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

Abstract

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. In a randomized controlled trial, Adrian Wells and colleagues test the effectiveness of adding self-help metacognitive therapy to cardiac rehabilitation in reducing anxiety and depression. Author summary Why was this study done? One-third of cardiovascular disease (CVD) patients suffer anxiety and depression symptoms, but psychological support in cardiac rehabilitation (CR) is limited and produces small effects. Treating anxiety and depression is important because they are associated with worse health outcomes and impair quality of life. Previously, a recent treatment called metacognitive therapy (MCT) significantly improved anxiety and depression in patients undergoing CR when delivered by cardiac staff. Home-based self-help MCT was previously found to be feasible and acceptable to deliver alongside CR, hence a full-scale trial was required to test the effectiveness of this self-help intervention. What did the researchers do and find? We used a single-blind parallel randomised trial to test the effectiveness of self-help MCT. A total of 240 CR patients with elevated anxiety and/or depression received either usual CR or usual CR plus self-help MCT. The addition of self-help MCT significantly improved anxiety and depression (Hospital Anxiety and Depression Scale (HADS)) compared to CR alone (standardised mean difference (SMD) = 0.38). In CR alone, 36% of patients met criteria for minimal clinically important improvement, compared to 59% achieving this status under MCT self-help. MCT self-help plus CR was also found to improve post-traumatic stress symptoms to a greater extent than CR alone. An unexpected finding was that MCT self-help was also associated with a reduced rate in worsening of anxiety and depression during CR. What do these findings mean? Anxiety and depression in CVD can be effectively managed with self-help MCT. Self-help MCT has the potential in the future to improve health outcomes, reduce the risk of psychological deterioration in CVD, and improve access to evidence-based psychological care. The current findings do not address long-term outcomes, but they support a future policy of managing the psychological needs of patients undergoing CR with a menu of MCT options that includes home-based self-help.