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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02902458

Acronym

PEACE

Enrollment

Registered

2016-09-15

Start date

2014-09-30

Completion date

2016-08-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable Defibrillator User

Keywords

implantable cardioverter defibrillator, primary prevention, psychological follow-up, anxiety, depression, quality of life

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.

Interventions

OTHERIndividual interview with a qualified psychologist

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mini International Neuropsychiatric Interview score	48 hours after implantation

Secondary

Measure	Time frame	Description
Quality of life	48 hours after implantation	Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
State-Trait Anxiety Inventory	48 hours after implantation	Measure of state and trait anxiety
Minnesota Living with Heart Failure questionnaire	48 hours after implantation	Evaluation of the quality of life in patients with heart failure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026