Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device — MBI-CIED  

Depression Clinical Trial

Official title: Efficacy of a Mindfulness-Based Intervention on Resilience, Perceived Stress, Anxiety, and Depression, in Patients With Cardiovascular Implantable Electronic Device: A Mixed-Methods Research

Status Enrolling by invitation

Clinical Trial Summary

An implantable cardiac defibrillator (implantable cardioverter-defibrillator; ICD) can effectively improve heart rhythm problems and reduce sudden death, and is widely used in the treatment of high-risk patients with fatal arrhythmias or heart rhythm problems that cannot be controlled by drugs . In the whole case of arrhythmia, after receiving home-based cardiac fibrillator treatment, Patients often experience uncertainty, feel the changes in heart, feel the shock of being shocked by the electric shock, and worry about death, These psychological distress, which were characterized by anxiety and depression. for universal. About 25% of patients present with symptoms of anxiety at the time of hospitalization, and 50% suffer from depression which seriously affects quality of life. Therefore, the main purpose of this study to alleviate the occurrence of anxiety and depression, promote disease patients to regain life adaptation, develop accessible care strategies with midfulness-based intervention to help patients overcome psychological distress, reduce stress, anxiety and prevent depression.

Clinical Trial Description

This study with randomized clinical trial design (randomized clinical trial) and qualitative research, which is a qualitative mixed-methods research. Patients were randomly assigned to the experimental group and the control group in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care , and the control group received general routine care. Both groups completed a total of four questionnaires at the pretest (T0), discharge (T1), the first month of discharge (T2), and the third month of discharge (T3), including anxiety, depression, resilience, stress perception scale and other basic data such as demographics and disease characteristics were collected in the pretest.

This study held an expert meeting to extract the techniques of mindfulness measures suitable for this disease attribute and the elderly group, including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patient signed up for the first cardiac device surgery schedule, the experimental group who met the including criteria followed the routine care of the hospital and was involved in teaching the above mindfulness skills, while the control group still followed the routine care. ;

Related Conditions & MeSH terms

• Anxiety
• Cardiac Resynchronization Therapy Devices
• Depression
• Mindfulness Training
• Perceived Stress
• Resilience, Psychological

• NCT number: NCT06021236
• Study type: Interventional
• Source: National Taipei University of Nursing and Health Sciences
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2024
• Completion date: December 30, 2025