NCT03278171: STRESSREA

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

Completed Last updated 25 September 2018

What this trial tests

trial testing Impact Event Scale Revisited in Post Traumatic Stress Disorder in 208 participants. Completed in 10 July 2018.

Timeline

20 September 2017

Primary endpoint
10 July 2018

10 July 2018

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	208
Start date	20 September 2017
Primary completion	10 July 2018
Estimated completion	10 July 2018
Sites	1 location across France

Drugs / interventions tested

• Impact Event Scale Revisited

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.