AimsAnxiety, depression, and post-traumatic stress symptoms are common in cardiac rehabilitation (CR) patients. Group metacognitive therapy (MCT) alongside CR can significantly improve such symptoms compared to usual care. We aimed to conduct the first implementation study of group-MCT in NHS CR services. The objectives were: 1. Establish sites and assess levels of adoption; 2. Revise and pilot data capture via national auditing systems to assess MCT attendance and uptake; 3. Assess site-level MCT-adherence under roll-out conditions.MethodsA mixed-methods study evaluated implementation of group-MCT in routine care in CR services. Services across England were recruited as early adopters and staff were trained. The National Audit of Cardiac Rehabilitation (NACR) database was modified to collect and assess performance of group-MCT data capture. Five implementation outcomes were assessed; uptake and adherence, data-capture and quality, patient characteristics, site-level of adoption, and treatment adherence.ResultsTwenty-six courses of group-MCT were delivered across six services, with an average of 4.3 courses per site and 131 patients receiving treatment. 82.4% of patients attended at least four sessions. Five services met all outcomes and were classed as green; one failed on one criterion and was rated amber. Data capture worked but with some minor discrepancies. Levels of intervention adherence were excellent, with high consistency across sites and time.ConclusionsWe established six sites meeting our recruitment threshold and demonstrated satisfactory data capture on MCT attendance and uptake via national auditing systems. Five out of six sites met all adoption criteria. Site level adherence and compliance was excellent at 86.7%. Wider-scale adoption could improve access to evidence-based psychological therapy and enhance outcomes across the 188 CR-services in England.

Background This study was designed to explore cardiac rehabilitation (CR) practitioners' experiences and perceptions of group metacognitive therapy training, identifying the facilitators and barriers encountered. Methods A nested qualitative study using reflexive thematic analysis was conducted as part of PATHWAY‐Beacons (National Institute for Health and Care Research 202956), a mixed‐methods study evaluating the implementation of group metacognitive therapy as part of routine care in CR services. Practitioners from 6 CR services in England enrolled in interviews at 3 stages: before training, after training, and after delivering all group sessions. Results Nine practitioners participated in the study, with 7 completing all 4 interviews, 1 completing 2 interviews (pre‐ and posttraining), and another completing just 1 (pretraining). Key enablers for effective training emerged in 3 subthemes: training delivery style, essential training components, and the online training format. These aspects contributed positively to the practitioners' training experiences and improved their understanding of group metacognitive therapy. Conversely, barriers included issues related to training structure, staff skepticism, and specific additional training needs. Conclusion The findings support the positive value of training CR staff in group metacognitive therapy and offer important insights for enhancing the delivery and uptake of training within the National Health Service. Although the study findings represent views of a predominantly female sample, this reflects the composition of the current CR workforce.

IntroductionThe Attention Training Technique (ATT) is a brief metacognitive intervention recognised as a possibly efficacious standalone transdiagnostic treatment for emotional disorders. The cognitive and neuropsychological mechanisms underlying its clinical effects are of particular interest in understanding and developing the technique. The aim of the systematic review was to synthesise and evaluate the cognitive-attentional task performance and neurocognitive correlates of ATT in the context of theoretical mechanisms from which ATT is derived.MethodsFive electronic databases (PsycINFO, MEDLINE, PubMed, Web of Science and EMBASE) were searched from January 1990 to November 2025. Studies that used ATT as part of a metacognitive multi-component treatment package or combined with other therapy/technique(s) were excluded. Sample inclusion was diverse to capture effects on non-clinical and clinical individuals and across age groups for potential sub-group analyses.ResultsIn total, 20 studies with 1, 230 participants met the inclusion criteria. Four studies included clinical samples, four studies included non-clinical participants, two studies used experimental induction of pain or mind wandering, and 10 used healthy samples of which two used school children. Study quality varied from strong to weak with the majority receiving ‘moderate’ ratings. Across 14 cognitive-attentional tasks and three neural methodologies (EEG, fNIRS, fMRI), the review found small to large cognitive and neural effects associated with ATT. Nine cognitive tasks showed significant ATT-dependent effects in at least one study, with the most consistency shown on the emotional dot-probe. Neural findings across all methodologies converged, suggesting that ATT modulates cognitive control, frontoparietal, dorsal attention networks and reduces default mode network connectivity.DiscussionInterpretation and synthesis of findings based on the S-REF model are consistent with cognitive and neural effects involving reduced threat monitoring, improved executive control, and enhanced disengagement from self-referential processing; central theoretical mechanisms and design parameters of ATT. Where inconsistencies across study effects emerged, they may be due to heterogeneity in cognitive task and measurement factors and ATT protocol deviations. Future research on individual differences in neurocognitive effects associated with ATT across clinical and sub-clinical populations is needed. Studies must safeguard fidelity and adherence to the ATT protocol and improve reporting of these important factors.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42024483053.

Background:Employment is a key determinant of health, but mental health treatments have limited success on return-to-work (RTW) in depression and anxiety. We investigated the effectiveness of metacognitive therapy combined with work-focused components (MCT + WF) to improve RTW and reduce anxiety and depression in patients on sick leave. Methods:This single-centre, open-label, randomised controlled trial was conducted at an outpatient clinic (Diakonhjemmet Hospital) in Norway. Eligible patients were adults on sick leave with depression and/or anxiety. Patients with severe mental disorder or substance abuse were excluded. Participants were randomly assigned using computer-generated block randomisation, stratified by gender and percentage of sick leave, to receive either immediate MCT + WF or delayed MCT + WF after 8-12 weeks on a waitlist. Outcome assessors were blinded. Primary outcomes were depression (BDI-II), anxiety (BAI), and RTW at 12 weeks. Sick leave data were obtained from a national registry and self-report; symptoms were self-reported. Analyses followed the intention-to-treat principle, including all randomised participants. This trial was registered with ClinicalTrials.gov, NCT03301922. Findings:Between Sept 11, 2017, and Nov 17, 2020, 236 patients were enrolled and randomly assigned to immediate MCT + WF (n = 121) or waitlist (n = 115). At 12 weeks, logistic regression of registry data showed significantly higher RTW in the immediate MCT + WF group (39%; 47/121) than in the waitlist group (20%; 23/115; OR = 2.39, 95% CI 1.32-4.32; p = 0.0040), consistent with self-reported RTW (42% (51/121) versus 18% (20/114); OR = 3.44, 95% CI: [1.87, 6.35], p < 0.0001). Multilevel models revealed greater reductions in anxiety (time × group interaction coefficient = -8.35, 95% CI -10.61 to -6.09; p < 0.0001) and depression (-10.84, 95% CI -13.25 to -8.44; p < 0.0001) for immediate MCT + WF versus waiting. No serious adverse events were reported during the study. Interpretation:Immediate MCT + WF significantly improved RTW and reduced symptoms of depression and anxiety compared with waiting. Generalisability may be constrained by Norway's welfare system; strengths include registry data and naturalistic outpatient setting. The favourable outcomes suggest that MCT + WF could be integrated into mental health care. Funding:The study was funded by the South-Eastern Norway Regional Health Authority and DAM foundation-Mental Health, Diakonhjemmet Hospital.

Attentional control (AC) plays a causal role in various mental disorders and, within the metacognitive model, contributes to maladaptive repetitive cognitive processes such as rumination and worry. The Attention Training Technique (ATT), an auditory psychotherapeutic intervention, improves AC and is associated with the efficiency of large-scale fronto-parietal control networks (FPN). This study investigates the neural correlates of ATT by applying a newly tailored fMRI paradigm, focusing on FPN engagement and its relationship with AC. We adapted ATT to examine neural responses during ATT compared to passive listening in ATT-naïve participants (N = 43) and ensured the robustness of results by validating the findings in a second independent sample (N = 28). To optimize the paradigm, we compared two ATT conditions, rapidly switching (ATTswitch) and selectively focusing (ATTfocus) attention, against multiple passive-listening control conditions, to probe ATT-related FPN activation. We also tested whether trial-wise subjective effort and self/external focus ratings differentiated ATT from control trials, parametrically modulated FPN activation, and whether ATT-related FPN activation correlated with trait AC. ATT versus control conditions activated the FPN (pFWE < 0.05). This effect was present in both ATT conditions, with stronger activation in the ATTswitch versus ATTfocus condition, and independent of the specific control condition. Ratings of self/external focus and effort significantly differentiated ATT from control conditions (all p < 0.001) and parametrically modulated FPN activation (pFWE < 0.05). All effects were replicated in the second sample. Across both samples, FPN activation in ATT versus control conditions and trial-wise ratings related to trait AC. Using a novel fMRI paradigm in two independent samples, we demonstrate that the ATT is associated with activation of the FPN, a key network for AC and mental health. The relationship between FPN activation and self-report measures supports the relevance of the data for understanding ATT and its links to clinical phenotypes.

BackgroundMental health problems in children and young people (CYP) are increasing with a pressing need for more effective treatments. However, the development of psychological interventions seldom explores young patients experiences of treatment, which is crucial in understanding factors influencing the uptake, impact and validity of therapy. We aimed to explore for the first time CYP experiences of how they received group metacognitive therapy for anxiety disorders and depression.MethodsA qualitative study was embedded in a larger feasibility RCT (n=95) comparing group-based MCT with treatment as usual. Seventeen CYP aged 11-17yrs who had been part of the group-MCT arm consented to participate. Interviews were semi-structured, open-ended and followed an a-priori guide. Coding and analysis adhered to guidelines for reflexive thematic analysis.ResultsThree overarching themes emerged in patient experiences: treatment fidelity, treatment delivery, and experiences of homework. Treatment fidelity had two subthemes: i) treatment receipt- which included patients understanding of MCT and performance of MCT techniques during the intervention, and ii) treatment enactment- which included performance of MCT techniques in applied settings, plus perceived benefits of treatment. Treatment delivery included two subthemes; i) format of therapy and, ii) therapist characteristics.ConclusionsThe results support the use of MCT in children and young people with mixed anxiety disorders and depression. Patients reported understanding the treatment rationale and benefiting from the intervention. They described, consistent with purported mechanisms, how treatment helped them make a shift in beliefs about thoughts and see worry as powerless and under personal control. Patients described an ability to apply specific techniques in real-life settings, despite noting major challenges with homework compliance. The results emphasised areas that might be improved and important recommendations are made for MCT delivery and practise in children and adolescents.

Preliminary evidence indicates that metacognitive therapy (MCT) is a promising treatment in children and adolescents; however, little is known about the influence of parental factors on MCT outcomes. Based on secondary analyses from a recent trial of MCT in young people with anxiety and depressive disorders, the aim of this study was to evaluate cross-sectional associations between child and parental symptoms, metacognitive beliefs and attention control beliefs and whether such parent variables predicted symptom scores following MCT. The sample consisted of 97 children and adolescents aged 10-17 years (M = 12.85 ± 1.9, 82.5% females) and their parents (n = 145, 57.9% mothers). The majority of the sample had a primary anxiety disorder (n = 96). Participants received eight sessions of MCT in transdiagnostic groups. The majority of baseline correlations were small and non-significant with some exceptions. Small significant relationships emerged between maternal attention shifting and child attention shifting, total attention control and symptoms. Also, child depressive symptoms were associated with maternal anxiety, maternal cognitive self-consciousness, and paternal attention control beliefs, with small to moderate effects. Parental factors did not predict symptom scores at post-treatment nor at 6-month follow-up. The findings should be considered preliminary and seen in light of the overall good mental health of the parents. If results are replicated in the future with broader samples, it suggests that MCT outcomes in young people may have little association with the symptoms and higher-order beliefs of parents. Trial Registration: AsPredicted number: 152970.

ObjectivesTo examine whether there is a relationship between anxiety and/or depression and wound healing.DesignSystematic review and meta-analysis.Data sourcesSearches were conducted on PsycINFO, MEDLINE, EMBASE, CINAHL and Web of Science on the 06-March-2023.MethodsEligible studies explored the effects of anxiety and/or depression on wound healing in adults. Healing outcomes included time to heal and complication rates. Anxiety and depression outcomes were considered separately.ResultsFifty-five studies were included in the narrative synthesis (26,612,809 participants), and 26 studies in the meta-analysis. Studies utilised a range of observational and experimental designs. Wounds included in the review were: surgical, ulcer, burn and experimental wounds. The narrative synthesis gave mixed results, with some studies noting positive associations between increased anxiety or depression and wound healing, while others did not find an association. Results from the meta-analysis found no significant effect of anxiety on wound healing outcomes. However, depression was associated with significantly higher odds of delayed wound healing, OR = 2.10, [1.02, 4.33]; higher risk of wound complications, RR = 1.30, [1.11, 1.53] and increased risk of wound infection RR = 1.25, [1.09, 1.44].ConclusionThese findings suggest depression negatively impacts wound healing. There is less evidence for an association with anxiety, but this may be due to less research in this area. Future studies should explore the mechanism of associations between depression and wound healing to inform clinical interventions.

The metacognitive model of psychological disorders emphasises common causal factors across psychopathologies and assigns a central role to maladaptation in metacognition. Metacognitions concerning the uncontrollability of thoughts are considered central, occurring in most disorders, whilst other more specific metacognitions, make additional contributions to particular disorders. The Meta-cognitions about Health Anxiety questionnaire (MCQ-HA) was developed to assess metacognitive beliefs relevant to health anxiety and includes three subdomains: beliefs that thoughts cause illness; beliefs about biased thinking; and beliefs that thoughts are uncontrollable. As these metacognitive domains may improve our understanding of health anxiety, the aim of the current study was to assess the psychometric properties of the MCQ-HA in a Norwegian sample and test the fit of the metacognitive model applied to health anxiety symptoms. Eight-hundred and thirty-nine participants completed a battery of self-report questionnaires. Confirmatory factor analysis supported the a-priori three-factor solution of the MCQ-HA, with acceptable internal consistency and demonstrable convergent- and incremental validity. A test of the goodness of fit of a pre-specified metacognitive model of health anxiety based on associations indicated a good model fit. Our findings support the use of the MCQ-HA and support the metacognitive conceptualisation of health anxiety symptoms.

BACKGROUND:As hypothesized in the Self-Regulatory Executive Function (S-REF) model, metacognitive beliefs are associated with anxiety and depression in adults. An important question is the extent to which such effects are present in children and adolescents, with the implication that the model may also apply to young people. The aim of this meta-analysis was to synthesize results on the nature and magnitude of associations between metacognitive beliefs and anxiety and depression in children and adolescents. METHODS:Systematic searches were conducted to identify studies that investigated: (1) group differences in metacognitive beliefs in clinical compared to non-clinical samples or (2) correlations between metacognitive beliefs and symptoms of anxiety and depression. RESULTS:Forty papers were identified comprising a total sample of 9,887 participants aged 7-18 years. Meta-analyses revealed that clinical samples endorsed significantly elevated metacognitive beliefs on four out of the five domains measured (i.e., negative beliefs about worry, cognitive confidence, need for control, and cognitive self-consciousness, with the only exception being positive beliefs about worry) compared to non-clinical samples with a small to large effect (Hedges' gs = 0.45-1.22). Moreover, all five domains of metacognitive beliefs were significantly and positively correlated with symptoms of anxiety and depression of a small to large effect (rs = .24-.53). Negative beliefs about worry showed the strongest relationship with clinical status and the magnitude of symptoms. LIMITATIONS:The number of studies did not allow for an evaluation of metacognitive beliefs at a disorder-specific level. CONCLUSIONS:In line with the S-REF model, our findings provide evidence of robust cross-sectional relationships between metacognitions and both anxiety and depression in childhood and adolescence.

Background Cardiac rehabilitation improves health and quality of life and reduces risk of further cardiac events. Twenty-eight per cent of cardiac rehabilitation patients experience clinically significant anxiety and 19% suffer depression. Such patients are at greater risk of death, further cardiac events and poorer quality of life and use more health care, leading to higher NHS costs. The available psychological treatments for cardiac patients have small effects on anxiety and depression and quality of life; therefore, more effective treatments are needed. Research shows that a thinking style dominated by rumination and worry maintains anxiety and depression. A psychological intervention (metacognitive therapy) effectively reduces this style of thinking and alleviates depression and anxiety in mental health settings. The PATHWAY study evaluated two versions of metacognitive therapy applied in cardiac rehabilitation services. Objectives The primary aim was to improve psychological outcomes for cardiac rehabilitation patients. We evaluated two formats of metacognitive therapy: (1) a group-based face-to-face intervention delivered by cardiac rehabilitation staff (group-based metacognitive therapy) and (2) a paper-based, self-directed intervention (home-based metacognitive therapy). Each was compared with usual cardiac rehabilitation alone in separate randomised controlled trials. Design A randomised feasibility trial (work stream 1) and a full-scale randomised controlled trial (work stream 2) evaluated group-metacognitive therapy, while separate feasibility and full-scale trials (work stream 3 and work stream 3+, respectively) evaluated home-based metacognitive therapy. A cost-effectiveness analysis of group-metacognitive therapy was conducted, along with stated preference surveys and qualitative studies examining patient psychological needs and therapists’ perspectives on metacognitive therapy. Setting Seven NHS cardiac rehabilitation services across the north-west of England. Participants Adults aged ≥ 18 years who met cardiac rehabilitation eligibility criteria, scored ≥ 8 on depression or anxiety subscales of the Hospital Anxiety and Depression Scale, and were able to read, understand and complete questionnaires in English. Interventions Work stream 1 and work stream 2 – a 6-week group-metacognitive therapy intervention delivered by cardiac rehabilitation staff plus usual cardiac rehabilitation compared with usual cardiac rehabilitation alone. Group-metacognitive therapy was delivered once per week for 6 weeks, with each session lasting 90 minutes. Work stream 3 and work stream 3+ – home-based metacognitive therapy plus usual cardiac rehabilitation compared with usual cardiac rehabilitation alone. Home-metacognitive therapy was a paper-based manual that included six modules and two supportive telephone calls delivered by cardiac rehabilitation staff. Main outcome measures The Hospital Anxiety and Depression Scale total score at 4-month follow-up was the primary outcome in all trials. A range of secondary outcomes were also evaluated. Results Our qualitative study with 46 patients across three cardiac rehabilitation services suggested that cardiac rehabilitation patients’ psychological needs were not met by current approaches and that metacognitive therapy might offer an improved fit with their psychological symptoms. The internal pilot feasibility study (work stream 1; n = 54) demonstrated that a full-scale randomised controlled trial was feasible and acceptable and confirmed our sample size estimation. A subsequent full-scale, single-blind randomised controlled trial (work stream 2; n = 332) showed that adding group-based metacognitive therapy to cardiac rehabilitation was associated with statistically significant improvements on the Hospital Anxiety and Depression Scale (primary outcome) in anxiety and depression compared with cardiac rehabilitation alone at 4-month (adjusted mean difference −3.24, 95% confidence interval −4.67 to −1.81, p < 0.001; standardised mean difference 0.52) and 12-month follow-up (adjusted mean difference −2.19, 95% confidence interval −3.72 to −0.66, p = 0.005; standardised mean difference 0.33). The cost-effectiveness analysis suggested that group-metacognitive therapy was dominant, that it could be cost saving (net cost −£219, 95% confidence interval −£1446 to £1007) and health increasing (net quality-adjusted life-year 0.015, 95% confidence interval −0.015 to 0.045). However, confidence intervals were wide and overlapped zero, indicating high variability in the data and uncertainty in the estimates. A pilot feasibility trial (work stream 3; n = 108) supported a full-scale trial of home-metacognitive therapy and was extended (work stream 3+; n = 240). In the full trial, the adjusted mean difference on the Hospital and Anxiety and Depression Scale favoured the metacognitive therapy + cardiac rehabilitation arm (adjusted mean difference −2.64, 95% confidence interval −4.49 to −0.78, p = 0.005; standardised mean difference 0.38), with statistically significant greater improvements in anxiety and depression in home-metacognitive therapy plus cardiac rehabilitation than in cardiac rehabilitation alone at 4-month follow-up. A stated preference survey on clinic-delivered psychological therapy (not specific to metacognitive therapy) indicated a preference for including psychological therapy as part of cardiac rehabilitation. Participants favoured individual therapy, delivered by cardiac rehabilitation staff, with information provided prior to therapy and at a lower cost to the NHS. A pilot stated preference study focused on preferences for home- or clinic-based psychological therapy. Preferences were stronger for home-based therapy than for centre-based, but this was not statistically significant and participants highly valued receiving therapy and having reduced waiting times. Limitations Limitations include no control for additional contact as part of metacognitive therapy to estimate non-specific effects. Work stream 3+ did not include 12-month follow-up and therefore the long-term effects of home-based metacognitive therapy are unknown. The health economics analysis was limited by sample size and large amount of missing data in the final follow up. Findings from the qualitative study cannot necessarily be generalised. Conclusions Both group-based and home-based metacognitive therapy were associated with significantly greater reductions in anxiety and depression symptoms at 4 months, compared with cardiac rehabilitation alone. The results in group-based metacognitive therapy appeared to be stable over 12 months. Introducing metacognitive therapy into cardiac rehabilitation has the potential to improve mental health outcomes. Future work Future studies should evaluate the long-term effects of home-metacognitive therapy and the effect of metacognitive therapy against other treatments offered in cardiac rehabilitation. Given the uncertainty in the economic evaluation, further work is needed to determine the cost-effectiveness of metacognitive therapy. Trial registration Work stream 1/work stream 2: NCT02420431 and ISRCTN74643496; work stream 3: NCT03129282; work stream 3+: NCT03999359. The trial is registered with clinicaltrials.gov NCT03999359. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-1211-20011) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information. Plain language summary Depression and anxiety are common among cardiac rehabilitation patients. Cardiac patients with anxiety and depression are at greater risk of death, further cardiac events and poorer quality of life and use more health care, leading to higher NHS costs. Current talking-based therapies have small effects on anxiety and depression in patients with cardiovascular disease. It is important that more effective treatments for mental health are added to cardiac rehabilitation. We applied two versions of a recent treatment called metacognitive therapy in cardiac rehabilitation: a group version and a home-based (self-help) paper-based manual. The programme had three work streams conducted across seven NHS trusts. In work stream 1, we ran a pilot trial showing that adding group-metacognitive therapy to cardiac rehabilitation was feasible and acceptable A full-scale trial (work stream 2) followed, and this showed that adding group-metacognitive therapy to cardiac rehabilitation was associated with greater improvement in anxiety and depression than cardiac rehabilitation alone. In work stream 3, we created a home-based version of metacognitive therapy and ran a feasibility trial, which was extended to a full-scale trial and showed that home-metacognitive therapy plus cardiac rehabilitation was associated with improved anxiety and depression outcomes compared with cardiac rehabilitation alone. Interview studies of patients’ needs, treatment preferences and reactions to treatment were included, and our patient and public involvement group advised the research team throughout the trial. The originator of metacognitive therapy, Adrian Wells, was the chief investigator of the study and is the director of the Metacognitive Therapy Institute. He has funding for the study ‘Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons; NIHR29567)’ as chief investigator. To maintain objectivity along with the trial statistician and research assistants he did not know patient treatment allocation, data were managed by a separate clinical trials unit and a plan for analysis was devised before analysis took place. Project oversight and monitoring were undertaken by an independent Trial Steering Committee. Scientific summary Background Cardiac rehabilitation (CR) aims to improve heart disease patients’ health and quality of life and reduce the risk of further cardiac events: 28% of cardiac patients have clinically significant anxiety and 19% have depression. Such patients are at greater risk of death, further cardiac events and poorer quality of life and use more health care, leading to higher NHS costs. Available psychological treatments for patients with heart disease have small effects on improving anxiety, depression and quality of life. Therefore, more effective treatments for depression and anxiety need to be explored and made available in CR services. Research in mental health contexts shows that a style of thinking dominated by rumination and worry maintains distress. A psychological intervention [metacognitive therapy (MCT)] reduces this style of thinking and alleviates depression and anxiety. The PATHWAY study evaluated two versions of MCT applied in heart disease patients attending CR: (1) a 6-week intervention delivered face to face in a group setting by CR staff (group-based MCT) and (2) a paper-based, six-module, self-directed intervention (home-based MCT). Objectives The primary aim is to improve access to more effective psychological interventions for the range of heart disease patients attending CR services. The specific objectives were to: conduct a pilot randomised controlled trial (RCT) of group-based MCT (Group-MCT) to evaluate the acceptability and feasibility of delivering the intervention to CR patients who have symptoms of anxiety and depression establish evidence of the effectiveness and cost-effectiveness of Group-MCT in CR in a full-scale RCT produce a rigorous, well-specified Group-MCT package develop a home-based metacognitive intervention (Home-MCT) for CR patients with depression and/or anxiety establish the feasibility and acceptability of integrating Home-MCT into the CR pathway in a pilot RCT establish provisional evidence of the effectiveness and cost-effectiveness of Home-MCT develop a protocol and manual for Home-MCT to inform a full-scale RCT conduct a full-scale RCT evaluating the effectiveness of Home-MCT. Methods We conducted a randomised controlled pilot trial and a full-scale RCT comparing usual CR alone against CR plus group-based MCT [work stream (WS) 1 and WS2; n = 332)]. We also conducted a randomised controlled pilot trial and a full-scale RCT of home-based metacognitive therapy (WS3 and WS3+; n = 240). All trials included integrated qualitative (n = 52) and economic evaluations (n = 339; stated preference survey). Participants A total of seven NHS trusts that provided a routine CR service participated in the research, with the number of participants and specific sites varying by trial. Work streams 1 and 2 explored the acceptability and effectiveness of Group-MCT integrated into usual CR in hospital settings, whereas WS3 and WS3+ explored the acceptability and effectiveness of Home-MCT integrated into usual CR in hospital and community settings. Work stream 1 recruited participants from three NHS trusts in north-west England. Participant recruitment for WS2 took place in five NHS trusts across north-west England. WS3 and WS3+ patients were recruited from CR services at five NHS hospital trusts across north-west England. Participating CR patients in all trials had to score ≥ 8 on the anxiety and/or depression subscale of the Hospital Anxiety and Depression Scale (HADS), be aged ≥ 18 years and meet the British Association for Cardiovascular Prevention and Rehabilitation criteria for attending CR. Participants were randomly allocated in a one-to-one ratio to receive either MCT plus usual CR or usual CR only using a randomisation procedure that balanced the trial arms with respect to gender, HADS scores and trial sites. Interventions Group-MCT: a 6-week manualised MCT intervention delivered face to face in a group setting. Therapists were CR staff who were not mental health specialists (e.g. clinical psychologists) but were trained to deliver the intervention. The intervention was developed by Adrian Wells based on the metacognitive model of psychological disorder and uses effective metacognitive therapy methods tested in mental health settings. Home-MCT: a paper-based, self-directed MCT intervention consisting of six modules in a treatment manual following a structure and content like that of the group-based MCT intervention. Adrian Wells provided pre-trial training for staff but was not involved in the ongoing supervision of staff delivering the intervention to maintain blinding and objectivity. Outcome measures The primary outcome was HADS total score at 4 months, with HADS total scores at 12 months as a secondary outcome (WS1 and WS2, i.e. Group-MCT only). Other secondary outcomes were the separate HADS anxiety and depression subscales, traumatic stress symptoms, and psychological mechanisms including metacognitive beliefs and repetitive negative thinking. For both interventions, qualitative interviews were conducted to assess patients’ emotional experiences and needs following cardiac events, and their understanding and experience of MCT. In Group-MCT, practitioners were interviewed to understand their experience of delivering the intervention and their understanding of patients’ responses to it and patients’ emotional needs. Statistical analysis For the pilot studies, statistical analysis was principally descriptive. We assessed the acceptability of adding Group-MCT and Home-MCT to usual CR regarding rates of recruitment into the study, attrition by the primary end point, and numbers of MCT and CR modules/sessions completed. The feasibility of conducting a full RCT was assessed against the completion of follow-up questionnaires, adequate variability in the outcome measures, and re-estimation of the required sample size based on pilot study findings. Therapist adherence to the Group-MCT treatment protocol was also assessed. The full-scale RCTs of Group-MCT and Home-MCT were designed to detect a standardised mean difference (SMD) between trial arms of 0.4 in HADS total score at 4-month follow-up with 90% power, based on effect sizes reported for other psychological interventions for depression. Analysis was conducted following a prespecified plan detailing the analytic models, primary and secondary outcomes, choice of covariates, sensitivity analyses, and all other key aspects of the analysis. The primary analyses used intention-to-treat principles. To reduce bias, data from the trial were managed by a separate clinical trials unit and locked prior to analysis. The chief investigator (AW), trial statisticians and research assistants were kept unaware of patient treatment allocation throughout the programme and the analyses followed a prespecified plan. Cost-effectiveness analysis For Group-MCT only, a within-trial cost-effectiveness analysis with a 12-month time horizon compared the cost-effectiveness of MCT plus usual CR with that of CR alone, from a UK health and social care perspective. Key measures included health status (measured using the EuroQol-5 Dimensions, five-level) and self-reported health and social care use. Total costs and quality-adjusted life-years (QALYs) were calculated for the trial follow-up. Missing values were addressed using multiple imputation. The primary outcome was the incremental cost-effectiveness ratio. Regression analysis was used to estimate net costs and net QALYs, and 10,000 bootstrapped pairs of net costs and QALYs were generated to inform the probability of cost-effectiveness. For the home-based MCT pilot study, a simple between-group comparison of the available economic data (health status and NHS and social care costs), using summary statistics, was performed. Two stated preference studies (using discrete choice experiment designs), one focused on Group-MCT and the other on Home-MCT, were conducted to explore patient preferences for the delivery of psychological therapy in CR. Participants were asked to choose between two hypothetical interventions, described using five attributes. The cost to the NHS was used to estimate willingness to pay for aspects of intervention delivery. Results Group-MCT Fifty-two CR patients were consented to the pilot trial of Group-MCT + CR versus CR alone, of whom 23 were randomly allocated to Group-MCT + CR and 29 to CR. The trial recruited to target, and > 70% of participants completed the 4-month follow-up questionnaire. More than half of the patients in both arms attended at least six CR sessions, and 57% of Group-MCT participants completed an a priori defined minimal dose of the intervention likely to produce the benefit of at least four of the six MCT sessions. The addition of MCT to rehabilitation did not negatively impact on CR attendance, and we observed high therapist adherence to the protocol. The trial concluded that Group-MCT is an acceptable and feasible intervention to deliver in CR services. The Trial Steering Committee and NIHR as funder agreed to support the progression to a full-scale RCT of the Group-MCT intervention. No substantive changes were required to the trial procedures; therefore, the pilot and full RCT samples were pooled for final analysis. A total of 332 patients (including 52 from the pilot trial) consented to the full-scale RCT of Group-MCT + CR versus CR alone, with 163 randomly allocated to Group-MCT + CR and 169 randomly allocated to CR alone; 81% returned data at 4-month follow-up. The adjusted group difference on the primary outcome of HADS total score at 4 months significantly favoured Group-MCT + CR [–3.24, 95% confidence interval (CI) –4.67 to –1.81, p < 0.001; SMD 0.52], as did the difference at the 12-month secondary outcome point (–2.19, 95% CI –3.72 to –0.66, p < 0.01; SMD 0.33). Patients in the Group-MCT + CR arm also had lower mean HADS anxiety and depression subscale scores at 4 months (p < 0.001). Differences in anxiety remained statistically significant at 12 months (p < 0.01), but those in depression did not (p = 0.065). Most of the other secondary outcomes also favoured the MCT intervention. Attendance at CR sessions did not differ between trial arms. Over 60% of Group-MCT + CR participants attended four or more of the six MCT intervention sessions. However, Group-MCT did not appeal to some patients, with 40 (25%) of the 163 patients randomised to receive MCT attending no MCT intervention sessions. Home-MCT One hundred and eight CR patients consented to the pilot trial of Home-MCT, with 54 randomised to Home-MCT + CR and 54 randomised to CR alone. The trial recruited to target, with 96% of CR only and 83% of Home-MCT + CR participants completing 4-month follow-up measures. Forty-four per cent of patients in the MCT arm completed a minimally effective dose of more than four out of six modules. Exit questionnaire ratings were good. However, views about telephone support were mixed and the quality of calls was rated low. Home-MCT appeared to be acceptable and feasible to deliver in CR services. The Trial Steering Committee and NIHR as funder agreed to support the progression to a full-scale RCT of the Home-MCT intervention. We submitted a no-additional-cost variation to contract (VTC) on 29 January 2019 to progress WS3 to a full-scale RCT (WS3+). The VTC was awarded on 12 March 2019. No substantive changes were required to the trial procedures; therefore, the pilot sample was pooled with the sample from the full RCT in final analysis. A total of 240 patients (including 108 from the pilot trial) were consented to the full-scale RCT of Home-MCT, with 118 randomly allocated to Home-MCT + CR and 122 randomly allocated to CR alone; 89% returned 4-month follow-up data. The adjusted group difference on the primary outcome of HADS total score at 4 months significantly favoured the MCT + CR arm (−2.64, 95% CI −4.49 to −0.78, p = 0.005; SMD 0.38). Patients in the MCT + CR arm also reported significantly lower mean HADS anxiety and depression scores (p < 0.05). Most other secondary outcomes also favoured the MCT intervention. Attendance at CR sessions did not differ between the trial arms. Over 70% of participants in the Home-MCT arm completed more than four MCT modules, but the intervention did not appeal to some patients; 21 participants (18%) withdrew or were not contactable at 4 months, compared with only one in the CR-alone arm. An investigation of the impact of differential attrition on the findings using last-observation-carried-forward resulted in no changes in statistical significance for the primary outcome and most of the secondary outcomes. In the primary cost-effectiveness analysis, the Group-MCT intervention was dominant, that is cost saving (net cost −219, 95% CI −£1446 to £1007) and health increasing (net QALY 0.015, 95% CI −0.015 to 0.045). However, the CIs are wide and overlap zero, indicating a high level of variability in the data and uncertainty in the estimates. Stated preference research indicated a preference for the inclusion of psychological therapy as part of a programme of CR. Conclusions There is not currently a standardised approach for psychological interventions in CR, and interventions can vary. There is a preference for the inclusion of psychological therapy in rehabilitation. Group-based MCT and Home-MCT were associated with significantly better anxiety and depression outcomes when added to CR compared with CR alone. The implications for health care are (1) MCT could be provided as part of the menu of approaches used in CR and (2) patients could be given the option to choose between group-based or home-based treatment to increase access. The recommendations for future research are (1) implementation studies that assess barriers to and enablers of roll-out in the NHS, (2) studies of longer-term outcomes of home-based MCT and (3) an evaluation of MCT against alternative therapies. Trial registration Work stream 1/work stream 2: NCT02420431 and ISRCTN74643496; work stream 3: NCT03129282; work stream 3+: NCT03999359. The trial is registered with clinicaltrials.gov NCT03999359. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1211-20011) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.

BackgroundPsychological difficulties are prevalent in patients undergoing Cardiac Rehabilitation (CR). Recent guidelines recommend that practitioners inquire and address patients’ psychological concerns during CR. Therefore, Study One aimed to explore practitioners’ understanding of patients’ psychological needs, their confidence in supporting those needs, and their views on whether current CR meets patients’ needs. Study Two aimed to validate Study Ones’ findings among a wider sample of CR practitioners.MethodsThis study consisted of two interrelated qualitative interviews. Study One utilised qualitative interview data from the PATHWAY trial (REC Reference:15/NW/0163), while Study Two utilised new interview data collected as part of the PATHWAY Beacons study (REC Reference: 22/HRA/2220). In Study One semi-structured interviews with six CR practitioners were analysed using thematic analysis. In Study Two, 11 CR practitioners across England were interviewed using member-checking principles. Transcripts were coded systematically using the codes developed in Study One and, through constant comparative analysis.ResultsFour main themes were identified: staff’s awareness of mental health problems, CR patients’ needs, staff’s self-efficacy to support patients’ psychological needs, and current psychological provision in CR. The main themes and 11 subthemes were transferable to a wider range of CR practitioners, thereby indicating the trustworthiness of the findings.ConclusionPractitioners described that patients experience a range of psychological concerns, including adjustment difficulties, anxiety, and cardiac and noncardiac worries. Most practitioners normalise patient concerns and offer relaxation techniques. However, practitioners have noted that patients often have complex psychological needs, but practitioners’ confidence in discussing and supporting psychological concerns varies. Practitioners expressed the need for training to support patients’ psychological needs.

Background: Health anxiety is a pervasive mental health condition, in which people worry about having or developing a serious illness or disease. Cognitive behavioural therapy (CBT) is currently considered the most researched psychological treatment for health anxiety, although several systematic reviews and meta-analysis have shown mixed findings for its efficacy. More efficacious interventions that can be easily integrated within services are required. An alternative to CBT, that has proven more effective in some other disorders, is metacognitive therapy (MCT). The aim was to evaluate the feasibility of delivering MCT for health anxiety and to collect pilot data on the treatment's preliminary efficacy. Method: Twenty participants with health anxiety were recruited to an open randomized feasibility trial and randomized to MCT or waitlist control. Acceptability and feasibility of MCT was based on recruitment rates, withdrawal, and drop-out, number of MCT sessions attended, completion of questionnaires, and any adverse reactions observed. The study was also used to evaluate initial treatment effects. Results: MCT was found to be feasible and acceptable for individuals with health anxiety. Recruitment and retention of all participants was high, and no adverse events were observed in either group. Pre to post between group effect sizes on the primary outcome measure The Whiteley Index (Pilowsky, 1967) were large (Hedges’ g = 3.18-Mdiff= 26.2, [95 % CI=18.7–33.6]) in favour of MCT. Clinically significant recovery rates were 80 % at post treatment and follow up. Conclusion: The results suggest that a trial of MCT was acceptable and feasible in individuals with health anxiety and the treatment effects were statistically significant in comparison to the waiting list. Based upon the design used in this study MCT should be compared with active treatments such as medication, treatment as usual or specific cognitive behaviour therapy protocols in a future definitive randomised trial.

After mild traumatic brain injury (mTBI), a subgroup of individuals experience persistent post-concussion symptoms (PPCS) that include headaches, cognitive difficulties, and fatigue. The aim of this preliminary study was to investigate possible effects associated with metacognitive therapy (MCT) on PPCS, maladaptive coping strategies, and positive and negative metacognitive beliefs following mTBI. A pre-post design supplemented with single-case A-B replication series to assess potential MCT mechanisms was used. Of the nine participants who received MCT, all experienced a decrease in PPCS, which constituted a reliable improvement for eight participants. For eight participants (we could calculate effect sizes for eight out of nine participants), moderate to very large decreases in maladaptive coping styles and positive and negative metacognitive beliefs were observed. However, based on visual analyses, participants 6, 8, and 9 show a downward baseline trend regarding MCT mechanisms that may have persisted into the intervention phase. No adverse events were reported. In conclusion, MCT was associated with improvements in PPCS and unhelpful psychological mechanisms, but caution is required in interpreting this association. Future research using formal single-case replication on symptom measures and randomized controlled trials appears to be justified.

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.

Objectives The burden of cardiovascular disease (CVD) is increasing. Cardiac rehabilitation (CR) is a complex intervention offered to patients with CVD, following a heart event, diagnosis or intervention, and it aims to reduce mortality and morbidity. The objective of this within-trial economic evaluation was to compare the cost-effectiveness of metacognitive therapy (MCT) plus usual care (UC) to UC, from a health and social care perspective in the UK.Methods A multicentre, single-blind, randomised controlled trial (ISRCTN74643496) was conducted in the UK involving 332 patients with CR with elevated symptoms of anxiety and/or depression and compared group-based MCT with UC. The primary outcome of the cost-effectiveness analysis was quality-adjusted life-years (QALYs). The time horizon of the primary analysis was a 12-month follow-up. Missing data were imputed using multiple imputation. Uncertainty was explored by probabilistic bootstrapping. Sensitivity analyses tested the impact of the study design and assumptions on the incremental cost-effectiveness ratio.Results In the primary cost-effectiveness analysis, MCT intervention was dominant, with a cost-saving (net cost −£219; 95% CI −£1446, £1007) and QALY gains (net QALY 0.015; 95% CI −0.015, 0.045). However, there is a high level of uncertainty in the estimates. At a threshold of £30 000 per QALY, MCT intervention of around 76% was likely to be cost-effective.Conclusions Results suggest that intervention may be cost-saving and health-increasing; however, findings are uncertain and subject to limitations. Further research should aim to reduce the uncertainty in the findings (eg, with larger sample sizes) and explore potential longer-term economic benefits associated with MCT in this setting.

IntroductionBurns and other injuries requiring plastic and/or reconstructive surgery (BPRS) are lifechanging, often unexpected, and increase the risk of psychiatric morbidity. There are no published studies we are aware of that explores the applicability of psychological models to BPRS patients. Cognitive behavioural therapy (CBT) is the benchmark treatment in mental health but may be less effective in physical health settings. Metacognitive therapy (MCT)can be more effective than CBT in mental health settings and shows promise in reducing anxiety and depression symptoms in people with cancer and cardiac disease. The present study explored the psychological experiences (feelings, thoughts, and coping strategies) of BPRS patients, and whether the concepts underpinning cognitive and metacognitive models can be elicited from these accounts.MethodSemi structured interviews were conducted with 11 patients recruited from a BPRS psychology service. Data was analysed using Thematic Analysis. Patients described a range of emotions including low mood, anxiety, anger, guilt, loss, and negative thinking.ResultsFrom the perspective of the cognitive model, there were examples of each of 10 pre-specified distorted thinking types (cognitive distortions), and patient talk seemed to fit problem-specific cognitive models. From the perspective of the metacognitive model, all patients described the “cognitive attentional syndrome,” i.e., how they engaged in repetitive negative thinking (worry, rumination) and thought-focused regulation strategies. Patient talk also demonstrated both positive and negative metacognitive beliefs.ConclusionThe implications of applying the findings from each model to clinical practice are discussed. The metacognitive model may offer benefits in clinical practice that should be investigated further.

Preliminary research supports the feasibility of metacognitive therapy (MCT) in children with generalized anxiety, but the effectiveness of MCT in treating children with other anxiety and depressive disorders largely remains unknown. The purpose of this study was to investigate the effects associated with MCT in targeting symptoms of anxiety and depression in children and adolescents and to investigate mechanisms proposed by the metacognitive model. Ninety-seven participants aged 10-17 years (M = 12.9 ± 1.9, 82.5 % females) with anxiety and depressive disorders received eight sessions of group MCT. Participants were diagnostically assessed at pre- and post-treatment and completed symptom and process measures before, during, and after treatment, and again at three- and six-month follow-up. Multilevel models were conducted to investigate treatment-related and mediation effects. Results showed large reductions in total symptoms following treatment (d = 1.28). These reductions were associated with, and temporally preceded by changes in cognitive attentional syndrome (CAS), metacognitive beliefs, and self-reported attention control, but not objective attention control. Treatment gains were maintained at six-month follow-up (d = 1.18). Our results indicate that MCT may be a promising treatment for children and adolescents with anxiety and depression and provide preliminary evidence of changes in CAS, metacognition, and perceived attention control as potential drivers of treatment effects.

BackgroundCardiac rehabilitation (CR) services aim to improve heart disease patients’ health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients but psychological treatments have usually had small effects. In contrast, the recent NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. The next stage is to test implementation of MCT within the National Health Service through the creation of a network of CR beacon sites. The study will test the quality of data capture following addition of a new MCT data-field to the national audit of cardiac rehabilitation (NACR), examine level of adoption at sites, examine mental health outcomes benchmarked against usual CR and the PATHWAY data, examine the enablers and barriers to implementation and the expected resource requirements. The study has been registered: NCT05956912 (13th July, 2023).MethodsBeacon sites will be recruited as preliminary adopters of group MCT from NHS CR services in England. A national invitation for expressions of interest from CR services will be issued and those meeting eligibility criteria will be considered for inclusion. Two staff at each site will receive training in MCT, and mixed-methods will be used to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. Exploration of implementation will be informed by Normalisation Process Theory.DiscussionThe study will support development of an NHS roll-out strategy, assess the mental health outcomes associated with MCT, examine treatment fidelity in real-world settings, and evaluate revised data collection structures that can be used to assess the impact of national-level implementation. Trial RegistrationNCT05956912; 13th July 2023.

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.