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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT04921514

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder Resuscitated Sudden Cardiac Death	Behavioral: SASRQ questionnaire Behavioral: PCL-5 with LEC-5 questionnaire	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

40 participants (20 patients and 20 relatives)40 participants (20 patients and 20 relatives)

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 18, 2021

Anticipated Primary Completion Date :

Aug 18, 2023

Anticipated Study Completion Date :

Aug 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient and relatives	Behavioral: SASRQ questionnaire 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"). Behavioral: PCL-5 with LEC-5 questionnaire 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.

Arm

Intervention/Treatment

Experimental: Patient and relatives

Behavioral: SASRQ questionnaire

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").

Behavioral: PCL-5 with LEC-5 questionnaire

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD [Month 3]
The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire

Secondary Outcome Measures

Proportion of patients and/or relatives with acute stress disorder [Day 0]
The percentage of patients and relatives is determined using the SASRQ questionnaire
Proportion of patients and/or relatives with trauma vulnerability [Month3]
The percentage of patients and/or relatives is determined using the LEC-5 included in the PCL-5 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bordeaux University Hospital	Pessac		France	33604

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator: Adeline Banos, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT04921514

Other Study ID Numbers:

CHUBX 2020/44

First Posted:

Jun 10, 2021

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Bordeaux

Sudden cardiac death

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 10, 2021