Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
STRESSREA
1 other identifier
observational
208
1 country
1
Brief Summary
Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. This trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have personal, professional and economic consequences at the level of the individual and society. Some studies looked at the psychological effects induced by a stay in intensive care unit (ICU) since few years. The emergence of PTSD in these patients has been described, with an incidence varying from 4% to 60%. The literature is contradictory about identified risk factors for PTSD. It's not possible to design a screening of these patients actually, only focused on the risk factors. It has been shown that the presence of acute stress trouble (presence of symptoms during the first month after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care consultations have been done at 6 months, but not systematically. Only few symptoms are looked for and a sizable part of this population were not being followed probably due to a non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients will never be diagnosed and treated, favoring all complications linked to this trouble. Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would permit an exhaustive screening of patients at risk for PTSD and could permit to propose them an adapted care and then limit the emergence of PTSD and its consequences.. In this study, the investigators will screen acute stress symptoms within 8 days following the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedSeptember 25, 2018
September 1, 2017
10 months
September 5, 2017
September 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Impact Event Scale Revisited
Impact Event Scale Revisited (IES-R) will be carried out by a psychiatry clinician within 8 days following the intensive care unit in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.
3 months
Study Arms (1)
Patients in intensive care unit
Cohort of patients leaving intensive care unit after a stay of more than 72 hours
Interventions
Evaluating the ability of the Impact Event Scale -Revisited within 8 days following the intensive care unit exit to predict a post-traumatic stress disorder at 3 months (Impact Event Scale -Revisited score strictly greater than 34)
Eligibility Criteria
People over 18 years old, staying more than 72 hours in intensive care unit
You may qualify if:
- Patient over 18 years old leaving an intensive care unit after a stay of more than 72 hours, in one of the medical and surgical intensive care units of the E Herriot Hospital
- Patient having given his agreement to participate in this study
You may not qualify if:
- Patient not understanding French language
- Confused patient (clinical assessment)
- Patient under protection measure or deprived from his rights
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatrie des urgences, Hôpital Edouard Herriot
Lyon, 69423, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 11, 2017
Study Start
September 20, 2017
Primary Completion
July 10, 2018
Study Completion
July 10, 2018
Last Updated
September 25, 2018
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share