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

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Implantable Defibrillator User

Treatments: Other: Individual interview with a qualified psychologist

Study type: Interventional

Funder types: Other

Identifiers

NCT02902458

P/2014/217

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Psychological follow-up

Experimental group

Description:

Patients undergoing implantation of an ICD for primary prevention will have an individual interview with a qualified psychologist in addition to standard medical follow-up.

Treatment:

Other: Individual interview with a qualified psychologist

Control

No Intervention group

Description:

Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up.