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Objective
The purpose of this study is to explore the relationship between mindfulness, resilience, depression and quality of life in patients with heart failure, and the effect of mindfulness-based stress reduction intervention with mobile phone application on subjects with depressive symptoms. Therefore, the research objectives are as follows:
Methods This study will be conducted in two parts. The first part will be a cross-sectional study. It is planned to be conducted in the cardiology ward or outpatient clinic of a university-affiliated hospital in northern Taiwan between September and December 2023 after the approval of the Human Experiment Ethics Committee. Contact the patients who meet the research conditions, adopt the intentional sampling method, and plan to accept 180 research objects for the questionnaire survey, the collection tools are the basic information of the research objects, mindfulness, resilience, depression, quality of life scale; in the first part, the patients' Health Questionnaire (patient health questionnaire-9, PHQ-9) was used to screen for depressive symptoms, and when the total score ≧ 5 points, they were invited to participate in the second part of the study. The second part plans to include 68 subjects in the study, adopting a single-blind random allocation waiting list design, using the app designed by the researcher to implement the mindfulness-based stress reduction intervention program, which is planned to be carried out for 8 weeks, and since the beginning of the study, the 8th week (After the intervention in the experimental group), and the 16th week (after the intervention in the control group), a total of three research data collections were carried out.
Expected research results The expected results of the first part of the research are that the research subjects with higher mindfulness have less depression, higher resilience, and better quality of life, and the mindfulness of the research subjects can play a mediating role between depression and quality of life; the second part expects the research subjects After receiving the intervention of mindfulness-based stress reduction on the mobile phone application, it can increase their mindfulness, resilience and quality of life, reduce depression, blood pressure, and improve heart rate variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR | Experimental | The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practising audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate. |
|
| waiting list | Placebo Comparator | The waiting list used only the Heart Care Life app for the first eight weeks, as self-management is an essential element of heart failure treatment (Tsami et al., 2023), following the situation-specific theory of heart failure self-management (the situation- specific theory of heart failure self-care:) (Riegel et al., 2022) and American heart failure guidelines (Heidenreich et al., 2022) design (Tsami et al., 2023; Vellone et al., 2020), mainly for Disease-related knowledge and self-management tools, built-in disease health education electronic audiobooks, diet sodium content calculator, diet water content calculator, activity step calculation, etc., to help research subjects self-manage the disease. Measure T2 at week 8. From the ninth to the sixteenth week, use the Mindful Live app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The experimental group used App for MBSR intervention | Other | The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in Life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practicing audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate. |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life (SF-12v2) | short-form health survey (SF-12v2), Cronbach's α = 0.76~0.85. | T0, T1 = 8 weeks, T2 = 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| depression | patient health questionnaire (PHQ-9), Cronbach's α = 0.84 | T0, T1 = 8 weeks, T2 = 16 weeks. |
| mindfulness | five facet mindfulness questionnaire-short form (FFMQ-SF), Cronbach's α= 0.69~0.85. |
| Measure | Description | Time Frame |
|---|---|---|
| medication adherence | Medication Adherence Self-Reported by Patient | T0, T1 = 8 weeks, T2 = 16 weeks. |
| Heart rate variability (HRV) | Measured with a non-plunging wrist-worn instrument |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100225 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | MIT (2012). APP Inventor. Massachusetts Institute of Technology. United States. https://appinventor.mit.edu/ | ||
| 10037647 | Background | Edhouse J, Wardrope J, Morris FP. Call to needle times after acute myocardial infarction. Delay in calling for help for chest pain. BMJ. 1999 Feb 27;318(7183):597; author reply 598. No abstract available. | |
| 35482335 |
| Label | URL |
|---|---|
| Chih-fan Yeh | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Difficult to blind study caregivers and study outcome assessors due to the nature of the mindfulness-based stress reduction intervention
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| the "Heart Care Life" app | Other | Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app. |
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| APP | Other | APP |
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| T0, T1 = 8 weeks, T2 = 16 weeks. |
| Resilience | Connor-Davidson resilience scale (CD-RISC-10), Cronbach's α = 0.94 | T0, T1 = 8 weeks, T2 = 16 weeks. |
| T0, T1 = 8 weeks, T2 = 16 weeks. |
| heart rate (pulse) | Measured according to the blood pressure measuring instrument regularly calibrated by the hospital | T0, T1 = 8 weeks, T2 = 16 weeks. |
| blood pressure (BP) | Measured according to the blood pressure measuring instrument regularly calibrated by the hospital | T0, T1 = 8 weeks, T2 = 16 weeks. |
| Background |
| Riegel B, Dickson VV, Vellone E. The Situation-Specific Theory of Heart Failure Self-care: An Update on the Problem, Person, and Environmental Factors Influencing Heart Failure Self-care. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):515-529. doi: 10.1097/JCN.0000000000000919. Epub 2022 Apr 27. |
| 35379503 | Background | Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1. |
| 25694852 | Background | McCraty R, Shaffer F. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk. Glob Adv Health Med. 2015 Jan;4(1):46-61. doi: 10.7453/gahmj.2014.073. |
| 37001879 | Background | Vandenbogaart E, Gawlinski A, Grimley KA, Lewis MA, Pavlish C. App-Based Mindfulness Intervention to Improve Psychological Outcomes in Pretransplant Patients With Heart Failure. Crit Care Nurse. 2023 Apr 1;43(2):15-25. doi: 10.4037/ccn2023411. |
| 36556174 | Background | Tabernero C, Gutierrez-Domingo T, Steca P, Castillo-Mayen R, Cuadrado E, Rubio SJ, Farhane-Medina NZ, Luque B. Effectiveness of Mindfulness and Positive Strengthening mHealth Interventions for the Promotion of Subjective Emotional Wellbeing and Management of Self-Efficacy for Chronic Cardiac Diseases. J Pers Med. 2022 Nov 25;12(12):1953. doi: 10.3390/jpm12121953. |
| 6895078 | Background | MacEwen EG, Brown NO, Patnaik AK, Hayes AA, Passe S. Cyclic combination chemotherapy of canine lymphosarcoma. J Am Vet Med Assoc. 1981 Jun 1;178(11):1178-81. No abstract available. |
| 28661991 | Background | Heo S, McSweeney J, Ounpraseuth S, Shaw-Devine A, Fier A, Moser DK. Testing a Holistic Meditation Intervention to Address Psychosocial Distress in Patients With Heart Failure: A Pilot Study. J Cardiovasc Nurs. 2018 Mar/Apr;33(2):126-134. doi: 10.1097/JCN.0000000000000435. |
| 6996728 | Background | Curtis PJ. Globin mRNA in Friend cells: its structure, function and synthesis. Biochim Biophys Acta. 1980 Sep 22;605(3):347-64. doi: 10.1016/0304-419x(80)90016-5. |
| 4671576 | Background | Simas W, Chiossi JC, Abib OA. [Urethral prolapse in a young woman]. Rev Paul Med. 1972 Aug;80(2):83-6. No abstract available. Portuguese. |
| 36181030 | Background | Kang Q, Luo A. The efficacy of mindfulness-based intervention for heart diseases: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2022 Sep 30;101(39):e29649. doi: 10.1097/MD.0000000000029649. |
| 31011624 | Background | Jalali D, Abdolazimi M, Alaei Z, Solati K. Effectiveness of mindfulness-based stress reduction program on quality of life in cardiovascular disease patients. Int J Cardiol Heart Vasc. 2019 Apr 12;23:100356. doi: 10.1016/j.ijcha.2019.100356. eCollection 2019 Jun. |
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| 33010903 | Background | Felsted KF. Mindfulness, Stress, and Aging. Clin Geriatr Med. 2020 Nov;36(4):685-696. doi: 10.1016/j.cger.2020.06.010. Epub 2020 Aug 17. |
| Background | Kabat-Zinn, J., & Hanh, T. N. (2009). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta. |
| Chia-Jung Hsieh | View source |
| Shu-Ling Wang | View source |