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Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit (STRESSREA)

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ClinicalTrials.gov Identifier: NCT03278171
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Post Traumatic Stress Disorder Behavioral: Impact Event Scale Revisited

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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients in intensive care unit
Cohort of patients leaving intensive care unit after a stay of more than 72 hours
Behavioral: Impact Event Scale Revisited
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)




Primary Outcome Measures :
  1. Impact Event Scale Revisited [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People over 18 years old, staying more than 72 hours in intensive care unit
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient not understanding French language
  • Confused patient (clinical assessment)
  • Patient under protection measure or deprived from his rights

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278171


Locations
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France
Psychiatrie des urgences, Hôpital Edouard Herriot
Lyon, France, 69423
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03278171     History of Changes
Other Study ID Numbers: 69HCL17_0462
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders