Depression Clinical Trial
— MBI-CIEDOfficial 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
Verified date | March 2024 |
Source | National Taipei University of Nursing and Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | MacKay Junior College of Medicine, Nursing and Management | Taipei |
Lead Sponsor | Collaborator |
---|---|
Chien Chih-Yin | National Taipei University of Nursing and Health Sciences |
Taiwan,
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
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 |
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