An interventional study of Baseline activities and Clinical interview with a psychologist in Stress Disorders, Post-Traumatic and Depression, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other
This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.
The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.
The secondary objectives of this study are:
A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.
B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?
C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?
D. To study potential risk factors for cognitive problems at 4 months after ICU discharge.
E. If objective C determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization?
F. To study potential risk factors for poor quality of life at 4 months:
2,237 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.
This study's enrollment of 125 is above the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
See in inclusion/exclusion criteria. Interventions: Baseline activities; Clinical interview with a psychologist; Telephone interview 2 months after ICU discharge; Clinical interview with a psychologist .
Other: Baseline activities · Other: Clinical interview with a psychologist · Other: Telephone interview 2 months after ICU discharge
Initial consent procedures and baseline data collection.
Clinical interview with a psychologist. This interview with a psychologist will take place after patient consent procedures, and at least 2 days after discontinuation of sedation, and before leaving the ICU. This interview will include: * An inventory of peritraumatic distress symptoms * A questionnaire on peritraumatic dissociative experiences * An assessment of related, potential impacts * The HADS questionnaire
At 2 months after leaving the ICU, a psychologist will contact the patient with questions regarding his/her representation of hospitalization. This implies the following: * Questionnaires assessing memories and stressors (Questionnaires ICUMT, and ICU-SEQ * An assessment of psychological trauma * An assessment of potential impacts
At 4 months after ICU discharge, the patient has a clinical interview during which a psychologist will: * assess cognitive functions * evaluate clinical symptoms of depression * assess quality of life * assess symptoms of post traumatic stress
Presence/absence of cognitive impairment
based on D2 test
Time frame: 4 months after ICU discharge
Duration of sedation
Time frame: expected average of 48 hours
Duration of ventilation
Time frame: expected average of 36 hours
Daily average for RASS scale
Time frame: Expected maximum of 28 days
Daily average for Behaviour pain scale
Time frame: expected average of 48 hours
CAM ICU score
Time frame: upon awakening (expected average of 48 hours)
Peritraumatic distress inventory
Time frame: expected average of 5 days (end of ICU stay)
Questionnaire PDEQ-10
Time frame: expected average of 5 days (end of ICU stay)
Assessment of potential impacts
Time frame: expected average of 5 days (end of ICU stay)
HADS score
Time frame: expected average of 5 days (end of ICU stay)
ICUMT questionnaire
Time frame: 60 +- 3 days after ICU discharge
ICU-SEQ questionnaire
Time frame: 60 +- 3 days after ICU discharge
Assessment of psychotramatisme
Time frame: 60 +- 3 days after ICU discharge
HADS score
Time frame: 60 +- 3 days after ICU discharge
PCLS scale (DSM IV items)
Time frame: 4 months after ICU discharge
IDS-C Questionnaire
Time frame: 4 months after ICU discharge
SF-36
Time frame: 4 months after ICU discharge
Forward span test
Time frame: 4 months after ICU discharge
Backwards span test
Time frame: 4 months after ICU discharge
Rey 15-word test
Time frame: 4 months after ICU discharge
Test D2 (units = n)
Time frame: 4 months after ICU discharge
Wisconsin test
Time frame: 4 months after ICU discharge
Stroop test
Time frame: 4 months after ICU discharge
Verbal fluency test
Time frame: 4 months after ICU discharge
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Centre Hospitalier Universitaire de Nīmes