Cardiac rehabilitation for children and young people (CardioActive): protocol for a single-blind randomised feasibility and acceptability study of a centre-based cardiac rehabilitation programme versus usual care in 11-16 years with heart conditions.

BACKGROUND: Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million CYP globally. While survival rates are increasing, support for young people adjusting to life with a heart condition is lacking. Furthermore, one in three CYP with heart conditions also experiences anxiety, depression or adjustment disorder, for which little support is offered. While adults are offered cardiac rehabilitation (CR) to support their mental and physical health, this is not offered for CYP.One way to overcome this is to evaluate a CR programme comprising exercise with mental health support (CardioActive; CA) for CYP with heart conditions. The exercise and mental health components are informed by the metacognitive model, which has been shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR. METHOD AND ANALYSIS: The study is a single-blind parallel randomised feasibility trial comparing a CR programme (CA) plus usual care against usual care alone with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition. CA will include six group exercise, lifestyle and mental health modules. Usual care consists of routine outpatient management. Participants will be assessed at three time points: baseline, 3-month (post-treatment) and 6-month follow-up. Primary outcomes are feasibility and acceptability (ie, referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow-up data). Coprimary symptom outcomes (Strength and Difficulties Questionnaire and Paediatric Quality of Life) and a range of secondary outcomes will be administered at each time point. A nested qualitative study will investigate CYP, parents and healthcare staff views of CR and its components, and staff's experience of delivering CA. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Descriptive data on study processes and clinical outcomes will be reported. Data analysis will follow intention to treat. Qualitative data will be analysed using thematic analysis and the theoretical framework of acceptability. ETHICS AND DISSEMINATION: Ethical approval was granted on 14 February 2023 by the Greater Manchester East Research Ethics Committee (22/NW/0367). The results will be disseminated through peer-reviewed journals, conference presentations and local dissemination. TRIAL REGISTRATION NUMBER: ISRCTN50031147; NCT05968521.

Prevalence of post-traumatic stress and tests of metacognition as a PTSD risk marker in patients with coronary heart disease and elevated HADS scores: analysis of data from the PATHWAY RCT's in UK cardiac rehabilitation.

Introduction: Anxiety and depression in coronary heart disease (CHD) are associated with poorer health outcomes, greater healthcare use and reduced quality of life. Post-traumatic stress symptoms may be a particular concern as they are associated with increased mortality at follow-up. We examined prevalence of PTSD in patients with elevated anxiety/depression scores referred for cardiac rehabilitation (CR) across seven NHS sites in North-West England. We tested a possible mechanism (metacognition) linking CHD to PTSD symptom severity as implicated in the metacognitive model. Methods: Data was collected at baseline as part of the NIHR funded PATHWAY trial of metacognitive therapy for anxiety and depression in CHD. Patients (n = 572) with at least mild symptoms of anxiety and depression under routine screening (assessed with the Hospital Anxiety and Depression Scale) and attending CR were eligible for the study. A battery of questionnaires, including assessment of demographic variables, PTSD symptoms (using the IES-R) and metacognitive beliefs was administered prior to random allocation and intervention delivery. Results: Rates of PTSD were high, with 48% of patients meeting threshold for PTSD and a further 15% partial PTSD. All five metacognition subscales were positively associated with PTSD vs. no PTSD, with beliefs about the uncontrollability and danger of worry and beliefs about need to control thoughts being most strongly related. For every unit increase in uncontrollability and danger metacognitions the odds of being in the PTSD group increased 30%, whilst the odds of partial PTSD increased 16%. Stepwise regression analysis using the metacognitive subscales along with demographic and health-related covariates found that uncontrollability/danger and need for control metacognitions explained unique variation in PTSD symptom severity, with unique contributions also for age, sex, and number of comorbidities. Conclusion: PTSD symptoms appeared highly prevalent in the current CR sample. Metacognitive beliefs were individually associated with symptom severity with the strongest positive relationship observed for beliefs about uncontrollability and dangerousness of worry, followed by need to control thoughts. The results highlight the importance in assessing PTSD in CR patients and add support to implementing metacognitive therapy in CHD to target particular metacognition risk factors in anxiety, depression and PTSD.

Effectiveness of physical and mental health interventions for young people with heart conditions: protocol for a systematic review and meta-analysis.

INTRODUCTION: Cardiovascular disease is among the most common of non-communicable diseases, affecting 13.9 million children and young people (CYP) globally. Survival rates for CYP with heart conditions are rising, however, support for adjusting to life with a heart condition is lacking, as such it is unsurprising that one in three suffer from anxiety, depression or adjustment disorder. The proposed review aims to identify and assess the effectiveness of physical and mental health interventions across physical and mental health outcomes in young people with cardiac conditions using narrative synthesis and meta-analysis if appropriate. METHODS AND ANALYSIS: Embase, Medline, PubMed, PsycINFO, Cochrane Databases, Web of Science and reference lists of relevant publications will be searched from 1980 to June 2022 for articles published in English or Italian. Screening, data extraction, intervention coding and risk of bias will be performed by two independent reviewers using an extraction checklist. Intervention content and features will be identified and reported using the Template for Intervention Description and Replication checklist. A narrative review of the included studies will be conducted. If possible and appropriate, a random-effects model meta-analysis will be conducted to calculate the pooled within-group and between-group effect sizes for the primary outcome measures. If sufficient data are available, a subgroup meta-analysis will investigate whether specific intervention types are associated with different levels of intervention effectiveness. ETHICS AND DISSEMINATION: This systematic review does not directly involve the use of human beings, therefore, there is no requirement for ethical approval. Findings will be disseminated through peer-reviewed publication and in various media, such as conferences, congresses or symposia. PROSPERO REGISTRATION NUMBER: CRD42022330582.

Cost-effectiveness of home-based cardiac rehabilitation: a systematic review.

OBJECTIVE: Centre-based cardiac rehabilitation (CR) is recognised as cost-effective for individuals following a cardiac event. However, home-based alternatives are becoming increasingly popular, especially since COVID-19, which necessitated alternative modes of care delivery. This review aimed to assess whether home-based CR interventions are cost-effective (vs centre-based CR). METHODS: Using the MEDLINE, Embase and PsycINFO databases, literature searches were conducted in October 2021 to identify full economic evaluations (synthesising costs and effects). Studies were included if they focused on home-based elements of a CR programme or full home-based programmes. Data extraction and critical appraisal were completed using the NHS EED handbook, Consolidated Health Economic Evaluation Reporting Standards and Drummond checklists and were summarised narratively. The protocol was registered on the PROSPERO database (CRD42021286252). RESULTS: Nine studies were included in the review. Interventions were heterogeneous in terms of delivery, components of care and duration. Most studies were economic evaluations within clinical trials (8/9). All studies reported quality-adjusted life years, with the EQ-5D as the most common measure of health status (6/9 studies). Most studies (7/9 studies) concluded that home-based CR (added to or replacing centre-based CR) was cost-effective compared with centre-based options. CONCLUSIONS: Evidence suggests that home-based CR options are cost-effective. The limited size of the evidence base and heterogeneity in methods limits external validity. There were further limitations to the evidence base (eg, limited sample sizes) that increase uncertainty. Future research is needed to cover a greater range of home-based designs, including home-based options for psychological care, with greater sample sizes and the potential to acknowledge patient heterogeneity.

A framework for implementing Patient and Public Involvement in mental health research: The PATHWAY research programme benchmarked against NIHR standards.

BACKGROUND: Patient and Public Involvement (PPI) in research has become a key component recommended by research commissioners, grant award bodies and specified in government policies. Despite the increased call for PPI, few studies have demonstrated how to implement PPI within large-scale research studies. OBJECTIVE: The aim of the current study was to provide a case example of the implementation of a patient advisory group in a large-scale mental health research programme (PATHWAY) and to benchmark this against UK standards. METHOD: A PPI group was incorporated throughout the PATHWAY research programme, from grant development to dissemination. The group attended regular meetings and supported participant recruitment, evaluated patient-facing documents, supported the piloting of the research intervention and co-developed the dissemination and impact strategy. The implementation of PPI throughout the project was benchmarked against the UK standards for PPI. RESULTS: The inclusion of PPI in the PATHWAY project provided tangible changes to the research project (i.e., improving study documents, co-developing dissemination materials) but also proved to be a beneficial experience to PPI members through the development of new skills and the opportunity to provide a patient voice in research. We show how PPI was involved across seven study phases and provide examples of implementation of the six UK standards. The study did not include PPI in data analysis but met all the UK standards for PPI. Challenges regarding practical components (i.e., meeting frequency, language use), increasing diversity and PPI members' knowledge of research were highlighted as areas for further improvement. CONCLUSIONS: We provide a case example of how PPI can be implemented throughout a research lifecycle and we note the barriers faced and make suggestions for PPI in future implementation and research. PATIENT AND PUBLIC CONTRIBUTION: PPI members were involved throughout the lifecycle of the research programme. The PPI lead was a co-author on the manuscript and contributed to report writing.

Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.

BACKGROUND: Anxiety and depression in cardiac rehabilitation (CR) are associated with greater morbidity, mortality, and increased healthcare costs. Current psychological interventions within CR have small effects based on low-quality studies of clinic-based interventions with limited access to home-based psychological support. We tested the effectiveness of adding self-help metacognitive therapy (Home-MCT) to CR in reducing anxiety and depression in a randomised controlled trial (RCT). METHODS AND FINDINGS: We ran a single-blind, multi-centre, two-arm RCT. A total of 240 CR patients were recruited from 5 NHS-Trusts across North West England between April 20, 2017 and April 6, 2020. Patients were randomly allocated to Home-MCT+CR (n = 118, 49.2%) or usual CR alone (n = 122, 50.8%). Randomisation was 1:1 via randomised blocks within hospital site, balancing arms on sex and baseline Hospital Anxiety and Depression Scale (HADS) scores. The primary outcome was the HADS total score at posttreatment (4-month follow-up). Follow-up data collection occurred between August 7, 2017 and July 20, 2020. Analysis was by intention to treat. The 4-month outcome favoured the MCT intervention group demonstrating significantly lower end of treatment scores (HADS total: adjusted mean difference = -2.64 [-4.49 to -0.78], p = 0.005, standardised mean difference (SMD) = 0.38). Sensitivity analysis using multiple imputation (MI) of missing values supported these findings. Most secondary outcomes also favoured Home-MCT+CR, especially in reduction of post-traumatic stress symptoms (SMD = 0.51). There were 23 participants (19%) lost to follow-up in Home-MCT+CR and 4 participants (3%) lost to follow-up in CR alone. No serious adverse events were reported. The main limitation is the absence of longer term (e.g., 12-month) follow-up data. CONCLUSION: Self-help home-based MCT was effective in reducing total anxiety/depression in patients undergoing CR. Improvement occurred across most psychological measures. Home-MCT was a promising addition to cardiac rehabilitation and may offer improved access to effective psychological treatment in cardiovascular disease (CVD) patients. TRIAL REGISTRATION: NCT03999359.

Improving access to psychological therapies: Analysis of effects associated with remote provision during COVID-19.

BACKGROUND: COVID-19 had an immediate impact on the way Improving Access to Psychological Therapy (IAPT) services in the United Kingdom were delivered, requiring services to move to remote therapy. While remote therapy has been shown to be effective, little is known about the effects associated with moving to remote therapy delivered during COVID-19 within IAPT services. OBJECTIVE: The objective of the study was to assess the characteristics of those undergoing remote therapy and test the effects associated with the effect of remote delivery on anxiety and depression symptoms compared with in-person therapy before lockdown. METHODS: We conducted a retrospective, cross-sectional benchmark comparison of remote therapy across four IAPT services in Greater Manchester. Routinely collected measures of anxiety (GAD-7) and depression (PHQ-9) were used to compare effects across the two time periods. A mixed-effects model was conducted to assess within and between group changes in anxiety and depression, while controlling for pre-specified confounders. FINDINGS: Remote therapy did not appear to impact on service provision, with the number of sessions offered and attended being similar to those prior to COVID-19. Both face-to-face (pre-COVID-19) and remote therapy (during COVID-19) were associated with variable improvements in anxiety and depression with no significant difference between them. However, remote therapy was associated with a more rapid decrease in symptoms in comparison with face-to-face treatment. Mean improvement in symptoms was small and increased as number of sessions/time increased and analysis of rates of improvement indicated that both face-to-face and remote therapy might need more time to reach target cut-off points on measures. CONCLUSIONS: Both face-to-face and remote therapies delivered under IAPT were associated with improvements in symptoms with no apparent difference apart from the finding that remote therapy was associated with more rapid change. CLINICAL IMPLICATIONS: Remote therapy delivery in IAPT does not appear to confer a disadvantage over face-to-face contact, but at a group mean level the magnitude of improvement associated with both treatments was small. Remote therapy provision may widen patient access to and engagement with psychological services.

Discrete choice experiment to investigate preferences for psychological intervention in cardiac rehabilitation.

OBJECTIVE: Cardiac rehabilitation (CR) is offered to people who recently experienced a cardiac event, and often comprises of exercise, education and psychological care. This stated preference study aimed to investigate preferences for attributes of a psychological therapy intervention in CR. METHODS: A discrete choice experiment (DCE) was conducted and recruited a general population sample and a trial sample. DCE attributes included the modality (group or individual), healthcare professional providing care, information provided prior to therapy, location and the cost to the National Health Service (NHS). Participants were asked to choose between two hypothetical designs of therapy, with a separate opt-out included. A mixed logit model was used to analyse preferences. Cost to the NHS was used to estimate willingness to pay (WTP) for aspects of the intervention design. RESULTS: Three hundred and four participants completed the DCE (general public sample (n=262, mean age 47, 48% female) and trial sample (n=42, mean age 66, 45% female)). A preference for receiving psychological therapy was demonstrated by both samples (general population WTP £1081; 95% CI £957 to £1206). The general population appeared to favour individual therapy (WTP £213; 95% CI £160 to £266), delivered by a CR professional (WTP £48; 9% % CI £4 to £93) and with a lower cost (ß=-0.002; p<0.001). Participants preferred to avoid options where no information was received prior to starting therapy (WTP -£106; 95% CI -£153 to -£59). Results for the location attribute were variable and challenging to interpret. CONCLUSIONS: The study demonstrates a preference for psychological therapy as part of a programme of CR, as participants were more likely to opt-in to therapy. Results indicate that some aspects of the delivery which may be important to participants can be tailored to design a psychological therapy. Preference heterogeneity is an issue which may prevent a 'one-size-fits-all' approach to psychological therapy in CR.

Youth Metacognitive Therapy (YoMeta): protocol for a single-blind randomised feasibility trial of a transdiagnostic intervention versus treatment as usual in 11-16-year-olds with common mental health problems.

BACKGROUND: Mental health disorders in children and young people (CYP) are increasing but the provision of current evidence-based treatment for common mental health problems is limited. Treatment effects vary widely with no clear superiority of a single treatment approach. Further evaluation of contemporary and effective treatments in CYP is needed. Metacognitive therapy (MCT) has shown enhanced efficacy over 'gold standard' approaches in adult mental health, but so far has not been evaluated in a randomised trial of CYP. As such, we aim to assess the acceptability and feasibility of group-MCT for CYP with common mental health problems in comparison to usual treatment within Child and Adolescent Mental Health Services (CAMHS). METHOD: YoMeta is a multicentre, two-arm, single-blind randomised feasibility trial comparing group-MCT to usual care in CYP with common mental health problems in CAMHS. CYP (target sample n = 100) with a common mental health problem will be recruited across at least three CAMHS services in the UK. Participants in the intervention arm will receive up to eight sessions of group-MCT delivered by a CAMHS mental health practitioner. The control arm will receive usual care in CAMHS which includes individual or group-based therapy. Feasibility will be assessed by the success of recruitment, retention, and data quality. Acceptability of the intervention will be assessed by the number of sessions attended and through qualitative interviews aimed at exploring CYP acceptability and understanding of the intervention. Symptoms of psychological distress will be assessed using the Revised Children Anxiety and Depression Scale (RCADS) at 20 weeks. We will also assess psychological well-being, symptoms of depression, metacognitive beliefs, quality of life, and measures to support economic evaluation (health status and health and social care use). Qualitative interviews will be conducted to understand practitioner's views on training and delivery of group-MCT. DISCUSSION: The trial is designed to evaluate the acceptability and feasibility of group-MCT for CYP with common mental health problems. Group-MCT may aid in improving access to treatment, reduce waiting times, and improve outcomes for CYP with common mental health disorders. The study will provide important information and data to evaluate future research potential and confirm sample size estimation for a definitive large-scale RCT to test the effectiveness and cost-effectiveness of group-MCT in CYP. TRIAL REGISTRATION: NCT05260060; ISCTRN18335255.

Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme.

Background: Anxiety and depression contribute to poorer physical and mental health outcomes in cardiac patients. Psychological treatments are not routinely offered in cardiac care and have mixed and small effects. We conducted a series of studies under the PATHWAY research programme aimed at understanding and improving mental health outcomes for patients undergoing cardiac rehabilitation (CR) through provision of metacognitive therapy (MCT). Methods: PATHWAY was a series of feasibility trials, single-blind, multicenter, randomized controlled trials (RCTs), qualitative, stated preferences for therapy and health economics studies. Findings: Patients felt their psychological needs were not met in CR and their narratives of distress could be parsimoniously explained by the metacognitive model. Patients reported they would prefer therapy over no therapy as part of CR, which included delivery by a cardiac professional. Two feasibility studies demonstrated that RCTs of group-based and self-help MCT were acceptable, could be embedded in CR services, and that RCTs of these interventions were feasible. A definitive RCT of group-MCT within CR (n = 332) demonstrated significantly greater reductions in the severity of anxiety and depression, exceeding CR alone, with gains maintained at 12 month follow-up (SMD HADS total score = 0.52 at 4 months and 0.33 at 12 months). A definitive trial of self-help MCT is ongoing. Conclusion: There is a need to better meet the psychological needs of CR patients. Embedding MCT into CR demonstrated high acceptability and improved efficacy on psychological outcomes. Results support roll-out of MCT in CR with evaluation of national implementation. Registration: URL: NCT02420431; ISRCTN74643496; NCT03129282.

Metacognitive therapy self-help for anxiety-depression: Single-blind randomized feasibility trial in cardiovascular disease.

BACKGROUND: One in three cardiovascular disease (CVD) patients experience significant anxiety and depression. Current psychological interventions have limited efficacy in reducing such symptoms and are offered as a face-to-face intervention that may be a barrier to accessing treatment. We evaluated the feasibility and acceptability of delivering assisted home-based self-help metacognitive therapy (home-MCT) to cardiac rehabilitation (CR) patients experiencing anxiety and depression. METHOD: One hundred eight CR patients with elevated anxiety and/or depression were recruited to a single-blind randomized feasibility trial across two United Kingdom National Health Service Trusts and were randomized to usual CR or usual CR plus home-MCT. The feasibility and acceptability of adding home-MCT to CR was based on credibility or expectancy ratings, recruitment rate, drop-outs, number of CR and home-MCT modules completed, and ability of outcome measures to discriminate between patients. The study was used to refine the sample size estimate for a full-scale trial. The quality of telephone support calls delivered by CR staff trained in MCT was assessed. RESULTS: Home-MCT was found to be feasible and acceptable for the current CR patients with anxiety and depression. Recruitment and retention of participants was high, and attendance at CR was similar for both groups. Completion of home-MCT was high, but the quality of telephone support calls delivered was lower than expected. CONCLUSIONS: Home-MCT was acceptable and feasible to deliver to CR patients experiencing anxiety and depression, and the feasibility of conducting a full-scale trial of the intervention was established. Home-MCT may provide additional treatment options for cardiac patients experiencing psychological distress. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Delivery preferences for psychological intervention in cardiac rehabilitation: a pilot discrete choice experiment.

BACKGROUND: Cardiac rehabilitation (CR) is a programme of care offered to people who recently experienced a cardiac event. There is a growing focus on home-based formats of CR and a lack of evidence on preferences for psychological care in CR. This pilot study aimed to investigate preferences for delivery attributes of a psychological therapy intervention in CR patients with symptoms of anxiety and/or depression. METHODS: A discrete choice experiment (DCE) was conducted and recruited participants from a feasibility trial. Participants were asked to choose between two hypothetical interventions, described using five attributes; intervention type (home or centre-based), information provided, therapy manual format, cost to the National Health Service (NHS) and waiting time. A separate opt-out was included. A conditional logit using maximum likelihood estimation was used to analyse preferences. The NHS cost was used to estimate willingness to pay for aspects of the intervention delivery. RESULTS: 35 responses were received (39% response rate). Results indicated that participants would prefer to receive any form of therapy compared with no therapy. Statistically significant results were limited, but included participants being keen to avoid not receiving information prior to therapy (ß=-0.270; p=0.03) and preferring a lower cost to the NHS (ß=-0.001; p=0.00). No significant results were identified for the type of psychological intervention, format of therapy/exercises and programme start time. Coefficients indicated preferences were stronger for home-based therapy compared with centre-based, but this was not significant. CONCLUSIONS: The pilot study demonstrates the feasibility of a DCE in this group, it identifies potential attributes and levels, and estimates the sample sizes needed for a full study. Preliminary evidence indicated that sampled participants tended to prefer home-based psychological therapy in CR and wanted to receive information before initiating therapy. Results are limited due to the pilot design and further research is needed.

Cardiac rehabilitation patients experiences and understanding of group metacognitive therapy: a qualitative study.

OBJECTIVE: Depression and anxiety are up to three times more prevalent in cardiac patients than the general population and are linked to increased risks of future cardiac events and mortality. Psychological interventions for cardiac patients vary in content and are often associated with weak outcomes. A recent treatment, metacognitive therapy (MCT) has been shown to be highly effective at treating psychological distress in mental health settings. This is the first study to explore qualitatively, cardiac rehabilitation (CR) patients' experiences and understanding of group MCT with the aim of examining aspects of treatment that patients experienced as helpful. METHODS: In-depth qualitative interviews were conducted with 24 purposively sampled CR patients following group MCT. Data were analysed using thematic analysis. RESULTS: Two main themes were identified: (1) general therapy factors that were seen largely as beneficial, where patients highlighted interaction with other CR patients and CR staff delivery of treatment and their knowledge of cardiology; (2) group MCT-specific factors that were seen as beneficial encompassed patients' understanding of the intervention and use of particular group MCT techniques. Most patients viewed MCT in a manner consistent with the metacognitive model. All the patients who completed group MCT were positive about it and described self-perceived changes in their thinking and well-being. A minority of patients gave specific reasons for not finding the treatment helpful. CONCLUSION: CR patients with anxiety and depression symptoms valued specific group MCT techniques, the opportunity to learn about other patients, and the knowledge of CR staff. The data supports the transferability of treatment to a CR context and advantages that this might bring.

Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in Cardiac Rehabilitation: PATHWAY-A Single-Blind, Parallel, Randomized, Controlled Trial of Group Metacognitive Therapy.

BACKGROUND: Depression and anxiety in cardiovascular disease are significant, contributing to poor prognosis. Unfortunately, current psychological treatments offer mixed, usually small improvements in these symptoms. The present trial tested for the first time the effects of group metacognitive therapy (MCT; 6 sessions) on anxiety and depressive symptoms when delivered alongside cardiac rehabilitation (CR). METHODS: A total of 332 CR patients recruited from 5 National Health Service Trusts across the North-West of England were randomly allocated to MCT+CR (n=163, 49.1%) or usual CR alone (n=169, 50.9%). Randomization was 1:1 via minimization balancing arms on sex and Hospital Anxiety and Depression Scale scores within hospital site. The primary outcome was Hospital Anxiety and Depression Scale total after treatment (4-month follow-up). Secondary outcomes were individual Hospital Anxiety and Depression Scales, traumatic stress symptoms, and psychological mechanisms including metacognitive beliefs and repetitive negative thinking. Analysis was intention to treat. RESULTS: The adjusted group difference on the primary outcome, Hospital Anxiety and Depression Scale total score at 4 months, significantly favored the MCT+CR arm (-3.24 [95% CI, -4.67 to -1.81], P<0.001; standardized effect size, 0.52 [95% CI, 0.291 to 0.750]). The significant difference was maintained at 12 months (-2.19 [95% CI, -3.72 to -0.66], P=0.005; standardized effect size, 0.33 [95% CI, 0.101 to 0.568]). The intervention improved outcomes significantly for both depression and anxiety symptoms when assessed separately compared with usual care. Sensitivity analysis using multiple imputation of missing values supported these findings. Most secondary outcomes favored MCT+CR, with medium to high effect sizes for psychological mechanisms of metacognitive beliefs and repetitive negative thinking. No adverse treatment-related events were reported. CONCLUSIONS: Group MCT+CR significantly improved depression and anxiety compared with usual care and led to greater reductions in unhelpful metacognitions and repetitive negative thinking. Most gains remained significant at 12 months. Study strengths include a large sample, a theory-based intervention, use of longer-term follow-up, broad inclusion criteria, and involvement of a trials unit. Limitations include no control for additional contact as part of MCT to estimate nonspecific effects, and the trial was not intended to assess cardiac outcomes. Nonetheless, results demonstrated that addition of the MCT intervention had broad and significant beneficial effects on mental health symptoms. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: ISRCTN74643496.

Utilising Patient and Public Involvement in Stated Preference Research in Health: Learning from the Existing Literature and a Case Study.

Publications reporting discrete choice experiments of healthcare interventions rarely discuss whether patient and public involvement (PPI) activities have been conducted. This paper presents examples from the existing literature and a detailed case study from the National Institute for Health Research-funded PATHWAY programme that comprehensively included PPI activities at multiple stages of preference research. Reflecting on these examples, as well as the wider PPI literature, we describe the different stages at which it is possible to effectively incorporate PPI across preference research, including the design, recruitment and dissemination of projects. Benefits of PPI activities include gaining practical insights from a wider perspective, which can positively impact experiment design as well as survey materials. Further benefits included advice around recruitment and reaching a greater audience with dissemination activities, amongst others. There are challenges associated with PPI activities; examples include time, cost and outlining expectations. Overall, although we acknowledge practical difficulties associated with PPI, this work highlights that it is possible for preference researchers to implement PPI across preference research. Further research systematically comparing methods related to PPI in preference research and their associated impact on the methods and results of studies would strengthen the literature.

Metacognitive beliefs and their relationship with anxiety and depression in physical illnesses: A systematic review.

Anxiety and depression are common among patients with chronic physical illnesses and have a significant impact on morbidity, quality of life, and health service utilisation. Psychological treatment of anxiety and depression has small to moderate efficacy in this group and is not commonly based on a model of causal mechanisms. A novel approach to understanding and improving mental health outcomes in physical illnesses is needed. One approach may be to explore the role of metacognitive beliefs which are reliably associated with anxiety and depression in individuals with mental health difficulties. The current systematic review aimed to evaluate the contribution of metacognitive beliefs to anxiety and depression across physical illnesses. Systematic searches were conducted on Web of Science, PsychINFO, MEDLINE, Embase, and CINAHL of studies published between 1997 and January 2019. 13 eligible studies were identified that in sum comprised 2851 participants. Metacognitive beliefs were found to have reliable, moderate, positive and significant associations with anxiety and depression symptoms across a range of physical illnesses. There appeared to be commonality and some specificity in the relationships. Negative metacognitive beliefs concerned with uncontrollability and danger of worry were associated with both anxiety and depression across all physical illnesses assessed, whilst more specific associations emerged for individual medical conditions where positive beliefs about worry, cognitive confidence and cognitive self-consciousness were unique correlates. Negative metacognitive beliefs of uncontrollability and danger significantly and positively predicted symptoms of anxiety and depression after controlling for factors including age, gender, disease factors and cognition (illness perceptions and intolerance of uncertainty). The results suggest that the metacognitive model of psychological disorder is applicable to psychological symptoms of anxiety and depression across a range of chronic medical conditions, implying that metacognitive therapy might be helpful in improving outcomes in multiple morbidities that involve poor mental and medical health.

Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression.

INTRODUCTION: Cardiac rehabilitation (CR) is offered to reduce the risk of further cardiac events and to improve patients' health and quality of life following a cardiac event. Psychological care is a common component of CR as symptoms of depression and/or anxiety are more prevalent in this population, however evidence for the cost-effectiveness of current interventions is limited. Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients. This protocol describes the planned approach to the economic evaluation of MCT for CR patients. METHODS AND ANALYSIS: The economic evaluation work will consist of a within-trial analysis and an economic model. The PATHWAY Group MCT study has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomised controlled trial study design (UK Clinical Trials Gateway). A within-trial economic evaluation and economic model will compare the cost-effectiveness of MCT plus usual care (UC) to UC, from a health and social care perspective in the UK. The within-trial analysis will use intention-to-treat and estimate total costs and quality-adjusted life-years (QALYs) for the trial follow-up. Single imputation will be used to impute missing baseline variables. Multiple imputation will be used to impute values missing at follow-up. Items of resource use will be multiplied by published national healthcare costs. Regression analysis will be used to estimate net costs and net QALYs and these estimates will be bootstrapped to generate 10 000 net pairs of costs and QALYs to inform the probability of cost-effectiveness. A decision analytical economic model will be developed to synthesise trial data with the published literature over a longer time frame. Sensitivity analysis will explore uncertainty. Guidance of the methods for economic models will be followed and dissemination will adhere to reporting guidelines. ETHICS AND DISSEMINATION: The economic evaluation includes a within-trial analysis. The trial which included the collection of this data was reviewed and approved by Ethics. Ethics approval was obtained by the Preston Research Ethics Committee (project ID 156862). The modelling analysis is not applicable for Ethics as it will use data from the trial (secondary analysis) and the published literature. Results of the main trial and economic evaluation will be published in the peer-reviewed National Institute for Health Research (NIHR) journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences. TRIAL REGISTRATION NUMBER: ISRCTN74643496; Pre-results.

Establishing the Feasibility of Group Metacognitive Therapy for Anxiety and Depression in Cardiac Rehabilitation: A Single-Blind Randomized Pilot Study.

BACKGROUND: Anxiety and depression are common in cardiac rehabilitation (CR) patients. However, CR programs which incorporate psychological techniques achieve modest reductions in emotional distress. More efficacious interventions that can be easily integrated within services are required. A promising alternative to current psychological interventions is metacognitive therapy (MCT). The aim was to evaluate the acceptability and feasibility of delivering Group-MCT to CR patients experiencing symptoms of anxiety and depression. METHOD AND RESULTS: Fifty-two CR patients with elevated anxiety and/or depression were recruited to a single-blind randomized feasibility trial across three UK National Health Service Trusts and randomized to usual CR or usual CR plus six weekly sessions of group-MCT. Acceptability and feasibility of adding group-MCT to CR was based on recruitment rates, withdrawal, and drop-out by the primary end-point of 4 months; number of MCT and CR sessions attended; completion of follow-up questionnaires; and ability of the outcome measures to discriminate between patients. The study was also used to re-estimate the required sample size for a full-scale trial. We also examined the extent by which non-specialists adhered to the Group-MCT protocol. Group-MCT was found to be feasible and acceptable for CR patients with anxiety and depression. Recruitment and retention of participants was high, and attendance rates at CR were similar for both groups. CONCLUSION: The results suggest the addition of MCT to CR did not have a negative impact on retention and support a full-scale trial of Group-MCT for cardiac patients.

What Comes First Metacognition or Negative Emotion? A Test of Temporal Precedence.

The Self-Regulatory Executive Function model predicts that emotional symptoms and metacognition can causally affect each other. Crucially, for the model metacognition must cause emotion disorder symptoms. Therefore, in time-series data involving repeated measurements, metacognitions should predict subsequent changes in emotion. 265 participants completed a questionnaire battery three times over a 2 month period. Structural equation modeling (SEM) using cross-lagged panel analysis tested the inter-relationships between metacognitive beliefs, anxiety and depression symptoms over time. The cross-lagged structural model was a significantly better fit than the autoregressive model. Metacognitive beliefs were found to predict subsequent symptoms of anxiety while symptoms of anxiety predicted later metacognition over different time courses. The metacognition factor representing uncontrollability and danger of thoughts appeared to be prominent in the effects observed. Metacognitions and depression were also positively related over time to a lesser degree, but in the cross-lagged model these temporal relationships were non-significant. This is likely due to low levels of depression within the sample and low variability over time. The findings for anxiety are consistent with the S-REF model and with experimental and prospective studies supporting metacognitive beliefs as a causal mechanism in psychological distress symptoms.