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

Centre Hospitalier Universitaire de Besancon1 site in 1 country18 target enrollmentSeptember 2014

ConditionsImplantable Defibrillator User

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Implantable Defibrillator User
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 18
Locations: 1
Primary Endpoint: Mini International Neuropsychiatric Interview score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

Eligibility Criteria

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