MBSR on Physiological and Psychological Factors in Patients With HF

NCT05967247 | Completed DMC

• 1 other identifier: 202307171RINA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Heart Failure

Keywords

Mindfulness-based stress reduction; Application; Resilience; Heart failure

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• depression

  T0, T1 = 8 weeks, T2 = 16 weeks.

• mindfulness

  T0, T1 = 8 weeks, T2 = 16 weeks.

• Resilience

  T0, T1 = 8 weeks, T2 = 16 weeks.

Other Outcomes (4)

• medication adherence

  T0, T1 = 8 weeks, T2 = 16 weeks.

• Heart rate variability (HRV)

  T0, T1 = 8 weeks, T2 = 16 weeks.

• heart rate (pulse)

  T0, T1 = 8 weeks, T2 = 16 weeks.

Study Arms (2)

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.

Other: The experimental group used App for MBSR intervention; Other: the "Heart Care Life" app; Other: APP

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.

Other: the "Heart Care Life" app; Other: APP

Interventions

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.

Also known as: Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.

MBSR

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.

MBSR; waiting list

APP OTHER

APP

MBSR; waiting list

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

• (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).
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Related Publications (16)

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

  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.

  PMID: 10037647 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.

  PMID: 35482335 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.

  PMID: 35379503 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.

  PMID: 25694852 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.

  PMID: 37001879 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.

  PMID: 36556174 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.

  PMID: 6895078 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.

  PMID: 28661991 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.

  PMID: 6996728 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.

  PMID: 4671576 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.

  PMID: 36181030 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.

  PMID: 31011624 BACKGROUND

• 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.

  PMID: 31573916 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.

  PMID: 33010903 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.

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Difficult to blind study caregivers and study outcome assessors due to the nature of the mindfulness-based stress reduction intervention
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: September 18, 2023
• Primary Completion: February 28, 2024
• Study Completion: November 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-08

Locations

TW (1)