Wells, Adrian, Reeves, David, Heal, Calvin, Fisher, Peter 
ORCID: 0000-0002-7388-720X, Doherty, Patrick, Davies, Linda, Heagerty, Anthony and Capobianco, Lora
(2023)
Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.
PLOS MEDICINE, 20 (1).
e1004161-.
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Abstract
<h4>Background</h4>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).<h4>Methods and findings</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>NCT03999359.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Cardiovascular Diseases, Depression, Anxiety, Anxiety Disorders, Quality of Life, Cost-Benefit Analysis, England |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 01 Feb 2023 16:31 |
| Last Modified: | 03 May 2023 18:04 |
| DOI: | 10.1371/journal.pmed.1004161 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3168078 |
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