCPs to adopt practices of shared sensemaking and shared decision-making. Explanations should be adaptable to specific symptom presentations and different health literacy levels.

One or many labels? a longitudinal qualitative study of patients' journey to diagnosis at a specialist NHS Postural Tachycardia Syndrome (PoTS) clinic.

OBJECTIVES: Postural Tachycardia Syndrome (PoTS) is a poorly understood syndrome of multiple disabling symptoms. This study explored the process of seeking a diagnosis of PoTS. Analysis focused on changes before and after participants' first appointment with a national PoTS clinic, and explored whether a diagnosis is beneficial in the context of multiple co-occurring conditions and an absence of licenced treatments. DESIGN: A longitudinal, qualitative study. METHODS: Participants (n = 15) in this nested qualitative study were recruited from a larger study of people who had been newly referred to a National specialist NHS Cardiology PoTS service. Semi-structured interviews were conducted remotely before, and 6 months after their first appointment with the clinic. Data was analysed longitudinally and inductively using Reflexive Thematic Analysis. RESULTS: Three overarching themes were identified: "Slowly moving forward and finding positive gains", "Needing more pieces of the puzzle to see the bigger picture", and "The value and impact of investigations". Findings suggested that not much had changed in the 6 months between interviews. Participants were moving forward in terms of diagnoses, treatment and adjustment following their appointment, but many were still seeking further clarity and possible diagnoses. Investigations, appointments, and new-found problems, continued to have a substantial impact over time. CONCLUSIONS: The journey to diagnosis for patients with suspected PoTS appeared to promote acceptance of self, and of limitations posed by symptoms. However, many participants continued their search for an explanation for every symptom experience, and this may become increasingly complex, the more labels that have been acquired. Lack of clarity contributed to ongoing difficulties for this patient group alongside fraught relations with health care professionals (HCPs). A more coherent, integrated approach which is communicated clearly to patients is recommended.

Development and preliminary evaluation of a suicidal risk assessment protocol in a randomised controlled trial using the Patient Health Questionnaire (PHQ-9).

BACKGROUND: Participants in research trials often disclose severe depression symptoms, including thoughts of self-harm and suicidal ideation, in validated self-administered questionnaires such as the Patient Health Questionnaire (PHQ-9). However, there is no standard protocol for responding to such disclosure, and the opportunity to support people at risk is potentially missed. We developed and evaluated a risk assessment protocol for the IBD-BOOST randomised controlled trial (ISRCTN71618461 09/09/2019). METHODS: Participants completed the PHQ-9 at baseline and 6-month and 12-month follow-ups. The trial database automatically alerted the research team to risk assess participants. Trial researchers, trained in the protocol, contacted participants by telephone, completed the risk assessment, and signposted participants to appropriate professional services. RESULTS: Seven hundred eighty participants were randomised in the trial; 41 required risk assessment. One participant declined assessment, so 40 risk assessments were completed. Twenty-four participants were assessed as low-risk and 16 participants as medium-risk, with 12 declaring previous suicide attempts. None were rated as high-risk. Trial participants expressed appreciation for being contacted, and all except two wished to receive information about professional support services. Trial risk assessors reported positive experiences of conducting the risk assessment with suggestions for improvement, which resulted in minor modifications to the protocol. DISCUSSION: Our evaluation demonstrated that it was viable for a research trial team to successfully conduct a risk-assessment protocol for trial participants reporting thoughts of self-harm, with training and support from senior colleagues. Resources are required for training and delivery, but it is not unduly onerous. Trial participants appeared to find completing the assessment acceptable.

Management of refractory disease and persistent symptoms in inflammatory arthritis: qualitative framework analysis of interviews with patients and healthcare professionals.

Objectives: This study aims to explore patients' and clinicians' experiences in managing and living with refractory disease (RD) and persistent physical and emotional symptoms (PPES) in patients with RA or polyarticular JIA from their perspectives through interviews and/or focus groups. Methods: A qualitative exploration with 25 patients and 32 multidisciplinary rheumatology healthcare professionals (HCPs) was conducted to obtain participants respective understanding and experiences of managing RD/PPES and its impact on the patient-professional relationship. A pragmatic epistemology approach with framework analysis was employed. Results: Four key themes were identified from both patients and professionals in the management of RD/PPES: risk/perpetuating factors/triggers; need for a patient-centred holistic approach to care, diagnosis and treatment; discordance and impact on the patient-practitioner relationship and current problems in managing RD/PPES. These themes covered 22 subthemes, with none being patient specific and seven being HCP specific. Suggestions for potential management strategies were highlighted throughout, such as involving other specialties or a multidisciplinary team, assessing/treating patient-reported outcome measures and psychosocial factors, patient (re)education, need for adjustments/aids or adaptations, checking the diagnosis and further investigations/imaging and optimizing medications. Conclusion: Management strategies need to be developed that enable appropriate treatment plans for those with RD/PPES that account for wider biopsychosocial factors beyond inflammation and reduce discordance in the patient-practitioner relationship.

Training and supervision of physical health professionals to implement mental health care in paediatric epilepsy clinics.

BACKGROUND: Children and young people with epilepsy are more likely to experience multiple mental health problems than those without chronic physical health conditions, yet they often do not receive evidence-based (or indeed any) psychological interventions. Integrated healthcare is recommended as a solution to address these inequalities, but remains limited in the United Kingdom. This is partly due to the lack of training and availability of ongoing supervision for clinicians to ensure the safe and effective delivery of treatments. This study aimed to train and provide supervision for health professionals to deliver a modular cognitive-behavioural intervention for common mental health problems, optimised for use in paediatric epilepsy. Specifically, this study aimed to measure therapist competence and evaluate the acceptability of training and supervision. METHODS: Fifteen health professionals working in paediatric epilepsy services were trained over a six-month period. Training included face-to-face training workshops and completing at least one training case of a young person with epilepsy and anxiety, depression and/or behavioural problems under close clinical supervision. Throughout the training, health professionals were offered weekly one-hour supervisions with an experienced Clinical Psychologist. Clinical competence was assessed using a widely used measure of therapist competence in cognitive-behavioural therapy. Rates of attendance at supervision sessions and therapist ratings of satisfaction were recorded. RESULTS: At the end of the six-month training, 14 health professionals reached clinical competence in delivering the mental health intervention. One person left the service and therefore did not complete the training. Overall, health professionals were satisfied with the training and supervision. However, 14 % of supervision sessions were cancelled and a further 11 % were not attended. Supervision sessions were also often shorter than the standard hour used in mental health settings (M = 41.18 min, SD = 10.30). CONCLUSIONS: Our findings suggest that health professionals working in paediatric epilepsy services can be trained to deliver a psychological intervention with proficiency. However, the supervision model typically used in mental health may need adaptation to be sustainable in physical health settings. Future research is needed to evaluate the impact of training and supervision on patient outcomes and to ensure that ethical delivery of psychological interventions by health professionals without a mental health background.

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

BACKGROUND & AIMS: Some brain-gut behavioral treatments (BGBTs) are beneficial for global symptoms in irritable bowel syndrome (IBS). United States 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 December 16, 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 the P score. RESULTS: We identified 42 eligible randomized controlled trials comprising 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 was superior to another.

Gastrointestinal pain: A systematic review of temporal summation of pain paradigms and outcomes.

BACKGROUND AND OBJECTIVE: Since targeted treatment for gastrointestinal pain is elusive, identifying the mechanistic underpinning of this pain type is important. Facilitation of spinal neuronal responses underpins certain pain types, and the psychophysical temporal summation of pain (TSP) paradigm provides a proxy measure of spinal facilitatory processes. Our aim was to systematically review whether facilitated TSP is a feature of gastrointestinal pain in patients with, or pain-free people experiencing experimentally induced, gastrointestinal pain. DATABASES AND DATA TREATMENT: EMBASE, MEDLINE, PsychInfo, CINAHL, and Web of Science were systematically searched, from inception to July 2023, for human studies reporting TSP paradigm outcomes in the context of gastrointestinal pain. The Appraisal tool for Cross-Sectional studies was used for quality assessment and applied independently by two researchers. RESULTS: Fifteen papers consisting of cross-sectional (n = 6), case-control (n = 8), and retrospective cohort (n = 1) studies, were included. Thirteen studies investigated TSP in people with gastrointestinal pain with (n = 5) or without (n = 8) defined pathology. Two studies evoked TSP by repetitive gut stimulation in people undergoing abdominal medical procedures. Preliminary evidence showed that facilitated TSP correlated with the presence of functional gastrointestinal pain in women, and those with a history of trauma. No effect was observed in people with inflammatory bowel disease, although it was often unclear if they experienced pain. CONCLUSIONS: It is not possible to conclude whether facilitated TSP is a feature of gastrointestinal pain. We recommend that subgroup findings are corroborated and that TSP paradigms are standardized in order that direct comparisons between studies may be made. SIGNIFICANCE STATEMENT: Evidence indicated that pain facilitatory processes, as evidenced by a facilitated TSP outcome, contribute to functional gastrointestinal pain in women and those with a history of trauma. However, heterogeneity of study populations and paradigms precluded statistical synthesis and findings would need be corroborated. Studies exploring facilitatory processes in people with inflammatory bowel diseases did not report significant results, but pain is not a given in these conditions and, conversely, may be driven by peripheral inflammation during active disease. This should be taken in consideration in future explorations. REGISTRATION REVIEW: PROSPERO CRD42022341845.

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.

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.

'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.

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.