PTSD - Post Traumatic Stress DisorderVISUNCT06755606
Evaluation of the Effect of an Emergency Department Information Video on the Risk of Post-Traumatic Stress Disorder 30 Days After an Emergency Visit.
An observational study of PTSD - Post Traumatic Stress Disorder and Stress Disorder, Post Traumatic, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Post-traumatic stress disorder (PTSD) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Stress Disorder, Post Traumatic
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient coming for an unscheduled emergency consultation
Who may be able to join
- Age ≥ 18 years
- Triage level 1, 2, 3 by the triage nurse (according to CIMU, FRENCH or other scale used locally)
- Non-opposition to participation in the study after information and delivery of the information note
- Possibility of 30-day follow-up (self-questionnaire to be completed by e-mail)
- Patient with cognitive or sensory capacity to view and understand information videos
Who cannot join
- Inability to consent (neurological disorder, coma, acute intoxication, cognitive impairment)
- Patient does not have a good understanding of the French language.
- Estimated life expectancy less than 6 months
- Participation in other clinical intervention research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jennifer TRUCHOT, MD, PhD contact
About this study
Post-traumatic stress disorder (PTSD) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. The consequences of PTSD are manifold: financial, quality of life, absenteeism, morbidity, and mortality.
An emergency department visit can be a traumatic event and associated with anxiety.
Read more
Studies have explored the prevalence and factors associated with the occurrence of PTSD among a selected population of patients admitted to the emergency department for either cardiological or traumatological reasons. The prevalence of PTSD at 1 month varied among these populations, from 12% to 25%.
Several factors have been described that could be independently associated with an increased risk of developing PTSD: factors linked to the patient himself (basal state and severity of acute pathology) or to the patient pathway (care structure, care modalities, waiting time). Given the serious medical, psycho-social and economic consequences of PTSD, it is important to identify the risk factors that can be controlled during a patient's stay in the emergency department.
In 2025, a general information procedure for patients and next of kin will be deployed in three emergency departments.
The aim of this procedure is to improve the quality of the information provided to emergency patients, thereby enhancing the experience of patients and those accompanying them. It will consist of video support delivering standardized information to patients from the moment they arrive in the emergency department until they are discharged. These videos will describe the patient's journey through the emergency department.
The aim of this study is to evaluate the effect of this information procedure on the risk of developing PTSD.
- Keywords
- stress disorders, interventions, communication, emergency medicine
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BEFORE | Group pf patients enrolled Before the information procedure was set up | |
| AFTER | Group pf patients enrolled After the information procedure was set up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence PTSD
assessed by calculation of PCL-5 score
Measured: DaAy 30
Secondary outcomes (2)
Identify factors associated with the occurrence of PTSD
Identify factors associated with the occurrence of PTSD in relation to the acute pathology, the patient's baseline condition, and the patient's pathway through the emergency department.
Measured: Day 30
HAD score at D30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer TRUCHOT, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755606
- Sponsor's protocol ID
- APHP231231
- Other IDs
- IDRCB : 2023-A01766-39
- Acronym
- VISU
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an Emergency Department Information Video on the Risk of Post-Traumatic Stress Disorder 30 Days After an Emergency Visit.
- ClinicalTrials.gov ID
- NCT06755606
- Acronym / sponsor ID
- VISU / APHP231231
- Keywords
- stress disorders, interventions, communication, emergency medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Jan 2025 (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.
Post-traumatic stress disorder (PTSD) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. The consequences of PTSD are manifold: financial, quality of life, absenteeism, morbidity, and mortality.
An emergency department visit can be a traumatic event and associated with anxiety.
Studies have explored the prevalence and factors associated with the occurrence of PTSD among a selected population of patients admitted to the emergency department for either cardiological or traumatological reasons. The prevalence of PTSD at 1 month varied among these populations, from 12% to 25%.
Several factors have been described that could be independently associated with an increased risk of developing PTSD: factors linked to the patient himself (basal state and severity of acute pathology) or to the patient pathway (care structure, care modalities, waiting time). Given the serious medical, psycho-social and economic consequences of PTSD, it is important to identify the risk factors that can be controlled during a patient's stay in the emergency department.
In 2025, a general information procedure for patients and next of kin will be deployed in three emergency departments.
The aim of this procedure is to improve the quality of the information provided to emergency patients, thereby enhancing the experience of patients and those accompanying them. It will consist of video support delivering standardized information to patients from the moment they arrive in the emergency department until they are discharged. These videos will describe the patient's journey through the emergency department.
The aim of this study is to evaluate the effect of this information procedure on the risk of developing PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEFORE | – | –Group pf patients enrolled Before the information procedure was set up |
| AFTER | – | –Group pf patients enrolled After the information procedure was set up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient coming for an unscheduled emergency consultation
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Triage level 1, 2, 3 by the triage nurse (according to CIMU, FRENCH or other scale used locally)
- Non-opposition to participation in the study after information and delivery of the information note
- Possibility of 30-day follow-up (self-questionnaire to be completed by e-mail)
- Patient with cognitive or sensory capacity to view and understand information videos
Key exclusion criteria (4 listed)
- Inability to consent (neurological disorder, coma, acute intoxication, cognitive impairment)
- Patient does not have a good understanding of the French language.
- Estimated life expectancy less than 6 months
- Participation in other clinical intervention research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence PTSD
Time frame: DaAy 30
assessed by calculation of PCL-5 score
2 secondary outcomes
Identify factors associated with the occurrence of PTSD
Time frame: Day 30
HAD score at D30
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer TRUCHOT, MD, PhD contact
Jennifer TRUCHOT, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD - Post Traumatic Stress Disorder and Stress Disorder, Post Traumatic, run by Assistance Publique - Hôpitaux de Paris.
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 4 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer TRUCHOT, MD, PhD (jennifer.truchot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence PTSD (time frame: DaAy 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2025.