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Emotional Regulation in Patients With Implanted Automatic Defibrillator

NCT04235881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-01-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Beatriz Rodríguez Vega, Doctor · La Paz University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-02-15
Completion
2018-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235881 on ClinicalTrials.gov