Clinical trial NCT04921514: Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
Official title: Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Resuscitated Sudden Cardiac Death
Keywords: Sudden cardiac death
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 40 participants (20 patients and 20 relatives)
Primary purpose: OTHER

Brief summary: This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.

Detailed description: In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent (60000/year in France) and often fatal disease (5% survival). Because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. However little studies have evaluated it. Patients who later develop PTSD, generally have acute stress disorder. In patients with resuscitated sudden cardiac death, acute psychological distress is frequent and PTSD was identified in 40% of patients. Concerning relatives, Haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. PTSD was more frequent in people who were witness of the SCD vs those who were not there. Hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others.

This study will evaluate acute stress disorder with SASRQ scale in patients with resuscitated SCD and their relative just after the event. At 3 months, presence of PTSD will be evaluated with PCL-5 and LEC-5 in patients and their relatives.

Eligibility criteria: Inclusion Criteria:

* Patients with resuscitated sudden cardiac death and/or their relative
* Patients who are fluent in French
* Patients who have given their 'no objection to participation to the research'
* Patients of both gender over 18 years
* Women with childbearing potential and effective contraception

Exclusion Criteria:

* People who are not able to give their 'no objection to participate to the research'
* People with major cognitive disorders post sudden cardiac death
* People with known psychiatric disorder
* Women who are known to be pregnant or lactating
* Person deprived of liberty by judicial or administrative decision
* People under legal protection (under the protection of a conservator)

Primary outcomes:
measure: Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
timeFrame: Month 3
Secondary outcomes:
measure: Proportion of patients and/or relatives with acute stress disorder
timeFrame: Day 0
measure: Proportion of patients and/or relatives with trauma vulnerability
timeFrame: Month3
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Adeline Banos
role: PRINCIPAL_INVESTIGATOR
References: