Emotional Regulation in Patients With Implanted Automatic Defibrillator

NCT04235881 | Completed

• 1 other identifier: MF_DAI_La_PAZ
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The general objective of the study was to evaluate the impact of two emotional regulation programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and, another, implemented through a mobile phone application (REM\_Volver a casa; ERBM\_Back home: Emotional Regulation Based on Mindfulness), on the quality of life, the state emotional and psychological and biological variables associated with stress, in a sample of patients with ICD (implantable cardioverter defibrillator). The working hypotheses were that after training in emotional regulation, patients with ICD would have better quality of life, lower symptoms of anxiety, depression and hostility, and lower incidence of ventricular arrhythmias than patients in the control group, as well as that there would be no differences between the two tools used for training.

Conditions

Cardiac Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia

Keywords

Implantable automatic defibrillator; Emotional regulation; MBSR; App; Quality of life; Mindfulness; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life

  The questionnaire (SF-36: Short Form) uses a Likert scale of 3 or 5 points, with a range of scores from 0 to 100, average of 50 and standard deviation 10.

  In order to assess the change at the Quality of life variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.

Secondary Outcomes (8)

• Anxiety and Depression

  In order to assess the change at the anxiety and depression variables, were measured just before starting the mindfulness training program and, eight weeks later, after finishing it.

• Anger

  In order to assess the change at the Anger variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.

• AHR

  To assess the change in the AHR variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.

• NSVT

  To assess the change in the NSVT variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.

• LVEF

  The value of this parameter is recorded at the beginning of the study.

Other Outcomes (1)

• Mindfulness attitude

  The data corresponding to the mindfulness attitude measured just before starting the mindfulness training program and, eight weeks later, after finishing it.

Study Arms (3)

MBSR group

EXPERIMENTAL

Enforcement of the standardized program Mindfulness-Based Stress Reduction

Behavioral: Mindfulness-based stress reduction program

App group.

EXPERIMENTAL

Enforcement of the emotional regulation program based on mindfulness (ERM) through the mobile phone application REM volver a casa

Behavioral: App REM volver a casa

Control group

NO INTERVENTION

Usual care

Interventions

Mindfulness-based stress reduction program BEHAVIORAL

Mindfulness training through an adaptation of the standardized MBSR program. This program was conducted in person and in a group, with a maximum of 25 participants per group and a total duration of 8 weeks. The training was carried out in 8 sessions, one each week, with a duration of 2 h each session.

MBSR group

App REM volver a casa BEHAVIORAL

The intervention was carried out through the computer application for mobile phone "REM volver a casa". This application has been developed to carry out training in the emotional regulation program based on mindfulness, autonomously. The application is designed to carry out the program in 8 weeks.

App group.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or greater than 18 years.
• Be a patient of the University Hospital La Paz and have an ICD implanted whose implant was equal to or greater than three months.
• Sufficient knowledge of the Spanish language.
• Have a mobile phone and the ability to handle applications on the phone.
• Availability and sufficient physical conditions to attend mindfulness training in the face-to-face format.

You may not qualify if:

• Be over 75 years old.
• Be waiting for a heart transplant or other operation related to cardiac pathology.
• Have previous training in mindfulness, unless it had been done before 5 years and had not been practiced since then.
• Being diagnosed with a serious mental disorder and being in an acute symptomatic period of the disease.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular; Emotional Regulation; Alzheimer Disease; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Self-Control; Social Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms

Study Officials

• Beatriz Rodríguez Vega, Doctor

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental study was developed through a randomized controlled clinical trial, with simple random probabilistic sampling. With a pre-post design, the variables measured in the participants before performing the mindfulness training were measured again at the end of the program, eight weeks later, in order to compare the values of both measurements.

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: January 22, 2020
• Study Start: February 15, 2017
• Primary Completion: February 15, 2017
• Study Completion: May 30, 2018
• Last Updated: January 22, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)