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

Depression Clinical Trial

— MBI-CIED  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06021236
• Other study ID #: MKC-23MMHIS220e
• Secondary ID: 23MMHIS220e
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Patients receiving implanted cardiac devices for the first time (including cardiac defibrillator ICD and Pacemaker).

2. Adults over 20 years old.

3. Those who have clear consciousness and can communicate in Chinese and Taiwanese.

4. Score of 8 or above on the Hospital Anxiety or Depression Scale.

5. Barthel Index above 70 points.

Exclusion Criteria:

1. Diagnosed with dementia by a physician.

2. Diagnosed with mental disorders, including cognitive disorders, organic psychosis and affective psychosis.

3. Patients who have been diagnosed with cancer.

4. Long-term bed ridden.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• mindfulness-based intervention
Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing

Other:
• CIED procedure routine care
CIED procedure home care guidance

Locations

Country	Name	City	State
Taiwan	MacKay Junior College of Medicine, Nursing and Management	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chien Chih-Yin	National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Freedenberg VA, Thomas SA, Friedmann E. A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers. Pediatr Cardiol. 2015 Apr;36(4):786-95. doi: 10.1007/s00246-014-1081-5. Epub 2 — View Citation

Hazlett-Stevens H, Singer J, Chong A. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy with Older Adults: A Qualitative Review of Randomized Controlled Outcome Research. Clin Gerontol. 2019 Jul-Sep;42(4):347-358. doi: 10.1080/073 — View Citation

Hopgood DA, Czosek RJ, Bakas T, Garritano N, Gillespie GL. The Capture Gap: Implantable Cardioverter-Defibrillator Quality of Life. Clin Nurs Res. 2020 Feb;29(2):97-107. doi: 10.1177/1054773818803741. Epub 2018 Oct 7. — View Citation

Li SYH, Bressington D. The effects of mindfulness-based stress reduction on depression, anxiety, and stress in older adults: A systematic review and meta-analysis. Int J Ment Health Nurs. 2019 Jun;28(3):635-656. doi: 10.1111/inm.12568. Epub 2019 Jan 17. — View Citation

Marino F, Failla C, Carrozza C, Ciminata M, Chila P, Minutoli R, Genovese S, Puglisi A, Arnao AA, Tartarisco G, Corpina F, Gangemi S, Ruta L, Cerasa A, Vagni D, Pioggia G. Mindfulness-Based Interventions for Physical and Psychological Wellbeing in Cardiov — View Citation

Rafsanjani MHAP, Masoudi S, Radmanesh M, Bostani Z. Comparison of depression and anxiety among pacemaker and implantable cardioverter-defibrillator recipients: A cross-sectional study. Pacing Clin Electrophysiol. 2021 Feb;44(2):235-239. doi: 10.1111/pace. — View Citation

Schulz SM, Ritter O, Zniva R, Nordbeck P, Wacker C, Jack M, Groschup G, Deneke T, Puppe F, Ertl G, Angermann C, Stork S, Pauli P. Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibril — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores.	From enrollment to the end of treatment at 6 months
Primary	Resilience	This study uses the Connor-Davidson Resilience Scale (Connor-Davidson Resilience Scale), which was developed by Connor and Davidson (2003) in the United States who regarded resilience as a measurable stress response ability.	From enrollment to the end of treatment at 6 months
Primary	Perceived Stress	This study uses the Perceived Stress Scale, which was compiled by Cohen et al. (1983) and translated from the Chinese version of Chu and Gao (2005). , the degree of stress in life.	From enrollment to the end of treatment at 6 months
Primary	Depression	This study used the Hospital Anxiety and Depression Scale (HADS) to assess depression in patients. This scale provides anxiety (HADS-D) scores.	From enrollment to the end of treatment at 6 months
Secondary	Demographic Information	Collect age, gender, education level, marital status, occupation, smoking, drinking, disease history, other disease history, and exercise habits with self-made basic data sheets.	From enrollment to the end of treatment at 6 months
Secondary	body mass index	weight and height will be combined to report BMI in kg/m^2	From enrollment to the end of treatment at 6 months
Secondary	Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program	Intentional sampling with phenomenological method. Conduct one-on-one interview recordings for the research subjects in the experimental group to collect the feelings and experiences of patients with implanted cardiac devices who received the mindfulness-based preoperative intervention program. It is expected to close the case until the data is saturated.	From enrollment to the end of treatment at 6 months