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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Arras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Patient speaking French;

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.)

Time frame
inclusion

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
1 month

Other outcomes

Sponsors and contacts

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Centre Hospitalier Arras

Lead sponsor

F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)

Collaborator