Abstract
BackgroundAnxiety 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03129282, Submitted to Registry: 11 April 2017.
Highlights
Anxiety and depression are common among patients attending cardiac rehabilitation services
European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5 L) [56, 57] The ED-5D-5 L is a standardised questionnaire for use as a measure of health status and its use is recommended in the National Institute for Health and Clinical Excellence guidelines for economic evaluation [58]
Forty-five percent of patients referred to cardiovascular rehabilitation (CR) report clinically significant levels of anxiety or depression, and most patients continue to experience these symptoms after completing CR programmes [28]
Summary
Design The PATHWAY Home-MCT is a single-blind feasibility randomised controlled trial with 4- and 12-month follow-up comparing Home-MCT alongside usual CR (intervention) versus usual CR (control). Adherence and User-Friendliness Questionnaire The Adherence and User-Friendliness Questionnaire was developed for this study and includes six questions that assess how many modules were completed (ranging from 0 to 6), how accessible, easy to follow, easy to understand and easy to use the Home-MCT manual is, and how much the participant needed the supportive telephone calls. Quantitative analysis To assess acceptability of Home-MCT, descriptive statistics will be used to evaluate participant ratings on the credibility, adherence and user-friendliness questionnaires, along with rates of completion of the first four modules of the Home-MCT manual. Within trial analyses include using a 4-month time horizon, varying the assumptions and components used to estimate the unit cost of Home-MCT and using alternative measures of health benefit (primary and key secondary clinical outcomes). The findings will be presented at national, international and regional conferences and in public involvement events where the information from this study is relevant
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