Impact of a Stress Reduction, Meditation, and Mindfulness Program in Patients with Chronic Heart Failure: A Randomized Controlled Trial

Abstract

Heart Failure is a significant public health problem leading to a high burden of physical and psychological symptoms despite optimized therapy. To evaluate primarily the impact of a Stress Reduction, Meditation, and Mindfulness Program on stress reduction of patients with Heart Failure. A randomized and controlled clinical trial assessed the effect of a stress reduction program compared to conventional multidisciplinary care in two specialized centers in Brazil. The data collection period took place between April and October 2019. Thirty-eight patients were included and allocated to the intervention or control groups. The intervention took place over 8 weeks. The protocol assessed the scales of perceived stress, depression, quality of life, anxiety, mindfulness, quality of sleep, a 6-minute walk test, and biomarkers analyzed by a blinded team, considering a p-value <0.05 statistically significant. The intervention resulted in a significant reduction in perceived stress from 22.8 ± 4.3 to 14.3 ± 3.8 points in the perceived stress scale-14 items in the intervention group vs. 23.9 ± 4.3 to 25.8 ± 5.4 in the control group (p-value<0.001). A significant improvement in quality of life (p-value=0.013), mindfulness (p-value=0.041), quality of sleep (p-value<0.001), and the 6-minute walk test (p-value=0.004) was also observed in the group under intervention in comparison with the control. The Stress Reduction, Meditation, and Mindfulness Program effectively reduced perceived stress and improved clinical outcomes in patients with chronic Heart Failure.

: Impacto de um Programa de Redução do Estresse, Meditação e Mindfulness em Pacientes com Insuficiência Cardíaca Crônica: Um Ensaio Clínico Randomizado

Figura 1. – Fluxograma do processo de seleção de participantes para o ensaio clínico randomizado.

Figura 2. – Média e intervalo de confiança de 95% das medidas: A) Escala de estresse percebido, 14 itens – PSS-14; B) Inventário Freiburg de Mindfulness-Brasil – FMI-Br; C), Questionário de qualidade de vida de Minnesota – MLHFQ; D) Índice de qualidade do sono de Pittsburgh – PSQI; E) Teste de 6 minutos de caminhada – T6MC; F) Cortisol, todos em relação ao comportamento cruzado de grupo e tempo (p-valor dentro do quadro para I: Interação, G: Grupo, T: Tempo) e com p-valor nas chaves do resultado post-hoc < 0,05 via Bonferroni. Todas as variáveis foram medidas em pontos dos respectivos escores das escalas, exceto capacidade funcional e cortisol, que foram medidos em metros e mcg/dL, respectivamente.

: Impact of a Stress Reduction, Meditation, and Mindfulness Program in Patients with Chronic Heart Failure: A Randomized Controlled Trial

Figure 1. – Selection process flowchart of the participants for the randomized controlled trial.

Figure 2. – Mean and 95% confidence interval of measurements: A) Perceived stress scale, 14 items – PSS-14; B) Freiburg Mindfulness Inventory - Brazil – FMI-Br; C) Minnesota living with heart failure questionnaire – MLHFQ; D) Pittsburgh sleep quality index – PSQI; E) 6-minute walk test – T6MC; F) Cortisol, all concerning cross-group behavior and time (p-value within the frame for I: Interaction, G: Group, T: Time) and with a p-value of the in post-hoc results < 0.05 via Bonferroni on the brackets. All the variables were measured in points of the respective scale scores, except for functional capacity and cortisol, measured in meters and mcg/dL, respectively.