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The heart & mind trial: intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety:
Selina Kikkenborg Berg1,2,3, Margrethe Herning4, Inge Schjødt5
1The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen O, 2100, Denmark selina@rh.dk.
Insights
Anxiety significantly increases mortality risk in cardiac patients. This study investigates if cognitive-behavioral therapy (CBT) reduces anxiety in these patients, aiming to improve outcomes and reduce healthcare costs.
Area of Science:
- Cardiology
- Psychiatry
- Clinical Trials
Background:
- Anxiety affects 20-25% of cardiac patients, doubling their mortality risk.
- Effective anxiety reduction interventions are crucial for improving outcomes in cardiovascular disease patients.
Purpose of the Study:
- To evaluate the efficacy of cognitive-behavioral therapy (CBT) in reducing anxiety among cardiac patients.
- To assess the impact of CBT on secondary outcomes including anxiety symptoms, heart rate variability, stress markers, quality of life, readmission, and mortality.
Main Methods:
- A randomized clinical trial involving 336 cardiac patients screened for anxiety using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A).
- Participants were randomized (1:1) to receive either usual care alone or usual care plus CBT delivered by a trained cardiac nurse.
- Anxiety was assessed using HADS-A at 5 months (primary outcome) and other measures at 12 months.
Main Results:
- Primary outcome: Anxiety levels measured by HADS-A at 5 months.
- Secondary outcomes: Becks Anxiety Inventory, heart rate variability, cortisol, C-reactive protein, quality of life, readmission, mortality, and costs at 12 months.
- Statistical analysis includes linear regression for the primary outcome and mixed regression models for long-term outcomes.
Conclusions:
- The Heart & Mind Trial aims to provide evidence for the effectiveness of CBT in managing anxiety in cardiac patients.
- Findings will inform clinical practice and potentially reduce mortality risk and healthcare costs associated with anxiety in cardiovascular disease.
Introduction:
Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety.
Methods And Analysis:
The Heart & Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements.
Ethics And Dissemination:
The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published.
Trial Registration Number:
NCT04582734.
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