Emotional Regulation in Patients With Implanted Automatic Defibrillator

NCT ID: NCT04235881

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2018-05-30

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.

Detailed Description

The recruitment process of the participants was carried out by telephone, by the medical staff of the arrhythmia's section, who informed the patients the characteristics and objectives of the study.

The sample size was estimated considering an alpha risk of 0.05 and a beta risk of 0.2, in a bilateral contrast, to detect a difference equal to or greater than 10 units in the Quality of life variable. A standard deviation of 20 points and a 20% loss rate were assumed. The estimated n was 237 patients, to distribute in three branches of 79 patients each.

Before beginning the intervention, participants were informed about the research, and were offered the opportunity to ask questions in order to clarify any doubts about it. Next, they were given a Participant Data Collection Notebook. The Notebook included the information on the investigation and the Informed Consent, to be completed and signed; the request for demographic data (age, gender, educational level, etc.); and, the four questionnaires used to assess the psychological variables of study: SF-36 (quality of life), HADS (anxiety and depression), STAXI (hostility) and FFMQ (Mindfulness) For the descriptive analysis, the number of subjects and the corresponding percentage was used in the qualitative variables. In the quantitative variables the mean and standard deviation were used when the variables adjusted to the normal distribution; otherwise, the median and interquartile range (first and third quartile) were used. The normality test used was the Shapiro-Wilk.

In the hypothesis contrast of the pre-post values, of the variables with distribution adjusted to normal, the Student´s t statistic was used for paired data; For the variables whose distribution did not conform to normal, the Wilcoxon Test was chosen.

For the contrast of inter-group hypothesis (independent samples with distribution not adjusted to normal), the Mann Whitney test was used.

For the statistical analysis of data, the SPSS program, version 20, was used.

Conditions

Cardiac Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBSR group

Enforcement of the standardized program Mindfulness-Based Stress Reduction

Group Type: EXPERIMENTAL

Mindfulness-based stress reduction program

Intervention Type: 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.

App group.

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

Group Type: EXPERIMENTAL

App REM volver a casa

Intervention Type: 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.

Control group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-based stress reduction program

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.

Intervention Type: BEHAVIORAL

App REM volver a casa

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Rodríguez Vega, Doctor

Role: PRINCIPAL_INVESTIGATOR

La Paz University Hospital

Locations

La Paz University Hospital

Madrid, , Spain

Countries

Spain

Other Identifiers

MF_DAI_La_PAZ

Identifier Type: -

Identifier Source: org_study_id