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

NCT06021236 | Terminated DMC

• 2 other identifiers: MKC-23MMHIS220e23MMHIS220e
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Demographic Information

  From enrollment to the end of treatment at 6 months

• body mass index

  From enrollment to the end of treatment at 6 months

• Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program

  From enrollment to the end of treatment at 6 months

Study Arms (2)

mindfulness-based intervention and routine care

EXPERIMENTAL

mindfulness-based intervention including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the experimental group that met the including criteria, in addition to following the routine care of the hospital, was involved in teaching the above mindfulness skills, and Osaka continued to follow the regular care.

Behavioral: mindfulness-based intervention; Other: CIED procedure routine care

The control group received the CIED procedure routine care

OTHER

From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the control group that met the including criteria take routine care of the hospital.

Other: CIED procedure routine care

Interventions

mindfulness-based intervention BEHAVIORAL

Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing

Also known as: mindfulness-based intervention with CIED procedure routine care

mindfulness-based intervention and routine care

CIED procedure routine care OTHER

CIED procedure home care guidance

The control group received the CIED procedure routine care; mindfulness-based intervention and routine care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving implanted cardiac devices for the first time (including cardiac defibrillator ICD and Pacemaker).
• Adults over 20 years old.
• Those who have clear consciousness and can communicate in Chinese and Taiwanese.
• Score of 8 or above on the Hospital Anxiety or Depression Scale.
• Barthel Index above 70 points.

You may not qualify if:

• Diagnosed with dementia by a physician.
• Diagnosed with mental disorders, including cognitive disorders, organic psychosis and affective psychosis.
• Patients who have been diagnosed with cancer.
• Long-term bed ridden.

Sponsors & Collaborators

• Chien Chih-Yin: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

MacKay Junior College of Medicine, Nursing and Management

Taipei, 11260, Taiwan

Location

Related 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 2014 Dec 12.

  PMID: 25519914 RESULT

• 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: 10.1080/07317115.2018.1518282. Epub 2018 Sep 11.

  PMID: 30204557 RESULT

• 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.

  PMID: 30295057 RESULT

• 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.

  PMID: 30656813 RESULT

• 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 Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Brain Sci. 2021 May 29;11(6):727. doi: 10.3390/brainsci11060727.

  PMID: 34072605 RESULT

• 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.14152. Epub 2021 Jan 12.

  PMID: 33372277 RESULT

• 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-defibrillators: the randomized controlled ICD-FORUM trial. Eur Heart J. 2020 Mar 14;41(11):1203-1211. doi: 10.1093/eurheartj/ehz134.

  PMID: 30957867 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• CY Chien, PI

  MKC/MMH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: This study is a randomized clinical trial design (randomized clinical trial) with qualitative analysis, which is a mixed-methods research. Research objects were randomly assigned to the experimental and control groups in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care, and the control group received usual care. A total of four questionnaires were filled in the pretest (T0), the first month of discharge (T1), the 3rd month of discharge(T2), and the 6th month of discharge (T3), including anxiety, depression, mental toughness, and stress perception. Qualitative interviews were conducted at T2 and T3 to understand the improvement of psychological problems.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: September 1, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)