MBSR on Physiological and Psychological Factors in Patients With HF

Heart Failure Clinical Trial

— MBSR-PP-HF  

Official title:

The Effect of App-Based Mindfulness-Based Stress on Physiological and Psychological Factors in Patients With Heart Failure: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967247
• Other study ID #: 202307171RINA
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: Shu-Ling Wang, RN
• Phone: +886223123456
• Email: cryetaljessie[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. To explore the relationship between mindfulness, resilience, depression, and quality of life in patients with heart failure, and to explore the mediating role of positive emotions (mindfulness, resilience).

2. Using a mobile phone app to conduct mindfulness-based stress reduction interventions, to explore the effects of physiological and psychological factors in heart failure patients with depressive symptoms.

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Inclusion Criteria:

• (1) The diagnosis of heart failure is confirmed by a clinician, and the definition of the diagnosis is based on the international statistical classification of diseases and related health problems 10th revision (ICD-10), including I50 Heart failure ( heart failure) related diagnostic codes.

• (2) Legally recognized as an adult ? 18 years old.

• (3) The second part of the experimental research, in addition to the above inclusion conditions, also needs to have a patient health questionnaire = 5 points, which means mild or above (including) depression (Kroenke et al., 2001; Yeung et al., 2008) can be included in the study.

2. Exclusion Criteria:

• (1) Diagnosed by a physician as having depression or taking antidepressant drugs regularly, such as selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), monoamine oxidase inhibitors (monoamine oxidase inhibitor, MAOI), tetracyclic antidepressants (TeCA), norepinephrine And specific serotonergic antidepressants (Noradrenergic and specific serotonergic antidepressants, NaSSA).

• (2) New York heart association functional classification (NYHA Fc) IV, which means that it is uncomfortable to perform any physical activity, even when lying in bed or moving, you may feel symptoms such as dyspnea or palpitations.

• (3) Those who still need to use oxygen or breathing aids throughout the day.

• (4) Those who are still equipped with ventricular assist devices and rely on life-support devices.

• (5) Activities of daily living (ADL) < 60 points, unable to take care of themselves in daily life.

• (6) For those with abnormal cognitive function, the mini-mental state examination (MMSE) < 24 points.

• (7) Those who have undergone heart transplantation have lost innervation because there is no connection between the autonomic nerve and the heart (McCraty & Shaffer, 2015).

• (8) In the second part of the interventional experimental research, in addition to the above exclusion conditions, in order to avoid interference with the research, it is also necessary to exclude:

• A. Those who cannot read traditional Chinese or communicate in Mandarin or Taiwanese, because health education-related materials, videos and applications are all in traditional Chinese.

• B. Those who cannot use Android devices at home with smartphones or tablets need to operate the application at home due to intervention measures.

• C. Those who have regularly taken measures related to mindfulness, meditation, and sitting meditation in the past year are not included in order to avoid interfering with the research results.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• The experimental group used App for MBSR intervention
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.
• the "Heart Care Life" app
Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.
• Phone interview once a week
Phone interview once a week

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567. — View Citation

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. — View Citation

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. Erratum In: BMJ 1999 Jun 12;318(7198):1584. — View Citation

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. — View Citation

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. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

MIT (2012). APP Inventor. Massachusetts Institute of Technology. United States. https://appinventor.mit.edu/

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	medication adherence	Medication Adherence Self-Reported by Patient	T0, T1 = 8 weeks, T2 = 16 weeks.
Other	Heart rate variability (HRV)	Measured with a non-plunging wrist-worn instrument	T0, T1 = 8 weeks, T2 = 16 weeks.
Other	heart rate (pulse)	Measured according to the blood pressure measuring instrument regularly calibrated by the hospital	T0, T1 = 8 weeks, T2 = 16 weeks.
Other	blood pressure (BP)	Measured according to the blood pressure measuring instrument regularly calibrated by the hospital	T0, T1 = 8 weeks, T2 = 16 weeks.
Primary	quality of life (SF-12v2)	short-form health survey (SF-12v2), Cronbach's a = 0.76~0.85.	T0, T1 = 8 weeks, T2 = 16 weeks.
Secondary	depression	patient health questionnaire (PHQ-9), Cronbach's a = 0.84	T0, T1 = 8 weeks, T2 = 16 weeks.
Secondary	mindfulness	five facet mindfulness questionnaire-short form (FFMQ-SF), Cronbach's a= 0.69~0.85.	T0, T1 = 8 weeks, T2 = 16 weeks.
Secondary	Resilience	Connor-Davidson resilience scale (CD-RISC-10), Cronbach's a = 0.94	T0, T1 = 8 weeks, T2 = 16 weeks.

External Links

•   Chia-Jung Hsieh
•   Chih-fan Yeh
•   Shu-Ling Wang