Emotional Regulation in Patients With Implanted Automatic Defibrillator
Condition: Cardiac Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia
MeSH terms: Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation
Study type: Interventional

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.
    

Intervention name(s): Mindfulness-based stress reduction program; App REM volver a casa
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Implantable automatic defibrillator; Emotional regulation; MBSR; App; Quality of life; Mindfulness; Anxiety; Depression