Clinical trial NCT05967247: MBSR on Physiological and Psychological Factors in Patients With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Mindfulness-based stress reduction
Application
Resilience
Heart failure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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. 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: quality of life (SF-12v2）
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
Secondary outcomes:
measure: depression
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
measure: mindfulness
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
measure: Resilience
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
Other outcomes:
measure: medication adherence
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
measure: Heart rate variability (HRV)
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
measure: heart rate (pulse)
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
measure: blood pressure (BP)
timeFrame: T0, T1 = 8 weeks, T2 = 16 weeks.
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
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