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Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.
Wells, Adrian; Reeves, David; Heal, Calvin; Fisher, Peter; Doherty, Patrick; Davies, Linda; Heagerty, Anthony; Capobianco, Lora.
Affiliation
  • Wells A; Faculty of Biology, Medicine and Health, School of Psychological Sciences, The University of Manchester, Manchester, United Kingdom.
  • Reeves D; Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.
  • Heal C; NIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.
  • Fisher P; NIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.
  • Doherty P; Institute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom.
  • Davies L; Liverpool Clinical Health, The Royal Liverpool and Broadgreen University Hospital NHS Trust, Liverpool, United Kingdom.
  • Heagerty A; Department of Health Sciences, University of York, York, United Kingdom.
  • Capobianco L; Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology Medicine and Health, School of Health Sciences, The University of Manchester, Manchester, United Kingdom.
PLoS Med ; 20(1): e1004161, 2023 01.
Article in En | MEDLINE | ID: mdl-36719886
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.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cardiovascular Diseases Type of study: Clinical_trials / Diagnostic_studies Aspects: Patient_preference Limits: Humans Country/Region as subject: Europa Language: En Journal: PLoS Med Journal subject: MEDICINA Year: 2023 Document type: Article Affiliation country: United kingdom Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cardiovascular Diseases Type of study: Clinical_trials / Diagnostic_studies Aspects: Patient_preference Limits: Humans Country/Region as subject: Europa Language: En Journal: PLoS Med Journal subject: MEDICINA Year: 2023 Document type: Article Affiliation country: United kingdom Country of publication: United States