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

ABSTRACT: 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.

SUBMITTER: Shields GE

PROVIDER: S-EPMC7485258 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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

Shields Gemma E GE Wells Adrian A Doherty Patrick P Reeves David D Capobianco Lora L Heagerty Anthony A Buck Deborah D Davies Linda M LM

BMJ open 20200910 9

<h4>Introduction</h4>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 dep ...[more]

PMID: 32912974

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Project description:BACKGROUND:Anxiety and depression are common among patients attending cardiac rehabilitation services. Currently available pharmacological and psychological interventions have limited effectiveness in this population. There are presently no psychological interventions for anxiety and depression integrated into cardiac rehabilitation services despite emphasis in key UK National Health Service policy. A new treatment, metacognitive therapy, is highly effective at reducing anxiety and depression in mental health settings. The principal aims of the current study are (1) to evaluate the acceptability of delivering metacognitive therapy in a home-based self-help format (Home-MCT) to cardiac rehabilitation patients experiencing anxiety and depressive symptoms and conduct a feasibility trial of Home-MCT plus usual cardiac rehabilitation compared to usual cardiac rehabilitation; and (2) to inform the design and sample size for a full-scale trial. METHODS:The PATHWAY Home-MCT trial is a single-blind feasibility randomised controlled trial comparing usual cardiac rehabilitation (control) versus usual cardiac rehabilitation plus home-based self-help metacognitive therapy (intervention). Economic and qualitative evaluations will be embedded within the trial. Participants will be assessed at baseline and followed-up at 4 and 12 months. Patients who have been referred to cardiac rehabilitation programmes and have a score of ??8 on the anxiety and/or depression subscales of the Hospital Anxiety and Depression Scale will be invited to take part in the study and written informed consent will be obtained. Participants will be recruited from the National Health Service in the UK. A minimum of 108 participants will be randomised to the intervention and control arms in a 1:1 ratio. DISCUSSION:The Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03129282 , Submitted to Registry: 11 April 2017.

Project description:Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms.The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health-related quality of life, severity of post-traumatic stress symptoms and strength of metacognitive beliefs at 4- and 12-month follow-up. Qualitative interviews will help to develop an account of barriers and enablers to the effectiveness of the intervention.This trial will evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy in alleviating anxiety and depression in cardiac rehabilitation patients. The therapy, if effective, offers the potential to improve psychological wellbeing and quality of life in this large group of patients.UK Clinical Trials Gateway, ISRCTN74643496 , Registered on 8 April 2015.

Project description:IntroductionIt is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.Methods and analysisThe within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.Ethics and disseminationThe study protocol has been approved under Australia's National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001458224).

Project description:BackgroundCardiac rehabilitation (CR), a multidisciplinary program consisting of exercise, risk factor modification and psychosocial intervention, forms an integral part of managing patients after myocardial infarction (MI), revascularization surgery and percutaneous coronary interventions, as well as patients with heart failure (HF). This systematic review seeks to examine the cost-effectiveness of CR for patients with MI or HF and inform policy makers in Singapore on published cost-effectiveness studies on CR.MethodsElectronic databases (EMBASE, MEDLINE, NHS EED, PEDro, CINAHL) were searched from inception to May 2010 for published economic studies. Additional references were identified through searching bibliographies of included studies. Two independent reviewers selected eligible publications based on the inclusion/exclusion criteria. Quality assessment of economic evaluations was undertaken using Drummond's checklist.ResultsA total of 22 articles were selected for review. However five articles were further excluded because they were cost-minimization analyses, whilst one included patients with stroke. Of the final 16 articles, one article addressed both centre-based cardiac rehabilitation versus no rehabilitation, as well as home-based cardiac rehabilitation versus no rehabilitation. Therefore, nine studies compared cost-effectiveness between centre-based supervised CR and no CR; three studies examined that between centre- and home based CR; one between inpatient and outpatient CR; and four between home-based CR and no CR. These studies were characterized by differences in the study perspectives, economic study designs and time frames, as well as variability in clinical data and assumptions made on costs. Overall, the studies suggested that: (1) supervised centre-based CR was highly cost-effective and the dominant strategy when compared to no CR; (2) home-based CR was no different from centre-based CR; (3) no difference existed between inpatient and outpatient CR; and (4) home-based programs were generally cost-saving compared to no CR.ConclusionsOverall, all the studies supported the implementation of CR for MI and HF. However, comparison across studies highlighted wide variability of CR program design and delivery. Policy makers need to exercise caution when generalizing these findings to the Singapore context.

Project description: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.

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

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

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