Post Traumatic Stress DisorderTEMPONCT04921514
Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
A study testing SASRQ questionnaire and PCL-5 with LEC-5 questionnaire in people with Post Traumatic Stress Disorder and Resuscitated Sudden Cardiac Death, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Resuscitated Sudden Cardiac Death
- What is being tested?
- SASRQ questionnaire and PCL-5 with LEC-5 questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2021to 26 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- SASRQ questionnaire, PCL-5 with LEC-5 questionnaire
- Keywords
- Sudden cardiac death
- Medical subject headings
- Stress Disorders, Post-Traumatic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASRQ questionnaireBehavioural
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").
PCL-5 with LEC-5 questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient and relatives | Experimental | Not described Receives: Behavioral: SASRQ questionnaire; Behavioral: PCL-5 with LEC-5 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 3
Secondary outcomes (2)
Proportion of patients and/or relatives with acute stress disorder
The percentage of patients and relatives is determined using the SASRQ questionnaire
Measured: Day 0
Proportion of patients and/or relatives with trauma vulnerability
The percentage of patients and/or relatives is determined using the LEC-5 included in the PCL-5 questionnaire
Measured: Month3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start18 May 2021
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 40 participants (20 patients and 20 relatives)
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline Banos, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921514
- Sponsor's protocol ID
- CHUBX 2020/44
- Other IDs
- 2021-A00075-36
- Acronym
- TEMPO
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Banos A, Bouteiller XP, Beneyto M, Duchateau J, Rousseau C, Tixier R, Andre C, Sacher F. Psychological sequalae of patients experiencing aborted sudden cardiac death and their relatives. Encephale. 2026 Jan 21:S0013-7006(25)00225-8. doi: 10.1016/j.encep.2025.10.007. Online ahead of print.
PubMed 41571537
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
- ClinicalTrials.gov ID
- NCT04921514
- Acronym / sponsor ID
- TEMPO / CHUBX 2020/44
- Keywords
- Sudden cardiac death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 40 participants (20 patients and 20 relatives)
| Arm | Type | Receives |
|---|---|---|
| Patient and relatives | Experimental | Behavioral: SASRQ questionnaire, Behavioral: PCL-5 with LEC-5 questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SASRQ questionnaireDuring 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"). | Behavioural | Patient and relatives |
| PCL-5 with LEC-5 questionnaireThis 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. | Behavioural | Patient and relatives |
Primary outcome
Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
Time frame: Month 3
The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire
2 secondary outcomes
Proportion of patients and/or relatives with acute stress disorder
Time frame: Day 0
Proportion of patients and/or relatives with trauma vulnerability
Time frame: Month3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 41571537Banos A, Bouteiller XP, Beneyto M, Duchateau J, Rousseau C, Tixier R, Andre C, Sacher F. Psychological sequalae of patients experiencing aborted sudden cardiac death and their relatives. Encephale. 2026 Jan 21:S0013-7006(25)00225-8. doi: 10.1016/j.encep.2025.10.007. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Banos principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SASRQ questionnaire and PCL-5 with LEC-5 questionnaire in people with Post Traumatic Stress Disorder and Resuscitated Sudden Cardiac Death, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.