Stress Disorders, Post-TraumaticNeuroPsy RéaNCT01838798
Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
A study testing Baseline activities, Clinical interview with a psychologist and Telephone interview 2 months after ICU discharge in people with Stress Disorders, Post-Traumatic and Depression, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression
- What is being tested?
- Baseline activities, Clinical interview with a psychologist and Telephone interview 2 months after ICU discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- The patient (or his/her "trusted person") must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
- Patient admitted to the ICU and intubated and ventilated for at least 48 hours
Who cannot join
- The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contra-indication for a treatment used in this study
Show all 16Show fewer
- Patient admitted to intensive care with sedation started for more than 24 hours
- Patient with neurological or psychiatric (cognitive) disorders
- Patient admitted for cardiac arrest
- Patient admitted for stroke
- Patient admitted for cervical trauma > C6
- Patient presenting with tracheotomy accompanied by long-term mechanical ventilation
- Moribund patient or with little hope of survival beyond 48 hours
- Patients for whom a limitation or termination of care is considered
- McCabe Score = 0
- Knauss Scale = C or D
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The secondary objectives of this study are:
- To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.
- To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?
- To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?
- To study potential risk factors for cognitive problems at 4 months after ICU discharge.
- 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?
- To study potential risk factors for poor quality of life at 4 months:
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Being tested
- Baseline activities, Clinical interview with a psychologist, Telephone interview 2 months after ICU discharge
- Keywords
- cognitive disorders, quality of life, Intensive care
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline activitiesOther
Initial consent procedures and baseline data collection.
Clinical interview with a psychologistOther
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
Telephone interview 2 months after ICU dischargeOther
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
Clinical interview with a psychologistOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | 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 . Receives: Other: Baseline activities; Other: Clinical interview with a psychologist; Other: Telephone interview 2 months after ICU discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of cognitive impairment
based on D2 test
Measured: 4 months after ICU discharge
Secondary outcomes (23)
Duration of sedation
Measured: expected average of 48 hours
Duration of ventilation
Measured: expected average of 36 hours
Daily average for RASS scale
Measured: Expected maximum of 28 days
Daily average for Behaviour pain scale
Measured: expected average of 48 hours
CAM ICU score
Measured: upon awakening (expected average of 48 hours)
Peritraumatic distress inventory
Measured: expected average of 5 days (end of ICU stay)
Questionnaire PDEQ-10
Measured: expected average of 5 days (end of ICU stay)
Assessment of potential impacts
Measured: expected average of 5 days (end of ICU stay)
HADS score
Measured: expected average of 5 days (end of ICU stay)
ICUMT questionnaire
Measured: 60 +- 3 days after ICU discharge
ICU-SEQ questionnaire
Measured: 60 +- 3 days after ICU discharge
Assessment of psychotramatisme
Measured: 60 +- 3 days after ICU discharge
HADS score
Measured: 60 +- 3 days after ICU discharge
PCLS scale (DSM IV items)
Measured: 4 months after ICU discharge
IDS-C Questionnaire
Measured: 4 months after ICU discharge
SF-36
Measured: 4 months after ICU discharge
Forward span test
Measured: 4 months after ICU discharge
Backwards span test
Measured: 4 months after ICU discharge
Rey 15-word test
Measured: 4 months after ICU discharge
Test D2 (units = n)
Measured: 4 months after ICU discharge
Wisconsin test
Measured: 4 months after ICU discharge
Stroop test
Measured: 4 months after ICU discharge
Verbal fluency test
Measured: 4 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine Pereira, Study director, Centre Hospitalier Universitaire de NīmesClaire Roger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838798
- Sponsor's protocol ID
- LOCAL/2012/CR-02
- Other IDs
- 2013-A00022-43
- Acronym
- NeuroPsy Réa
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
- ClinicalTrials.gov ID
- NCT01838798
- Acronym / sponsor ID
- NeuroPsy Réa / LOCAL/2012/CR-02
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Keywords
- cognitive disorders, quality of life, Intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- 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.
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.
Detailed description
The secondary objectives of this study are:
- To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.
- To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?
- To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?
- To study potential risk factors for cognitive problems at 4 months after ICU discharge.
- 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?
- To study potential risk factors for poor quality of life at 4 months:
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Other: Baseline activities, Other: Clinical interview with a psychologist, Other: Telephone interview 2 months after ICU dischargeSee in inclusion/exclusion criteria. Interventions: Baseline activities; Clinical interview with a psychologist; Telephone interview 2 months after ICU discharge; Clinical interview with a psychologist . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient (or his/her "trusted person") must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
- Patient admitted to the ICU and intubated and ventilated for at least 48 hours
Key exclusion criteria (16 listed)
- The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline activitiesInitial consent procedures and baseline data collection. | Other | Study population |
| Clinical interview with a psychologistClinical 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 | Other | Study population |
| Telephone interview 2 months after ICU dischargeAt 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 | Other | Study population |
| Clinical interview with a psychologistAt 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 | Other | Study population |
Primary outcome
Presence/absence of cognitive impairment
Time frame: 4 months after ICU discharge
based on D2 test
23 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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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. This study is not recruiting at the moment.
Justine Pereira study director
Centre Hospitalier Universitaire de Nīmes
Claire Roger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline activities, Clinical interview with a psychologist and Telephone interview 2 months after ICU discharge in people with Stress Disorders, Post-Traumatic and Depression, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of cognitive impairment (time frame: 4 months after ICU discharge). 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 19 Dec 2025.