Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives

NCT04921514 | Completed

• 1 other identifier: CHUBX 2020/44
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Resuscitated Sudden Cardiac Death

Keywords

Sudden cardiac death

Outcome Measures

Primary Outcomes (1)

• Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD

  The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire

  Month 3

Secondary Outcomes (2)

• Proportion of patients and/or relatives with acute stress disorder

  Day 0

• Proportion of patients and/or relatives with trauma vulnerability

  Month3

Study Arms (1)

Patient and relatives

EXPERIMENTAL

Behavioral: SASRQ questionnaire; Behavioral: PCL-5 with LEC-5 questionnaire

Interventions

SASRQ questionnaire BEHAVIORAL

During an interview with a trained psychologist, the presence of acute stress will be assessed by the SASRQ test within one week of the occurrence of a sudden recovered death. The diagnosis of acute post-traumatic stress disorder is made according to the presence of at least three dissociative symptoms out of five, and other symptoms of re-experiencing, avoidance or marked anxiety or hypervigilance. Each symptom is thus evaluated dichotomously. A symptom is present if the intensity of the response is 3 or more (0 "from 0 to 2" and 1 "from 3 to 5").

Patient and relatives

PCL-5 with LEC-5 questionnaire BEHAVIORAL

This questionnaire will be completed during an interview with a psychologist trained in the protocol, 3 months after the sudden death. The PCL-5 is a 20-item self-report questionnaire that assesses the 20 symptoms of PTSD according to the DSM-V. It is associated with the LEC-5 questionnaire. The self-reported scale uses ratings of "0 to 4" to assess each of the symptoms. A threshold of 38 on the PCL-5 seems reasonable to suggest the presence of PTSD.

Patient and relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeline Banos

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 40 participants (20 patients and 20 relatives)

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: May 18, 2021
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

FR (1)