Abstract
BackgroundMany patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress. Such stress is associated with increased morbidity, reduced quality of life and delayed return to work. European guidelines emphasize recognition and intervention, but evidence-based treatment options are limited and perceived as costly. The present study will test the effect of brief, group-based cognitive therapy as an adjunct to usual cardiac rehabilitation in a randomized design.MethodsA total of 148 patients with CAD and/or VHD after surgical intervention and concomitant psychological distress (defined as HADS anxiety (A) or depression (D) score ≥8) will be randomized to either usual out-patient cardiac rehabilitation (CR) comprising an 8-week multidisciplinary programme or usual care supplemented by five group-based cognitive therapy sessions performed by trained CR nurses. A structured, standardized treatment manual will be used. Patients will be randomized 1:1 at three different sites. Additionally, a non-randomized sub-group of 40 matched patients without signs of psychological distress will be followed to investigate spontaneous variation in HADS. The primary outcome is Hospital Anxiety and Depression Score (HADS). Secondary outcomes are adherence to cardiac rehabilitation (CR), health-related quality of life measured by HeartQoL, time to return to work, adherence to lifestyle interventions and cardiovascular readmissions. Patients are followed up for 12 months.DiscussionTo our knowledge, this is the first randomized controlled trial (RCT) on patients with cardiac disease with an intensive group-based programme of cognitive therapy performed by CR nurses, which makes it affordable and widely implementable. The outcome will elucidate the feasibility and effect of cognitive therapy as an adjunct to CR in patients with post-surgery CAD and/or VHD and psychological distress and could possibly benefit patients with other heart conditions as well. The clinical trial complies with the Declaration of Helsinki. The trial has been approved by The Regional Research Ethics Committee (file number H-16042832) and The Danish Data Protection Agency. The results will be disseminated as original research in peer-reviewed manuscripts.Trial registrationwww.clinicaltrials.govNCT04254315. Retrospectively registered on 30 January 2020.
Highlights
Many patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress
The importance of recognizing this condition is underlined by studies that find that psychological distress impairs quality of life (QoL) but is associated with increased rates of cardiac and all-cause mortality [3, 4]
Data from the national SWEDEHEART registry show that patients with persistent emotional distress following acute coronary syndrome (ACS) were more likely to die from cardiovascular and non-cardiovascular causes than those with no distress [5]
Summary
Many patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress. Such stress is associated with increased morbidity, reduced quality of life and delayed return to work. Patients undergoing valvular heart surgery have received less attention in current research, but one study has indicated that after aortic valve surgery female patients have anxiety symptoms at a level equal to that of patients with coronary artery disease (CAD) [6]. In one study of 5908 patients with heart disease and moderate depression, those with anxiety or stress symptoms were significantly less likely to adhere to CR than those with normal-to-mild symptoms [8]. Psychological distress has an impact by retaining patients with cardiac disease from returning to working.
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