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.

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.

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.

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.

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.

An Evidence-Based Theory of Psychological Adjustment to Long-Term Physical Health Conditions: Applications in Clinical Practice.

OBJECTIVE: Around 30% of people with long-term physical health conditions (LTCs) experience comorbid anxiety and depression. For many, comorbid distress is linked to difficulties adjusting to the challenges of the LTC. The aims of this article are to present a transdiagnostic theoretical model of adjustment to LTCs (TMA-LTC), demonstrate the application of this model in clinical practice, and highlight the distinguishing features of treating LTC-related distress compared with treating primary anxiety and/or depression. METHODS: A systematic review (k = 21) was conducted to collate preexisting evidence-based models of adjustment across LTCs. Models of adjustment for a range of LTCs were extracted and synthesized into a new preliminary TMA-LTC. Two expert consensus meetings were held, where experts rated the relevance and importance of all concepts within the models. RESULTS: The TMA-LTC proposes that acute critical events or ongoing illness stressors can disrupt emotional equilibrium, and that whether a person returns to equilibrium and achieves good psychological adjustment depends on a number of cognitive and behavioral factors, as well as their interpersonal, intrapersonal, environmental, and illness-specific contexts. A case study is presented to demonstrate the clinical application of this model in treating illness-related distress, highlighting how it overcomes roadblocks that may be encountered when working primarily within traditional mental health paradigms. CONCLUSIONS: As an empirically and clinically informed model, TMA-LTC provides a useful guide for assessment, formulation, and treatment in the context of psychological adjustment to LTCs. Future studies are needed to test treatments that have been developed based on TMA-LTC.

The effectiveness of cognitive behavioural therapy and third-wave cognitive behavioural interventions on diabetes-related distress: A systematic review and meta-analysis.

AIM: Diabetes-related distress is common in diabetes and has implications for well-being. Cognitive behavioural therapy (CBT) and third-wave CBT hold promise as treatments for diabetes-related distress, although previous findings are inconclusive. We aimed to conduct a systematic review with meta-analysis to understand the efficacy of these interventions in treating diabetes-related distress, while also assessing the associative benefits of these interventions on depression, anxiety and glycaemic control. We also aimed to conduct a narrative synthesis, and subgroup analyses to identify intervention components most useful in treating diabetes-related distress. METHOD: We searched seven electronic databases from inception to April 2021. Data extraction was independently performed by two reviewers. Methodological quality was assessed. The protocol was registered with the Prospective Register Of Systematic Reviews (PROSPERO): CRD42021240628. RESULTS: We included 22 randomised controlled trials investigating the efficacy of CBT and third-wave CBT interventions on diabetes-related distress. CBT for diabetes-related distress significantly reduced distress (SMD = -0.278, p = 0.010) and depression (SMD = -0.604, p = 0.016). Third-wave CBT for diabetes-related distress significantly reduced anxiety (SMD = -0.451, p = 0.034). No significant effect of either intervention on glycated haemoglobin was observed. CBT interventions that included a digital component, were delivered by a psychological practitioner, and included behavioural activation bolstered the effects on diabetes-related distress. CONCLUSIONS: CBT aiming to target diabetes-related distress is beneficial for distress and depression. Third-wave CBT for diabetes-related distress is beneficial for anxiety. More work is needed to optimise interventions to improve both mental and physical health outcomes in people with diabetes.

An experimental study to identify key psychological mechanisms that promote and predict resilience in the aftermath of treatment for breast cancer.

OBJECTIVE: Women living with and beyond breast cancer (BC) frequently encounter cancer-related information in day-to-day life. The extent they are emotionally resilient to this information differs between women. Identifying key modifiable psychological mechanisms predicting resilience in these women could highlight targets for interventions to improve resilience in others. This study investigates resilience over time in women living beyond BC and how this relates to individual differences in the way the brain processes information. METHODS: Seventy women within a year of finishing first-line treatment for BC (clinical and community recruitment) completed computerised tasks to assess the tendency to attend to cancer information (dot-probe task), the tendency to draw negative cancer-related interpretations from ambiguous information (ambiguous scenarios task) and extent of executive functioning (attentional network task). Questionnaires were completed assessing resilience, and other clinically relevant psychological variables (fear of cancer recurrence, distress, quality of life, and worry) at the time of the laboratory tasks (T1) and again 6 months later (T2). RESULTS: The only cognitive process associated with self-reported resilience was interpretation bias. Generating more negative cancer-related interpretations of ambiguous information at T1 significantly predicted resilience at T2, whilst controlling for T1 resilience and other clinically relevant variables. Furthermore, resilience scores were relatively stable over time and moderately correlated with other clinically relevant variables. CONCLUSIONS: This study is the first to identify a key cognitive mechanism that predicts resilience in women living beyond BC. This finding suggests interventions to reduce cancer-related interpretations of ambiguous information could promote resilience in women living beyond BC.

Distinct Illness Representation Profiles Are Associated With Anxiety in Women Testing Positive for Human Papillomavirus.

BACKGROUND: Testing positive for human papillomavirus (HPV) at cervical cancer screening has been associated with heightened anxiety. To date, the cognitive determinants of heightened anxiety remain unclear, making it difficult to design effective interventions. PURPOSE: This study investigated latent illness representation profiles in women testing positive for HPV with no abnormal cells (normal cytology) and explored associations between these profiles and anxiety. METHODS: Women aged 24-66 (n = 646) who had tested HPV-positive with normal cytology at routine HPV primary screening in England completed a cross-sectional survey shortly after receiving their result. RESULTS: Latent profile analysis identified three distinct profiles of illness representations (termed "adaptive," "negative," and "negative somatic"), which differed significantly in their patterns of illness perceptions. Hierarchal linear regression revealed that these latent illness representation profiles accounted for 21.8% of the variance in anxiety, after adjusting for demographic and clinical characteristics. When compared with adaptive representations (Profile 1), women with negative representations (Profile 2) and negative somatic representations (Profile 3) had significantly higher anxiety, with clinically meaningful between-group differences (mean difference [MD] = 17.26, confidence interval [CI]: 14.29-20.22 and MD = 13.20, CI: 9.45-16.96 on the S-STAI-6, respectively). CONCLUSION: The latent illness representation profiles identified in this study provide support for the role of negative beliefs contributing to anxiety in women testing HPV-positive with normal cytology. Characteristics specific to subgroups of highly anxious women (Profiles 2 and 3) could be used by policymakers to target information in routine patient communications (e.g., test result letters) to reduce unnecessary burden. Future research should adopt longitudinal designs to understand the trajectory of illness representations from HPV diagnosis through to clearance versus persistence.

Disparities in access to mobile devices and e-health literacy among breast cancer survivors.

BACKGROUND: The number of e-health interventions developed for breast cancer survivors continues to increase. However, issues with engagement and retention are common. This study aimed to explore e-health literacy rates and access to smartphones and tablets in a large sample of breast cancer survivors. METHODS: In study 1, women were recruited from outpatient breast clinics across England and Wales. Eligible women were asked to complete a questionnaire pack to assess their access to devices and their e-health literacy. Multiple regression analyses were run to assess the relationship between technology access and e-health literacy with sociodemographic variables such as age, social deprivation, and education. Study 2 presents a smaller sample recruited through social media who answered a questionnaire relating to use of mobile devices and e-health, and apps. RESULTS: Two thousand nine women participated in the study. Seventy-one percent had access to a smartphone, 54% had access to a tablet, and 20% did not have access to either device. Multiple logistic regressions showed that women who were younger, had higher levels of education, and who were from less deprived areas were more likely to have access to either device. Poorer e-health literacy was associated with being older, having less education, and not having access to a mobile device. CONCLUSIONS: Whilst the results show relatively widespread access to mobile devices, there is evidence of a digital divide across some groups. Online interventions should be developed with consideration of individuals who are less e-health-literate and less technologically adept in order to increase the likelihood of engagement.

Developing an Online Program for Self-Management of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Patients' Needs and Wants.

BACKGROUND: Inflammatory bowel disease (IBD) is a lifelong relapsing-remitting condition, characterized by troublesome symptoms including fatigue, pain, and bowel urgency. These symptoms can persist even in clinical remission and have a debilitating impact on social, work-related and intimate domains of life. Symptom self-management can be challenging for some patients, who could potentially benefit from an online self-management tool. AIMS: We aimed to understand patients' symptom self-management strategies and preferred design for a future online symptom self-management intervention. METHODS: Using exploratory qualitative methods, we conducted focus group and individual interviews with 40 people with IBD recruited from UK clinics and from community-dwelling members of the Crohn's and Colitis UK charity; data were collected using a digital audio recorder, and transcribed and anonymized by a third party (professional) transcriber. We used framework analysis for focus group data and thematic analysis for interview data. RESULTS: The data provided three core themes: ways of coping; intervention functionality; and intervention content. Participants attempt to manage all three symptoms simultaneously, recognizing the combined influence of factors such as food, drink, stress, and exercise on all symptoms. They wanted an accessible online intervention functioning across several platforms, with symptom and medication management, and activity-tracking features. CONCLUSIONS: Patients reported numerous ways of self-managing symptoms of fatigue, pain, and urgency/incontinence related to IBD and expressed their needs for content, design, and functionality of the proposed intervention. Based on this and existing intervention development literature, the IBD-BOOST online self-management intervention has now been developed and is undergoing testing.

Atrial fibrillation, quality of life and distress: a cluster analysis of cognitive and behavioural responses.

PURPOSE: Few studies have examined specific cognitive and behavioural responses to symptoms, which may impact health-related outcomes, in conjunction with illness representations, as outlined by the Common-Sense-Model. Patients with atrial fibrillation (AF) report poor quality-of-life (QoL) and high distress. This cross-sectional study investigated patterns/clusters of cognitive and behavioural responses to illness, and illness perceptions, and relationships with QoL, depression and anxiety. METHODS: AF patients (N = 198) recruited at cardiology clinics completed the AF-Revised Illness Perception Questionnaire, Atrial-Fibrillation-Effect-on-Quality-of-Life Questionnaire, Patient Health Questionnaire-8 and Generalized Anxiety Disorder Questionnaire. Cluster analysis used Ward's and K-means methods. Hierarchical regressions examined relationships between clusters with QoL, depression and anxiety. RESULTS: Two clusters of cognitive and behavioural responses to symptoms were outlined; (1) 'high avoidance'; (2) 'low symptom-focussing'. Patients in Cluster 1 had lower QoL (M = 40.36, SD = 18.40), greater symptoms of depression (M = 7.20, SD = 5.71) and greater symptoms of anxiety (M = 5.70, SD = 5.90) compared to patients in Cluster 2 who had higher QoL (M = 59.03, SD = 20.12), fewer symptoms of depression (M = 3.53, SD = 3.56) and fewer symptoms of anxiety (M = 2.56, SD = 3.56). Two illness representation clusters were outlined; (1) 'high coherence and treatment control', (2) 'negative illness and emotional representations'. Patients in Cluster 2 had significantly lower QoL (M = 46.57, SD = 19.94), greater symptoms of depression (M = 6.12, SD = 5.31) and greater symptoms of anxiety (M = 4.70, SD = 5.27), compared with patients in Cluster 1 who had higher QoL (M = 61.52, SD = 21.38), fewer symptoms of depression (M = 2.85, SD = 2.97) and fewer symptoms of anxiety (M = 2.16, SD = 3.63). Overall, clusters of cognitive and behavioural responses to symptoms, and illness perceptions significantly explained between 14 and 29% of the variance in QoL, depression and anxiety. CONCLUSION: Patterns of cognitive and behavioural responses to symptoms, and illness perceptions are important correlates of health-related outcomes in AF patients.

Adherence to adjuvant endocrine therapy among White British and ethnic minority breast cancer survivors in the United Kingdom.

OBJECTIVE: Around half of women do not take adjuvant endocrine therapy (AET) as prescribed. Research suggests that adherence rates vary across ethnic groups. This study compared AET adherences rates in White British women and women from minority ethnic groups in the United Kingdom. METHODS: This is an observational study with 2001 breast cancer survivors recruited from outpatient clinics. Eligible women were diagnosed with primary breast cancer and prescribed AET within the last 3 years. Adherence was measured using the Medication Adherence Rating Scale. Eligible women were asked to complete a questionnaire pack that collected sociodemographic data such as age, relationship status and ethnicity. Independent samples t tests and χ2 tests were used to compare White British women and women from minority ethnic groups on self-reported adherence to AET. RESULTS: Of White British women, 27.8% were classed as non-adherent, compared to 44.4% of women from minority ethnic groups. A logistic regression controlling for relevant demographics indicated that women from minority ethnic groups had a significantly higher risk of non-adherence than women who were White British (odds ratio = 1.50, p = 0.03) CONCLUSION: Rates of non-adherence to AET are higher in women from minority ethnic groups, which may contribute towards racial disparities in breast cancer outcomes. Research with larger and more diverse samples is needed to explore this further and to investigate the psychosocial factors driving differences in adherence.

Clinician and patient experiences when providing and receiving information and support for managing chemotherapy-induced peripheral neuropathy: A qualitative multiple methods study.

OBJECTIVE: To improve patient experience of chemotherapy-induced peripheral neuropathy (CIPN), it is crucial to identify how patients develop their understanding and perception of CIPN. A wider understanding of the experiences of clinicians who provide CIPN information and support is also needed. This study explored clinician and patient experience of the provision of care, information and support for CIPN. METHODS: Data were collected between July and November 2019 using multiple qualitative methods. Non-participant observations were undertaken in colorectal and breast cancer clinics and at clinician stations, including the observation of chemotherapy consultations between patients and clinicians. Semi-structured interviews with people with cancer and clinicians were also conducted. Data were analysed using inductive reflexive thematic analysis. RESULTS: Three major themes emerged: (1) CIPN is a hidden chemotherapy side effect, (2) assessment and management of CIPN is disconnected and (3) patients and clinicians expect openness in CIPN symptom reporting, information provision and management. CONCLUSION: Findings show the need to address the lack of patients' overall familiarity with CIPN. Echoing earlier studies, our findings suggest that knowledge and understanding about CIPN among clinicians are limited or lacking. These insights from patient and clinicians' CIPN experiences can inform future interventions that may address the genuine needs of patients and enhance CIPN support.

Co-designing a behavioural intervention for reducing the impact of chemotherapy-induced peripheral neuropathy symptoms: An evidence- and theory-driven approach.

OBJECTIVE: This study aims to co-design an evidence- and theory-based behavioural intervention to reduce the impact of chemotherapy-induced peripheral neuropathy (CIPN) symptoms on patients' quality of life. METHODS: Guided by the Medical Research Council Framework for developing and evaluating complex interventions, our intervention development process was guided by (a) findings of systematic reviews, (b) inductive analysis of 39 h of observational fieldwork, 12 patient and 11 clinician interviews, (c) deductive analysis using the Common-Sense Model to develop a Self-Regulation Model of CIPN and (d) 17 patients and 18 clinicians co-designing the intervention. RESULTS: CIPN perception and coping behaviours were highlighted as processes to target when co-designing an intervention. The processes targeted in our intervention are CIPN perception and coping behaviours, namely, (a) self-monitoring of symptoms, (b) communicating and early reporting of symptoms to clinicians, (c) participating in making chemotherapy dose reduction decisions with their clinicians and (d) engaging in self-management and safety strategies to reduce impact of CIPN symptoms. To address these, a behavioural intervention was deemed suitable. CONCLUSION: We developed a self-regulation model of CIPN and a logic model for documenting the proposed mechanism of action of our co-designed behavioural intervention for reducing impact of CIPN symptoms.

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome.

Irritable bowel syndrome (IBS) remains one of the most common gastrointestinal disorders seen by clinicians in both primary and secondary care. Since publication of the last British Society of Gastroenterology (BSG) guideline in 2007, substantial advances have been made in understanding its complex pathophysiology, resulting in its re-classification as a disorder of gut-brain interaction, rather than a functional gastrointestinal disorder. Moreover, there has been a considerable amount of new evidence published concerning the diagnosis, investigation and management of IBS. The primary aim of this guideline, commissioned by the BSG, is to review and summarise the current evidence to inform and guide clinical practice, by providing a practical framework for evidence-based management of patients. One of the strengths of this guideline is that the recommendations for treatment are based on evidence derived from a comprehensive search of the medical literature, which was used to inform an update of a series of trial-based and network meta-analyses assessing the efficacy of dietary, pharmacological and psychological therapies in treating IBS. Specific recommendations have been made according to the Grading of Recommendations Assessment, Development and Evaluation system, summarising both the strength of the recommendations and the overall quality of evidence. Finally, this guideline identifies novel treatments that are in development, as well as highlighting areas of unmet need for future research.

Which exercise and behavioural interventions show most promise for treating fatigue in multiple sclerosis? A network meta-analysis.

BACKGROUND: Fatigue is a common, debilitating symptom of multiple sclerosis (MS) without a current standardised treatment. OBJECTIVE: The aim of this systematic review with network meta-analyses was to estimate the relative effectiveness of both fatigue-targeted and non-targeted exercise, behavioural and combined (behavioural and exercise) interventions. METHODS: Nine electronic databases up to August 2018 were searched, and 113 trials (n = 6909) were included: 34 were fatigue-targeted and 79 non-fatigue-targeted trials. Intervention characteristics were extracted using the Template for Intervention Description and Replication guidelines. Certainty of evidence was assessed using GRADE. RESULTS: Pairwise meta-analyses showed that exercise interventions demonstrated moderate to large effects across subtypes regardless of treatment target, with the largest effect for balance exercise (SMD = 0.84). Cognitive behavioural therapies (CBTs) showed moderate to large effects (SMD = 0.60), with fatigue-targeted treatments showing larger effects than those targeting distress. Network meta-analysis showed that balance exercise performed significantly better compared to other exercise and behavioural intervention subtypes, except CBT. CBT was estimated to be superior to energy conservation and other behavioural interventions. Combined exercise also had a moderate to large effect. CONCLUSION: Treatment recommendations for balance and combined exercise are tentative as the certainty of the evidence was moderate. The certainty of the evidence for CBT was high.

Cost effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome: the ACTIB randomised trial.

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).

"A greatest hits compilation of mental health support": A qualitative study of health professionals' perceptions of modular CBT in pediatric epilepsy services.

OBJECTIVES: The primary aim of this qualitative study was to explore the views of health professionals, with little previous clinical mental health training, of an adapted modular cognitive-behavioral intervention (MATCH-ADTC) for common mental health problems in children and young people with epilepsy. METHODS: Healthcare Professionals (HCPs) and their supervisors were interviewed at the start (n = 23) and end (n = 15) of the six-month training period. The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: Three higher order themes with sub-themes were identified: (1) strengths of the MATCH-ADTC content and manual; (2) expectations of the treatment; and (3) improving practice with MATCH-ADTC. Overall impressions of the training and treatment were largely positive, with HCPs viewing MATCH-ADTC as an acceptable treatment for the families that they worked with. HCPs highlighted some challenges in delivering an integrated service, particularly relating to the time commitment involved and their own confidence in delivering the intervention, as many participants did not have a mental health background. CONCLUSIONS: The findings suggested that the intervention and training was acceptable to HCPs working in pediatric epilepsy services, and confidence grew over the six-month training period. Further research is needed to understand how to best train, supervise, and support HCPs in pediatric epilepsy services to deliver mental health treatments.

Feasibility of telephone-delivered therapy for common mental health difficulties embedded in pediatric epilepsy clinics.

BACKGROUND: Mental and physical health treatment should be delivered together for children and young people with epilepsy. Training healthcare professionals (HCPs) in epilepsy services to deliver mental health interventions is an important way to facilitate integrated care. OBJECTIVE: To determine the feasibility of remotely delivered assessment and psychological treatment for mental health difficulties delivered by HCPs in pediatric epilepsy clinics with limited formal training in psychological interventions. We hypothesized that it would be (i) feasible to train HCPs to deliver the psychological intervention and (ii) that participants receiving the psychological therapy would report reductions in symptoms of mental health difficulties including anxiety, depression, and behavior difficulties and improve quality of life. METHODS: Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma) were allocated to receive 6 months of a modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience. Thirteen HCPs were trained in delivery of the intervention. Healthcare professional competence was assessed in a two-stage process. Parent-reported measures of mental health symptoms and quality of life were completed at baseline and following the intervention. Paired t-tests were used to analyze changes in symptoms over time. RESULTS: All thirteen HCPs who participated in the training were considered competent in therapeutic delivery by the end of the training period. Twenty-three patients completed pre- and post-intervention measures and were included in the analysis. There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57). CONCLUSION: A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy. Health-related Quality of Life also improved over the duration of treatment. A randomized controlled trial (RCT) is needed to demonstrate efficacy of the intervention.