Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

Centre Hospitalier Universitaire de Besancon18 enrolled

Overview

This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

The implantation of an ICD in primary prevention is known to increase the rates of anxiety and depression, which can reach up to 45% and 35% respectively in this patient population. Several studies have reported that psychological accompaniment for these patients can alleviate the symptoms of anxiety and/or depression. Therefore, we aim to investigate the utility of psychological follow-up for a period of 1 year after first implantation of an ICD for primary prevention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Implantable Defibrillator User

Interventions

Individual interview with a qualified psychologistOTHER

Individual, recorded interview with a qualified psychologist to discuss any and all subjects related to the ICD implantation, or any other topics deemed relevant by the patient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients (aged 18 years or over) * indication for implantation of an ICD for primary prophylaxis * written informed consent provided * patients with social security coverage Exclusion Criteria: * patients under legal tutorship or guardianship * patients with no social security coverage * patients still within the exclusion period after participation in another clinical trial, as indicated by the national registry of clinical trial volunteers * patients unable to complete the questionnaires (language barriers, mentally deficient, illiteracy or dementia) * patients awaiting heart transplant * patients who refuse to provide written informed consent

Locations (1)

CHU Besancon

Besançon, Besancon, France