MBSR on Physiological and Psychological Factors in Patients With HF (MBSR-PP-HF)

December 23, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBSR
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
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.
Other Names:
  • Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.
Other: the "Heart Care Life" app
Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.
Other: APP
APP
Placebo Comparator: waiting list

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life (SF-12v2）
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
short-form health survey (SF-12v2）, Cronbach's α = 0.76～0.85.
T0, T1 = 8 weeks, T2 = 16 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
patient health questionnaire (PHQ-9）, Cronbach's α = 0.84
T0, T1 = 8 weeks, T2 = 16 weeks.
mindfulness
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
five facet mindfulness questionnaire-short form (FFMQ-SF）, Cronbach's α= 0.69～0.85.
T0, T1 = 8 weeks, T2 = 16 weeks.
Resilience
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
Connor-Davidson resilience scale (CD-RISC-10）, Cronbach's α = 0.94
T0, T1 = 8 weeks, T2 = 16 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication adherence
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
Medication Adherence Self-Reported by Patient
T0, T1 = 8 weeks, T2 = 16 weeks.
Heart rate variability (HRV)
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
Measured with a non-plunging wrist-worn instrument
T0, T1 = 8 weeks, T2 = 16 weeks.
heart rate (pulse)
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
Measured according to the blood pressure measuring instrument regularly calibrated by the hospital
T0, T1 = 8 weeks, T2 = 16 weeks.
blood pressure (BP)
Time Frame: T0, T1 = 8 weeks, T2 = 16 weeks.
Measured according to the blood pressure measuring instrument regularly calibrated by the hospital
T0, T1 = 8 weeks, T2 = 16 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

November 20, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307171RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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