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Post-traumatic Stress DisorderPRECLIPNCT05358067

Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact

An observational study of Post-traumatic Stress Disorder, run by Centre Hospitalier Arras at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Post-traumatic Stress Disorder
How many people
241 participants
Where
5 sitesFrance
Study dates
24 Oct 2022to 23 Apr 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patient who has experienced a traumatic event in the last 48 hours All patients meeting the inclusion criteria will be identified by the staff of the CUMP (medico-psychological emergency unit) either during an intervention (in the emergency department or outside) or during a psychiatric consultation at the emergencies

Who may be able to join

  • Patient who has experienced a traumatic event in the last 48 hours;
  • Patient speaking French;

Who cannot join

  • Patient participating in another clinical trial on the treatment of his psychotraumatic experience.
  • Person deprived of liberty (prisoners, defendants);
  • Persons under legal protection (protected adults: under guardianship, curatorship, etc.);
  • Opposition of the patient to participate in the research.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

France5 sites, 5 recruiting
  • Arras General Hospital

    Arras, 62000

    Laure ROUGEGREZ, MD

    Marine DUPONT, Msc

    Recruiting
  • Arras General Hospital

    Arras, 62000

    Maxime THERY VANDEVILLE, MD

    Recruiting
  • Douai General Hospital

    Douai, 59507

    Anne CRETON, MD

    Recruiting
  • Lens General Hospital

    Lens, 62300

    Celine PENNEL, MD

    Not yet recruiting
  • Lille University Hospital

    Lille, 59000

    Frédérique WAREMBOURG, MD

    Recruiting

Other trials in France

About this study

The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. This could allow, in future, implementation of a systematic telephone reminder of psychotraumatized patients when they have a high score on the CGI scale, and thus detect onset of a stress disorder as early as possible, post-traumatic and orientation of these patients on specialized care.

Read the detailed description

A functional unit of Urgent Medical Aid Service (SAMU), Medical-psychological emergency cell (CUMP) is an emergency medical device and provides immediate and post-immediate medico-psychological care for mentally injured people in psychotraumatic situations. CUMP also ensures immediate post follow-up of these patients, as well as departmental organization of psychotrauma consultation.

During the course of the treatment, victims are oriented, with a telephone callback which can be decided, allowing a remote reassessment of any psychotraumatic sequelae of the event. This phone reminder is part of routine practice following a CUMP intervention. The objective is then early detection of sequelae allowing rapid orientation on specific care pathways, in particular on the consultation of psychotrauma.

Post-traumatic stress disorder is a syndromic entity reactive to experience of a traumatogenic event (defined by the brutal, sudden and unexpected confrontation with death, or the loss of physical or psychological integrity), bringing together intrusive symptoms of reliving, behavioral avoidance of stimuli related to the traumatic event, persistent negative alterations in cognitions and mood, and neurovegetative hyperactivity, causing clinically significant distress and impaired the usual functioning of the subject.

Experiencing a psychotraumatic event in one's life is a frequent experience. Epidemiological data show a lifetime prevalence of around 30%. During and/or in the hours following a psychotraumatic event, people experience psychological, physiological and emotional upheavals called peritraumatic distress. Although most people recover on their own, a portion (8.3%) develop post-traumatic stress disorder.

However, one of the main characteristics of post-traumatic stress disorder is the presence of avoidance symptoms. Avoidance can take different forms such as non-confrontation with all the evocative clues of the traumatic event such as places, people and situations related to the traumatic event, but also the avoidance of thoughts, memories, conversations related to the traumatic event. This avoidance of thoughts and conversations can be a barrier to entry into trauma-focused psychotherapy. Indeed, talking about the traumatic event goes against this avoidance. A proactive approach at a distance from the event to re-evaluate the symptomatology of the people involved and thus propose an orientation towards specialized care in the field of psychotrauma in order to counter avoidance would seem entirely relevant.

Indeed, studies show the interest of a telephone follow-up by the Medical-Psychological Unit 15 days before an emergency repatriation of French people during the Lebanon war in 2016. On the one hand, remote telephone reminder of event is experienced positively by the people involved in the event and was able to highlight the presence of post-traumatic stress symptoms in 23% of cases. On the other hand, 56% of people were able to be referred to appropriate medio-psychological care following this telephone interview.

However, depending on the situation, all of the subjects involved in a psychotraumatic event cannot be reassessed, especially when event involves too many people. On the other hand, a significant proportion of subjects will not present psychotraumatic sequelae. Under these conditions, it seems appropriate to be able to define the proportion of psychotraumatized subjects most at risk of developing post-traumatic stress disorder (PTSD). Data from literature find that a high level of peritraumatic distress is largely associated with severity of post-traumatic stress symptoms .

Thus, peritraumatic distress reactions would be a good indicator of risk of developing a subsequent post-traumatic stress disorder. Several questionnaires exist to assess this peritraumatic distress. However, in a disaster situation and in view of the large number of victims potentially involved, it may be interesting to use a rapid and global assessment tool.

To do this, the severity item of the global clinical impression scale would respond to this clinical reality.

Research hypothesis

Hypothesis is that the severity item of the global clinical impression scale evaluated immediately after in a subject who has experienced a psychotraumatic event is a predictor of post-traumatic stress symptoms at 1 month and 6 months. Investigators expect a correlation between the scores of the PDI and the severity item of the global clinical impression while controlling the socio-demographic characteristics of the worker as well as his clinical experience. Patients included will have similar profiles and will be confronted with the same type of traumatic event.

Brief Protocol

  • Inclusion visit : psychiatric assessment, socio-demographic data, questionnaire (CGI and Peritraumatic Distress Inventory scale(PDI))
  • Follow-up visit: M1 and M6 : phone call (Post traumatic stress disorder Checklist Scale questionnaire (PCL 5), Mini International Neuropsychiatric Interview (MINI) : major depressive episod, alcohol consumption disorder, substance-related disorder (non-alcoholic).

Expected results

Investigators expect this work to confirm the prediction between the initial score on the CGI and the score at M1 and M6 on the PCL5. This result will make it possible to define an initial threshold for the CGI allowing the occurrence of a constituted post-traumatic stress disorder to be predicted, defined by a score greater than or equal to 33 on the PCL5. The objective is to set up a systematic recall protocol for subjects presenting with a state of acute stress for which an initial CGI score will be higher than the determined threshold, in order to be able, depending on the subsequent symptomatology, to offer early management. and focus of post traumatic stress disorder. This reminder protocol will be integrated into routine practices and deployed on the emergency reception service of Hospital.

Keywords
Post-traumatic Stress Disorder
Medical subject headings
Stress Disorders, Post-Traumatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder

    Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.)

    Measured: inclusion

Secondary outcomes (9)
  1. Correlation between CGI score and Peritraumatic Distress Inventory scale score (PDI)

    Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of the patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients).

    PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

    Measured: Inclusion

  2. Correlation coefficient between CGI score and PCL 5 score at 1 month.

    Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of the patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients).

    The PCL-5 (Post-traumatic stress disorder Checlist version DSM-5) is a self-assessment comprising 20 items that measures the 20 symptoms of a post-traumatic stress disorder from the DSM-5 (MANUAL. DIAGNOSTIC AND STATISTICS. OF DISORDERS MENTALS. 5th edition.).

    The objectives of the PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with an episode of post-traumatic stress, making a provisional diagnosis.

    Measured: 1 month

  3. Correlation coefficient between CGI score and PCL 5 score at 6 months.

    Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of the patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients).

    The PCL-5 (Post-traumatic stress disorder Checlist version DSM-5) is a self-assessment comprising 20 items that measures the 20 symptoms of a post-traumatic stress disorder from the DSM-5 (MANUAL. DIAGNOSTIC AND STATISTICS. OF DISORDERS MENTALS. 5th edition.).

    The objectives of the PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with an episode of post-traumatic stress, making a provisional diagnosis.

    Measured: 6 months

  4. Presence/absence of a major depressive episode at 1 month in connection with traumatic event

    Presence/absence of a major depressive episode assessed by the MINI at 1 month. Search for an association between the CGI score and the presence of a major depressive episode.

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 1 month

  5. Presence/absence of a major depressive episode at 6 months in connection with traumatic event

    Presence/absence of a major depressive episode assessed by the MINI at 6 month. Search for an association between the CGI score and the presence of a major depressive episode.

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 6 months

  6. Presence/absence of a consumption of alcohol at 1 month in connection with traumatic event

    Presence/absence of a consumption of alcohol assessed by the MINI at 1 month. Search for an association between the CGI score and the presence of a consumption of alcohol.

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 1 month

  7. Presence/absence of a consumption of alcohol at 6 months in connection with traumatic event

    Presence/absence of a consumption of alcohol assessed by the MINI at 6 month. Search for an association between the CGI score and the presence of a consumption of alcohol.

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 6 months

  8. Presence/absence of a consumption of substances (except alcohol) at 1 month in connection with traumatic event

    Presence/absence of a consumption of substances (except alcohol) assessed by the MINI at 1 month. Search for an association between the CGI score and the presence of a consumption of substances (except alcohol).

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 1 month

  9. Presence/absence of a consumption of substances (except alcohol) 6 months in connection with traumatic event

    Presence/absence of a consumption of substances (except alcohol) assessed by the MINI at 6 month. Search for an association between the CGI score and the presence of a consumption of substances (except alcohol).

    Mini International Neuropsychiatric Interview (MINI) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start24 Oct 2022
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion23 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
241 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358067
Sponsor's protocol ID
2021-02
Acronym
PRECLIP
Status last verified
Jun 2026
First submitted
11 Apr 2022
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Sante mentale en population generale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

    PubMed 19081454
  • Kilpatrick DG. The DSM-5 got PTSD right: comment on Friedman (2013). J Trauma Stress. 2013 Oct;26(5):563-6. doi: 10.1002/jts.21844.

    PubMed 24151004
  • Pietrzak RH, Goldstein RB, Southwick SM, Grant BF. Prevalence and Axis I comorbidity of full and partial posttraumatic stress disorder in the United States: results from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. J Anxiety Disord. 2011 Apr;25(3):456-65. doi: 10.1016/j.janxdis.2010.11.010. Epub 2010 Nov 26.

    PubMed 21168991
  • Vance MC, Kovachy B, Dong M, Bui E. Peritraumatic distress: A review and synthesis of 15 years of research. J Clin Psychol. 2018 Sep;74(9):1457-1484. doi: 10.1002/jclp.22612. Epub 2018 Mar 15.

    PubMed 29543336
  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

    PubMed 20526405

Questions about this trial

What is this clinical trial studying?

An observational study of Post-traumatic Stress Disorder, run by Centre Hospitalier Arras at 5 sites 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathleen JACQUEZ, MSC (03 21 21 15 99, kathleen.jacquez@gh-artoisternois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder (time frame: inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358067, which also lists 5 linked publications.

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 5 Jun 2026.

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